The Medical Device Business Journal — Medical Device News & Articles | MassDevice
TOTAL 510(k)s THIS PERIOD 238 TOTAL WITH SUMMARIES 222 TOTAL WITH STATEMENTS 16
DEVICE: J-SCREW COMPRESSION SCREW COMPETITIVE ENGINEERING INC. 510(k) NO: K130019(Traditional) ATTN: DAVID M DAVIS PHONE NO : 520 746-0270 106 3371 E. HEMISPHERE LOOP SE DECISION MADE: 18-NOV-14 TUCSON AZ 85706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNEXEF-38G ULTRASOUND SYSTEM TOYOTA TSUSHO CORPORATION 510(k) NO: K131973(Traditional) ATTN: DOUG BLAKELY PHONE NO : 210 240-4521 504 RITTIMAN RD. SE DECISION MADE: 18-NOV-14 SAN ANTONIO TX 78209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICE ZIRKON TRANSLUZENT ZIRKONZAHN SRL 510(k) NO: K132230(Traditional) ATTN: DONNA M HARTNETT PHONE NO : 716 934-3395 67 MAIN STREET SE DECISION MADE: 05-NOV-14 SILVER CREEK NY 14136 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL90 FLEX RADIOMETER MEDICAL APS 510(k) NO: K132691(Traditional) ATTN: SOREN BOGESTRAND PHONE NO : 45 382 73852 AKANDEVEJ 21 SE DECISION MADE: 13-NOV-14 BRONSHOJ DK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INS HILDEN TALUS ARZZL LOCKING NAIL & SCREW TRUEMED GROUP, LLC 510(k) NO: K133166(Traditional) ATTN: RHONDA ALEXANDER PHONE NO : 757 224-0177 144 RESEARCH DR. SE DECISION MADE: 06-NOV-14 HAMPTON VA 23669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAEGER JAUNDICE METER JM-105 DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K133175(Traditional) ATTN: BRYAN OVERTON PHONE NO : 215 6602135 3135 QUARRY RD. SE DECISION MADE: 13-NOV-14 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device BIO-ANALYSIS, INC. 510(k) NO: K133303(Traditional) ATTN: REGINA J O’MEARA PHONE NO : 714 308-6657 27735 TAMARA DRIVE SE DECISION MADE: 19-NOV-14 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIM PROBE SPES MEDICA S.R.L. 510(k) NO: K133348(Traditional) ATTN: GIORGIO FACCO PHONE NO : 390 828 614191 VIA EUROPA-ZONA INDUSTRIALE SE DECISION MADE: 21-NOV-14 BATTIPAGLIA IT 84091 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SGS DENTAL IMPLANT SGS INTERNATIONAL LTD 510(k) NO: K133362(Abbreviated) ATTN: DANIELA LEVY PHONE NO : 213 787-3026 22817 VENTURA BLVD #161 SE DECISION MADE: 21-NOV-14 WOODLAND HILLS CA 91364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS II DORNIER MEDTECH AMERICA, INC. 510(k) NO: K133434(Traditional) ATTN: JOHN HOFFER PHONE NO : 770 514-6163 1155 ROBERTS BLVD. SE DECISION MADE: 26-NOV-14 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation 510(k) NO: K133446(Traditional) ATTN: JOHN LINFANTE PHONE NO : 732 643-6088 1933 HECK AVE SE DECISION MADE: 14-NOV-14 NEPTUNE NJ 07753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDOSS NIBEC CO LTD 510(k) NO: K133507(Traditional) ATTN: DANIEL NAM PHONE NO : 213 626-1544 4568 W. 1ST STREET, STE 104 SE DECISION MADE: 05-NOV-14 LOS ANGELES CA 90004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXAN ANTERIOR CERVICAL PLATE SYSTEM BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K133518(Traditional) ATTN: KIMBERLY MCCOY PHONE NO : 303 465-8923 399 JEFFERSON ROAD SE DECISION MADE: 05-NOV-14 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO, CT LIVER ANALYSIS SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K133643(Traditional) ATTN: KIMBERLY MANGUM PHONE NO : 610 448-4912 51 VALLEY STREAM PARKWAY MAIL CODESE DECISION MADE: 13-NOV-14 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS IQON SPECTRAL CT PHILIPS HEALTHCARE (CLEVELAND) 510(k) NO: K133674(Traditional) ATTN: CATHERINE M CONNELL PHONE NO : 440 483-5581 595 MINER RD. SE DECISION MADE: 21-NOV-14 CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMICARE D900 GRUENDLER GMBH 510(k) NO: K133766(Traditional) ATTN: JIM CASSI PHONE NO : 858 836-6081 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 24-NOV-14 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-LINK Z OSTEO VASIVE LLC 510(k) NO: K133827(Traditional) ATTN: KEVIN A THOMAS PHONE NO : 858 792-1235 12264 EL CAMINO REAL SUITE 400 SE DECISION MADE: 17-NOV-14 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REJUVALITE MD TROPHY SKIN, INC. 510(k) NO: K133896(Traditional) ATTN: SUSAN ANTHONEY-DEWET PHONE NO : 865 329-6882 2424 DEMPSTER DRIVE SE DECISION MADE: 13-NOV-14 CORALVILLE IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIOX VERO AIRWAY INFLAMMATION MONITOR AEROCRINE AB 510(k) NO: K133898(Traditional) ATTN: Susanne Parks PHONE NO : 919 666-2279 5151 MCCRIMMON PARKWAY SE DECISION MADE: 06-NOV-14 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH EXPERT ELCTRONIC STIMULATOR SHENZHEN OSTO TECHNOLOGY COMPANY L510(k) NO: K133929(Traditional) ATTN: LI YANG PHONE NO : 86 755297 69546 N0. 43 LONGFENG ROAD XINSHENG COMMSE DECISION MADE: 12-NOV-14 SHENZHEN CITY, GUANGDONG PROVINCE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANTHEON ELECTROSTIMULATOR PANTHEON RESEARCH 510(k) NO: K133980(Traditional) ATTN: YOLANDA SMITH PHONE NO : 888 729-9674 1468 HARWELL AVE SE DECISION MADE: 07-NOV-14 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM MORTARA INSTRUMENT, INC. 510(k) NO: K133989(Abbreviated) ATTN: AMY YANG PHONE NO : 414 354-1600 7727 7865 NORTH 86TH ST. SE DECISION MADE: 25-NOV-14 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LG SMARTHEALTH LG ELECTRONICS 510(k) NO: K133997(Traditional) ATTN: DIANE SUDDUTH PHONE NO : 512 327-9997 816 CONGRESS AVE. #1400 SE DECISION MADE: 21-NOV-14 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE MODERN MEDICAL EQUIPMENT MANUFACTU510(k) NO: K134006(Traditional) ATTN: THOMAS CHAN TSZ FUNG PHONE NO : 867 698897 8999 35-41 TAI LIN PAI ROAD, 5F GOLD KISE DECISION MADE: 21-NOV-14 HONG KONG CN CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM GENORAY CO., LTD. 510(k) NO: K140041(Traditional) ATTN: KAITLYNN MIN PHONE NO : 714 289-8020 3002 DOW AVENUE SUITE 420 SE DECISION MADE: 28-NOV-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECOTHERM NEO (T NEO) INSPIRATION HEALTHCARE LTD 510(k) NO: K140078(Abbreviated) ATTN: WAYNE IDDON PHONE NO : 44 014 55840555 GILDOR HOUSE, WEST STREET SE DECISION MADE: 14-NOV-14 EARL SHILTON, LEICESTER GB LE9 7E510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSA PERCULTANEOUS DRAINAGE CATHETER COOK INCORPORATED 510(k) NO: K140085(Traditional) ATTN: ELYSIA EASTON PHONE NO : 812 339-2235 750 DANIELS WAY SE DECISION MADE: 18-NOV-14 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED ENCORE MEDICAL, L.P. 510(k) NO: K140130(Traditional) ATTN: TEFFANY HUTTO PHONE NO : 512 834-6255 9800 METRIC BLVD. SE DECISION MADE: 06-NOV-14 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX EMBRACE PERSONAL LUBRICANT RECKITT BENCKISER, LLC 510(k) NO: K140193(Traditional) ATTN: SAPANA AMIN PHONE NO : 973 404-2687 399 INTERPACE PARKWAY SE DECISION MADE: 04-NOV-14 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAIPH KNEE