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U.S. Department of Health and Human Services

Medical Devices

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March 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2014


DEVICE: AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
APEX BIOTECHNOLOGY CORP.          510(k) NO: K131750(TRADITIONAL)
ATTN: HSUE-MEI  LEE               PHONE NO : 011 866 35641952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 06-MAR-14
HSINCHU    TW 30078               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCP MULTI-DRUG TEST KEY CUPS
UCP BIOSCIENCES, INC.             510(k) NO: K132812(TRADITIONAL)
ATTN: NANCY  CHEN                 PHONE NO : 408 392 0064   
1445 KOLL CIRCLE, STE. 111        SE DECISION MADE: 06-MAR-14
SAN JOSE CA 95112                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K140248(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 11-MAR-14
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREND TSH (REAGENT CARTRIDGE)
NANOEN TEK USA, INC.              510(k) NO: K131928(TRADITIONAL)
ATTN: JUDITH E LOEBEL             PHONE NO : 203 881 1032   
1 JACKS' HILL ROAD, STE 1 (A&B)   SE DECISION MADE: 14-MAR-14
OXFORD CT 06478                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET
DIAZYME LABORATORIES              510(k) NO: K133410(TRADITIONAL)
ATTN: ABHIJIT  DATTA              PHONE NO : 858 455 4762   
12889 GREGG COURT                 SE DECISION MADE: 14-MAR-14
POWAY CA 92064                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
THE BINDING SITE                  510(k) NO: K140105(TRADITIONAL)
ATTN: PAUL  KENNY                 PHONE NO : 440 121456 9500
8 Calthorpe Road Edgbaston        SE DECISION MADE: 18-MAR-14
BIRMINGHAM    GB B15 1QT          510(k) STATEMENT

DEVICE: VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K140465(TRADITIONAL)
ATTN: MORT  MINAEE                PHONE NO : 408 207 4201   
203 Ravendale Dr                  SE DECISION MADE: 20-MAR-14
Mountain View CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
NOVA BIOMEDICAL CORPORATION       510(k) NO: K131703(TRADITIONAL)
ATTN: PAUL W MCDONALD             PHONE NO : 781 894 0800   
200 Prospect St                   SE DECISION MADE: 25-MAR-14
WALTHAM MA 02454                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K133673(TRADITIONAL)
ATTN: MICHELLE L SMITH            PHONE NO : 513 271 3700   
3471 River Hills Dr               SE DECISION MADE: 25-MAR-14
CINCINNATI OH 45244               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMIPLIVUE HSV 1&2 ASSAY
QUIDEL CORPORATION                510(k) NO: K140029(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 740 589 3300   
10165 MCKELLAR COURT              SE DECISION MADE: 26-MAR-14
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
SEBIA                             510(k) NO: K133344(TRADITIONAL)
ATTN: KAREN  ANDERSON             PHONE NO : 800 835 6497   
1705 CORPORATE DRIVE SUITE 400    SE DECISION MADE: 28-MAR-14
NORCROSS GA 30093                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SFI-ANCHOR
CENDRES & METAUX SA               510(k) NO: K130618(TRADITIONAL)
ATTN: TANJA  BONGNI               PHONE NO : 415 836023 02
RUE DE BOUJEAN 122                SE DECISION MADE: 03-MAR-14
BIEL/BIENNE    SZ 2501            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISICLEAR SMOKE EVACUATION SYSTEM
BUFFALO FILTER CO., INC.          510(k) NO: K131402(TRADITIONAL)
ATTN: CARRIE  TERMIN              PHONE NO : 716 835 7000   
5900 GENESEE STREET               SE DECISION MADE: 03-MAR-14
LANCASTER NY 14086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPM WOUND GEL BIO
GLYCOBIOSCIENCES, INC             510(k) NO: K123193(TRADITIONAL)
ATTN: KEVIN  DRIZEN               PHONE NO : 905 854 0631
7 TIMBER COURT                    SE DECISION MADE: 03-MAR-14
GERGETOWN, ONTARIO    CA L7G 4S4  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SKINTELL
AGFA HEALTHCARE N.V.              510(k) NO: K132800(TRADITIONAL)
ATTN: SHAEANN  CAVANAGH           PHONE NO : 864 421 1766   
10 SOUTH ACADEMY STREET           SE DECISION MADE: 03-MAR-14
GREENVILLE SC 29601               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOERAE VEIN PREPARATION KIT
MOERAE MATRIX, INC.               510(k) NO: K131659(TRADITIONAL)
ATTN: ROBERT J CHIN               PHONE NO : 650 593 5225   
25 HARTFORD AVENUE                SE DECISION MADE: 03-MAR-14
SAN CARLOS CA 94070               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
SHOULDER OPTIONS, INC.            510(k) NO: K133668(TRADITIONAL)
ATTN: JOHN  KAPITAN               PHONE NO : 704 512 0000   
100 E. SOUTH MAIN ST. P.O. BOX 145SE DECISION MADE: 03-MAR-14
WAXHAW NC 28173                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NXSTAGE SYSTEM ONE WITH NXVIEW
NXSTAGE MEDICAL, INC.             510(k) NO: K133547(TRADITIONAL)
ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872   
350 MERRIMACK STREET              SE DECISION MADE: 03-MAR-14
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RITHM ID ELECTROPHYSIOLOGY CATHETER
SYNAPTIC MEDICAL LIMITED          510(k) NO: K133028(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 04-MAR-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANDON BLOOD PRESSURE CUFF
ANDON HEALTH CO., LTD             510(k) NO: K133117(TRADITIONAL)
ATTN: LIU  YI                     PHONE NO : 86 22 60526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 04-MAR-14
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED
ZIMMER DENTAL INC.                510(k) NO: K133339(TRADITIONAL)
ATTN: JULIE L CORMAN              PHONE NO : 760 929 4300   
1900 ASTON AVE.                   SE DECISION MADE: 04-MAR-14
CARLSBAD CA 92008 7308            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVOPORE DRESSING
POLYNOVO BIOMATERIALS PTY LTD     510(k) NO: K132936(TRADITIONAL)
ATTN: CARRIE  HETRICK             PHONE NO : 512 327 9997   
816 CONGRESS AVE. SUITE 1400      SE DECISION MADE: 04-MAR-14
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHSTATS A-PULSE CASPAL + AND MC3100 MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE
HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K131788(TRADITIONAL)
ATTN: STEPHEN  GORSKI             PHONE NO : 262 594 2114   
S65 W35739 PIPER ROAD             SE DECISION MADE: 04-MAR-14
EAGLE WI 53119                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
MEDTEC, INC.                      510(k) NO: K132908(TRADITIONAL)
ATTN: AMANDA  STAHLE              PHONE NO : 319 248 6628   
1401 8TH ST. S.E.                 SE DECISION MADE: 04-MAR-14
Orange City IA 51041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTHOUSE URINARY CATHETER
SEEDINGS LIFE SCIENCE VENTURES, LL510(k) NO: K140099(TRADITIONAL)
ATTN: KEN  SOLOVAY                PHONE NO : 954 336 0777   
230 EAST 15TH STREET SUITE 1-A    SE DECISION MADE: 04-MAR-14
NEW YORK NY 10003                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEM-7320
OMRON HEALTHCARE, INC.            510(k) NO: K133383(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DR.                SE DECISION MADE: 04-MAR-14
BONITA SPRINGS FL 34134   34134   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
CHANGZHOU DEAN MEDICAL INSTRUMENT 510(k) NO: K133525(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212281 5850
P.O. BOX 120-119                  SE DECISION MADE: 04-MAR-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
SOUFLON PHARMACEUTICALS LTD       510(k) NO: K133472(TRADITIONAL)
ATTN: CHRISTOPHER  SMEJKAL        PHONE NO : 44 208 3224200
49-53 YORK STREET                 SE DECISION MADE: 04-MAR-14
TWICKENHAM    UK TW1 3LP          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VELOFIXTM INTERBODY FUSION SYSTEM
U&I CORP.                         510(k) NO: K132926(TRADITIONAL)
ATTN: GYEONG  JE-KWON             PHONE NO : 823 18 520102X610
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 05-MAR-14
Uijeongbu-si    KR 480-859        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
VISION SCIENCE CO LTD             510(k) NO: K132714(TRADITIONAL)
ATTN: BRET  ANDRE                 PHONE NO : 503 372 5226   
21225 NW WILKINS ST.              SE DECISION MADE: 05-MAR-14
BEAVERTON OR 97006                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLURA XPER FD; OR TABLE
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K133292(ABBREVIATED)
ATTN: KLIEN  VAN DAM              PHONE NO : 310 402795 225
VEENPLUIS 4-6                     SE DECISION MADE: 05-MAR-14
BEST    NL 5684 PC                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTEC ELECTROCARDIOGRAPH
CONTEC MEDICAL SYSTEM CO., LTD.   510(k) NO: K131900(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122815 850
P.O. BOX 120-119                  SE DECISION MADE: 05-MAR-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVLIFE Q-SWITCHED ND:YAG LASER SYSTEM
CYNOSURE, INC.                    510(k) NO: K133254(TRADITIONAL)
ATTN: HUDA  YUSUF                 PHONE NO : 781 993 2311   
5 CARLISLE ROAD                   SE DECISION MADE: 05-MAR-14
WESTFORD MA 01886                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K140258(ABBREVIATED)
ATTN: ASHA  GARTLAND              PHONE NO : 914 524 3257   
511 BENEDICT AVENUE               SE DECISION MADE: 05-MAR-14
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K140208(SPECIAL)
ATTN: LINDSAY  MARTIN             PHONE NO : 801 565 5388   
12050 LONE PEAK PKWY              SE DECISION MADE: 05-MAR-14
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K133618(TRADITIONAL)
ATTN: PATRICK  CHOW               PHONE NO : 008 52 28516789
ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 05-MAR-14
SHENSHEN, GUANG DONG    CH 518118 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K133619(TRADITIONAL)
ATTN: PATRICK  CHOW               PHONE NO : 008 52 28516789
ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 05-MAR-14
SHENSHEN, GUANG DONG    CH 518118 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
SAUFLON PHARMACEUTICALS, LTD.     510(k) NO: K133740(TRADITIONAL)
ATTN: CHRISTOPHER  SMEJKAL        PHONE NO : 44 20832 24200
49-53 YORK ST.                    SE DECISION MADE: 05-MAR-14
TWICKENHAM, MIDDLESEX    UK TW1-3L510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI PICC IV
NAVILYST MEDICAL, INC.            510(k) NO: K140266(SPECIAL)
ATTN: BRANDON M BRACKETT          PHONE NO : 508 658 7984   
26 FOREST STREET                  SE DECISION MADE: 05-MAR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIOVAC CANNULA
VORTEX MEDICAL INC                510(k) NO: K133445(TRADITIONAL)
ATTN: LORRAINE M HANLEY           PHONE NO : 508 658 7945   
26 FOREST ST.                     SE DECISION MADE: 05-MAR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
CABIN PLASTIC CO., LTD.           510(k) NO: K130751(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
RM 1606 BLDG. 1.JIANXIANG YUAN NO.SE DECISION MADE: 05-MAR-14
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
LEXION MEDICAL, LLC.              510(k) NO: K140263(SPECIAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231 1761   
4486 TIMBERLINE CT                SE DECISION MADE: 05-MAR-14
VADNAIS HEIGHTS MN 55127          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CATHETER INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K131627(TRADITIONAL)
ATTN: LUKE  MEIDELL               PHONE NO : 801 565 6212   
12050 LONE PEAK PKWY              SE DECISION MADE: 06-MAR-14
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRWAY SUPPORT SYSTEM / AIRPORT
ABEON MEDICAL CORPORATION         510(k) NO: K131506(TRADITIONAL)
ATTN: ALLISON  SLAGA              PHONE NO : 440 262 6000   
8000 Katherine Boulevard          SE DECISION MADE: 06-MAR-14
Brecksville OH 44141              510(k) STATEMENT

