The Medical Device Business Journal — Medical Device News & Articles | MassDevice
We are convinced that a healthy, vibrant smile is the most attractive feature around. Through our comprehensive teeth cleaning treatment plans we use restorative and cosmetic practices to help our patients receive the smile they are proud of.
TOTAL 510(k)s THIS PERIOD 284 TOTAL WITH SUMMARIES 280 TOTAL WITH STATEMENTS 4
DEVICE: HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) SHENZHEN MINDRAY BIO-MEIDCAL ELECT510(k) NO: K132036(ABBREVIATED) ATTN: RUSSELL OLSEN PHONE NO : 201 995 8391 800 MACARTHUR BLVD. SE DECISION MADE: 01-JUL-14 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASPIAN OCT SPINAL SYSTEM K2M, INC. 510(k) NO: K133288(TRADITIONAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 01-JUL-14 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRE VENTURA DRE MEDICAL, INC. 510(k) NO: K132903(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 1800 WILLIAMSON CT. SE DECISION MADE: 01-JUL-14 LOUISVILLE KY 40026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESARA BLUE OV, DESARA BLUE SS CALDERA MEDICAL 510(k) NO: K140843(SPECIAL) ATTN: VICKI GAIL PHONE NO : 818 483 7602 5171 Clareton Dr SE DECISION MADE: 01-JUL-14 Agoura Hills CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ES2 NEUROMONITORING ACCESSORY INSTRUMENTS STRYKER CORPORATION 510(k) NO: K140400(TRADITIONAL) ATTN: SORAYA KING PHONE NO : 201 760 8296 2 PEARL COURT SE DECISION MADE: 01-JUL-14 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 BIOSENSE WEBSTER, INC. 510(k) NO: K133916(TRADITIONAL) ATTN: WAYNE R HOHMAN PHONE NO : 909 839 8597 3333 DIAMOND CANYON RD SE DECISION MADE: 01-JUL-14 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA BIG BOY CONDOM OKAMOTO U.S.A., INC. 510(k) NO: K140379(ABBREVIATED) ATTN: JEFFREY N GIBBS PHONE NO : 202 737 4288 700 THIRTEENTH STREET, N.W. SUITE SE DECISION MADE: 01-JUL-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTERA SPACER GLOBUS MEDICAL INC. 510(k) NO: K140411(TRADITIONAL) ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 01-JUL-14 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS IMMUNALYSIS CORPORATION 510(k) NO: K141406(TRADITIONAL) ATTN: JOSEPH GINETE PHONE NO : 909 482 0840 829 TOWNE CENTER DR. SE DECISION MADE: 01-JUL-14 POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODISSEY TISSUE OXIMETER VIOPTIX, INC. 510(k) NO: K141234(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 01-JUL-14 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK FOCUS DIAGNOSTICS 510(k) NO: K141458(SPECIAL) ATTN: SHARON YOUNG PHONE NO : 562 240 6680 11331 VALLEY VIEW STREET SE DECISION MADE: 01-JUL-14 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET COOK VASCULAR, INC. 510(k) NO: K141148(TRADITIONAL) ATTN: THOMAS J KARDOS PHONE NO : 724 845 8621 1186 MONTGOMERY LANE SE DECISION MADE: 01-JUL-14 VANDERGRIFT PA 15690 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL RADIOGRAPHY CXDI-401C WIRELESS CANON, INC. 510(k) NO: K133693(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE, STE 280 SE DECISION MADE: 01-JUL-14 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORPORATION 510(k) NO: K133110(TRADITIONAL) ATTN: RENEE MITCHELL PHONE NO : 763 494 1405 ONE SCIMED PLACE SE DECISION MADE: 02-JUL-14 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA ENDOSEC CORPORATION 510(k) NO: K132384(TRADITIONAL) ATTN: PIN YU PHONE NO : 650 397 5174 4546 EL CAMINO REAL, STE 215 SE DECISION MADE: 02-JUL-14 LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOW-NAIL FLOW-FX, LLC 510(k) NO: K140601(TRADITIONAL) ATTN: MICHELLE MCDONOUGH PHONE NO : 202 552 5800 1331 H STREET NW, 12TH FLOOR REGULSE DECISION MADE: 02-JUL-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIO BLUE BELT TECHNOLOGIES, INC. 510(k) NO: K140596(TRADITIONAL) ATTN: RICHARD G CONFER PHONE NO : 412 683 3844 2828 LIBERTY AVENUE SUITE 100 SE DECISION MADE: 02-JUL-14 PITTSBURGH PA 15222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM PHILIPS ULTRASOUND, INC. 510(k) NO: K141369(TRADITIONAL) ATTN: SARASWATHI DEORA PHONE NO : 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 02-JUL-14 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: X-REPAIRSL SYNTHASOME, INC. 510(k) NO: K141499(SPECIAL) ATTN: ANTHONY RATCLIFFE PHONE NO : 858 490 9400 3030 BUNKER HILL ST. SUITE 308 SE DECISION MADE: 02-JUL-14 SAN DIEGO CA 92109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW GPSCATH BALLOON DILATATION CATHETER HOTSPUR TECHNOLOGIES,INC SUBSIDIAR510(k) NO: K140351(TRADITIONAL) ATTN: ERIC ANKERUD, JD PHONE NO : 978 302 9467 880 Maude Ave Ste A SE DECISION MADE: 02-JUL-14 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCKESSON RADIOLOGY MCKESSON MEDICAL IMAGING COMPANY 510(k) NO: K140909(TRADITIONAL) ATTN: PAUL SUMNER PHONE NO : 404 338 3556 5995 WINWARD PARKWAY SE DECISION MADE: 02-JUL-14 ALPHARETTA GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER ICU MEDICAL, INC. 510(k) NO: K140129(TRADITIONAL) ATTN: KRISTIN CASPER PHONE NO : 801 264 1313 4455 ATHERTON DRIVE SE DECISION MADE: 02-JUL-14 SALT LAKE CITY UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD 510(k) NO: K140121(SPECIAL) ATTN: LIU YI PHONE NO : 86 22 60526161 No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 02-JUL-14 TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM SYBRONENDO 510(k) NO: K140685(TRADITIONAL) ATTN: COURTNEY CLARK PHONE NO : 714 516 7426 1717 W.COLLINS AVENUE SE DECISION MADE: 02-JUL-14 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AP EXPANDABLE XLIF SYSTEM NUVASIVE, INC. 510(k) NO: K140162(TRADITIONAL) ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549 7475 LUSK BLVD SE DECISION MADE: 02-JUL-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOSEED ECKERT & ZIEGLER BEBIG GMBH 510(k) NO: K140849(ABBREVIATED) ATTN: SVEN LANGER PHONE NO : 49 30 941084734 ROBERT-ROSSLE STR.10 SE DECISION MADE: 02-JUL-14 BERLIN GM 13125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE JUNO DENTISTRY LP 510(k) NO: K140512(TRADITIONAL) ATTN: ROGER MASTRONY PHONE NO : 203 298 0438 848-1/2 DERBY AVE SE DECISION MADE: 02-JUL-14 ORANGE CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKYHAWK LATERAL PLATE SYSTEM ORTHOFIX INC. 510(k) NO: K140260(TRADITIONAL) ATTN: TROY BROOKS PHONE NO : 214 937 2047 3451 PLANO PARKWAY SE DECISION MADE: 02-JUL-14 LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSKELETON(R) TL INTERBODY FUSION DEVICE TITAN SPINE, LLC 510(k) NO: K140055(TRADITIONAL) ATTN: CHRISTINE SCIFERT PHONE NO : 901 831 8035 3416 ROXEE RUN COVE SE DECISION MADE: 02-JUL-14 BARTLETT TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS80A DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD 510(k) NO: K141620(TRADITIONAL) ATTN: PARK KYEONG-MI PHONE NO : 42, TEHERAN-RO 108-GIL SE DECISION MADE: 02-JUL-14 GANGNAM-GU, SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: AVREO INTERWORKS SYSTEM AVREO, INC. 510(k) NO: K141556(SPECIAL) ATTN: ALISON MCKEE PHONE NO : 866 286 8082 4050 Azalea Dr SE DECISION MADE: 02-JUL-14 N Charleston SC 29405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPHYGMOMANOMETER SUZHOU JJ METER CO., LTD. 510(k) NO: K141392(TRADITIONAL) ATTN: LONG YANG PHONE NO : 86 755 86664986 R1508, EAST BLDG, YIHAI PLAZA CHUASE DECISION MADE: 02-JUL-14 SHENZHEN, GUANGDONG CH 518054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K140572(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 02-JUL-14 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM OSTIAL CORPORATION 510(k) NO: K133861(TRADITIONAL) ATTN: JAKE WOLENBERG PHONE NO : 650 903 9100 1221 INNSBRUCK DRIVE SE DECISION MADE: 02-JUL-14 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEFORTE NEURO SYSTEM BONE PLATE AND SCREW JEIL MEDICAL CORPORATION 510(k) NO: K141452(SPECIAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 02-JUL-14 FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE GALIL MEDICAL LTD. 510(k) NO: K141485(SPECIAL) ATTN: LYNN DAVIES PHONE NO : 651 287 5098 4364 ROUND LAKE ROAD SE DECISION MADE: 02-JUL-14 ARDEN HILLS MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS TECHLINK INTERNATIONAL 510(k) NO: K131923(TRADITIONAL) ATTN: TARA CONRAD PHONE NO : 305 377 0077 PO BOX 694125 SE DECISION MADE: 03-JUL-14 MIAMI FL 33269 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPUNCTURE INTRODUCER SET COOK INCORPORATED 510(k) NO: K133114(TRADITIONAL) ATTN: DAVID LEHR, RAC PHONE NO : 812 335 3575 750 DANIELS WAY SE DECISION MADE: 03-JUL-14 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z5C Z-SYSTEMS AG 510(k) NO: K132881(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 12264 EL CAMINO REAL STE. 400 SE DECISION MADE: 03-JUL-14 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBRA FUNDUS CAMERA C.S.O. S.R.L. 510(k) NO: K132987(TRADITIONAL) ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630 110 EAST GRANADA BLVD, STE 209 SE DECISION MADE: 03-JUL-14 ORMOND BEACH FL 32716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT INCUBATOR BISTOS CO., LTD. 510(k) NO: K132543(TRADITIONAL) ATTN: YOUNG CHI PHONE NO : 973 278 5222 27 NEW ENGLAND DRIVE SE DECISION MADE: 03-JUL-14 RAMSEY NJ 07446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS TRANSFEMORAL BALLOON CATHETER EDWARDS LIFESCIENCES, LLC. 510(k) NO: K140241(TRADITIONAL) ATTN: ERIC CARRIER PHONE NO : 949 250 6443 ONE EDWARDS WAY SE DECISION MADE: 03-JUL-14 IRVINE CA 92663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM ARTHROSURFACE, INC. 510(k) NO: K133835(TRADITIONAL) ATTN: DAWN J WILSON PHONE NO : 508 520 3003 28 FORGE PARKWAY SE DECISION MADE: 03-JUL-14 FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H&H EMERGENCY CRICOTHYROTOMY KIT H&H MEDICAL CORPORATION 510(k) NO: K133528(TRADITIONAL) ATTN: J. LAWRENCE STEVENS PHONE NO : 508 926 8330 290 TURNPIKE RD. SUITE 200 SE DECISION MADE: 03-JUL-14 WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG BIOMET, INC. 510(k) NO: K140902(TRADITIONAL) ATTN: AMY L WALRIVEN PHONE NO : 574 372 6660 56 EAST BELL DR. BOX 587 SE DECISION MADE: 03-JUL-14 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK PT. MEDISAFE TECHNOLOGIES 510(k) NO: K133689(TRADITIONAL) ATTN: ANIL TANEJA PHONE NO : 626 13000 7134 JL.BATANG KUIS GG.TAMBAK REJO DESASE DECISION MADE: 03-JUL-14 MEDAN, NORTH SUMATERA ID 20362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. 510(k) NO: K140141(SPECIAL) ATTN: DANA MOON PHONE NO : 82 41 5298427 16 JEONGIAL-GIL, SEONGGEO-EUP, SEOSE DECISION MADE: 03-JUL-14 CHEONAN, CHUNGCHEONGNAM-DO KS 3510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POROUS COATED COMPREHENSIVE FRACTURE STEMS BIOMET MANUFACTURING CORP. 510(k) NO: K140652(TRADITIONAL) ATTN: BRIAN KINCAID PHONE NO : 574 267 6639 56 EAST BELL DRIVE SE DECISION MADE: 03-JUL-14 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POD SYSTEM PENUMBRA, INC. 510(k) NO: K141134(SPECIAL) ATTN: CHARLES DENAULT PHONE NO : 510 748 3302 1351 Harbor Bay Parkway SE DECISION MADE: 03-JUL-14 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCEND NEUROMETRIX, INC. 510(k) NO: K140333(TRADITIONAL) ATTN: RAINER MAAS PHONE NO : 781 314 2781 62 FOURTH AVE. SE DECISION MADE: 03-JUL-14 Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED VARIO SUBTALAR SCREW NORMED NEDIZIN TECHNIK GMBH 510(k) NO: K140962(TRADITIONAL) ATTN: DAVID FURR PHONE NO : 512 906 9654 8708 CAPEHART COVE SE DECISION MADE: 03-JUL-14 AUSTIN TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA BOSTON SCIENTIFIC CORPORATION 510(k) NO: K140641(TRADITIONAL) ATTN: KURTIS HUNSBERGER PHONE NO : 763 494 1204 ONE SCIMED PLACE SE DECISION MADE: 03-JUL-14 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DCAS I GP&P CO., LTD. 510(k) NO: K140869(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 12226 WASHINGTON LANE SE DECISION MADE: 03-JUL-14 PARKER AZ 85344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELL U3014 WITH QUBYX PERFECTLUM BUNDLE QUBYX LIMITED 510(k) NO: K131601(TRADITIONAL) ATTN: ALICE KOTYLARENKO PHONE NO : 33 01 80963820 80, RUE MARECHAL JOFFRE SE DECISION MADE: 07-JUL-14 NICE FR 06000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE HAGER & MEISINGER GMBH 510(k) NO: K132214(TRADITIONAL) ATTN: WIEBKE STOLTEN PHONE NO : 004 92 1312012388 HANSEMANNSTRASSE 10 SE DECISION MADE: 07-JUL-14 NEUSS GM D-41468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAB ‘N GO PLUS, GRAB ‘N GO DIGITAL PRAXAIR HEALTHCARE SERVICES 510(k) NO: K132778(TRADITIONAL) ATTN: TINA WU, PH.D. PHONE NO : 443 352 3909 62 FOREST STREET, STE 300 SE DECISION MADE: 07-JUL-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY FRESENIUS MEDICAL CARE, NORTH AMER510(k) NO: K133299(TRADITIONAL) ATTN: DENISE M OPPERMANN PHONE NO : 781 699 4044 920 WINTER ST. SE DECISION MADE: 07-JUL-14 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO, CT DUAL ENERGY SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133648(TRADITIONAL) ATTN: KIMBERLY MANGUM PHONE NO : 610 448 4912 51 VALLEY STREAM PKWY. SE DECISION MADE: 07-JUL-14 MALVERN PA 19355 1406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU ARROW INTERNATIONAL, INC. 510(k) NO: K141051(SPECIAL) ATTN: FRANK PELC PHONE NO : 610 378 0131 2400 BERNVILLE RD. SE DECISION MADE: 07-JUL-14 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL DEPUY MITEK, A JOHNSON AND JOHNSON510(k) NO: K140324(TRADITIONAL) ATTN: YAYOI FUJIMAKI PHONE NO : 508 828 3541 325 PARAMOUNT DRIVE SE DECISION MADE: 07-JUL-14 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K133784(TRADITIONAL) ATTN: JUDITH ROSEN PHONE NO : 973 576 0032 10 POMEROY RD. SE DECISION MADE: 07-JUL-14 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSE OXIMETER NONIN MEDICAL, INC. 510(k) NO: K140785(TRADITIONAL) ATTN: BRODIE PEDERSEN PHONE NO : 763 577 3180 13700 1ST AVE, NORTH SE DECISION MADE: 07-JUL-14 Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH MAQUET CARDIOPULMONARY AG 510(k) NO: K141432(SPECIAL) ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 49 747199730 KEHLER STRASSE 31 SE DECISION MADE: 07-JUL-14 RASTATT GM 76437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRELESS THERMOMETER RAIING MEDICAL COMPANY 510(k) NO: K132761(TRADITIONAL) ATTN: WU WEI PHONE NO : 86 106411 8658 21 Huoju St SE DECISION MADE: 08-JUL-14 Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) BETTER CARE PLASTIC TECHNOLOGY CO.510(k) NO: K140816(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 08-JUL-14 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT MIDLINE MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K141151(TRADITIONAL) ATTN: TIMOTHY HOLWICK PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 08-JUL-14 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K141228(TRADITIONAL) ATTN: ANNA HWANG PHONE NO : 310 533 9966 3203 KASHIWA STREET SE DECISION MADE: 08-JUL-14 TORRANCE CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENDA WEDGE CENTRIX, INC. 510(k) NO: K140144(TRADITIONAL) ATTN: GREG MOREAU PHONE NO : 203 567 7444 770 RIVER RD. SE DECISION MADE: 08-JUL-14 SHELTON CT 06484 5458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE HOSPIRA, INC. 510(k) NO: K141102(SPECIAL) ATTN: TOM GUTIERREZ PHONE NO : 858 391 1142 275 NORTH FIELD DR. SE DECISION MADE: 08-JUL-14 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTORIS POROUS PARTIAL KNEE SYSTEM MAKO SURGICAL CORP. 510(k) NO: K133811(TRADITIONAL) ATTN: TERRY POWELL PHONE NO : 703 562 9800 575 EIGHTH AVE, SUITE 1212 SE DECISION MADE: 08-JUL-14 NEW YORK NY 10018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY DEPUY MITEK, A JOHNSON AND JOHNSON510(k) NO: K140643(TRADITIONAL) ATTN: YAYOI FUJIMAKI PHONE NO : 508 828 3541 325 PARAMOUNT DRIVE SE DECISION MADE: 08-JUL-14 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-IO INTRAOSSEOUS INFUSION SYSTEM VIDACARE LLC 510(k) NO: K141117(TRADITIONAL) ATTN: DIANA F MONTEZ, BSN, RN PHONE NO : 210 375 8500 4350 LOCKHILL SELMA RD. SE DECISION MADE: 08-JUL-14 SHAVANO PARK TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE WELLDOC, INC 510(k) NO: K141273(SPECIAL) ATTN: DIVYA KALLAMADI PHONE NO : 443 692 3100 1501 SAINT PAUL STREET SUITE 118 SE DECISION MADE: 08-JUL-14 BALTIMORE MD 21202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS ARROW INTERNATIONAL, INC (SUBSIDIA510(k) NO: K141618(SPECIAL) ATTN: ELIZABETH DUNCAN PHONE NO : 610 378 0131 2400 BERNVILLE ROAD SE DECISION MADE: 08-JUL-14 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FRACTURE PLATES AND SCREWS ARTHREX, INC. 510(k) NO: K141478(SPECIAL) ATTN: DAVID L ROGERS PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 08-JUL-14 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER, MODEL ADELANTE MAGNUM OSCOR INC. 510(k) NO: K140917(TRADITIONAL) ATTN: LAURA SOBRIN PHONE NO : 727 937 2511 3816 DE SOTO BLVD. SE DECISION MADE: 09-JUL-14 PALM HARBOR FL 34683 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETEX MIXING AND DELIVERY SYSTEM ETEX CORPORATION 510(k) NO: K141245(TRADITIONAL) ATTN: ANDY SOMAN PHONE NO : 617 871 6342 675 MASSACHUSETTS AVE 12TH FLOOR SE DECISION MADE: 09-JUL-14 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLENTS PLASTIC EYE WASH CUP APOTHECARY PRODUCTS, INC. 510(k) NO: K140409(TRADITIONAL) ATTN: JAMES JENKINS PHONE NO : 952 808 8364 11750 12TH AVE. SOUTH SE DECISION MADE: 09-JUL-14 BURNSVILLE MN 55337 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K141444(ABBREVIATED) ATTN: DONNA VELASQUEZ PHONE NO : 310 645 8200 5210 PACIFIC CONCOURSE DRIVE SE DECISION MADE: 09-JUL-14 LOS ANGELES CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFOAM BONE WEDGE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K140531(TRADITIONAL) ATTN: VAL MYLES PHONE NO : 901 290 5162 1023 CHERRY ROAD SE DECISION MADE: 09-JUL-14 MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K141417(SPECIAL) ATTN: LESLIE FITCH PHONE NO : 901 867 4120 1023 CHERRY ROAD SE DECISION MADE: 09-JUL-14 MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIROCAM CAPSULE ENDOSCOPE SYSTEM INTROMEDIC CO., LTD 510(k) NO: K134005(TRADITIONAL) ATTN: JINYOUNG LEE PHONE NO : 82 2 8019300 STE 1104, E&C VENTURE DREAM TOWER SE DECISION MADE: 09-JUL-14 GURO-GU , SEOUL KS 152-719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K140417(TRADITIONAL) ATTN: SHWETA SHARMA PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 09-JUL-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT SAFETY INTRODUCER NEEDLE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140513(TRADITIONAL) ATTN: SUSAN CHRISTENSEN PHONE NO : 801 208 4789 1600 WEST MERIT PKWY. SE DECISION MADE: 09-JUL-14 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GANTRY BEAM LINE ION BEAM APPLICATIONS S.A. 510(k) NO: K132919(TRADITIONAL) ATTN: BRUCE D ARMON PHONE NO : 215 972 7985 1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 10-JUL-14 PHILADELPHIA PA 19102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOSSOM SALINE DELIVERY ASSIST DEVICE MARZ MEDICAL, INC 510(k) NO: K131692(TRADITIONAL) ATTN: MARY PASCUAL GALLUP PHONE NO : 510 441 4017 2500 HOSPITAL DRIVE BUILDING 9 SE DECISION MADE: 10-JUL-14 MOUNTAIN VIEW CA 94040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARATHON NO STING LIQUID SKIN PROTECTANT ADVANCED MEDICAL SOLUTIONS (PLYMOU510(k) NO: K133443(TRADITIONAL) ATTN: ROSE GUANG PHONE NO : 44 416068 63500 WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 10-JUL-14 PLYMOUTH, DEVON UK PL7 5BG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES CONMED CORPORATION 510(k) NO: K140658(TRADITIONAL) ATTN: SANDY LECLAIR PHONE NO : 315 624 3435 525 FRENCH RD. SE DECISION MADE: 10-JUL-14 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP IMPLANTECH ASSOCIATES INC. 510(k) NO: K141027(TRADITIONAL) ATTN: STEPHEN MEADE PHONE NO : 805 339 9415 6025 NICOLLE ST., SUITE B SE DECISION MADE: 10-JUL-14 VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC. 510(k) NO: K140765(TRADITIONAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 10-JUL-14 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MELUNA CLASSIC/SPORT MENSTRUAL CUP MELUNA 510(k) NO: K140626(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 888 729 9674 1468 HARWELL AVE SE DECISION MADE: 10-JUL-14 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERADIUS PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K133819(ABBREVIATED) ATTN: RUOJUAN ZHANG PHONE NO : 310 6316 85825 VEENPLUIS 4-6 SE DECISION MADE: 10-JUL-14 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS ABMEDICA SAS 510(k) NO: K140101(TRADITIONAL) ATTN: DANIEL DONOVAN PHONE NO : 203 799 2400 333 QUARRY ROAD SE DECISION MADE: 10-JUL-14 MILFORD CT 06460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENADEN FLOW KM CORPORATION 510(k) NO: K140976(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 10-JUL-14 FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIMOVE DORSA VI PTY. LTD 510(k) NO: K131094(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 430 8695 1914 J N PEASE PLACE SE DECISION MADE: 11-JUL-14 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY RITM OKB ZAO 510(k) NO: K131513(TRADITIONAL) ATTN: LARISA SHPUNGINA PHONE NO : 7 8634 623179 99, PETROVSKAYA SE DECISION MADE: 11-JUL-14 TAGANROG RS 347900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE FOTONA D.D. 510(k) NO: K132806(TRADITIONAL) ATTN: STOJAN TROST PHONE NO : 386 1 5009100 STEGNE 7, SE DECISION MADE: 11-JUL-14 LJUBLJANA SI 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL QUALITY ELECTRODYNAMICS, LLC. 510(k) NO: K140998(TRADITIONAL) ATTN: KATHLEEN ARAS PHONE NO : 440 484 2964 700 BETA DRIVE STE 100 SE DECISION MADE: 11-JUL-14 MAYFIELD VILLAGE OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESIE APPS SUITE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141554(TRADITIONAL) ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 685 East Middlefield Road SE DECISION MADE: 11-JUL-14 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INSTAFIX SHAPE MEMORY FIXATION SYSTEM OT MEDICAL 510(k) NO: K141550(SPECIAL) ATTN: WILLIAM RHODA PHONE NO : 484 588 2063 1000 CONTINENTAL DRIVE, SUITE 240 SE DECISION MADE: 11-JUL-14 KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM CONMED CORPORATION 510(k) NO: K140459(TRADITIONAL) ATTN: LISA ANDERSON PHONE NO : 315 624 3371 525 FRENCH RD. SE DECISION MADE: 11-JUL-14 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION WELCH ALLYN 510(k) NO: K141582(SPECIAL) ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609 4341 STATE STREET ROAD SE DECISION MADE: 11-JUL-14 SKANEATELES FALLS NY 13153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA MICRO ALB CONTROL L/H HORIBA ABX SAS 510(k) NO: K133676(ABBREVIATED) ATTN: CAROLINE FERRER PHONE NO : 33 46714 1843 PARC EUROMEDECINE RUE DU CADUCEE SE DECISION MADE: 11-JUL-14 MONTPELLIER FR 34184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXAMINATION GLOVES HL RUBBER INDUSTRIES SDN BHD 510(k) NO: K140316(TRADITIONAL) ATTN: NOORZALIZA AHMAD PHONE NO : 606 481 108788 LOT 10, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 11-JUL-14 KUALA PILAH, NEGERI SEMBILAN MY510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROPACE BURR HOLE COVER NEUROPACE INC 510(k) NO: K141368(SPECIAL) ATTN: ISABELLA R ABATI PHONE NO : 650 237 2700 455 N. BERNARDO AVE SE DECISION MADE: 11-JUL-14 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLABSIX ULTRASOUND SYSTEM ESAOTE EUROPE B.V. 510(k) NO: K141486(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 228 8719 PHILIPSWEG 1 SE DECISION MADE: 11-JUL-14 MAASTRICHT NL 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) KEELER LIMITED 510(k) NO: K140451(TRADITIONAL) ATTN: EUGENE VAN ARSDALE PHONE NO : 610 353 4350 456 PARKWAY SE DECISION MADE: 11-JUL-14 BROOMALL PA 19008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXLOCK EXTREME ELBOW FRACTURE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K141301(TRADITIONAL) ATTN: BRIAN HOCKETT PHONE NO : 330 869 9562 1065 Medina Rd. SUITE 500 SE DECISION MADE: 11-JUL-14 Medina OH 44256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE SURGICAL SPECIALTIES CORP. 510(k) NO: K141558(SPECIAL) ATTN: KIRSTEN STOWELL FRANCO PHONE NO : 610 404 3367 100 DENNIS DR. SE DECISION MADE: 11-JUL-14 READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE STORK OTC RINOVUM WOMEN’S HEALTH, INC 510(k) NO: K140186(TRADITIONAL) ATTN: ANDREW ZELTWANGER PHONE NO : 724 241 8934 300 Oxford Dr Suite 330 SE DECISION MADE: 11-JUL-14 Monroeville PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPRT REVISION KNEE ENCORE MEDICAL, L.P. 510(k) NO: K140830(TRADITIONAL) ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255 9800 METRIC BLVD. SE DECISION MADE: 11-JUL-14 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM CALIBRATER BECKMAN COULTER IRELAND INC 510(k) NO: K141388(ABBREVIATED) ATTN: DAVID G DAVIS PHONE NO : 469 236 8180 250 S. KRAEMER BLVD. E1.SE.01 SE DECISION MADE: 11-JUL-14 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE GUIDE KOELIS 510(k) NO: K141334(TRADITIONAL) ATTN: LAETITIA GERVAIS PHONE NO : 334 766375 87 5 AVENUE DU GRAND SABLON SE DECISION MADE: 11-JUL-14 LA TRONCHE FR 38700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PFX SPINOUS PROCESS FIXATION SYSTEM INNOVASIS, INC. 510(k) NO: K132765(TRADITIONAL) ATTN: MARSHALL MCCARTY PHONE NO : 801 261 2236 614 EAST 3900 SOUTH SE DECISION MADE: 14-JUL-14 SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K141532(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 14-JUL-14 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSENSUS VITALITE TIBIAL INSERT CONSENSUS ORTHOPEDICS, INC. 510(k) NO: K133919(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 916 355 7100 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 14-JUL-14 EL DORADO HILLS CA 95762 9623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K141605(SPECIAL) ATTN: MICHAEL SCOTT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 14-JUL-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT BECKMAN COULTER, INC. 510(k) NO: K140829(TRADITIONAL) ATTN: ANNETTE HELLIE PHONE NO : 714 961 4517 250 S. KRAEMER BLVD. MAIL STOP E1.SE DECISION MADE: 14-JUL-14 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY POWER WHEELCHAIR HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K132856(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 423580 357 NO. 6 ROAD 25 TAICHUNG INDUSTRIAL SE DECISION MADE: 15-JUL-14 TAICHUNG CITY, TAIWAN TW R.O.C.510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILESTONE SPINAL SYSTEM WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K133053(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 PO BOX 120-119 SE DECISION MADE: 15-JUL-14 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES COVIDIEN 510(k) NO: K140813(TRADITIONAL) ATTN: DANIEL CAMPION PHONE NO : 508 452 4135 15 HAMPSHIRE STREET SE DECISION MADE: 15-JUL-14 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTUS FEMTOSECOND LASER PLATFORM TECHNOLAS PERFECT VISION GMBH 510(k) NO: K140615(TRADITIONAL) ATTN: BETTY M JOHNSON PHONE NO : 714 273 8254 PO BOX 17190 SE DECISION MADE: 15-JUL-14 ANAHEIM CA 92817 7190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLXFIT INTERVERTEBRAL BODY FUSION DEVICE EXPANDING ORTHOPEDICS, INC. 510(k) NO: K133813(TRADITIONAL) ATTN: MEREDITH MAY PHONE NO : 719 337 7579 4628 NORTHPARK DRIVE SE DECISION MADE: 15-JUL-14 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORMATRIX ECM FOR VASCULAR REPAIR CORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K140789(TRADITIONAL) ATTN: BRYAN BROSSEAU PHONE NO : 470 514 4036 1100 OLD ELLIS ROAD SE DECISION MADE: 15-JUL-14 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM MEDIVATORS 510(k) NO: K140753(SPECIAL) ATTN: KINNARI SHAH PHONE NO : 763 553 3369 14605 28TH AVE. N. SE DECISION MADE: 15-JUL-14 MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP OPTILENE NONABSORBABLE SUTURE AESCULAP, INC. 510(k) NO: K133890(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 15-JUL-14 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK SPHERE EXTENSION MEDACTA INTERNATIONAL 510(k) NO: K140826(TRADITIONAL) ATTN: ADAM GROSS PHONE NO : 805 910 6511 1556 W CARROLL AVE. SE DECISION MADE: 15-JUL-14 CHICAGO IL 60607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSTAR LOGIX PUMP ALBAHEALTH LLC 510(k) NO: K141609(SPECIAL) ATTN: SHANE BRUCE PHONE NO : 865 354 0410 425 N GATEWAY AVE. SE DECISION MADE: 15-JUL-14 ROCKWOOD TN 37854 510(k) STATEMENT
DEVICE: LINSCAN 808, LINSCAN 980 GME (GERMAN MEDICAL ENGINEERING) G510(k) NO: K141063(TRADITIONAL) ATTN: MIKE JOHNSON, M.D. PHONE NO : 406 209 3039 PO BOX 106 SE DECISION MADE: 15-JUL-14 WILLOW CREEK MT 59760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC SYNERGY BIOMEDICAL, INC. 510(k) NO: K140844(TRADITIONAL) ATTN: RANDY PREBULA PHONE NO : 202 637 6548 555 THIRTEENTH ST, N.W. SE DECISION MADE: 16-JUL-14 WASHINGTON DC 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC RAYENCE CO., LTD 510(k) NO: K141563(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 8310 BUFFALO SPEEDWAY SE DECISION MADE: 16-JUL-14 HOUSTON TX 77025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORCINE ANORGANIC BONE MINERAL COLLAGEN MATRIX, INC. 510(k) NO: K140714(TRADITIONAL) ATTN: PEGGY HANSEN PHONE NO : 201 405 1477 15 THORNTON ROAD SE DECISION MADE: 16-JUL-14 OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCTIGARD ACCESS PHARMACEUTICALS, INC 510(k) NO: K140558(TRADITIONAL) ATTN: JEFFREY B DAVIS PHONE NO : 212 786 6205 1325 AVENUE OF THE AMERICA, 27TH FSE DECISION MADE: 16-JUL-14 NEW YORK NY 10019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC 510(k) NO: K141112(SPECIAL) ATTN: CAROL TIFFANY PHONE NO : 763 494 1106 ONE SCIMED PLACE SE DECISION MADE: 16-JUL-14 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-TL VITROLIFE, INC. 510(k) NO: K133568(TRADITIONAL) ATTN: MARK LARMAN PHONE NO : 303 762 1933 3601 SOUTH INCA ST. SE DECISION MADE: 16-JUL-14 ENGLEWOOD CO 80110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) CHOICE SPINE, LP 510(k) NO: K140142(TRADITIONAL) ATTN: KIM FINCH PHONE NO : 865 246 3333 306 ERIN DRIVE SE DECISION MADE: 16-JUL-14 KNOXVILLE TN 37919 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC RAYENCE CO., LTD 510(k) NO: K141566(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 8310 BUFFALO SPEEDWAY SE DECISION MADE: 16-JUL-14 HOUSTON TX 77025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCULIF TL AND PL CAGE STRYKER CORPORATION 510(k) NO: K141217(SPECIAL) ATTN: KRISTEN MEANY PHONE NO : 201 760 8070 2 PEARL COURT SE DECISION MADE: 16-JUL-14 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE SUSCEPTIBILITY PLATES THERMO FISHER SCIENTIFIC 510(k) NO: K141000(TRADITIONAL) ATTN: CYNTHIA KNAPP PHONE NO : 800 871 8909 1 THERMO FISHER WAY SE DECISION MADE: 16-JUL-14 OAKWOOD VILLAGE OH 44146 510(k) STATEMENT