SYSTEM MATORTHO 510(k) NO: K140222(Traditional) ATTN: MARCOS VELEZ-DURAN PHONE NO : 703 562-9800 815 KING STREET SE DECISION MADE: 17-NOV-14 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YONGHE YONGHE PLASTIC PRODUCTS CO., LTD. 510(k) NO: K140244(Traditional) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 06-NOV-14 HAIDAN DIS, BEIJING CN 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YONGFA YONGFA GLOVE CO., LTD. 510(k) NO: K140246(Traditional) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 06-NOV-14 HAIDIAN DIS, BEIJING CN 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERAPLUG KRISHNA IMPORTS INC DBA STEPHENS I510(k) NO: K140352(Traditional) ATTN: ARCHNA JOHNSON PHONE NO : 855 857-0518 2500 SANDERSVILLE RD. SE DECISION MADE: 13-NOV-14 LEXINGTON KY 40511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM TERANG NUSA SDN BHD 510(k) NO: K140355(Traditional) ATTN: ROBERT HILL PHONE NO : 609 774 7171 1, JALAN 8, PENGKALAN CHEPA 2 IND.SE DECISION MADE: 06-NOV-14 KOTA BHARU, KELANTAN MY 16100 510(k) STATEMENT
DEVICE: AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K140382(Traditional) ATTN: DAN LINDSAY PHONE NO : 801 208-4408 1600 WEST MERIT PKWY. SE DECISION MADE: 25-NOV-14 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8" X 2 3/4", 4" X 4 3/4" ENTROTECH LIFE SCIENCES INC. 510(k) NO: K140389(Traditional) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 400-0856 755 N. MATHILDA AVE., STE 100 SE DECISION MADE: 07-NOV-14 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRONICS REUSABLE HEATED TUBING RESPIRONICS, INC. 510(k) NO: K140424(Traditional) ATTN: ALEXANDER L FRIEDMAN PHONE NO : 724 387-5311 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 14-NOV-14 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO GUIDE CATHETER ELITE CORDIS CORP., A JOHNSON & JOHNSON 510(k) NO: K140438(Traditional) ATTN: Michelle Ragozzine Rodgers PHONE NO : 510 248 2450 6500 PASEO PADRE PKWY. SE DECISION MADE: 14-NOV-14 FREMONT CA 94555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIPOD INSULIN MANAGEMENT SYSTEM INSULET CORPORATION 510(k) NO: K140439(Traditional) ATTN: ANTONETTE M DELEO, RAC PHONE NO : 781 457-4913 9 OAK PARK DR. SE DECISION MADE: 13-NOV-14 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 ST. JUDE MEDICAL SYSTEMS AB 510(k) NO: K140466(Traditional) ATTN: Jeffrey Roberts PHONE NO : 978 5773451 PALMBLADSGATAN 10 SE DECISION MADE: 13-NOV-14 UPPSALA SE SE-751 35 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE MARVAO MEDICAL DEVICES, LTD. 510(k) NO: K140492(Traditional) ATTN: CHRISTINE NICHOLS PHONE NO : 508 351-8637 368 WEST MAIN STREET, SUITE 7 SE DECISION MADE: 13-NOV-14 NORTHBOROUGH MA 01532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECVUE MAPPING SYSTEM CARDIOINSIGHT TECHNOLOGIES, INC 510(k) NO: K140497(Traditional) ATTN: CHRISTINA V VACCA PHONE NO : 216 453-5950 11000 CEDAR AVE SUITE 210 SE DECISION MADE: 19-NOV-14 CLEVELAND OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL E SERIES ALS ZOLL MEDICAL CORPORATION 510(k) NO: K140502(Traditional) ATTN: TANMAY B SHUKLA PHONE NO : 978 421-9171 269 MILL ROAD SE DECISION MADE: 06-NOV-14 CHELMSFORD MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 PHILIPS MEDIZIN SYSTEME BOBLINGEN 510(k) NO: K140535(Abbreviated) ATTN: MICHAEL ASMALSKY PHONE NO : 497 031 4631277 HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 25-NOV-14 BOBLINGEN DE D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE CROSSTEX INTERNATIONAL 510(k) NO: K140566(Traditional) ATTN: MICHAEL G NOLAN PHONE NO : 585 359-0130 6789 WEST HENRIETTA ROAD SE DECISION MADE: 24-NOV-14 RUSH NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) MAQUET CARDIOPULMONARY AG 510(k) NO: K140569(Traditional) ATTN: SARAH BETZ PHONE NO : 49 7471 9973440 KEHLER STRASSE 31 SE DECISION MADE: 19-NOV-14 RASTATT DE 76437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOUNDCLOT HEMOSTATIC GAUZE CORE SCIENTIFIC LTD. 510(k) NO: K140573(Traditional) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA’AS STR., SUITE 102 SE DECISION MADE: 24-NOV-14 KFAR SABA IL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCEND ELECTRODE NEUROMETRIX, INC. 510(k) NO: K140586(Traditional) ATTN: RAINER MAAS PHONE NO : 784 314-2781 62 FOURTH AVE. SE DECISION MADE: 17-NOV-14 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. 510(k) NO: K140595(Traditional) ATTN: LOUIS FRIES PHONE NO : 408 733-1901 263 SANTA ANA CT. SE DECISION MADE: 17-NOV-14 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IG_PLEX CELIAC DGP PANEL SQI DIAGNOSTICS SYSTEMS INC. 510(k) NO: K140691(Traditional) ATTN: Kate Smith PHONE NO : 416 674 9500 X239 36 Meteor Dr. SE DECISION MADE: 06-NOV-14 TORONTO, ON CA M9W 1A4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE INTERVENTIONAL SPINE, INC. 510(k) NO: K140716(Traditional) ATTN: JANE METCALF PHONE NO : 949 525-1493 13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 24-NOV-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K140717(Traditional) ATTN: Susan Tibedo PHONE NO : 781 269-3888 2 EDGEWATER DRIVE SE DECISION MADE: 17-NOV-14 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTERA PICOSECOND LASER SYSTEM CUTERA, INC. 510(k) NO: K140727(Traditional) ATTN: BRADLEY RENTON PHONE NO : 415 657-5568 3240 BAYSHORE BLVD SE DECISION MADE: 06-NOV-14 BRISBANE CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA GENTLELASE FAMILY OF LASER SYSTEMS CANDELA CORP. 510(k) NO: K140732(Special) ATTN: SAM WADE PHONE NO : 508 358-7400 330 530 BOSTON POST ROAD SE DECISION MADE: 07-NOV-14 WAYLAND MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL 510(k) NO: K140738(Traditional) ATTN: AUDREY VION PHONE NO : 33 4 72018787 14 PORTE DU GRAND LYON SE DECISION MADE: 04-NOV-14 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT LEPU MEDICAL TECHNOLOGY (BEJING) C510(k) NO: K140768(Traditional) ATTN: ARTHUR GODDARD PHONE NO : 216 233-5722 1531 FELTON ROAD SE DECISION MADE: 25-NOV-14 SOUTH EUCLID OH 44121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPOSITE ORTHODONTIC BRACKETS ORTHO SPECIALTIES 510(k) NO: K140807(Traditional) ATTN: PAULA WENDLAND PHONE NO : 224 420-0125 207 PHEASANT MEADOW CT. SE DECISION MADE: 12-NOV-14 GURNEE IL 60031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART Siemens Healthcare Diagnostics Inc510(k) NO: K140842(Traditional) ATTN: FRANCES A DILLON PHONE NO : 302 631-6951 PO BOX 6101 M/S 514 SE DECISION MADE: 26-NOV-14 NEWARK DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMPOD ST2-3010 NERVE STIMULATOR XAVANT TECHNOLOGY (PTY) LTD 510(k) NO: K140853(Special) ATTN: BRIAN ROTHMAN PHONE NO : 27 12 7559491 Ravello 1st Floor, Delmondo OfficeSE DECISION MADE: 06-NOV-14 PRETORIA, GAUTENG ZA 0081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT Siemens Healthcare Diagnostics Inc510(k) NO: K140859(Traditional) ATTN: FRANCES A DILLON PHONE NO : 302 631-6951 P.O. BOX 6101, M/S 514 SE DECISION MADE: 26-NOV-14 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMETREX LONG TERM HEMODIALYSIS CATHETER PHASE ONE MEDICAL 510(k) NO: K140884(Traditional) ATTN: ADITYA SUKTHANKAR PHONE NO : 516 482-9001 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 26-NOV-14 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTERCROSS CATHETER ROXWOOD MEDICAL, INC. 510(k) NO: K140910(Traditional) ATTN: MEHRDAD FARHANGNIA PHONE NO : 408 373-4751 400 SEAPORT CT, SUITE #103 SE DECISION MADE: 19-NOV-14 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACTION POLYPECTOMY SNARE OVESCO ENDOSCOPY AG 510(k) NO: K140923(Traditional) ATTN: TANJA LINZER PHONE NO : 49 7071 96528169 DORFACKERSTRASSE 26 SE DECISION MADE: 18-NOV-14 TUEBINGEN, BADEN-WUERTTEMBERG DE 510(k) STATEMENT