DEVICE: CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
TELEFLEX, INC.                    510(k) NO: K131912(TRADITIONAL)
ATTN: AMANDA  WEBB                PHONE NO : 919 433 8050   
2917 WECK DR.                     SE DECISION MADE: 06-MAR-14
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
AMENDIA INC.                      510(k) NO: K133036(TRADITIONAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
11821 BRAMBLE COVE DRIVE          SE DECISION MADE: 06-MAR-14
FT. MYERS FL 33905                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROTABLE SYSTEM
FRED HAER COMPANY, INC.           510(k) NO: K132611(TRADITIONAL)
ATTN: KERI  SEITZ                 PHONE NO : 207 666 5651   
1201 MAIN STREET                  SE DECISION MADE: 06-MAR-14
BOWDOIN ME 04287                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N-FORCE FIXATION SYSTEM
INNOVISION, INC.                  510(k) NO: K132244(TRADITIONAL)
ATTN: MICHELLE  MCDONOUGH         PHONE NO : 202 552 5800   
1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 06-MAR-14
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREATHE NIOV VENTILATION SYSTEM
BREATHE TECHNOLOGIES              510(k) NO: K131562(TRADITIONAL)
ATTN: CRAIG  COOMBS               PHONE NO : 650 380 2474   
1193 SHERMAN ST                   SE DECISION MADE: 06-MAR-14
ALAMEDA CA 94501                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEDVIEW
LEXI CO., LTD.                    510(k) NO: K133022(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440 546 9810   
5905 FAWN LANE                    SE DECISION MADE: 06-MAR-14
CLEVELAND OH 44141                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODEL-BASED RSA SOFTWARE
HALIFAX BIOMEDICAL, INC.          510(k) NO: K133966(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 06-MAR-14
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: O2 NASAL CANNULA WITH CO2 MONITORING
FLEXICARE MEDICAL LTD.            510(k) NO: K140113(TRADITIONAL)
ATTN: CHRIS  WATKINS              PHONE NO : 44 0 1443474647
CYNON VALLEY BUSINESS PARK MOUTAINSE DECISION MADE: 06-MAR-14
MID GLAMORGAN    UK CF45 4ER      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OPTIGLAZE COLOR
GC AMERICA INC.                   510(k) NO: K133836(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 597 0900   
3737 W. 127TH STREET              SE DECISION MADE: 06-MAR-14
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTRIPOINT MEDICAL SYSTEM
VENTRIPOINT, INC.                 510(k) NO: K140153(TRADITIONAL)
ATTN: JIM  BODTKE                 PHONE NO : 206 283 0221   
24 ROY ST. #445                   SE DECISION MADE: 06-MAR-14
SEATTLE WA 98109                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH BITE
3M ESPE AG                        510(k) NO: K133400(TRADITIONAL)
ATTN: RUEDIGER  FRANKE            PHONE NO : 49 8152 7001802
ESPE PLATZ                        SE DECISION MADE: 06-MAR-14
SEEFELD    GM D-82229             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K133754(TRADITIONAL)
ATTN: ELIZABETH  MCMENIMAN        PHONE NO : 781 565 1347   
311 ENTERPRISE DRIVE              SE DECISION MADE: 06-MAR-14
PLAINSBORO NJ 08535               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPAX VOLUME VIEWING 3.0
AGFA HEALTHCARE N.V.              510(k) NO: K133135(TRADITIONAL)
ATTN: KOEN  COBBAERT              PHONE NO : 
SEPTESTRAAT 27                    SE DECISION MADE: 07-MAR-14
MORTSEL    BE B 2640              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
I.T.S. GMBH                       510(k) NO: K132945(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH STREET              SE DECISION MADE: 07-MAR-14
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLACKBIRD SPINAL SYSTEM
CHOICE SPINE, LP                  510(k) NO: K133214(TRADITIONAL)
ATTN: KIM  FINCH                  PHONE NO : 865 246 3333   
400 Erin Dr                       SE DECISION MADE: 07-MAR-14
KNOXVILLE TN 37919                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEINE MINI 3000(R) OPHTHALMOSCOPE
HEINE OPTOTECHNIK GMBH & CO. KG.  510(k) NO: K131959(ABBREVIATED)
ATTN: MANFRED  BARTSCH-TITTMANN   PHONE NO : 49 815238 419
KIENTALSTRASSE 7                  SE DECISION MADE: 07-MAR-14
HERRSCHING    GM D-82211          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MALE LATEX CONDOM
NULATEX SDN. BHD.                 510(k) NO: K132107(ABBREVIATED)
ATTN: AI  SIANG TEO               PHONE NO : 607 777 1820
LOT 1870, 4TH MILES JALAN MENGKIBOSE DECISION MADE: 07-MAR-14
KLUANG, JOHOR    MY 86000         510(k) STATEMENT