DEVICE: TATTOOSTAR EFFECT COMBO ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K131757(TRADITIONAL) ATTN: ANTJE KATZER PHONE NO : 493 641 7700309 BRUESSELER STR. 10 SE DECISION MADE: 17-JUL-14 JENA GM 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) HEALGEN SCIENTIFIC, LLC 510(k) NO: K141647(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 301 505 7880 504 EAST DIAMNOND AVE. SUITE F SE DECISION MADE: 17-JUL-14 GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVIS ARTHROSCOPE INTEGRATED ENDOSCOPY, INC. 510(k) NO: K140903(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949 777 6749 23141 ARROYO VISTA, STE 100 SE DECISION MADE: 17-JUL-14 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K140682(TRADITIONAL) ATTN: LEI CHEN PHONE NO : 86 10 88798300 NO. 9 SHUANGYUAN ROAD, BADACHU HI-SE DECISION MADE: 17-JUL-14 BEIJING CH 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES STERIS CORPORATION 510(k) NO: K140499(TRADITIONAL) ATTN: BILL BRODBECK PHONE NO : 440 392 7690 5960 HEISLEY ROAD SE DECISION MADE: 17-JUL-14 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL STERIS CORPORATION 510(k) NO: K140515(ABBREVIATED) ATTN: BILL BRODBECK PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 17-JUL-14 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELWORKS DR SYSTEM DEL MEDICAL, INC. 510(k) NO: K140825(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 17-JUL-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D2 HEMOSTANTIC DRESSING Z-MEDICA, LLC 510(k) NO: K140757(TRADITIONAL) ATTN: SHEILA WALLIN PHONE NO : 203 294 0000 4 FAIRFIELD BLVD. SE DECISION MADE: 17-JUL-14 Wallingford CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET ROCHE DIAGNOSTICS 510(k) NO: K141143(TRADITIONAL) ATTN: KHOA TRAN PHONE NO : 317 521 3409 9115 HAGUE ROAD SE DECISION MADE: 17-JUL-14 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM VASCULAR PATHWAYS, INC. 510(k) NO: K140504(TRADITIONAL) ATTN: BILL BOLD PHONE NO : 1847 Trade Center Way SE DECISION MADE: 17-JUL-14 Naples FL 34109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHILLA GROWTH GUIDANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K140750(TRADITIONAL) ATTN: LEE GRANT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 17-JUL-14 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE PJUR GROUP LUXEMBOURG SA 510(k) NO: K133233(TRADITIONAL) ATTN: CANDACE CEDERMAN PHONE NO : 503 201 2485 722 ARJEAN DRIVE SE DECISION MADE: 18-JUL-14 WILMINGTON NC 28411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX PIP DART ARTHREX, INC. 510(k) NO: K141577(SPECIAL) ATTN: DAVID L ROGERS PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 18-JUL-14 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALMA DIODE TABLETOP LASER ALMA LASERS LTD. 510(k) NO: K140005(TRADITIONAL) ATTN: KATHY MAYNOR PHONE NO : 352 586 3113 26 REBECCA CT SE DECISION MADE: 18-JUL-14 HOMOSASSA FL 34446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS BIOMET MANUFACTURING CORP. 510(k) NO: K141219(TRADITIONAL) ATTN: JARED COOPER PHONE NO : 574 372 1941 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 18-JUL-14 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM TORNIER SAS 510(k) NO: K140082(TRADITIONAL) ATTN: AYMEN AZAIEZ PHONE NO : 33 476613 500 161 RUE LAVOISIER SE DECISION MADE: 18-JUL-14 MONTBONNOT SAINT MARTIN FR 3833510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTILITE C1 INACTIVATOR KIT THE BINDING SITE GROUP LTD 510(k) NO: K141100(TRADITIONAL) ATTN: MARIANNE SENDER PHONE NO : 440 121456 9500 8 CALTHORPE ROAD EDGBASTON SE DECISION MADE: 18-JUL-14 BIRMINGHAM, WEST MIDLANDS UK B1510(k) STATEMENT
DEVICE: ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM ZIMMER DENTAL INC. 510(k) NO: K133551(TRADITIONAL) ATTN: MELISSA BURBAGE PHONE NO : 760 929 4110 1900 ASTON AVE. SE DECISION MADE: 18-JUL-14 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER EV3 INC 510(k) NO: K141118(SPECIAL) ATTN: LAURA J LIND PHONE NO : 763 398 7247 3033 CAMPUS DRIVE SUITE N550 SE DECISION MADE: 18-JUL-14 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM ZONARE MEDICAL SYSTEMS, INC. 510(k) NO: K141641(TRADITIONAL) ATTN: DAN BRADFORD PHONE NO : 650 316 3113 420 NORTH BERNARDO AVENUE SE DECISION MADE: 18-JUL-14 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES PT. SMART GLOVE INDONESIA 510(k) NO: K133699(TRADITIONAL) ATTN: KHON PU FOO PHONE NO : 616 17 940100 JL. PELITA RAUYA NO. 5-7,KIM STAR,SE DECISION MADE: 18-JUL-14 MEDAN, NORTH SUMATER ID 20362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVO TINNITUS MASKING SOFTWARE DEVICE OTOHARMONICS CORP 510(k) NO: K140845(TRADITIONAL) ATTN: YARMELA PAVLOVIC PHONE NO : 267 675 4618 1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 18-JUL-14 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYSYN SURGICAL SUTURE SURGICAL SPECIALTIES CORP. 510(k) NO: K141625(SPECIAL) ATTN: PAUL AMUDALA PHONE NO : 610 404 3367 100 DENNIS DR. SE DECISION MADE: 18-JUL-14 READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES NEUROINVENT INC. 510(k) NO: K140200(TRADITIONAL) ATTN: CHAO-SHENT CHAO PHONE NO : 886 227935 961 5F,NO.123,ANMEI ST.,NEIHU DISTRICTSE DECISION MADE: 18-JUL-14 TAIPEI CITY TW 11484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BELMONT RAPID INFUSER BELMONT INSTRUMENT CORPORATION 510(k) NO: K141654(SPECIAL) ATTN: URAIWAN P LABADINI PHONE NO : 978 663 0212 780 BOSTON ROAD SE DECISION MADE: 18-JUL-14 BILLERICA MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSON S6, VOLUSON S8 GE HEALTHCARE 510(k) NO: K141639(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 18-JUL-14 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT ELITECHGROUP 510(k) NO: K141265(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 18-JUL-14 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER GEISTLICH PHARMA AG 510(k) NO: K140518(TRADITIONAL) ATTN: DANIEL A KRACOV PHONE NO : 202 942 5120 555 TWELFTH STREET, NW SE DECISION MADE: 18-JUL-14 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS SEINOH OPTICAL CO. LTD. 510(k) NO: K141280(ABBREVIATED) ATTN: JENNIFER TING PHONE NO : 886 282823 192 6F, NO. 39, LN 224, JIXIAN RD, LUZSE DECISION MADE: 18-JUL-14 NEW TAIPEI CITY TW 247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX DISTAL RADIUS PLATING SYSTEM STRYKER LEIBINGER GMBH & CO. KG 510(k) NO: K141430(TRADITIONAL) ATTN: ELIJA WREH PHONE NO : 201 831 5691 325 CORPORATE DRIVE SE DECISION MADE: 18-JUL-14 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140897(TRADITIONAL) ATTN: CORDELL L FIELDS, ESQ. PHONE NO : 610 219 8518 51 VALLEY STREAM PARKWAY SE DECISION MADE: 18-JUL-14 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSURE HEALICOIL PK INTERFERENCE SCREW SMITH & NEPHEW, INC 510(k) NO: K140879(TRADITIONAL) ATTN: VIVEK MUKHATYAR PHONE NO : 978 749 1043 150 MINUTEMAN DR. SE DECISION MADE: 21-JUL-14 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCIA TOTAL HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K140915(SPECIAL) ATTN: JULIE T WING PHONE NO : 610 984 9147 3773 CORPORATE PARKWAY SE DECISION MADE: 21-JUL-14 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZUL PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. 510(k) NO: K141034(TRADITIONAL) ATTN: JOSEPH CICONE PHONE NO : 609 806 1994 500 CHARLES EWING BLVD SE DECISION MADE: 21-JUL-14 EWING NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABYMEG BIOMAGNETOMETER SYSTEM TRISTAN TECHNOLOGIES INC 510(k) NO: K133419(TRADITIONAL) ATTN: EUGENE HIRSCHKOFF PHONE NO : 619 992 6301 3365 CALLE MARGARITA SE DECISION MADE: 21-JUL-14 ENCINITAS CA 92024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER BOSTON SCIENTIFIC CORPORATION 510(k) NO: K134031(TRADITIONAL) ATTN: VICKY L HAGENS PHONE NO : 763 494 1522 ONE SCIMED PLACE SE DECISION MADE: 21-JUL-14 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES – BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES – BOX 5, CAPTIV BOSTON SCIENTIFIC CORP. 510(k) NO: K140726(TRADITIONAL) ATTN: TARA PAUL PHONE NO : 508 683 4296 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 21-JUL-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS AMERICAN MEDICAL MANUFACTURING, IN510(k) NO: K130097(TRADITIONAL) ATTN: MIKE HOFTMAN PHONE NO : 818 701 7171 8741 SHIRLEY AVE SE DECISION MADE: 22-JUL-14 NORTHRIDGE CA 91324 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 COMED MEDICAL SYSTEMS CO., LTD 510(k) NO: K131721(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832 675 9281 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 22-JUL-14 HOUSTON TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEVA DISH (WITH 12 MICROWELLS) AUXOGYN, INC. 510(k) NO: K141663(SPECIAL) ATTN: JULIA S ANASTAS PHONE NO : 650 763 3875 1490 O’BRIEN DRIVE, SUITE A SE DECISION MADE: 