DEVICE: HIOSSEN IMPLANT SYSTEM HIOSSEN INC. 510(k) NO: K140934(Traditional) ATTN: PATRICK LIM PHONE NO : 888 678-0001 85 BEN FAIRLESS DRIVE SE DECISION MADE: 12-NOV-14 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YEESCOPE LARYNGOSCOPES YEESCOPE PTY. LTD. 510(k) NO: K140951(Traditional) ATTN: PAUL DRYDEN PHONE NO : 239 4982155 10 BINNEY ROAD SE DECISION MADE: 10-NOV-14 KINGS PARK, NSW AU 2148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Trauma AG 510(k) NO: K140961(Traditional) ATTN: NESLI KARAKAYA, RAC PHONE NO : 41 32 6416930 BOHNACKERWEG 1 SE DECISION MADE: 10-NOV-14 SELZACH CH CH-2545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMGUARD SMART-FOLD STERILIZATION WRAP KIMBERLY-CLARK CORP. 510(k) NO: K140963(Traditional) ATTN: THOMAS KOZMA, PH.D. PHONE NO : 770 587-8393 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 10-NOV-14 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANT MODEL 1 ADVANCED NUCLIDE TECHNOLOGIES, LLC510(k) NO: K141038(Traditional) ATTN: SERGEY BAKLANOV, PH.D. PHONE NO : 267 253-2271 21756 GREEN STABLE SQ #309 SE DECISION MADE: 12-NOV-14 ASHBURN VA 20147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GARMENT ELECTRODES SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K141076(Traditional) ATTN: QILIAN LIU PHONE NO : 86 755 27652471 XILIXIAOBAIMANG SE DECISION MADE: 14-NOV-14 SHENZHEN, GUANGDONG CN 518108 510(k) STATEMENT
DEVICE: APEX INCONTROL MEDICAL, LLC 510(k) NO: K141158(Traditional) ATTN: JESSICA ANDRESHAK PHONE NO : 262 373-0422 3225 GATEWAY ROAD, SUITE 250 SE DECISION MADE: 26-NOV-14 BROOKFIELD WI 53045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FM-3000 FETAL MONITOR ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K141194(Traditional) ATTN: JORGE MILLAN PHONE NO : 305 9251260 601 WEST 20 STREET SE DECISION MADE: 19-NOV-14 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY ZELLER POWER PRODUCTS (BATTERY BEA510(k) NO: K141231(Traditional) ATTN: DOUGLAS AUSTIN PHONE NO : 702 609-9213 3975 WEST POST ROAD SE DECISION MADE: 25-NOV-14 LAS VEGAS NV 89118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR STERILUCENT, INC 510(k) NO: K141238(Traditional) ATTN: PETER KALKBRENNER PHONE NO : 612 767-3253 1400 MARSHALL STREET NE SE DECISION MADE: 03-NOV-14 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS BIOMET MANUFACTURING CORP. 510(k) NO: K141263(Traditional) ATTN: JARED COOPER PHONE NO : 574 372-1941 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 19-NOV-14 WARSAW IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTC COMBO TENS/EMS SYSTEM WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K141299(Traditional) ATTN: CHIN-CHIH HSIEH PHONE NO : 886 229 282112 1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 14-NOV-14 YUNGHE CITY, TAIPEI COUNTY TW 234510(k) STATEMENT
DEVICE: ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE, INC. 510(k) NO: K141317(Traditional) ATTN: JUSTIN EGGLETON PHONE NO : 202 552-5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 17-NOV-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE SPINEFRONTIER, INC. 510(k) NO: K141333(Traditional) ATTN: MEREDITH MAY MS, RAC PHONE NO : 719 337-7579 4628 NORTHPARK DRIVE SE DECISION MADE: 25-NOV-14 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAT STREP A ASSAY IQUUM INC 510(k) NO: K141338(Traditional) ATTN: Lingjun Chen PHONE NO : 508 970-0099 700 NICKERSON ROAD SE DECISION MADE: 04-NOV-14 MARLBOROUGH MA 01762-4663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CL DETECT RAPID TEST INBIOS INTERNATIONAL INC. 510(k) NO: K141341(Traditional) ATTN: ESTELA RAYCHAUDHURI PHONE NO : 206 344-5821 562 1ST AVE S STE 600 SE DECISION MADE: 14-NOV-14 SEATTLE WA 98104 510(k) STATEMENT
DEVICE: WEARABLE THERAPY GARMENTS AXIOBIONICS LLC 510(k) NO: K141342(Traditional) ATTN: ROBERT J BARD PHONE NO : 248 573-5040 PO BOX 506 SE DECISION MADE: 14-NOV-14 SOUTH LYON MI 48178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS FX2 Tornier SAS 510(k) NO: K141345(Traditional) ATTN: MAUD ANDRIOLLO PHONE NO : 33 4 76613500 161 RUE LAVOISIER SE DECISION MADE: 18-NOV-14 MONTBONNOT SAINT MARTIN FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD MERETE MEDICAL GMBH 510(k) NO: K141377(Traditional) ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 49 30 779920114 ALT LANKWITZ 102 SE DECISION MADE: 21-NOV-14 BERLIN DE 12247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERMITTENT PNEUMATIC COMPRESSION DEVICE WUHAN LANDING MEDICAL HI-TECH LTD 510(k) NO: K141390(Traditional) ATTN: YAN LIU PHONE NO : 86 000-0000 0000 818 GAOXIN RD EAST LAKE HIGH TECH SE DECISION MADE: 18-NOV-14 WUHAM CN 430206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K141408(Traditional) ATTN: CLEA FEIGHT PHONE NO : 801 826-4019 1600 WEST MERIT PKWY. SE DECISION MADE: 26-NOV-14 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS DENTIUM CO. LTD. 510(k) NO: K141457(Abbreviated) ATTN: SHERYL HIGGINS PHONE NO : 714 226-0229 107 6761 KATELLA AVE. SE DECISION MADE: 12-NOV-14 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIA-NCI NEUROCHAOS SOLUTIONS, INC. 510(k) NO: K141462(Traditional) ATTN: ELISA MALDONADO-HOLMERTZ PHONE NO : 512 431-6069 12416 FAIRFAX RIDGE PLACE SE DECISION MADE: 19-NOV-14 AUSTIN TX 78738 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOURNEY II XR KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K141471(Traditional) ATTN: Shereen Bienz PHONE NO : 901 399-6325 7135 GOODLET FARM PARKWAY SE DECISION MADE: 14-NOV-14 CORDOVA TN 38018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENALI 501CEMENT DENALI CORPORATION 510(k) NO: K141503(Traditional) ATTN: JAN G STANNARD PHONE NO : 781 826-9190 134 OLD WASHINGTON STREET SE DECISION MADE: 10-NOV-14 HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLY UPS COOPER SURGICAL, INC. 510(k) NO: K141523(Traditional) ATTN: TIM M LOHNES PHONE NO : 203 922-0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 25-NOV-14 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN:C2 