DEVICE: VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
VOLCANO CORPORATION               510(k) NO: K140291(SPECIAL)
ATTN: MARCUS  GARCIA              PHONE NO : 978 439 3312   
1 FORTUNE DR                      SE DECISION MADE: 07-MAR-14
BILLERICA MA 01821                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRO-TOE HAMMERTOE FIXATION SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K140148(TRADITIONAL)
ATTN: VAL  MYLES                  PHONE NO : 901 290 5162   
5677 AIRLINE RD.                  SE DECISION MADE: 07-MAR-14
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
OSSTEM GERMANY GMBH               510(k) NO: K133527(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR                SE DECISION MADE: 07-MAR-14
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TABLE
ANATOMAGE INC.                    510(k) NO: K140093(TRADITIONAL)
ATTN: MIKE  MENDEZ                PHONE NO : 408 885 1474   
111 N. MARKET STREET #800         SE DECISION MADE: 07-MAR-14
SAN JOSE CA 95113                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARLOTTE (TM) SNAP-OFF SCREW
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K133713(SPECIAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
5677 AIRLINE RD.                  SE DECISION MADE: 07-MAR-14
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K134026(TRADITIONAL)
ATTN: DAPHNEY  GERMAIN-KOLAWOLE   PHONE NO : 484 896 5691   
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 07-MAR-14
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATOR HD URETERAL ACCESS SHEATH SETS
BOSTON SCIENTIFIC                 510(k) NO: K140323(SPECIAL)
ATTN: NICHOLE  RIEK               PHONE NO : 508 683 4175   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 07-MAR-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
LDR SPINE, USA, INC.              510(k) NO: K133363(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DRIVE              SE DECISION MADE: 07-MAR-14
COLORADO SPRING CO 80918          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH AR; FLASH AR QUICK
3M DEUTSCHLAND GMBH               510(k) NO: K133436(TRADITIONAL)
ATTN: DESI  SOEGIARTO             PHONE NO : 49 815270 01169
ESPE PLATZ                        SE DECISION MADE: 07-MAR-14
SEEFELD, BAVARIA    GM 82229      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
CORDIS, A JOHNSON & JOHNSON CO.   510(k) NO: K140286(SPECIAL)
ATTN: SHAMSA  KARIMI              PHONE NO : 510 248 2896   
6500 PASEO PADRE PARKWAY          SE DECISION MADE: 07-MAR-14
FREMONT CA 94555                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOFUSIONARY BEBE
ROCKY MOUNTAIN BIOSYSTEMS, INC.   510(k) NO: K121123(TRADITIONAL)
ATTN: AMY  BENEDICT               PHONE NO : 303 277 1140   
3930 YOUNGFIELD STREET            SE DECISION MADE: 10-MAR-14
WHEAT RIDGE CO 80033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T4/T5 HYTREL TOGAS
STRYKER CORPORATION               510(k) NO: K121664(TRADITIONAL)
ATTN: CASEY A METZGER             PHONE NO : 269 389 3761   
4100 E. MILHAM AVE                SE DECISION MADE: 10-MAR-14
KALAMAZOO MI 49001                510(k) STATEMENT