22-JUL-14 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELOXTM INTERBODY FUSION SYSTEM U&I CORP. 510(k) NO: K140864(TRADITIONAL) ATTN: JI YEA LEE PHONE NO : 82 318520 102 20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 22-JUL-14 Uijeongbu-si KR 480-859 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-CONNEKT WOUND MATRIX MLM BIOLOGICS, INC. 510(k) NO: K140456(TRADITIONAL) ATTN: GREGG RITTER PHONE NO : 352 494 2122 12085 RESEARCH DRIVE SE DECISION MADE: 22-JUL-14 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW ICON ORTHOPEDIC CONCEPTS, LLC DBA 510(k) NO: K140876(TRADITIONAL) ATTN: JAN TRIANI PHONE NO : 201 543 9388 6 MARS COURT, UNIT 6-3 SE DECISION MADE: 22-JUL-14 BOONTON NJ 07005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICOSURE WORKSTATION CYNOSURE, INC. 510(k) NO: K133364(TRADITIONAL) ATTN: CONNIE HOY PHONE NO : 781 993 2414 5 CARLISLE ROAD SE DECISION MADE: 22-JUL-14 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE CEDARS-SINAI MEDICAL CENTER 510(k) NO: K141652(SPECIAL) ATTN: GEOFF POLLARD PHONE NO : 310 423 4663 8700 BEVERLY BOULEVARD SE DECISION MADE: 22-JUL-14 LOS ANGELES CA 90048 1869 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OARTRAC SYSTEM RADIADYNE 510(k) NO: K141154(TRADITIONAL) ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997 816 CONGRESS AVE. SUITE 1400 SE DECISION MADE: 22-JUL-14 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE SIGNATURE ORTHOPAEDICS PTY LIMITED510(k) NO: K133370(TRADITIONAL) ATTN: DECLAN BRAZIL PHONE NO : 61 2 94285181 7 Sirius Road LANE COVE SE DECISION MADE: 22-JUL-14 NSW AS 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUALIZER OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K140273(TRADITIONAL) ATTN: DIANE NELSON PHONE NO : ONE SCIMED PLACE SE DECISION MADE: 22-JUL-14 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR 510(k) NO: K141678(SPECIAL) ATTN: JESSICA KAO PHONE NO : 408 845 0696 3200 LAKESIDE DRIVE SE DECISION MADE: 22-JUL-14 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX ELBOW PLATING SYSTEM STRYKER TRAUMA AG 510(k) NO: K141677(TRADITIONAL) ATTN: ELIJAH N WREH PHONE NO : 201 831 5691 325 CORPORATE DRIVE SE DECISION MADE: 22-JUL-14 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY SHASER, INC. 510(k) NO: K141583(SPECIAL) ATTN: ANTHONY BURNS PHONE NO : 339 927 2599 10 Maguire Rd Ste 120 BUILDING 1 SE DECISION MADE: 22-JUL-14 Lexington MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING STERIS CORPORATION 510(k) NO: K140487(TRADITIONAL) ATTN: TONY PIOTRKOWSKI PHONE NO : 440 392 7437 5960 HEISLEY ROAD SE DECISION MADE: 22-JUL-14 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIS HERNIA GRAFT COOK BIOTECH, INC. 510(k) NO: K133306(TRADITIONAL) ATTN: PERRY W GUINN PHONE NO : 765 497 3355 1425 INNOVATION PLACE SE DECISION MADE: 23-JUL-14 West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM SPECTRANETICS CORPORATION 510(k) NO: K140775(TRADITIONAL) ATTN: AMANDA JOHNSON PHONE NO : 719 477 2000 9965 FEDERAL DRIVE SE DECISION MADE: 23-JUL-14 COLORADO SPRINGS CO 80921 3617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADWELL SPIKE AND SEIZURE DETECTOR CADWELL 510(k) NO: K140552(TRADITIONAL) ATTN: JINESH JAIN PHONE NO : 509 735 6481 909 N. KELLOGG ST. SE DECISION MADE: 23-JUL-14 KENNEWICK WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROSCOPIC ENERGY SYSTEM CONMED CORPORATION 510(k) NO: K140578(TRADITIONAL) ATTN: DIONNE SANDERS PHONE NO : 727 399 5564 525 FRENCH RD. SE DECISION MADE: 23-JUL-14 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFX-8000V, V5.30 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133535(TRADITIONAL) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896 2441 MICHELLE DRIVE SE DECISION MADE: 23-JUL-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES VILEX, INC. 510(k) NO: K132820(TRADITIONAL) ATTN: ABRAHAM LAVI PHONE NO : 941 373 3987 7214 LAKE FOREST GLEN SE DECISION MADE: 23-JUL-14 LAKEWOOD RANCH FL 34202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO SOLUTIONS ULTOS PLATING SYSTEM ORTHO SOLUTIONS LIMITED 510(k) NO: K141784(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858 3150 EAST 200TH STREET SE DECISION MADE: 23-JUL-14 PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIJOINT HIP INTELLIJOINT SURGICAL INC. 510(k) NO: K133759(TRADITIONAL) ATTN: BRANDON GINGRICH PHONE NO : 519 342 3178 X2104 60 BATHURST DR. SE DECISION MADE: 23-JUL-14 WATERLOO ONTARIO CA N2V 2A9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFUSE IMPLANT SYSTEM SI-BONE, INC. 510(k) NO: K141049(TRADITIONAL) ATTN: ROXANNE DUBOIS PHONE NO : 408 207 0700 3055 OLIN AVE SUITE 2200 SE DECISION MADE: 23-JUL-14 SAN JOSE CA 95128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OKAMOTO STUDDED CONDOM OKAMOTO U.S.A., INC. 510(k) NO: K141256(ABBREVIATED) ATTN: JOSEPH W CORMIER, JD, PHD PHONE NO : 202 737 7553 700 THIRTEENTH STREET, N.W. SUITE SE DECISION MADE: 23-JUL-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASPIAN SPINAL SYSTEM K2M, INC. 510(k) NO: K141284(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 23-JUL-14 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIC NEUROSCREENING DEVICE PROSENEX 510(k) NO: K141208(TRADITIONAL) ATTN: WILLIAM G MCLAIN PHONE NO : 717 656 9656 342 E. MAIN ST. SUITE 207 SE DECISION MADE: 23-JUL-14 LEOLA PA 17540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAPROBE LED LIGHT SOURCE NOVAPROBE INCORPORATED 510(k) NO: K131226(TRADITIONAL) ATTN: MANISH INGLE PHONE NO : 215 259 3673 2333W. MAIN STREET SUITE 210 SE DECISION MADE: 24-JUL-14 LANSDALE PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLIF LITE AND TLIF LITE SINTEA PLUSTEK 510(k) NO: K132907(TRADITIONAL) ATTN: RICH JANSEN PHONE NO : 612 281 5505 11821 BRAMBLE COVE DRIVE SE DECISION MADE: 24-JUL-14 FT. MYERS FL 33905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PJUR SILICONE GEL, PJUR BASIC, PJUR LIGHT, PJUR ANALYSE ME, PJUR BACKDOOR, PJUR MED PREMIUM GLIDE PJUR GROUP,LUXEMBOURG S.A. 510(k) NO: K133336(TRADITIONAL) ATTN: CANDACE CEDERMAN PHONE NO : 503 201 2485 722 ARJEAN DR. SE DECISION MADE: 24-JUL-14 WILMINGTON NC 28411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELPROCERA OVERDENTURE BAR NOBEL BIOCARE USA, LLC 510(k) NO: K132749(TRADITIONAL) ATTN: PHUONG NGUYEN SON PHONE NO : 714 282 4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 24-JUL-14 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-JAWS CERVICAL COMPRESSIVE STAPLE MEDICREA INTERNATIONAL 510(k) NO: K133906(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET NW SE DECISION MADE: 24-JUL-14 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLONGLIDE LUBRICANT PEDIATRIC PHARMACEUTICALS INC. 510(k) NO: K141028(SPECIAL) ATTN: ROBERT M HARRIS PHONE NO : 732 739 2018 2137 ROUTE 35 SE DECISION MADE: 24-JUL-14 HOLMDEL NJ 07733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM INFOPIA CO., LTD 510(k) NO: K141750(SPECIAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789 2651 E CHAPMAN AVE STE 110 SE DECISION MADE: 24-JUL-14 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM COLOPLAST A/S 510(k) NO: K140523(SPECIAL) ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987 1601 WEST RIVER ROAD N SE DECISION MADE: 24-JUL-14 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE PONTIS ORTHOPAEEICS, LLC 510(k) NO: K141711(SPECIAL) ATTN: LEONARD GORDON PHONE NO : 415 567 8935 2299 POST STREET, SUITE 103 SE DECISION MADE: 24-JUL-14 SAN FRANCISCO CA 94115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE HMICRO, INC. 510(k) NO: K140096(TRADITIONAL) ATTN: KIM TOMPKINS PHONE NO : 408 981 4889 4984 EL CAMINO REAL #200 SE DECISION MADE: 24-JUL-14 LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE NEOCOIL, LLC 510(k) NO: K133670(ABBREVIATED) ATTN: MICHEAL LEIGH PHONE NO : 262 374 1250 N27 W23910A PAUL RD. SE DECISION MADE: 24-JUL-14 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINOS MOH HAND PLATING SYSTEM KLS MARTIN L.P. 510(k) NO: K141489(SPECIAL) ATTN: JENNIFER DAMATO PHONE NO : 800 625 1557 11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 24-JUL-14 JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLIVUE GAS ASSAY QUIDEL CORPORATION 510(k) NO: K141173(TRADITIONAL) ATTN: RONALD H LOLLAR PHONE NO : 740 589 3373 2005 E State St Suite 100 SE DECISION MADE: 24-JUL-14 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133156(TRADITIONAL) ATTN: PHILIP LIU PHONE NO : 914 524 2443 511 BENEDICT AVE. SE DECISION MADE: 24-JUL-14 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICR02 OSA DEVICE MICRODENTAL, INC. 510(k) NO: K133683(TRADITIONAL) ATTN: LAURA SHEPPARD PHONE NO : 925 803 8643 5601 ARNOLD RD. SE DECISION MADE: 24-JUL-14 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) HARTALEGA NGC SDN. BHD. 510(k) NO: K140890(TRADITIONAL) ATTN: NURUL AISYAH KONG PHONE NO : 603 3280 3888 DATARAN SD PJU 9 SE DECISION MADE: 24-JUL-14 BANDAR SRI DAMANSARA, KUALA LUMPUR510(k) STATEMENT