SPINAL FIXATION SYSTME SPINESMITH HOLDINGS, LLC 510(k) NO: K141537(Traditional) ATTN: CLIFTON (CHRIS) NAIVAR PHONE NO : 512 637-2068 93 RED RIVER SE DECISION MADE: 25-NOV-14 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE LUTRONIC CORPORATION 510(k) NO: K141555(Traditional) ATTN: JHUNG W VOJIR PHONE NO : 215 205-2219 6 NESHAMINY INTERPLEX, SUITE 100 SE DECISION MADE: 06-NOV-14 TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM ORTHOFIX SRL 510(k) NO: K141571(Traditional) ATTN: TROY BROOKS PHONE NO : 214 937-2047 3451 PLANO PARKWAY SE DECISION MADE: 12-NOV-14 LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH UNIMICRO MEDICAL SYSTEMS (SHENZHEN510(k) NO: K141593(Traditional) ATTN: LONG YANG PHONE NO : 86 755 86664986 R15-08, EAST BUILDING, YIHAI PLAZASE DECISION MADE: 13-NOV-14 SHENZHEN, GUANGDONG CN 518054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL GOWN COBES INDUSTRIES CO., LTD. 510(k) NO: K141606(Traditional) ATTN: LYNN FU PHONE NO : 86 755 26903311 23 DENGLIANG ROAD HANKING CENTER 7SE DECISION MADE: 17-NOV-14 SHENZHEN, GUANGDONG CN 518052 510(k) STATEMENT
DEVICE: CLEANERXT ROTATIONAL THROMBECTOMY SYSTEM, CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM REX MEDICAL, L.P. 510(k) NO: K141617(Traditional) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516 482-9001 55 NORTHERN BOULBEVARD SE DECISION MADE: 14-NOV-14 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE SHANTOU WEALY MEDICAL INSTRUMENT C510(k) NO: K141640(Traditional) ATTN: CHARMAINE HENDERSON PHONE NO : 925 212-5264 570 SILVERADO DRIVE SE DECISION MADE: 19-NOV-14 LAFAYETTE CA 94549 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVASIS CRANIAL SYSTEM INNOVASIS, INC. 510(k) NO: K141644(Traditional) ATTN: MARSHALL MCCARTY PHONE NO : 801 261-2236 614 E 3900 S SE DECISION MADE: 07-NOV-14 SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEX SUPPORT CATHETER REFLOW MEDICAL 510(k) NO: K141649(Traditional) ATTN: Rebecca K Pine PHONE NO : 760 809-5178 1003 Calle Sombra SE DECISION MADE: 05-NOV-14 San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K141668(Traditional) ATTN: JANET C KAY PHONE NO : 609 750-2864 311 ENTERPRISE DR. SE DECISION MADE: 06-NOV-14 PLAINSBORO NJ 08535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K141674(Traditional) ATTN: TIMOTHY CONNORS PHONE NO : 609 750-2864 311 ENTERPRISE DR. SE DECISION MADE: 06-NOV-14 PLAINSBORO NJ 08535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM Renovis Surgical Technologies, Inc510(k) NO: K141676(Traditional) ATTN: Sharyn Orton, Ph.D. PHONE NO : 401 330-8264 200 HOMER AVE. SE DECISION MADE: 04-NOV-14 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc. 510(k) NO: K141682(Traditional) ATTN: STEVEN J CHARTIER PHONE NO : 781 345-9593 34 THIRD AVE SE DECISION MADE: 24-NOV-14 BURLINGTON MA 01803 510(k) STATEMENT
DEVICE: INTERNAL HYDRATING GEL COMBE INCORPORATED 510(k) NO: K141718(Traditional) ATTN: PUSHPA RAO PHONE NO : 914 461-4458 1101 WESTCHESTER AVE. SE DECISION MADE: 13-NOV-14 WHITE PLAINS NY 10604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUILION PRIME, V6.00 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K141741(Traditional) ATTN: ORLANDO TADEO PHONE NO : 714 669-7459 2441 MICHELLE DRIVE SE DECISION MADE: 26-NOV-14 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K141755(Special) ATTN: REN YUNHUA PHONE NO : 865 718 1957767 BLDG 2, NO. 202, ZHENZHONG RD WESTSE DECISION MADE: 19-NOV-14 HANGZHOU, ZHEJIANG CN 310030 510(k) STATEMENT
DEVICE: PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY NANOSTRING TECHNOLOGIES INC. 510(k) NO: K141771(Traditional) ATTN: SYLVA KRIZAN PHONE NO : 208 432-8854 530 FAIRVIEW AVE N, SUITE 2000 SE DECISION MADE: 07-NOV-14 SEATTLE WA 98109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL X SERIES ZOLL MEDICAL CORPORATION 510(k) NO: K141774(Traditional) ATTN: TAMMAY SHUKLA PHONE NO : 978 421-9171 269 MILL ROAD SE DECISION MADE: 19-NOV-14 CHELMSFORD MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS TOUCH SYSTEM HONEYWELL HOMMED 510(k) NO: K141792(Traditional) ATTN: CLAUDIA JACKSON PHONE NO : 262 252-5838 3400 INTERTECH DRIVE SE DECISION MADE: 25-NOV-14 BROOKFIELD WI 53045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO-MARYLAND DISSECTOR OVESCO ENDOSCOPY AG 510(k) NO: K141794(Traditional) ATTN: TANJA R LINZER PHONE NO : 49 7071 96528169 DORFACKERSTRASSE 26 SE DECISION MADE: 19-NOV-14 TUEBINGEN, BADEN-WUERTTEMBERG DE 510(k) STATEMENT
DEVICE: MORTARA MONITORING WAVEFORM VIEWER MORTARA INSTRUMENT, INC. 510(k) NO: K141811(Abbreviated) ATTN: AMY YANG PHONE NO : 414 354-1600 7727 7865 NORTH 86TH ST. SE DECISION MADE: 19-NOV-14 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER ETCH PREMIER DENTAL PRODUCTS CO. 510(k) NO: K141839(Traditional) ATTN: VINCENT D’ALESSANDRO PHONE NO : 610 239-6000 1710 ROMANO DR. SE DECISION MADE: 17-NOV-14 PLYMOUTH MEETING PA 19462 510(k) STATEMENT
DEVICE: RESCAN 700, CALLISTO EYE CARL ZEISS MEDITEC AG 510(k) NO: K141844(Traditional) ATTN: MANDY AMBRECHT PHONE NO : 925 557-4561 5160 HACIENDA DRIVE SE DECISION MADE: 18-NOV-14 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUDOSCAN IMPETO MEDICAL INC 510(k) NO: K141872(Traditional) ATTN: Calley Herzog PHONE NO : 720 883-3633 400 N. WASHINGTON ST., STE 100 MEDSE DECISION MADE: 21-NOV-14 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEAF PATIENT MONITORING SYSTEM LEAF HEALTHCARE, INC. 510(k) NO: K141877(Traditional) ATTN: RONALD S WARREN PHONE NO : 408 505-3926 755 N MATHILDA AVE. SUITE 100 SE DECISION MADE: 10-NOV-14 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBSIDIAN PRESS (ALL CERAMIC AND POM) PRISMATIK DENTALCRAFT, INC. 510(k) NO: K141887(Traditional) ATTN: ARMIN ZEHTABCHI PHONE NO : 949 399-1940 2212 DUPONT DRIVE, SUITE P SE DECISION MADE: 06-NOV-14 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT SYSTEM NUVASIVE, INCORPORATED 510(k) NO: K141896(Traditional) ATTN: OLGA LEWIS PHONE NO : 858 320-5257 7475 LUSK BOULEVARD SE DECISION MADE: 20-NOV-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN DENTAL MEMBRANE – CONFORMABLE PP COLLAGEN MATRIX, INC. 510(k) NO: K141909(Traditional) ATTN: PEGGY HANSEN PHONE NO : 201 405-1477 15 THORNTON ROAD SE DECISION MADE: 05-NOV-14 OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR Roche Diagnostics Operations (RDO)510(k) NO: K141928(Traditional) ATTN: NOEL K MENCIAS PHONE NO : 317 5213172 9115 Hague Road SE DECISION MADE: 25-NOV-14 Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET Teleflex Medical, Inc. 510(k) NO: K141939(Traditional) ATTN: JAMES A COCHIE PHONE NO : 919 433-2703 2917 WECK DR. SE DECISION MADE: 24-NOV-14 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCHASMART COLUMN TELEFLEX, INC. 510(k) NO: K141940(Traditional) ATTN: Amanda Webb PHONE NO : 919 4338050 2917 WECK DR. SE DECISION MADE: 24-NOV-14 