DEVICE: MM-SEAL
MICRO-MEGA SOCIETE ANONYME        510(k) NO: K123276(TRADITIONAL)
ATTN: PHILIPPE  CONCHE            PHONE NO : 330 381544 229
5-12 RUE DU TUNNEL                SE DECISION MADE: 10-MAR-14
CEDEX BESANCON    FR 25006        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAN HIP FRACTURE SYSTEM
EPIX ORTHOPAEDIC, CORP.           510(k) NO: K133104(TRADITIONAL)
ATTN: MICHELLE  MCDONOUGH         PHONE NO : 202 552 5800   
1331 H STREET, NW, 12TH FLOOR     SE DECISION MADE: 10-MAR-14
WASHINGTON DC 20008               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEWTRON P5, NEWTRON P5 B.LED
SATELEC-ACTEON GROUP              510(k) NO: K132267(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 800 289 6367   
124 GAITHER DRIVE , SUITE 140     SE DECISION MADE: 10-MAR-14
MT LAUREL NJ 08054                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY PINNACLE ALTRX ACETABULAR LINERS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K132959(TRADITIONAL)
ATTN: MEGAN  BURNS                PHONE NO : 574 372 7745   
700 ORTHOPAEDIC DR.               SE DECISION MADE: 10-MAR-14
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPACT MODEL 323 ASPIRATOR
IMPACT INSTRUMENTATION, INC.      510(k) NO: K133196(TRADITIONAL)
ATTN: ALAN  GIORDANO              PHONE NO : 973 882 1212   
27 FAIRFIELD PL. P.O. BOX 508     SE DECISION MADE: 10-MAR-14
WEST CALDWELL NJ 07006 0508       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BWCSH-1 SHARPS CONTAINER
BRADFORD WRIGHT COMPANIES, INC    510(k) NO: K131708(TRADITIONAL)
ATTN: MIKE  DEMELLO               PHONE NO : 503 635 6908   
4092 ORCHARD WAY                  SE DECISION MADE: 10-MAR-14
LAKE OSWEGO OR 97035 1871         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K140267(ABBREVIATED)
ATTN: FATIMA  PACHECO             PHONE NO : 914 524 2450   
511 BENEDICT AVENUE               SE DECISION MADE: 10-MAR-14
TARRYTOWN NY 10591 5097           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMED SUTURE ANCHOR SYSTEM
ACUMED, LLC                       510(k) NO: K133469(TRADITIONAL)
ATTN: LINO  TSAI                  PHONE NO : 503 207 1370   
5885 NW CORNELIUS PASS ROAD       SE DECISION MADE: 10-MAR-14
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CMC MINI TIGHTROPE
ARTHREX, INC.                     510(k) NO: K140328(SPECIAL)
ATTN: NANCY  HOFT                 PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 10-MAR-14
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMABOND PRINEO SKIN CLOSURE SYSTEM
ETHICON, INC.                     510(k) NO: K133864(SPECIAL)
ATTN: DONNA  MARSHALL             PHONE NO : 908 541 3990   
ROUTE 22 WEST P.O. BOX 151        SE DECISION MADE: 10-MAR-14
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEWTRON P5 XS B.LED
SATELEC-ACTEON GROUP              510(k) NO: K132322(TRADITIONAL)
ATTN: RICK  ROSATI                PHONE NO : 800 289 6367   
124 GAITHER DRIVE , SUITE 140     SE DECISION MADE: 11-MAR-14
MT LAUREL NJ 08054                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BPROSOFT CASP PC SOFTWARE
HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K131916(TRADITIONAL)
ATTN: STEPHEN  GORSKI             PHONE NO : 262 594 2114   
565 W35739 PIPER ROAD             SE DECISION MADE: 11-MAR-14
EAGLE WI 53119                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCURO 3000 ULTRASOUND SCANNER
RIVANNA MEDICAL, LLC              510(k) NO: K132736(TRADITIONAL)
ATTN: WILLIAM  MAULDIN            PHONE NO : 828 612 8191   
1304 STONEGATE CT.                SE DECISION MADE: 11-MAR-14
CROZET VA 22932                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIOS ALPHA
SIEMENS MEDICAL SOLUTIONS, INC.   510(k) NO: K132094(TRADITIONAL)
ATTN: DARREN  DORMAN              PHONE NO : 610 219 9066   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 11-MAR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISYS 1 (U.S),ACCESSORY, NON-STERILE
ISYS MEDIZINTECHNIK GMBH          510(k) NO: K131433(TRADITIONAL)
ATTN: CORNELIA  DAMSKY            PHONE NO : 203 323 7535   
56 WESTCOTT ROAD                  SE DECISION MADE: 11-MAR-14
STAMFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERE STABILIZATION SYSTEM
GLOBE MEDICAL, INC.               510(k) NO: K133350(TRADITIONAL)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 11-MAR-14
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOWA SL-17
KOWA CO. LTD.                     510(k) NO: K133755(TRADITIONAL)
ATTN: HIROYUKI  KOIDE             PHONE NO : 814 244450 79
4-14, NIHONBASHI-HONCHO 3-CHOME   SE DECISION MADE: 11-MAR-14
CHUO-KU, TOKYO    JA 103-8433     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133401(TRADITIONAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 11-MAR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
PORTABLE THERAPEUTIX              510(k) NO: K133483(TRADITIONAL)
ATTN: SHARYN  ORTON, PH.D.        PHONE NO : 401 330 8264   
2001 HONOR AVE.                   SE DECISION MADE: 11-MAR-14
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTIMUM EV HEMOSTASIS INTRODUCER
ST. JUDE MEDICAL                  510(k) NO: K140327(SPECIAL)
ATTN: LOUCINDA  BJORKLUND         PHONE NO : 651 756 5400   
5050 NATHAN LANE N                SE DECISION MADE: 11-MAR-14
PLYMOUTH MN 55442                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM
ORTHO DEVELOPMENT CORP.           510(k) NO: K133386(TRADITIONAL)
ATTN: MIKE  ENSIGN                PHONE NO : 801 553 9991   
12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 11-MAR-14
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BONE SUPPRESSION SOFTWARE
CARESTREAM HEALTH, INC.           510(k) NO: K133442(TRADITIONAL)
ATTN: CAROLYN  WAGNER             PHONE NO : 585 627 6588   
150 VERONA STREET                 SE DECISION MADE: 11-MAR-14
ROCHESTER NY 14608                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGISLEEVE WOUND PROTECTOR
COVIDIEN                          510(k) NO: K140064(TRADITIONAL)
ATTN: MICHAEL  KOCZOCIK           PHONE NO : 203 492 6312   
60 MIDDLETOWN DR                  SE DECISION MADE: 12-MAR-14
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SNAP WOUND CARE SYSTEM
SPIRACUR, INC.                    510(k) NO: K132080(TRADITIONAL)
ATTN: SARAH L CANIO               PHONE NO : 408 400 0856   
755 N. MATHILDA AVENUE            SE DECISION MADE: 12-MAR-14
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BODIHEALTH SYSTEM
EPRT TECHNOLOGIES, INC.           510(k) NO: K131675(SPECIAL)
ATTN: JEFF  MORGAN                PHONE NO : 253 208 3430   
468 N CAMDEN DRIVE SUITE 269C     SE DECISION MADE: 12-MAR-14
BEVERLY HILLS CA 90210            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TORRENT IRRIGATION SYSTEM
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K140405(SPECIAL)
ATTN: CARROLL  MARTIN             PHONE NO : 440 358 6259   
5976 HEISLEY RD.                  SE DECISION MADE: 12-MAR-14
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
EMERGE MEDICAL                    510(k) NO: K140119(TRADITIONAL)
ATTN: MEREDITH  MAY MS, RAC       PHONE NO : 719 337 7579   
EMPIRICAL CONSULTING 4628 NORTHPARSE DECISION MADE: 12-MAR-14
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K133746(TRADITIONAL)
ATTN: VIVIAN  KELLY, MS, RAC      PHONE NO : 973 299 9300   
399 JEFFERSON ROAD                SE DECISION MADE: 12-MAR-14
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
BIOSENSE WEBSTER                  510(k) NO: K140318(SPECIAL)
ATTN: MARINA  GUEVREKIAN          PHONE NO : 909 839 8714   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 12-MAR-14
BALDWIN BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STELLARIS PC VISION ENHANCEMENT SYSTEM
BAUSCH & LOMB                     510(k) NO: K133486(TRADITIONAL)
ATTN: TIMOTHY W CAPEHART          PHONE NO : 636 226 3017   
3365 TREE CT. INDUSTRIAL BLVD     SE DECISION MADE: 12-MAR-14
ST. LOUIS MO 63122   63122        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
EMERGE MEDICAL                    510(k) NO: K140098(TRADITIONAL)
ATTN: MEREDITH  MAY MS, RAC       PHONE NO : 719 337 7579   
4628 NORTHPARK DRIVE ATTN: EMPIRICSE DECISION MADE: 12-MAR-14
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
AVERY DENNISON BELGIE, BVBA       510(k) NO: K133764(SPECIAL)
ATTN: LISA  BARTAKOVICS           PHONE NO : 312 629 4608
TIEBLOKKENLAAN 1                  SE DECISION MADE: 13-MAR-14
TURNHOUT    BE B-2300             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTENSIF
ENDYMED MEDICAL LTD               510(k) NO: K130501(TRADITIONAL)
ATTN:                             PHONE NO : 
31 HAAVODA ST.                    SE DECISION MADE: 13-MAR-14
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
SUMMIT MEDICAL, INC.              510(k) NO: K133015(TRADITIONAL)
ATTN: NICOLE  DOVE                PHONE NO : 651 789 3939   
815 NORTHWEST PKWY, STE 100       SE DECISION MADE: 13-MAR-14
ST. PAUL MN 55121                 510(k) STATEMENT

DEVICE: HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
INSTRUMENTATION LABORATORY CO.    510(k) NO: K133005(SPECIAL)
ATTN: JACQUELINE  EMERY           PHONE NO : 781 861 4250   
180 HARTWELL ROAD                 SE DECISION MADE: 13-MAR-14
BEDFORD MA 01730                  510(k) STATEMENT

DEVICE: E-Z LINK
DUOJECT MEDICAL SYSTEMS, INC.     510(k) NO: K133097(TRADITIONAL)
ATTN: MARIE-CHRISTINE  MESSIER    PHONE NO : 450 534 3666
50 RUE DE GASPE COMPLEX B-5       SE DECISION MADE: 13-MAR-14
BROMONT, QC.    CA J2L 2N8        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K133205(TRADITIONAL)
ATTN: JULIE  BASSETT              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 13-MAR-14
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRACONGRUENT INSERT
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K132752(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 3577 3351X2212
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 13-MAR-14
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARSENAL SPINAL FIXATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K133221(TRADITIONAL)
ATTN: RENEE L MURPHY              PHONE NO : 760 494 6739   
5830 El Camino Real               SE DECISION MADE: 13-MAR-14
Carlsbad CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MALLEABLE SUCTION INSTRUMENTS
MEDTRONIC NAVIGATION, INC.        510(k) NO: K133665(TRADITIONAL)
ATTN: CHARLES M COPPERBERG        PHONE NO : 720 890 2291   
826 COAL CREEK CIR.               SE DECISION MADE: 13-MAR-14
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNI ARC MONOBLOCK HIP STEM
OMNILIFE SCIENCE                  510(k) NO: K133381(TRADITIONAL)
ATTN: CHRISTINA  FLORES           PHONE NO : 774 226 1835   
10 O'CONNELL WAY, STE 10          SE DECISION MADE: 13-MAR-14
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K140276(TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 344 0807   
1800 PYRAMID PLACE                SE DECISION MADE: 13-MAR-14
MEMPHIS TN 38135                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL DISTAL RADIUS SET
EMERGE MEDICAL                    510(k) NO: K140107(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
EMPIRICAL CONSULTING 4628 NORTHPARSE DECISION MADE: 13-MAR-14
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K133832(TRADITIONAL)
ATTN: BEN  CASEY                  PHONE NO : 801 486 6070   
1567 E. Stratford Avenue          SE DECISION MADE: 13-MAR-14
Salt Lake City UT 84106           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZ-OX PLUS GENERATION II
AIR LIQUIDE HEALTHCARE AMERICA    510(k) NO: K131386(TRADITIONAL)
ATTN: ANGIE  BEYER                PHONE NO : 713 624 8268   
2700 POST OAK BLVD. SUITE 1800    SE DECISION MADE: 14-MAR-14
HOUSTON TX 77056                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERCOM II CEMENT
DENALI CORPORATION                510(k) NO: K132393(TRADITIONAL)
ATTN: JAN G STANNARD              PHONE NO : 781 826 9190   
134 OLD WASHINGTON STREET         SE DECISION MADE: 14-MAR-14
HANOVER MA 02339                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K133227(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
3100 HANSEN WAY                   SE DECISION MADE: 14-MAR-14
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BG MORSELS
PROSIDYAN, INC                    510(k) NO: K132805(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET, 29TH FLOOR    SE DECISION MADE: 14-MAR-14
PHILADELPIHA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FASTOUCH FIXATION SYSTEM
VIA SURGICAL LTD.                 510(k) NO: K132698(TRADITIONAL)
ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   
93 BENEFIT ST.                    SE DECISION MADE: 14-MAR-14
PROVIDENCE RI 02904               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHINTERLINK BEACON
HEALTHINTERLINK, LLC              510(k) NO: K133252(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 482 9001   
55 NORTHERN BLVD, STE. 200        SE DECISION MADE: 14-MAR-14
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SW-THERM
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K131899(TRADITIONAL)
ATTN: JIANPING  KANG              PHONE NO : 867 55 27652471
No. 3 Building XiliBaimang XushengSE DECISION MADE: 14-MAR-14
SHENZHEN    CN 518108             510(k) STATEMENT