DEVICE: BNA ANALYSIS SYSTEM EIMINDA LTD. 510(k) NO: K121119(TRADITIONAL) ATTN: DALIA DICKMAN PHONE NO : 972 995164 76 16 HAMINHARA ST. BEIT BACHAR SE DECISION MADE: 25-JUL-14 HERZLIYA IS 46586 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIVOX SELF ADHESIVE ELECTRODE GEL PADS HIVOX BIOTEK, INC. 510(k) NO: K131720(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 2 85112668 8 F., NO. 98, SHINDE RD, SANCHONG SE DECISION MADE: 25-JUL-14 NEW TAIPEI CITY TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSON P6, VOLUSON P8 GE HEALTHCARE 510(k) NO: K141675(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 25-JUL-14 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) MAUNA KEA TECHNOLOGIES 510(k) NO: K133466(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 415 407 0223 8 SNOWBERRY COURT SE DECISION MADE: 25-JUL-14 ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE 3M HEALTH CARE 510(k) NO: K140250(TRADITIONAL) ATTN: KRISTIN TOTUSHEK PHONE NO : 651 736 6117 3M CENTER, 2510 CONWAY AVE. BLDG 2SE DECISION MADE: 25-JUL-14 ST. PAUL MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELTER BLOOD PRESSURE METER SHENZHEN BELTER HEALTH MEASUREMENT510(k) NO: K134029(TRADITIONAL) ATTN: PANG MING PHONE NO : 86 755 61869839 702, 704 BLOCK C, TSINGHUA UNIS SCSE DECISION MADE: 25-JUL-14 SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE BECTON, DICKINSON AND COMPANY 510(k) NO: K141311(SPECIAL) ATTN: JUMA HOSHINO PHONE NO : 201 847 4260 1 BECTON DRIVE SE DECISION MADE: 25-JUL-14 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-PRO STERILIZATION TRAY/ STERILIZATION MAT STERIS CORPORATION 510(k) NO: K140494(TRADITIONAL) ATTN: TONY PIOTRKOWSKI PHONE NO : 440 392 7437 5960 HEISLEY ROAD SE DECISION MADE: 25-JUL-14 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDI BLOOD PARAMETER MONITORING SYSTEM 500 TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K133658(TRADITIONAL) ATTN: KEVIN KONG PHONE NO : 734 663 4145 6200 JACKSON RD. SE DECISION MADE: 25-JUL-14 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) REGULATORY TECHNOLOGY SERVICES LLC510(k) NO: K141838(TRADITIONAL) ATTN: MARK JOB PHONE NO : 763 682 4139 1394 25TH STREET NW SE DECISION MADE: 25-JUL-14 BUFFALO MN 55313 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: HARD PACK SYRINGE JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K141359(SPECIAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 120-119 SE DECISION MADE: 25-JUL-14 SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST PHILIPS MEDICAL SYSTEMS DMC GMBH 510(k) NO: K141736(SPECIAL) ATTN: GEROLD SCHWARZ PHONE NO : 49 405078 1116 ROENTGENSTRASSE 24-26 SE DECISION MADE: 25-JUL-14 HAMBURG GM 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZQUIET-SA SLEEPING WELL, LLC 510(k) NO: K140777(TRADITIONAL) ATTN: WILLIAM MCLAIN PHONE NO : 717 656 9656 342 E. MAIN STREET, STE 207 SE DECISION MADE: 25-JUL-14 LEOLA PA 17540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON XL ANALYZER DIASORIN, INC. 510(k) NO: K141116(TRADITIONAL) ATTN: MARI MEYER PHONE NO : 651 351 5635 1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 25-JUL-14 STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 SMITHS MEDICAL ASD, INC. 510(k) NO: K141193(TRADITIONAL) ATTN: TOM BLISS PHONE NO : 651 628 7145 1265 GREY FOX ROAD SE DECISION MADE: 25-JUL-14 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MLX – MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE, INCORPORATED 510(k) NO: K140770(TRADITIONAL) ATTN: OLGA LEWIS PHONE NO : 858 320 5257 7475 LUSK BLVD SE DECISION MADE: 25-JUL-14 SAN DIEGO CA 92121 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM MEDTRONIC NAVIGATION, INC. 510(k) NO: K133444(TRADITIONAL) ATTN: KAYE WAITE PHONE NO : 720 890 2182 826 COAL CREEK CIR. SE DECISION MADE: 25-JUL-14 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS TOUCHSTONE INTERNATIONAL MEDICAL S510(k) NO: K141367(TRADITIONAL) ATTN: JO QIAO PHONE NO : 86 512 62991985 21A SCIENCE PLAZA, INTRENATIONAL SSE DECISION MADE: 25-JUL-14 SUZHOU, JIANGSU CH 215021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS INTUITIVE SURGICAL, INC. 510(k) NO: K140553(TRADITIONAL) ATTN: DAWN CHANG PHONE NO : 408 523 2347 1266 KIFER RD SE DECISION MADE: 25-JUL-14 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCOON CONVECTIVE WARMING SYSTEM CARE ESSENTIALS PTY LTD 510(k) NO: K140635(TRADITIONAL) ATTN: BIBIANA FRANCO PHONE NO : 618 7231 0324 SUITE 2/ 36-38 GLEN OSMOND ROAD SE DECISION MADE: 25-JUL-14 PARKSIDE, SOUTH AUSTRALIA AS 50510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDS COMBO-RINSE ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K140846(TRADITIONAL) ATTN: JEFFREY WAN PHONE NO : 201 487 9090 89 LEUNING STREET SUITE 8 SE DECISION MADE: 25-JUL-14 SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMELOCK II CEMENTED SHOULDER SYSTEM FX SOLUTIONS 510(k) NO: K140071(TRADITIONAL) ATTN: JEAN-JACQUES MARTIN PHONE NO : 33 474 553555 1663 rue de Majornas SE DECISION MADE: 28-JUL-14 Viriat FR 01440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET GENERICA MEDICAL INTERNATIONAL, IN510(k) NO: K133077(TRADITIONAL) ATTN: JIM BARLEY PHONE NO : 949 433 3058 1910 D ST. SE DECISION MADE: 28-JUL-14 LAVERNE CA 91750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT SMALL INTERBODY SYSTEM NUVASIVE, INCORPORATED 510(k) NO: K140921(TRADITIONAL) ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549 7475 LUSK BOULEVARD SE DECISION MADE: 28-JUL-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR SYRINGE DUAL PACK COEUR, INC. 510(k) NO: K140469(TRADITIONAL) ATTN: ERIN RHEINSCHELD PHONE NO : 615 547 7923 100 PHYSICIANS WAY SUITE 200 SE DECISION MADE: 28-JUL-14 LEBANON TN 37090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT XL-F SYSTEM NUVASIVE, INCORPORATED 510(k) NO: K140479(TRADITIONAL) ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549 7475 LUSK BLVD SE DECISION MADE: 28-JUL-14 SAN DIEGO CA 92121 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE OXFORD PERFORMANCE MATERIALS 510(k) NO: K133809(TRADITIONAL) ATTN: LEIGH AYRES PHONE NO : 860 698 9300 30 South Satellite Road SE DECISION MADE: 28-JUL-14 South Windsor CT 06074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUARIUS EXTENSION FEEDING SET DEGANIA SILICONE, LTD. 510(k) NO: K141631(SPECIAL) ATTN: ZOYA LEE PHONE NO : 972 467 55122 KIBBUTZ DEGANIA BET SE DECISION MADE: 28-JUL-14 EMEK HAYARDEN IS 1513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM COAG MEDICAL LLC 510(k) NO: K140313(TRADITIONAL) ATTN: BERNARD HORWATH PHONE NO : 651 231 1761 4486 TIMBERLINE CT. SE DECISION MADE: 28-JUL-14 VADNAIS HEIGHTS MN 55127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMGUARD ONE-STEP STERILIZATION WRAP KIMBERLY-CLARK HEALTH CARE 510(k) NO: K141071(TRADITIONAL) ATTN: THOMAS KOZMA, PH.D. PHONE NO : 770 587 8393 1400 HOLCOMB BRIDGE ROAD SE DECISION MADE: 