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDLINE II TI CENTINEL SPINE, INC. 510(k) NO: K141942(Traditional) ATTN: JUSTIN EGGLETON PHONE NO : 202 552-5800 1331 H. ST. NW, 12TH FLOOR SE DECISION MADE: 07-NOV-14 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED ETHICON ENDO-SURGERY, INC. 510(k) NO: K141952(Traditional) ATTN: LINDA HILL PHONE NO : 513 337-4623 4545 CREEK ROAD SE DECISION MADE: 24-NOV-14 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERB ENDORECTAL BALLOON EDGE MEDICAL LLC 510(k) NO: K141958(Traditional) ATTN: GREGORY MATHISON PHONE NO : 218 387-1559 3924 CASCADE BEACH RD. SE DECISION MADE: 18-NOV-14 LUTSEN MN 55612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUREFILL OXYGEN COMPRESSOR INOVO, INC. 510(k) NO: K141967(Traditional) ATTN: PAUL DRYDEN PHONE NO : 239 498-2155 401 Leonard Blvd N SE DECISION MADE: 07-NOV-14 Lehigh Acres FL 33971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE NVM5 SYSTEM NUVASIVE, INC. 510(k) NO: K141968(Traditional) ATTN: JEREMY MARKOVICH PHONE NO : 858 320-4515 7475 LUSK BLVD. SE DECISION MADE: 14-NOV-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141977(Traditional) ATTN: NADIA SOOKDEO PHONE NO : 610 448-4918 51 VALLEY STREAM PARKWAY SE DECISION MADE: 19-NOV-14 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION 510(k) NO: K141989(Special) ATTN: JONATHAN REEVES PHONE NO : 954 927-2044 2555 DAVIE ROAD SE DECISION MADE: 13-NOV-14 FORT LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE HUMERAL SHOULDER STEM ENCORE MEDICAL, L.P. 510(k) NO: K141990(Traditional) ATTN: TEFFANY HUTTO PHONE NO : 512 834-6255 9800 METRIC BLVD. SE DECISION MADE: 07-NOV-14 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAKOMA ACP ALLIANCE PARTNERS, LLC 510(k) NO: K141993(Traditional) ATTN: KELLEN HILLS PHONE NO : 901 433-1990 8215 4600 E SHELBY DR SE DECISION MADE: 06-NOV-14 MEMPHIS TN 38118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BULK FILL FLOWABLE COMPOSITE NOVOCOL, INC. 510(k) NO: K141994(Traditional) ATTN: CORA BRACHO-TROCONIS PHONE NO : 303 665-7535 416 SOUTH TAYLOR AVE. SE DECISION MADE: 14-NOV-14 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS CORPAK MEDSYSTEMS 510(k) NO: K142012(Traditional) ATTN: STEPHANIE WASIELEWKI PHONE NO : 847 403-3484 1001 ASBURY DR. SE DECISION MADE: 20-NOV-14 BUFFALO GROVE IL 60089 510(k) STATEMENT
DEVICE: CAPRI K2M, INC. 510(k) NO: K142016(Traditional) ATTN: NANCY GIEZEN PHONE NO : 709 777-3155 751 MILLER DR.,SE SE DECISION MADE: 06-NOV-14 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARVAL DEBRIDEMENT THERAPY PRODUCTS – LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 BIOMONDE 510(k) NO: K142020(Traditional) ATTN: ROSINA ROBINSON, RN, MED, RPHONE NO : 508 597-6000 62 FOREST STREET, STE 300 SE DECISION MADE: 05-NOV-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNA INTERBODY SYSTEM BENVENUE MEDICAL, INC. 510(k) NO: K142023(Traditional) ATTN: CINDY DOMECUS, R.A.C. (US &PHONE NO : 650 343-4813 1171 BARROILHET DR. SE DECISION MADE: 20-NOV-14 HILLSBOROUGH CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HOLOGIC, INC. 510(k) NO: K142029(Traditional) ATTN: SARAH FAIRFIELD PHONE NO : 508 263-8857 250 CAMPUS DRIVE SE DECISION MADE: 26-NOV-14 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPERT FLU/RSV XC ASSAY CEPHEID 510(k) NO: K142045(Traditional) ATTN: SCOTT A CAMPBELL,PH.D.,MBA PHONE NO : 847 228-3299 904 CARIBBEAN DRIVE SE DECISION MADE: 22-NOV-14 SUNNYVALE CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EIDON CENTERVUE SPA 510(k) NO: K142047(Traditional) ATTN: ROGER GRAY PHONE NO : 39 06 5782665 PIAZZA ALBANIA, 10 SE DECISION MADE: 12-NOV-14 ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSOM ANTERIOR CERVICAL PLATE NEUROSTRUCTURES, INC. 510(k) NO: K142060(Traditional) ATTN: MEREDITH MAY PHONE NO : 719 337-7579 4628 NORTHPARK DR. SE DECISION MADE: 18-NOV-14 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRAL FLOW PERIPHERAL VASCULAR GRAFT VASCULAR FLOW TECHNOLOGIES LTD 510(k) NO: K142062(Special) ATTN: EDWIN LINDSAY PHONE NO : 447 917 134922 Prospect Business Centre GEMINI CRSE DECISION MADE: 20-NOV-14 Dundee GB DD2 1TY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURNPIKE CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K142065(Traditional) ATTN: ELLIE GILLESPIE PHONE NO : 763 656-4300 6464 Sycamore Court North SE DECISION MADE: 25-NOV-14 Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERO-LL LUMBAR CAGE SYSTEM STRYKER CORPORATION 510(k) NO: K142066(Traditional) ATTN: TIFFANI ROGERS PHONE NO : 201 760-8206 2 PEARL COURT SE DECISION MADE: 13-NOV-14 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) CUSTOM ORTHOPAEDIC SOLUTIONS, INC.510(k) NO: K142072(Traditional) ATTN: JUSTIN J BAKER,PHD PHONE NO : 216 445-2164 10000 CEDAR AVENUE SE DECISION MADE: 24-NOV-14 CLEVELAND OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V20 SYSTEM VIORA LTD. 510(k) NO: K142093(Traditional) ATTN: OMRI KESLER PHONE NO : 972 9955 1344 3 MASKIT STREET SE DECISION MADE: 14-NOV-14 HERZLYIA IL 46733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA PET/MR GE MEDICAL SYSTEMS, LLC 510(k) NO: K142098(Traditional) ATTN: ROBIN MARTIN PHONE NO : 414 336-9228 3000 N GRANDVIEW BLVD. SE DECISION MADE: 24-NOV-14 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTANEOUS ELECTRODES BIO PROTECH, INC. 510(k) NO: K142099(Traditional) ATTN: Terry Kim PHONE NO : 82 33 7357720 Donghwa Medical Instrument ComplexSE DECISION MADE: 17-NOV-14 Wonju-si, Gangwon-do KR 220-801 510(k) STATEMENT
DEVICE: AIXPLORER SUPERSONIC IMAGINE 510(k) NO: K142100(Traditional) ATTN: AURELIE GRUENER PHONE NO : 33 442 992424 Les Jardins de la Duranne bat. E &SE DECISION MADE: 20-NOV-14 AIX-EN-PROVENCE FR 13857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT PRISMATIK DENTALCRAFT, INC. 510(k) NO: K142115(Traditional) ATTN: BRANDON SHEPARD PHONE NO : 949 225-1243 2212 DUPONT DRIVE, SUITE P SE DECISION MADE: 13-NOV-14 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE PRISMATIK DENTALCRAFT, INC. 510(k) NO: K142118(Traditional) ATTN: BRANDON SHEPARD PHONE NO : 949 225-1243 2212 DUPONT DRIVE SUITE P SE DECISION MADE: 25-NOV-14 IRVINE CA 92627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMR 40MM GLENOSPHERE LIMACORPORATE S.P.A. 510(k) NO: K142139(Traditional) ATTN: STEPHEN PEOPLES PHONE NO : 260 645-0327 5010 LODGE POLE LANE SE DECISION MADE: 07-NOV-14 FORT WAYNE IN 46814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEVA SYSTEM AUXOGYN, INC. 510(k) NO: K142147(Traditional) ATTN: JULIA S ANASTAS PHONE NO : 650 763-3875 1490 O’BRIEN DRIVE, SUITE A SE DECISION MADE: 24-NOV-14 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K142161(Traditional) ATTN: AMITA SHAH PHONE NO : 781 345-9164 28 Crosby Dr SE DECISION MADE: 14-NOV-14 Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLIDESHEATH SLENDER Terumo Medical