DEVICE: MANUKA FILL WOUND DRESSING
LINKS MEDICAL PRODUCTS, INC.      510(k) NO: K131796(TRADITIONAL)
ATTN: JAMES  SMITH, PH.D.         PHONE NO : 949 340 7261   
29442 POINTE ROYALE               SE DECISION MADE: 14-MAR-14
LAGUNA NIGUEL CA 92677            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOLCANO IFR MODALITY
VOLCANO CORPORATION               510(k) NO: K133323(TRADITIONAL)
ATTN: NEETA  SHARMA               PHONE NO : 858 720 4187   
3721 VALLEY CENTRE DR. SUITE 500  SE DECISION MADE: 14-MAR-14
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
GE HUNGARY KFT                    510(k) NO: K132944(TRADITIONAL)
ATTN: STEPHEN  SLAVENS            PHONE NO : 262 548 4992   
DBA GE HEALTHCARE 3000 N GRANDVIEWSE DECISION MADE: 14-MAR-14
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUMENIS PULSE 120H
LUMENIS LTD.                      510(k) NO: K140388(SPECIAL)
ATTN: MERAV  YARMUS               PHONE NO : 972 3 6123281
155 BIALIK STREET                 SE DECISION MADE: 14-MAR-14
RAMAT GAN    IS 5252346           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERASMART
GC AMERICA, INC.                  510(k) NO: K133824(TRADITIONAL)
ATTN: MARK  HEISS                 PHONE NO : 708 597 0900   
3737 WEST 127TH ST.               SE DECISION MADE: 14-MAR-14
ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CS 8100 3D
TROPHY                            510(k) NO: K133406(TRADITIONAL)
ATTN: MARIE  PIERRE               PHONE NO : 33 1 64808526
4 RUE F. PELLOUTIER CROISSY BEAUBOSE DECISION MADE: 14-MAR-14
MARNE LA VALLEE CEDEX 2    FR 7743510(k) STATEMENT

DEVICE: RADIANCE 330 PROTON THERAPY SYSTEM
PROTOM INTERNATIONAL, INC.        510(k) NO: K134052(TRADITIONAL)
ATTN: JOHN J SMITH, MD, JD        PHONE NO : 202 637 3638   
555 13TH ST. NW                   SE DECISION MADE: 14-MAR-14
WASHINGTON DC 20001               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
C.R. BARD, INC.                   510(k) NO: K140345(SPECIAL)
ATTN: JAMES R DAVIS               PHONE NO : 801 522 5000   
605 NORTH 5600 WEST               SE DECISION MADE: 14-MAR-14
SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERISPINE LC CAGE
SAFE ORTHOPAEDICS                 510(k) NO: K133893(ABBREVIATED)
ATTN: PIERRE  DUMOUCHEL           PHONE NO : 330 134 215000
Parc des Bellevues Allee R.LuxemboSE DECISION MADE: 14-MAR-14
Eragny sur Oise    FR 95610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINIA
BICON, LLC                        510(k) NO: K133608(ABBREVIATED)
ATTN: RICHARD  WU                 PHONE NO : 800 882 4266   
501 Arborway                      SE DECISION MADE: 14-MAR-14
Boston MA 02130                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SATURN DENTAL IMPLANT
CORTEX DENTAL IMPLANTS INDUSTRIES,510(k) NO: K131258(TRADITIONAL)
ATTN: SIMHA  SIBONY               PHONE NO : 972 498532 92
MOBILE POST ASHRAT                SE DECISION MADE: 17-MAR-14
MOBILE POST ASHRAT    IS 25201    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORESEE (4C) IMAGING SYSTEM
DIAGNOSTIC PHOTONICS, INC         510(k) NO: K133209(TRADITIONAL)
ATTN: JANICE  HOGAN               PHONE NO : 267 675 4611   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 17-MAR-14
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
BOVIE MEDICAL CORPORATION         510(k) NO: K134054(TRADITIONAL)
ATTN: RICHARD A KOZLOFF           PHONE NO : 727 803 8513   
5115 ULMERTON ROAD                SE DECISION MADE: 17-MAR-14
CLEARWATER FL 33760 4004          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRONIC BASAL BODY THERMOMETER
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K131210(TRADITIONAL)
ATTN: IVY  CHEN                   PHONE NO : 086 0755 26715351
KEJI NAN NO. 12 ROAD, HI-TECH PARKSE DECISION MADE: 18-MAR-14
SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TINNITUS SOUNDSUPPORT
OTICON A/S                        510(k) NO: K133308(TRADITIONAL)
ATTN: SOREN  JUEL WITT            PHONE NO : 45 3917 7100
KONGEBAKKEN 9                     SE DECISION MADE: 18-MAR-14
SMORUM    DA DK-2765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI GAIA FIRST, SECOND, THIRD
ASAHI INTECC CO., LTD.            510(k) NO: K133865(TRADITIONAL)
ATTN: CANDACE  CEDERMAN           PHONE NO : 410 674 2060   
5523 RESEARCH PARK DRIVE, SUITE 20SE DECISION MADE: 18-MAR-14
BALTIMORE MD 21228                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPHINX JR
ALLMED SYSTEMS INC.               510(k) NO: K132975(TRADITIONAL)
ATTN: PETER  ALLEN                PHONE NO : 925 468 0433   
9232 KLEMETSON DRIVE              SE DECISION MADE: 18-MAR-14
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V.                510(k) NO: K133894(TRADITIONAL)
ATTN: M.J.  AERTS                 PHONE NO : 321 638 1211
INTERLEUVENLAAN 40                SE DECISION MADE: 18-MAR-14
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MELYS ATRIAL FIBRILLATION SCREENING MONITOR
ADVANCED FLUIDICS, LLC            510(k) NO: K132206(TRADITIONAL)
ATTN: E J  SMITH                  PHONE NO : 888 729 9674   
1468 HARWELL AVE                  SE DECISION MADE: 19-MAR-14
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEED XL
BIOMEDICAL ENT., INC.             510(k) NO: K133780(TRADITIONAL)
ATTN: JOE  SOWARD                 PHONE NO : 210 677 0354   
14785 OMICRON DR., SUITE 205      SE DECISION MADE: 19-MAR-14
SAN ANTONIO TX 78245              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRRUS PHOTO
CARL ZEISS MEDITEC AG             510(k) NO: K133217(TRADITIONAL)
ATTN: MANDY  AMBRECHT             PHONE NO : 925 557 4561   
5160 HACIENDA DRIVE               SE DECISION MADE: 19-MAR-14
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
CROSSBAY MEDICAL, INC.            510(k) NO: K133144(TRADITIONAL)
ATTN: CINDY  DOMECUS              PHONE NO : 650 343 4813   
17141 MURPHY AVE, SUITE 5C        SE DECISION MADE: 19-MAR-14
IRVINE CA 94901                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METALLIC INTRAMEDULLARY NAIL SYSTEM
TIANJIN WALKMAN BIOMATERIAL CO., L510(k) NO: K132078(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122815 850
P.O. BOX 120-119                  SE DECISION MADE: 19-MAR-14
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SRS ENDOSCOPIC STAPLING SYSTEM
MEDIGUS, LTD.                     510(k) NO: K132151(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 19-MAR-14
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K133374(TRADITIONAL)
ATTN: SARAH  MCINTYRE             PHONE NO : 906 225 5861   
375 RIVER PARK CIRCLE             SE DECISION MADE: 19-MAR-14
MARQUETTE MI 49855   49855        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBOL-X INTRODUCER SHEATH
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K140398(SPECIAL)
ATTN: LUKE  MEIDELL               PHONE NO : 801 565 6212   
12050 LONE PEAK PKWY              SE DECISION MADE: 19-MAR-14
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEAL SINGLE-USE BIOPSY VALVE
ENDOCHOICE, INC.                  510(k) NO: K133734(SPECIAL)
ATTN: JANNA  BABSON               PHONE NO : 678 708 4773   
11810 WILLS RD.                   SE DECISION MADE: 19-MAR-14
ALPHARETTA GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IVUE 500
OPTOVUE, INC.                     510(k) NO: K133892(TRADITIONAL)
ATTN: MICHAEL J SARRASIN          PHONE NO : 510 897 1575   
2800 BAYVIEW DRIVE                SE DECISION MADE: 19-MAR-14
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRC-PEX, RADIC-SEALER
KM CORPORATION                    510(k) NO: K132123(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
1515 E KATELLA AVE UNIT 2115      SE DECISION MADE: 20-MAR-14
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IM60/IM70 PATIENT MONITOR
EDAN INSTRUMENTS, INC.            510(k) NO: K131971(TRADITIONAL)
ATTN: CHERRY  SUN                 PHONE NO : 86 755268 56469
NANHAI RD 1019 NO. SHEKOU, NANSHANSE DECISION MADE: 20-MAR-14
SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGORA OPTIME
INSTRUMENTARIUM DENTAL, PALODEX GR510(k) NO: K133231(SPECIAL)
ATTN: TERHO  TURKUMAKI            PHONE NO : 358 503209 113
NAHKELANTIE 160                   SE DECISION MADE: 20-MAR-14
TUUSULA, FINLAND    FI 04300      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIRTOUGH
KURARAY NORITAKE DENTAL INC.      510(k) NO: K133211(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 813 6701 1706
700 12TH STREET NW, SUITE 1100    SE DECISION MADE: 20-MAR-14
WASHINGTON DC 20005   20005       510(k) STATEMENT