28-JUL-14 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE CALIBRATOR SENTINEL CH. SPA 510(k) NO: K141728(ABBREVIATED) ATTN: PATRICIA DUPE PHONE NO : 39 02 34551496 VIA ROBERT KOCH, 2 SE DECISION MADE: 28-JUL-14 MILANO IT 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMERA ENABLED PROBE TRICE MEDICAL, INC. 510(k) NO: K141119(TRADITIONAL) ATTN: TIFFINI DIAGE PHONE NO : 707 799 6732 1000 CONTINENTAL DRIVE, SUITE 240 SE DECISION MADE: 29-JUL-14 KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDILOC FRAGMENT SYSTEM ORTHOPEDIATRICS, CORP. 510(k) NO: K140431(TRADITIONAL) ATTN: MARK FOX PHONE NO : 574 268 6379 2850 FRONTIER DRIVE SE DECISION MADE: 29-JUL-14 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT FACET TECHNOLOGIES, LLC 510(k) NO: K141749(SPECIAL) ATTN: JENNIFER REGISTER PHONE NO : 770 590 6455 112 TOWN PARK DR. SUITE 300 SE DECISION MADE: 29-JUL-14 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY) VITAL CONNECT INC. 510(k) NO: K141167(TRADITIONAL) ATTN: SAM MOSTAFAVI PHONE NO : 408 963 4620 900 E. HAMILTON AVE., SUITE 500 SE DECISION MADE: 29-JUL-14 CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT LEONHARD LANG GMBH 510(k) NO: K140500(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 P.O. BOX 560 SE DECISION MADE: 29-JUL-14 STILLWATER MN 55082 0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM X-SPINE SYSTEMS, INC 510(k) NO: K133947(TRADITIONAL) ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8410 452 Alexandersville Rd SE DECISION MADE: 29-JUL-14 Miamisburg OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM ZIMMER DENTAL INC. 510(k) NO: K141120(TRADITIONAL) ATTN: MELISSA BURBAGE PHONE NO : 760 929 4110 1900 ASTON AVE. SE DECISION MADE: 29-JUL-14 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KANGLI SUZHOU KANGLI ORTHOPAEDICS INSTRUM510(k) NO: K133840(TRADITIONAL) ATTN: ALICE GONG PHONE NO : 86 21 64957283 503 ROOM, 8 BUILDING, 600 LIU ZHOUSE DECISION MADE: 29-JUL-14 SHANGHAI CH 200233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTEON 6.5MM BONE SCREWS EXACTECH, INC. 510(k) NO: K141797(SPECIAL) ATTN: THOMAS MCNAMARA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 29-JUL-14 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXIPROBE E (OXIPROBE) BIO MEDICAL TECHNOLOGIES CO., LTD 510(k) NO: K132516(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 P.O. BOX 560 SE DECISION MADE: 30-JUL-14 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT IN2BONES SAS 510(k) NO: K132912(TRADITIONAL) ATTN: NORMAN F ESTRIN, PH.D. PHONE NO : 301 279 2899 9109 COPENHAVER DR. SE DECISION MADE: 30-JUL-14 POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUCTION LIPOPLASTY ACCESSORIES INEX 510(k) NO: K132353(TRADITIONAL) ATTN: RAYMOND PATEL PHONE NO : 330 344 741995 ZA LA GOBETTE 60540 PUISEUX LE HAUSE DECISION MADE: 30-JUL-14 PUISEUX LE HAUBERGER FR 60540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER VR MEDICAL 510(k) NO: K132709(TRADITIONAL) ATTN: LEE PAN, PHD PHONE NO : 86 137 88975958 90 GAOXIN ROAD, ZHOUZHUANG SE DECISION MADE: 30-JUL-14 KUN SHAN, JIANGSU CH 215325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOLED OLYMPUS WINTER & IBE GMBH 510(k) NO: K133311(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 484 986 3147 3500 CORPORATE PARKWAY SE DECISION MADE: 30-JUL-14 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L’DISQ U & I CORPORATION 510(k) NO: K132797(TRADITIONAL) ATTN: GYEONG-JE KWON PHONE NO : 82 318520 102 20, SANDAN-RO, 76BEON-GIL (RD) SE DECISION MADE: 30-JUL-14 UIJEONGBU-SI, GYEONGGI-DO KS 48510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPINE HIP STEM; ALPINE HA HIP STEM ORTHO DEVELOPMENT 510(k) NO: K141001(TRADITIONAL) ATTN: MIKE ENSIGN PHONE NO : 801 553 9991 12187 S. BUSINESS PARK DR. SE DECISION MADE: 30-JUL-14 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTETRAK LOGIC POROUS FEMORAL COMPONENTS EXACTECH, INC. 510(k) NO: K140302(TRADITIONAL) ATTN: PATRICK HUGHES PHONE NO : 352 327 4762 2320 N.W. 66TH CT. SE DECISION MADE: 30-JUL-14 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORPORATION 510(k) NO: K141778(SPECIAL) ATTN: KIRSTEN STOWELL FRANCO PHONE NO : 610 404 3367 100 DENNIS DRIVE SE DECISION MADE: 30-JUL-14 READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEADERFLEX VYGON 510(k) NO: K141026(TRADITIONAL) ATTN: JILLIAN MIKOVICH PHONE NO : 800 473 5414 2750 MORRIS ROAD, SUITE A200 SE DECISION MADE: 30-JUL-14 LANSDALE PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCOMPASS PANORAMIC CORP. 510(k) NO: K141130(TRADITIONAL) ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 30-JUL-14 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPEN FMSEALER DOMAIN SURGICAL, INC. 510(k) NO: K141484(TRADITIONAL) ATTN: CURTIS JENSEN PHONE NO : 801 924 4950 1370 SOUTH 2100 EAST SE DECISION MADE: 30-JUL-14 SALT LAKE SITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K2M MODULAR HOOKS K2M, INC. 510(k) NO: K133402(TRADITIONAL) ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 PO BOX 566 SE DECISION MADE: 30-JUL-14 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELCAM STOPCOCKS AND MANIFOLDS ELCAM MEDICAL ACAL 510(k) NO: K141254(SPECIAL) ATTN: NATASHA BRANZBURG PHONE NO : 972 772568 625 KIBBUTZ BARAM SE DECISION MADE: 30-JUL-14 MP MEROM HAGALIL IS 1386000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIBERTY PDX CYCLER FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K141145(TRADITIONAL) ATTN: DENISE M OPPERMANN PHONE NO : 781 699 4479 920 WINTER STREET SE DECISION MADE: 30-JUL-14 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT BIOMET, INC. 510(k) NO: K140883(TRADITIONAL) ATTN: JOHN HECKAMAN PHONE NO : 574 371 3707 56 EAST BELL DR. BOX 587 SE DECISION MADE: 30-JUL-14 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-FORCE GEN 2 SUTURE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K141011(TRADITIONAL) ATTN: DMITRI FALKNER PHONE NO : 901 290 5883 1023 CHERRY ROAD SE DECISION MADE: 30-JUL-14 MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVER DENTAL ARREST COOLEY CONSULTING, INC. 510(k) NO: K102973(TRADITIONAL) ATTN: WILLIAM COOLEY PHONE NO : 513 522 3797 531 CHISHOLM TRAIL SE DECISION MADE: 31-JUL-14 WYOMING OH 45215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYVEK RADIAL BAND MARINE POLYMER TECHNOLOGIES 510(k) NO: K132293(TRADITIONAL) ATTN: SERGIO FINKIELSZTEIN PHONE NO : 781 270 3200 107 WATER STREET SE DECISION MADE: 31-JUL-14 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSIZE THERENVA SAS 510(k) NO: K141475(TRADITIONAL) ATTN: CEMIL GOKSU PHONE NO : 33 299 283751 2 RUE HENRI LE GUILLOUX SE DECISION MADE: 31-JUL-14 RENNES FR 35000 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: ARGEN PMMA THE ARGEN CORPORATION 510(k) NO: K140894(TRADITIONAL) ATTN: CRAIG JOLICOEUR PHONE NO : 858 455 7900 5855 OBERLIN DRIVE SE DECISION MADE: 31-JUL-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSILIGHT MINI EL GLOBAL TRADE LTD. 510(k) NO: K140527(TRADITIONAL) ATTN: SHLOMIT SEGMAN PHONE NO : 972 9788 9069 TZORAN 4TH ST. SE DECISION MADE: 31-JUL-14 NETANYA IS 42504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGIARC 100AU+ BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K141672(SPECIAL) ATTN: JUNE LI PHONE NO : 861 067892 3558968 B2-2 NEW CITY INDUSTRIAL PARK, NO.SE DECISION MADE: 31-JUL-14 BEIJING CH 100023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S9 GREENHILLS RESMED LTD. 510(k) NO: K140279(TRADITIONAL) ATTN: JIM CASSI PHONE NO : 858 836 6081 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 31-JUL-14 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM SAPHENA MEDICAL, INC. 510(k) NO: K140603(TRADITIONAL) ATTN: CHERYL BLAKE PHONE NO : 949 285 3517 27392 CAPRICHO SE DECISION MADE: 31-JUL-14 MISSION VIEJO CA 92692 510(k) SUMMARY AVAILABLE FROM FDA
Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance
Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.