Corporation 510(k) NO: K142183(Special) ATTN: Erin Doyle PHONE NO : 410 392-7243 950 ELKTON BLVD SE DECISION MADE: 21-NOV-14 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM VERSE SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K142185(Traditional) ATTN: CATHERINE KILSHAW PHONE NO : 508 880-8412 325 PARAMOUNT DR SE DECISION MADE: 19-NOV-14 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK MP RECONSTRUCTION PROSTHESIS WALDEMAR LINK GMBH & CO. KG 510(k) NO: K142187(Traditional) ATTN: THOMAS MEHLER PHONE NO : 49 40 539950 BARKHAUSENWEG 10 SE DECISION MADE: 06-NOV-14 HAMBURG DE 22339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 KONICA MINOLTA INC. 510(k) NO: K142197(Traditional) ATTN: SHIGEYUKI KOJIMA PHONE NO : 81 42589 8429 1 SAKUA-MACHI SE DECISION MADE: 21-NOV-14 HINO-SHI JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atricure Cryo Module System; cryoICE cryoablation probe ATRICURE, INC. 510(k) NO: K142203(Traditional) ATTN: Jonathan McElwee PHONE NO : 513 6444249 6217 CENTRE PARK DRIVE SE DECISION MADE: 25-NOV-14 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Power Twin21-50/Power Twin21-100 LIVETEC GMBH 510(k) NO: K142215(Traditional) ATTN: Klaus Reichebach PHONE NO : 49 7621 1618960 Marie-Curie-Str. 8 SE DECISION MADE: 07-NOV-14 Loerrach DE D 79539 510(k) STATEMENT
DEVICE: GammaBeam 100 Best Theratronics Limited 510(k) NO: K142219(Special) ATTN: Mike de van der Schueren PHONE NO : 1 613 5912100 413 March Road SE DECISION MADE: 13-NOV-14 Ottawa CA k2k 0e4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYFIELD Skull Clamp INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K142238(Traditional) ATTN: Brian Hoy PHONE NO : 1 513 5337544 311 ENTERPRISE DR. SE DECISION MADE: 24-NOV-14 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LessRay with Tracking SAFERAY SPINE, LLC 510(k) NO: K142243(Traditional) ATTN: Michael Alrutz PHONE NO : 919 3239730 5102 Durham Chapel Hill Blvd. SuitSE DECISION MADE: 18-NOV-14 Durham NC 27707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVS AS PEEK Spacer Stryker Corporation 510(k) NO: K142251(Traditional) ATTN: Garry T Hayeck PHONE NO : 1 201 7608043 2 Pearl Court Stryker Spine DivisiSE DECISION MADE: 19-NOV-14 Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector St. Jude Medical 510(k) NO: K142254(Special) ATTN: Geena George PHONE NO : 1 818 4932629 15900 Valley View Court SE DECISION MADE: 13-NOV-14 Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE Snare Endovascular Microsnare System MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K142265(Traditional) ATTN: Mark Mullaney PHONE NO : 35 391703 700 3061 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 13-NOV-14 GALWAY IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE HARTALEGA SDB. BHD. 510(k) NO: K142270(Traditional) ATTN: KUAN KAM HON PHONE NO : 603 6277 1733 DATARAN SD PJU9 SE DECISION MADE: 25-NOV-14 BANDAR SRI DAMANSARA MY 52200 510(k) STATEMENT
DEVICE: SNaP Wound Care System SPIRACUR, INC. 510(k) NO: K142272(Traditional) ATTN: Lawrence Hu PHONE NO : 408 7015300 1180 BORDEAUX DRIVE SE DECISION MADE: 25-NOV-14 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KangLi pedical screw spinal system SUZHOU KANGLI ORTHOPAEDICS INSTRUM510(k) NO: K142290(Traditional) ATTN: Jin Hua Huang PHONE NO : 86 0512 58560562 SHA ZHOU EAST ROAD SE DECISION MADE: 24-NOV-14 ZHANGJIAGANG CITY CN 215625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Speed, Speed Shift, Speed Titan, Speed Arc BioMedical Enterprises, Inc. 510(k) NO: K142292(Traditional) ATTN: Joe Soward PHONE NO : 1 210 6770354 14785 Omicron Dr., Suite 205 SE DECISION MADE: 17-NOV-14 San Antonio TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoRoent Small Interlock System NUVASIVE, INCORPORATED 510(k) NO: K142299(Traditional) ATTN: Cynthia Adams PHONE NO : 1 858 3204549 7475 LUSK BLVD. SE DECISION MADE: 25-NOV-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath COOK VASCULAR, INC. 510(k) NO: K142301(Traditional) ATTN: Thomas J. Kardos PHONE NO : 724 845 8621 2225 1186 MONTGOMERY LANE SE DECISION MADE: 12-NOV-14 VANDERGRIFT PA 15690 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeumoFilt Ergo/Neumo Filt BiteOn Medical Respiratory Devices S.L. 510(k) NO: K142303(Traditional) ATTN: Jose Alberto Hernandez PHONE NO : 34 91 6745003 Avda. de las Americas 4, Nave A7 SE DECISION MADE: 20-NOV-14 Coslada(Madrid) ES 28823 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINOP Disposable Introducer 26F AESCULAP, INC. 510(k) NO: K142315(Special) ATTN: KATHY RACOSKY PHONE NO : 610 984 9072 3773 Corporate Parkway SE DECISION MADE: 14-NOV-14 Center Valley PA 18034 510(k) STATEMENT
DEVICE: Amedica Valeo II Interbody Fusion Device Amedica Corp 510(k) NO: K142347(Traditional) ATTN: William D Jordan PHONE NO : 801 8393562 1885 West 2100 South SE DECISION MADE: 18-NOV-14 Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hospira Primary Sets HOSPIRA, INC. 510(k) NO: K142367(Traditional) ATTN: CATHERINE KANG PHONE NO : 224 212 4421 375 N. FIELD DRIVE SE DECISION MADE: 25-NOV-14 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Variolink Esthetic IVOCLAR VIVADENT AG 510(k) NO: K142389(Abbreviated) ATTN: SANDRA CAKEBREAD PHONE NO : 423 2353535 BENDERERSTRASSE 2 SE DECISION MADE: 25-NOV-14 SCHAAN LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREDICATE III GUIDEWIRE LAKE REGION MEDICAL 510(k) NO: K142393(Special) ATTN: MATHEW PEXA PHONE NO : 1 952 4485111 340 LAKE HAZELTINE DR. SE DECISION MADE: 25-NOV-14 CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Root Monitoring System and Accesories MASIMO CORPORATION 510(k) NO: K142394(Traditional) ATTN: MARGUERITE THOMLINSON PHONE NO : 1 949 2977683 40 PARKER SE DECISION MADE: 25-NOV-14 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DualCap IV Pole Strips(Disinfectant Caps for Male Luers) CATHETER CONNECTIONS, INC. 510(k) NO: K142399(Traditional) ATTN: Donald d Soloman PHONE NO : 1 801 2091269 2455 E Parleys Way – Suite 150 SE DECISION MADE: 19-NOV-14 Salt Lake City UT 84109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System ZIMMER GMBH 510(k) NO: K142403(Traditional) ATTN: Roberto Tommasini PHONE NO : 41 588 548264 SULZERALLEE 8 SE DECISION MADE: 24-NOV-14 WINTERTHUR CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN Modular Total Shoulder System Ascension Orthopedics 510(k) NO: K142413(Traditional) ATTN: Jay Patel PHONE NO : 609 2752754 8700 Cameron Road SE DECISION MADE: 14-NOV-14 Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR300 HOLTER MONITOR NORTH EAST MONITORING INC. 510(k) NO: K142424(Traditional) ATTN: SHERRY STEELE PHONE NO : 978 4613992 2 CLOCK TOWER PLACE, STE 555 SE DECISION MADE: 25-NOV-14 MAYNARD MA 01754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shock Pulse-SE Lithotripsy System CYBERWAND II CYBERSONICS, INC. 