DEVICE: VARIOGUIDE DRILL KIT
MRI INTERVENTIONS, INC.           510(k) NO: K132436(TRADITIONAL)
ATTN: E. F WADDELL                PHONE NO : 949 900 6833   
5 Musick                          SE DECISION MADE: 20-MAR-14
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAIR DRIVE, NEUTRACLEAR
CAIR LGL                          510(k) NO: K133073(TRADITIONAL)
ATTN: IRVING  WIESEN              PHONE NO : 212 381 8774   
420 LEXINGTON AVE. STE. 2400      SE DECISION MADE: 20-MAR-14
NEW YORK NY 10170                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
LUMENIS LTD.                      510(k) NO: K133319(TRADITIONAL)
ATTN: IMAN  KHORSHID              PHONE NO : 972 4 9599000
6 HAKIDMA STREET, YOKNEAM INDUSTRISE DECISION MADE: 20-MAR-14
YOKNEAM    IS 2069204             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAMBER SPINE DIAGON OBLIQUE CAGE
CAMBER SPINE                      510(k) NO: K134038(SPECIAL)
ATTN: DANIEL A PONTECORVO         PHONE NO : 484 420 4671   
90 S. NEWTOWN STREET RD. SUITE 10 SE DECISION MADE: 20-MAR-14
NEWTOWN SQUARE PA 19073           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
MAQUET CRITICAL CARE AB           510(k) NO: K133958(ABBREVIATED)
ATTN: LIA  LIEBGOLD               PHONE NO : 973 709 7340   
45 BARBOUR POND DRIVE             SE DECISION MADE: 20-MAR-14
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRA-LOCK DENTAL IMPLANTS
INTRA-LOCK INTERNATIONAL, INC.    510(k) NO: K133613(TRADITIONAL)
ATTN: MARY L JEAN                 PHONE NO : 561 447 8282   
6560 W. ROGERS CIRCLE SUITE 24    SE DECISION MADE: 20-MAR-14
BOCA RATON FL 33487               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAMBER SPINE COVERIS CERVICAL CAGE
CAMBER SPINE                      510(k) NO: K133529(TRADITIONAL)
ATTN: DANIEL A PONTECORVO         PHONE NO : 484 420 4671   
90 S. NEWTOWN STREET RD. SUITE 10 SE DECISION MADE: 20-MAR-14
NEWTOWN SQUARE PA 19073           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140253(TRADITIONAL)
ATTN: CORDELL  FIELDS             PHONE NO : 610 219 8518   
51 VALLEY STREAM PARKWAY, MAILCODESE DECISION MADE: 20-MAR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER PEDIATRIC MANDIBLE DISTRACTOR
STRYKER                           510(k) NO: K133398(TRADITIONAL)
ATTN: MANISH  PATEL               PHONE NO : 269 389 4271   
750 TRADE CENTRE WAY STE 200      SE DECISION MADE: 20-MAR-14
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYBER MEDICAL TRAUMA SCREW
TYBER MEDICAL LLC                 510(k) NO: K133842(TRADITIONAL)
ATTN: JEFF  TYBER                 PHONE NO : 303 717 5060   
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 20-MAR-14
MORRISTOWN NJ 07960               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID
DORNOCH MEDICAL SYSTEMS, INC.     510(k) NO: K133786(TRADITIONAL)
ATTN: LARRY  SMITH                PHONE NO : 816 505 2226   
200 Nw Parkway Rd                 SE DECISION MADE: 21-MAR-14
RIVERSIDE MO 64150                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAVE II, SAVE II BASIC
AUTOMEDX INC.                     510(k) NO: K131877(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
1420 Lakeside Parkway, Suite 102  SE DECISION MADE: 21-MAR-14
Flower Mound TX 75028             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
AEA SRL                           510(k) NO: K132011(ABBREVIATED)
ATTN: MICHELE  MENGONI            PHONE NO : 003 907 318161
Via Fiume 16                      SE DECISION MADE: 21-MAR-14
Angeli di Rosora    IT 60030      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
AXIS-SHIELD POC AS                510(k) NO: K132031(TRADITIONAL)
ATTN: KARI  SKINNEMOEN            PHONE NO : 47 240560 00
P.O. BOX 6863 RODELOKKA           SE DECISION MADE: 21-MAR-14
OSLO    NO N-0504                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KERATOR
LK CONSULTING GROUP USA, INC.     510(k) NO: K132144(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 21-MAR-14
FULLERTON CA 92831                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K131652(TRADITIONAL)
ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   
670 Almanor Ave                   SE DECISION MADE: 21-MAR-14
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELIBRA SOFT-TISSUE FORCE SENSOR
KAMM & ASSOCIATES                 510(k) NO: K132104(SPECIAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 21-MAR-14
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTRA
SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K131553(TRADITIONAL)
ATTN: BARRY  SALL, RAC, FRAPS     PHONE NO : 781 434 4742   
195 WEST STREET                   SE DECISION MADE: 21-MAR-14
WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NS 2500 HOLMIUM LASER SYSTEM
NEW STAR LASERS, INC.             510(k) NO: K132607(TRADITIONAL)
ATTN: PAMELA M BUCKMAN, MSN       PHONE NO : 925 980 7007   
2800 PLEASANT HILL RD. STE #175   SE DECISION MADE: 21-MAR-14
PLEASANT HILL CA 94523            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K2M, INC.                         510(k) NO: K133944(TRADITIONAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 21-MAR-14
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA FA DR SYSTEM
SEDECAL SA                        510(k) NO: K133782(SPECIAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT.                  SE DECISION MADE: 21-MAR-14
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISCOVERY PET/CT 710
GE MEDICAL SYSTEMS, LLC           510(k) NO: K133657(TRADITIONAL)
ATTN: DAVID  DUERSTELER           PHONE NO : 262 312 7029   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 21-MAR-14
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
YUNG SHENG OPTICAL CO., LTD.      510(k) NO: K133735(TRADITIONAL)
ATTN: WEN-HAN  CHEN               PHONE NO : 886 425658 384
3F-1, NO. 6, JHONGKE ROAD, DAYA DISE DECISION MADE: 21-MAR-14
TAICHUNG CITY    TW 42881         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
TERATECH CORP.                    510(k) NO: K140524(TRADITIONAL)
ATTN: BEN  CHIAMPA                PHONE NO : 781 270 4143   
77-79 TERRACE HALL AVE.           SE DECISION MADE: 21-MAR-14
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: WITHINGS BLOOD PRESURE MONITOR
WITHINGS                          510(k) NO: K133125(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 33 1 41460460
20 RUE ROUGET DE LISLE            SE DECISION MADE: 24-MAR-14
ISSY LES MOULINEAUX    FR 92130   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREVENA INCISION MANAGEMENT SYSTEM  WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K133232(TRADITIONAL)
ATTN: BRIAN  YOUNG                PHONE NO : 210 255 6137   
6203 FARINON DRIVE                SE DECISION MADE: 24-MAR-14
