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