510(k) NO: K142428(Traditional) ATTN: Jeff Vaitekunas PHONE NO : 814 9201521 5340 Fryling Road SE DECISION MADE: 13-NOV-14 Erie PA 16510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142434(Traditional) ATTN: CHRISTINE DUNBAR PHONE NO : 925 2935442 757 "A" ARNOLD DRIVE SE DECISION MADE: 21-NOV-14 MARTINEZ CA 94553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCU-GUARD Peripheral Vascular Patch Synovis Life Technologies Inc. 510(k) NO: K142461(Traditional) ATTN: Jodi Jorgenson PHONE NO : 651 7967399 2575 University Ave. W. SE DECISION MADE: 25-NOV-14 St. Paul MN 55129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restoration Anatomic Shell STRYKER ORTHOPAEDICS 510(k) NO: K142462(Traditional) ATTN: Denise Daugert PHONE NO : 201 8315413 325 Corporate Drive SE DECISION MADE: 14-NOV-14 Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelAir Nasal Airway Support System ABEON MEDICAL CORPORATION 510(k) NO: K142467(Special) ATTN: ALLISON SLAGA PHONE NO : 440 2626000 8000 KATHERINE BOULEVARD SE DECISION MADE: 24-NOV-14 BRECKSVILLE OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Shield Multi-paried Subdermal Needle Electrodes NEUROINVENT INC. 510(k) NO: K142470(Special) ATTN: CHAO SHENT-CHAO PHONE NO : 917 9153568 19925 STEVENS CREEK BLVD., STE 100SE DECISION MADE: 05-NOV-14 CUPERTINO CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unimed Disposable ECG lead wires UNIMED MEDICAL SUPPLIES INC. 510(k) NO: K142489(Traditional) ATTN: Tan Xinmei PHONE NO : 86 755 26695165 NO.37, YANSHAN ROAD, SHEKOU SE DECISION MADE: 04-NOV-14 SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collagen Dental Membrane – Conformable IIBP COLLAGEN MATRIX, INC. 510(k) NO: K142496(Traditional) ATTN: GLORIA ZUCLICH PHONE NO : 201 4051477 15 THORNTON ROAD SE DECISION MADE: 24-NOV-14 OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reline System NUVASIVE, INCORPORATED 510(k) NO: K142499(Traditional) ATTN: Olga Lewis PHONE NO : 1 858 3205257 7475 LUSK BOULEVARD SE DECISION MADE: 19-NOV-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System CEPHEID 510(k) NO: K142501(Traditional) ATTN: KERRY J. FLOM PHONE NO : 1 408 4008460 904 CARIBBEAN DRIVE SE DECISION MADE: 26-NOV-14 SUNNYVALE CA 94089-1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens Synergeyes, Inc. 510(k) NO: K142510(Traditional) ATTN: Steven L. Ziemba PHONE NO : 1 760 4449687 2232 Rutherford Road SE DECISION MADE: 19-NOV-14 Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Barricade Embolization Coil System BLOCKADE MEDICAL 510(k) NO: K142513(Special) ATTN: Rebecca K Pine PHONE NO : 1 760 8095178 18 Technology Dr Ste 169 SE DECISION MADE: 13-NOV-14 Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software Smith & Nephew, Inc 510(k) NO: K142520(Special) ATTN: Martin Ostmann PHONE NO : 901 3991809 1450 Brooks Road SE DECISION MADE: 20-NOV-14 Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PK Lap Loop Olympus Winter & Ibe GmbH 510(k) NO: K142525(Traditional) ATTN: Graham A.L. Baillie PHONE NO : Kuehnstrasse 61 SE DECISION MADE: 21-NOV-14 Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments MICROPORT ORTHOPEDICS INC. 510(k) NO: K142550(Traditional) ATTN: Caroline Fryar PHONE NO : 901 2905100 5677 AIRLINE RD SE DECISION MADE: 07-NOV-14 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter Stryker Neurovascular 510(k) NO: K142565(Special) ATTN: Yoko Enrile PHONE NO : 1 510 4132619 47900 Bayside Parkway SE DECISION MADE: 14-NOV-14 Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PhaLinx Hammertoe System WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K142585(Traditional) ATTN: VAL MYLES PHONE NO : 901 2905162 1023 CHERRY ROAD SE DECISION MADE: 20-NOV-14 MEMPHIS TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vertical Expandable Prosthetic Titanium Rib Depuy Synthes Spine, Inc. 510(k) NO: K142587(Traditional) ATTN: Catherine Kilshaw PHONE NO : 508 8808412 325 Paramount Drive SE DECISION MADE: 18-NOV-14 Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AngioVac Cannula AngioDynamics, Inc. 510(k) NO: K142593(Traditional) ATTN: Wanda Carpinella PHONE NO : 1 508 6587929 26 Forest Street SE DECISION MADE: 12-NOV-14 Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: nva, nvp, nvt NVISION BIOMEDICAL TECHNOLOGIES, L510(k) NO: K142594(Traditional) ATTN: Brian Kieser PHONE NO : 18618 TUSCANY STONE SUITE 120 SE DECISION MADE: 28-NOV-14 SAN ANTONIO TN 78258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIAL-MATE Adaptor BAXTER HEALTHCARE CORPORATION 510(k) NO: K142600(Special) ATTN: GARY CHUMBIMUNE PHONE NO : 224 2703312 32650 N. WILSON ROAD, SE DECISION MADE: 19-NOV-14 ROUND LAKE IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panorama Patient Monitoring Network Shenzhen Mindray Bio-Medical Elect510(k) NO: K142601(Abbreviated) ATTN: Diane Arpino PHONE NO : 1 201 9958407 Bldg. 9-13 , Baiwangxin High-Tech SE DECISION MADE: 14-NOV-14 Nasham CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator BIO COMPRESSION SYSTEMS, INC. 510(k) NO: K142640(Traditional) ATTN: Barbara Whitman PHONE NO : 201 3406422 120 WEST COMMERCIAL AVE. SE DECISION MADE: 06-NOV-14 MOONACHIE NJ 07074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomet Headless Compression and Twist-off Screws BIOMET MANUFACTURING CORP. 510(k) NO: K142658(Traditional) ATTN: Victoria Scheitlin PHONE NO : 574 3726801 56 EAST BELL DRIVE SE DECISION MADE: 13-NOV-14 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lesion-Loc Iodine I-125 Seed/Needle Intramedical Imaging, LLC 510(k) NO: K142668(Traditional) ATTN: Farhad Daghighian PHONE NO : 424 4567316 12569 Crenshaw Blvd. SE DECISION MADE: 21-NOV-14 Hawthorne CA 90250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio-Medicus Adult Cannulae and Introducer Medtronic, Inc 510(k) NO: K142673(Traditional) ATTN: Bruce Backlund PHONE NO : 1 763 5262357 8200 Coral Sea St. NE SE DECISION MADE: 18-NOV-14 Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS (ZIO ECG Utilization Service) System iRhythm Technologies, Inc. 510(k) NO: K142681(Special) ATTN: Rich Laguna PHONE NO : 415 6325700 650 Townsend Street, Suite 380 SE DECISION MADE: 21-NOV-14 San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexCath Select Steerable Sheath (10 French) Medtronic CryoCath LP 510(k) NO: K142684(Traditional) ATTN: Vanessa Ware PHONE NO : 763 5262743 8200 Coral Sea Street NE Mail StopSE DECISION MADE: 06-NOV-14 Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytosponge Cell Collection Device Covidien LLC 510(k) NO: K142695(Traditional) ATTN: Richelle Hover PHONE NO : 408 3287342 15 HAMPSHIRE ST SE DECISION MADE: 26-NOV-14 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atlas SPEEDER Head/Neck Quality Electrodynamics, LLC 510(k) NO: K142802(Traditional) ATTN: Kathleen Aras PHONE NO : 440 4842964 700 Beta Drive Suite 100 