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
INTEGRA LIFE SCIENCES CORPORATION 510(k) NO: K132250(TRADITIONAL)
ATTN: FREDERIC  TESTA             PHONE NO : 609 903 0325   
311 ENTERPRISE DRIVE              SE DECISION MADE: 24-MAR-14
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRODENSE BONE GRAFT SUBSTITUTE
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K132656(TRADITIONAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
5677 AIRLINE RD.                  SE DECISION MADE: 24-MAR-14
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QB TEST
QBTECH AB                         510(k) NO: K133382(TRADITIONAL)
ATTN: HANS  BOSTROM               PHONE NO : 46 70633 9209
Kungsgatan 29                     SE DECISION MADE: 24-MAR-14
Stockholm    SE 11156             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
ENCORE MEDICAL, L.P.              510(k) NO: K130550(TRADITIONAL)
ATTN: WILLIAM  GARZON             PHONE NO : 512 834 6391   
9800 METRIC BLVD.                 SE DECISION MADE: 24-MAR-14
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIAX DISTAL RADIUS PLATING SYSTEM
STRYKER LEIBINGER GMBH            510(k) NO: K133974(TRADITIONAL)
ATTN: ELIJAH N WREH               PHONE NO : 201 831 5691   
325 CORPORATE DRIVE               SE DECISION MADE: 24-MAR-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T:SLIM INSULIN DELIVERY SYSTEM
TANDEM DIABETES CARE, INC.        510(k) NO: K133593(SPECIAL)
ATTN: JOHN  SHERIDAN              PHONE NO : 858 255 6345   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 24-MAR-14
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IOVERA
MYOSCIENCE INC                    510(k) NO: K133453(TRADITIONAL)
ATTN: BIJESH  CHANDRAN            PHONE NO : 650 474 2600   
1600 SEAPORT BLVD, STE 450 NORTH LSE DECISION MADE: 24-MAR-14
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HC550 RESPIRATORY HUMIDIFIER, RT100 ADULT VENTILATOR CIRCUIT
FISHER & PAYKEL HEALTHCARE, LTD.  510(k) NO: K132017(TRADITIONAL)
ATTN: ELIZABETH  GOLDSTEIN        PHONE NO : 64 9 5740100
15 MAURICE PAYKEL PLACE           SE DECISION MADE: 25-MAR-14
EAST TAMAKI    NZ 2013            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLACE SOUND GENERATORS
AMPLISOUND HEARING PRODUCTS & SERV510(k) NO: K132965(ABBREVIATED)
ATTN: RALPH T CAMPAGNA            PHONE NO : 860 779 6500   
594 PUTNAM ROAD                   SE DECISION MADE: 25-MAR-14
DANIELSON CT 06239                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIO COLOR 2MP
BARCO N.V.                        510(k) NO: K133663(TRADITIONAL)
ATTN:                             PHONE NO : 
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 25-MAR-14
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K140449(SPECIAL)
ATTN: GREGORY  MASCHEK            PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 25-MAR-14
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASIR-V
GE MEDICAL SYSTEMS, LLC           510(k) NO: K133640(TRADITIONAL)
ATTN: HUY  DOAN                   PHONE NO : 262 312 7751   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 25-MAR-14
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFETY BIOPSY NEEDLE SYSTEM
PFM MEDICAL, INC                  510(k) NO: K140137(TRADITIONAL)
ATTN: SALVADORE  PALOMARES        PHONE NO : 760 758 8749   
1815 ASTON AVE, SUITE 106         SE DECISION MADE: 25-MAR-14
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ASPIRE CRISTALLE
FUJIFILM MEDICAL SYSTEMS, USA INC.510(k) NO: K133972(TRADITIONAL)
ATTN: PETER  ALTMAN               PHONE NO : 203 602 3576   
419 WEST AVE.                     SE DECISION MADE: 25-MAR-14
STANFORD CT 06902                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
RANDOX LABORATORIES LIMITED       510(k) NO: K140393(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 440 28 94422413
55 DIAMOND RD.                    SE DECISION MADE: 25-MAR-14
CRUMLIN, CO.ANTRIM    UK BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILEX SACROILIAC JOINT FUSION SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K140079(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 Alexandersville Rd            SE DECISION MADE: 25-MAR-14
Miamisburg OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAUTILUS SPINAL SYSTEM
LIFE SPINE, INC                   510(k) NO: K140457(SPECIAL)
ATTN: RANDY  LEWIS                PHONE NO : 847 884 6117   
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 25-MAR-14
HOFFMAN ESTATES IL 60169          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAAS WORKSTATION
PIE MEDICAL IMAGING               510(k) NO: K133993(TRADITIONAL)
ATTN: FLORIE  DANIELS             PHONE NO : 33 43 3281328
PHILIPSWEG 1                      SE DECISION MADE: 25-MAR-14
MAASTRICHT, LIMBURG    NT 6227 AJ 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VEGA KNEE SYSTEM
AESCULAP IMPLANT SYSTEMS          510(k) NO: K140452(SPECIAL)
ATTN: JULIE  TOM WING             PHONE NO : 610 984 9147   
3773 CORPORATE PWKY.              SE DECISION MADE: 25-MAR-14
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WHIP MIX PREPPIES PLUS
WHIP-MIX CORP.                    510(k) NO: K131760(TRADITIONAL)
ATTN: JOHN P WATERS               PHONE NO : 502 634 5357   
361 FARMINGTON AVE.               SE DECISION MADE: 26-MAR-14
LOUISVILLE KY 40217               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMICO DH-W35 OPHTHALMOSCOPE SERIES
AMICO DIAGNOSTIC INCORPORATED     510(k) NO: K131939(TRADITIONAL)
ATTN: LAUREN  CHRAPOWITZKY        PHONE NO : 813 645 2855   
445 APOLLO BEACH BLVD.            SE DECISION MADE: 26-MAR-14
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTRAIN
DOLPHYS MEDICAL B.V.              510(k) NO: K132759(TRADITIONAL)
ATTN: FABIENNE  PETERS            PHONE NO : 310 40 7516020
DE LISMORTEL 31                   SE DECISION MADE: 26-MAR-14
EINDHOVEN    NL 5612AR            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE CL RESPIRATION POD
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K132320(TRADITIONAL)
ATTN: JOHANNES  SCHMID            PHONE NO : 49 7031 4631315
HEWLETT-PACKARD STR.2             SE DECISION MADE: 26-MAR-14
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESOLUTIONMD MOBILE
CALGARY SCIENTIFIC, INC.          510(k) NO: K133508(TRADITIONAL)
ATTN: KYLE  PETERSON              PHONE NO : 403 767 7945
SUITE 208, 1210 20TH AVENUE SE    SE DECISION MADE: 26-MAR-14
CALGARY, ALBERTA    CA T2G 1M8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORGRIP
CORPAK MEDSYSTEMS                 510(k) NO: K133599(TRADITIONAL)
ATTN: STEPHANIE  WASIELEWSKI      PHONE NO : 847 403 3484   
1001 ASBURY DR                    SE DECISION MADE: 26-MAR-14
BUFFALO GROVE IL 60089 0000       510(k) STATEMENT