SE DECISION MADE: 24-NOV-14 Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEGO-PGCL Absorbable Surgical Monofilament Suture FOOSIN MEDICAL SUPPLIES INC.LTD 510(k) NO: K142810(Special) ATTN: Suxia Zhao PHONE NO : 86 631 5621632 No.20, Xingshan Road Weihai Torch SE DECISION MADE: 14-NOV-14 WEIHAI CN 264210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Plates and Screws (ZPS), Forte Screws ZIMMER, INC. 510(k) NO: K142836(Traditional) ATTN: PATRICK MCCULLAGH PHONE NO : 574 3724656 P.O. BOX 708 SE DECISION MADE: 12-NOV-14 WARSAW IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Univers Rivers Shoulder Prosthesis System Arthrex, Inc. 510(k) NO: K142863(Traditional) ATTN: Courtney Smith PHONE NO : 239 6435553 1720 1370 Creekside Boulevard SE DECISION MADE: 25-NOV-14 Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin Purple Surgical International Limi510(k) NO: K142868(Traditional) ATTN: Jason Howes PHONE NO : 44 01923 839333 2 Chestnut House, Farm Close, SE DECISION MADE: 21-NOV-14 Shenley GB wd7 9ad 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US NEOSURGICAL LTD 510(k) NO: K142903(Special) ATTN: Oria Brennan PHONE NO : 353 91 421000 BLOCK 12 GALWAY TECHNOLOGY PARK, PSE DECISION MADE: 12-NOV-14 GALWAY IE EI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh SOFRADIM PRODUCTION 510(k) NO: K142908(Special) ATTN: Eric Jague PHONE NO : 33 474 089000 116 AVENUE DU FORMANS SE DECISION MADE: 14-NOV-14 TREVOUX FR 01600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G3 Active Plate Large Fragment System GENESIS FRACTURE CARE, INC. 510(k) NO: K142938(Traditional) ATTN: Michael Bottlang PHONE NO : 503 5284048 13568 SE 97th Ave. Suite 202 SE DECISION MADE: 26-NOV-14 Clackamas OR 97105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acrobat Calibrated Tip Wire Guide Wilson-Cook Medical, Inc 510(k) NO: K142950(Special) ATTN: Doris A Hawks PHONE NO : 336 7440157 6293 4900 Bethania Station Road SE DECISION MADE: 05-NOV-14 Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Audit MicroControls Linearity LQ Special Diabetes AALTO SCIENTIFIC LTD. 510(k) NO: K142978(Traditional) ATTN: Robert Burda PHONE NO : 760 4317922 134 1959 KELLOGG AVE. SE DECISION MADE: 20-NOV-14 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable ArthroCare Corporation 510(k) NO: K142999(Special) ATTN: Ashley M. Johnston PHONE NO : 512 3585762 7000 West William Cannon Drive SE DECISION MADE: 19-NOV-14 Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING ARGENTUM MEDICAL 510(k) NO: K143001(Special) ATTN: C. Richard Foster PHONE NO : 630 2322507 2571 KANEVILLE COURT SE DECISION MADE: 07-NOV-14 GENEVA IL 60134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity AALTO SCIENTIFIC LTD. 510(k) NO: K143026(Traditional) ATTN: ROBERT BURDA PHONE NO : 760 4317922 1959 KELLOGG AVE. SE DECISION MADE: 21-NOV-14 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xario 200, V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K143027(Traditional) ATTN: Paul Biggins PHONE NO : 1 714 6697808 1385 SHIMOISHIGAMI SE DECISION MADE: 20-NOV-14 OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gel-Block 10X embolization pledgets VASCULAR SOLUTIONS, INC. 510(k) NO: K143038(Special) ATTN: ADAM ETTL PHONE NO : 763 6564300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 20-NOV-14 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xario 100, V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K143046(Traditional) ATTN: Paul Biggins PHONE NO : 714 6697808 1385 SHIMOISHIGAMI SE DECISION MADE: 19-NOV-14 OTAWARA-SHI JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex iBalance Patella Implant, Dome ARTHREX, INC. 510(k) NO: K143047(Special) ATTN: LAURA MEDLIN PHONE NO : 239 6435553 72005 1370 CREEKSIDE BOULEVARD SE DECISION MADE: 19-NOV-14 NAPLES FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherpa Pak Kidney Transport System PARAGONIX TECHNOLOGIES, INC. 510(k) NO: K143054(Special) ATTN: Lisa Anderson PHONE NO : 617 8177790 639 GRANITE STREET SE DECISION MADE: 25-NOV-14 BRAINTREE MA 02184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Plates and Screws (ZPS) – Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers ZIMMER, INC. 510(k) NO: K143066(Traditional) ATTN: PATRICK MCULLAGH PHONE NO : 1 574 3724656 P.O. BOX 708 SE DECISION MADE: 28-NOV-14 WARSAW IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherpa Pak Cardiac Transport System PARAGONIX TECHNOLOGIES, INC. 510(k) NO: K143074(Special) ATTN: Lisa Anderson PHONE NO : 1 617 8177790 639 GRANITE STREET SE DECISION MADE: 25-NOV-14 BRAINTREE MA 02184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) JVC KENWOOD CORPORATION 510(k) NO: K143076(Traditional) ATTN: TSUKASA TASHIRO PHONE NO : 81 25824 6611 3-12 MORIYA-CHO, KANAGAWA-KU SE DECISION MADE: 12-NOV-14 YOKOHAMA-SHI JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD 510(k) NO: K143089(Third Party – Traditional) ATTN: PARK KYEONG-MI PHONE NO : 42, TEHERAN-RO 108-GIL SE DECISION MADE: 26-NOV-14 GANGNAM-GU KR 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: Surgisleeve Wound Protector Covidien LLC 510(k) NO: K143091(Special) ATTN: Michael Koczocik PHONE NO : 1 203 4926312 60 Middletown Avenue SE DECISION MADE: 26-NOV-14 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MP Color LCD monitor, RadiForce RS340 EIZO CORPORATION 510(k) NO: K143098(Traditional) ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76274 2468 153 SHIMOKASHIWANO SE DECISION MADE: 18-NOV-14 HAKUSAN JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEGA Knee System AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K143106(Special) ATTN: Julie Tom Wing PHONE NO : 610 9849147 3773 CORPORATE PARKWAY SE DECISION MADE: 21-NOV-14 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentinella 102; Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAG510(k) NO: K143156(Third Party – Traditional) ATTN: Jose Montes PHONE NO : 34 96 3722472 EDUARDO PEIMO YUFERA 3 SE DECISION MADE: 18-NOV-14 VALENCIA ES 46012 510(k) STATEMENT THIRD PARTY REVIEW
DEVICE: Coronis Fusion 4MP LED BARCO NV 510(k) NO: K143157(Special) ATTN: LIEVEN DE WANDEL PHONE NO : 325 6233459 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 12-NOV-14 KORTRIJK BE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxZero Administration Sets CAREFUSION 510(k) NO: K143234(Third Party – Traditional) ATTN: LARRY WALKER PHONE NO : 858 6173042 10020 PACIFIC MESA BLVD SE DECISION MADE: 20-NOV-14 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: 2.3MP Color LCD Monitor, RadiForce MX242W EIZO CORPORATION 510(k) NO: K143261(Traditional) ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468 153 SHIMOKASHIWANO SE DECISION MADE: 21-NOV-14 HAKUSAN,ISHIKAWA JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Respiratory
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