DEVICE: COLLAGEN TENDON SHEET-DDI (CTS-DDI)
ROTATION MEDICAL, INC.            510(k) NO: K140300(TRADITIONAL)
ATTN: JEFF  SIMS                  PHONE NO : 763 746 7502   
15350 25TH AVENUE N SUITE 100     SE DECISION MADE: 26-MAR-14
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
EXCITON TECHNOLOGIES INC.         510(k) NO: K133775(SPECIAL)
ATTN: MELANIE  USSYK              PHONE NO : 780 248 5868
SUITE 4000, 10230 JASPER AVE      SE DECISION MADE: 26-MAR-14
EDMONTON, ALBERTA    CA T5Z 3N5   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
GAMBRO RENAL PRODUCTS, INC.       510(k) NO: K133807(TRADITIONAL)
ATTN: KAE  MILLER                 PHONE NO : 303 222 6724   
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 26-MAR-14
LAKEWOOD CO 80401                 510(k) STATEMENT

DEVICE: MONOTEX
RIVERPOINT MEDICAL                510(k) NO: K140415(ABBREVIATED)
ATTN: DOUGLAS  ROWLEY             PHONE NO : 503 517 8001   
825 NE 25TH AVE.                  SE DECISION MADE: 26-MAR-14
PORTLAND OR 97232                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOTAL ACROSS
MEDTRONIC VASCULAR                510(k) NO: K133539(TRADITIONAL)
ATTN: DIANA  JOHNSON              PHONE NO : 707 591 2656   
3576 UNOCAL PLACE                 SE DECISION MADE: 26-MAR-14
SANTA ROSA CA 95403               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OP300
PALODEX GROUP OY                  510(k) NO: K133544(SPECIAL)
ATTN: TERHO  TURKUMAKI            PHONE NO : 358 10270 2000
NAHKELANTIE 160                   SE DECISION MADE: 26-MAR-14
TUUSULA    FI 04300               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE SYSTEM
SIESTA MEDICAL, INC.              510(k) NO: K133680(TRADITIONAL)
ATTN: MICHAEL  KOLBER             PHONE NO : 408 505 6626   
101 CHURCH STREET SUITE 3         SE DECISION MADE: 26-MAR-14
LOS GATOS CA 95030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEREGRINE SYSTEM INFUSION CATHETER
ABLATIVE SOLUTIONS, INC.          510(k) NO: K140637(TRADITIONAL)
ATTN: SHARON  ROCKWELL            PHONE NO : 714 695 9269   
801 Hermosa Way                   SE DECISION MADE: 26-MAR-14
Menlo Park CA 94025               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BIOMET ACCESS SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K132373(TRADITIONAL)
ATTN: VIVIAN  KELLY, MS, RAC      PHONE NO : 973 299 9300   
399 JEFFERSON ROAD                SE DECISION MADE: 27-MAR-14
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTED MILLEX -GV, CATHIVEX -GV
MERCK MILLIPORE LTD.              510(k) NO: K133004(TRADITIONAL)
ATTN: CINDY  PENNY                PHONE NO : 951 514 4367   
28820 SINGLE OAK DRIVE            SE DECISION MADE: 27-MAR-14
TEMECULA CA 92590                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
FLOWER ORTHOPEDICS CORPORATION    510(k) NO: K133930(TRADITIONAL)
ATTN: GARY  BARNETT               PHONE NO : 215 394 8903   
100 Witmer Rd Ste 280             SE DECISION MADE: 27-MAR-14
Horsham PA 19044                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
RAYNER INTRAOCULAR LENSES LTD.    510(k) NO: K132002(TRADITIONAL)
ATTN: JULIETTE E COOK             PHONE NO : 44 127320 5401
1-2 SACKVILLE ROAD                SE DECISION MADE: 27-MAR-14
HOVE, EAST SUSSEX    UK BN3 7AN   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MANDREL GUIDEWIRE
LAKE REGION MEDICAL               510(k) NO: K140485(SPECIAL)
ATTN: MATHEW  PEXA                PHONE NO : 952 488 5111   
340 LAKE HAZELTINE DRIVE          SE DECISION MADE: 27-MAR-14
CHASKA MN 55318                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS PRECICONTROL TS
ROCHE DIAGNOSTICS                 510(k) NO: K140534(TRADITIONAL)
ATTN: JANE  PHILLIPS              PHONE NO : 317 521 3338   
9115 HAGUE ROAD                   SE DECISION MADE: 27-MAR-14
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEXIPLIANT DILATOR SHEATH SET
SPECTRANETICS CORPORATION         510(k) NO: K133631(TRADITIONAL)
ATTN: STACEY A STRAND             PHONE NO : 719 447 2706   
9965 FEDERAL DRIVE                SE DECISION MADE: 27-MAR-14
COLORADO SPRINGS CO 80921 3617    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, INC510(k) NO: K140106(SPECIAL)
ATTN: SHARYN  ORTON               PHONE NO : 401 330 8264   
200 HOMER AVE.                    SE DECISION MADE: 27-MAR-14
ASHLAND MA 01721                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHFAST CTNL CALIBRATORS
MITSUBISHI CHEMICAL MEDIENCE CORPO510(k) NO: K130603(SPECIAL)
ATTN: JUDI  SMITH                 PHONE NO : 240 316 3377   
2 BETHESDA METRO CENTER SUITE 850 SE DECISION MADE: 27-MAR-14
BETHESDA MD 20814                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
PIONEER SURGICAL TECHNOLOGY, INC  510(k) NO: K133455(TRADITIONAL)
ATTN: EMILY  DOWNS                PHONE NO : 906 225 5602   
375 RIVER PARK CIRCLE             SE DECISION MADE: 27-MAR-14
Marquette MI 49855                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE USE STERILE SYRINGE WITH NEEDLE
JIANGXI KELUN MEDICAL DEVICES MANU510(k) NO: K133493(ABBREVIATED)
ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182
ROOM 302, NO.21 BUILDING KAIYU GARSE DECISION MADE: 27-MAR-14
WENZHOU    CH 325000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PDE-NEO
HAMAMATSU PHOTONICS, K.K.         510(k) NO: K133719(TRADITIONAL)
ATTN: JEFFREY K SHAPIRO           PHONE NO : 202 737 9633   
700 13TH STREET, NW SUITE 1200    SE DECISION MADE: 27-MAR-14
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
AJEX MEDITECH., LTD               510(k) NO: K122298(TRADITIONAL)
ATTN: WILLIAM  LITTLE             PHONE NO : 516 513 1330   
52 NEWTOWN PLAZA                  SE DECISION MADE: 28-MAR-14
PLAINVIEW NY 11803                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-RAY TV SYSTEM SONIAL VISION G4
SHIMADZU CORP.                    510(k) NO: K131075(ABBREVIATED)
ATTN: DON  KARLE                  PHONE NO : 310 217 8855   
20101 SOUTH VERMONT AVE.          SE DECISION MADE: 28-MAR-14
TORRANCE CA 90502 1328            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD 50/100S/200 TEST PACK
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K130263(TRADITIONAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DR.                 SE DECISION MADE: 28-MAR-14
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
CONMED CORPORATION                510(k) NO: K133116(TRADITIONAL)
ATTN: NANCY  GERTLAR              PHONE NO : 509 496 2248   
134 FLANDERS ROAD                 SE DECISION MADE: 28-MAR-14
WESTBOROUGH MA 01581              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I-HIP TOTAL HIP SYSTEM
ICONACY ORTHOPEDIC IMPLANTS, LLC  510(k) NO: K132572(TRADITIONAL)
ATTN: MARC E RUHLING              PHONE NO : 574 269 4266   
4130 CORRIDOR DRIVE               SE DECISION MADE: 28-MAR-14
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: B&B BUBBLER
S & T MEDICAL TECHNOLOGIES, INC.  510(k) NO: K133210(TRADITIONAL)
ATTN: DERICK  CORRENTE            PHONE NO : 760 929 9972   
1954 KELLOGG AVENUE SUITE 100     SE DECISION MADE: 28-MAR-14
CARLSBAD CA 92008                 510(k) STATEMENT

DEVICE: ORTHOSCAN FD MINI C-ARM
ORTHOSCAN, INC.                   510(k) NO: K133174(TRADITIONAL)
ATTN: ADAM  MENZIES               PHONE NO : 480 503 8010   
8212 E Evans Rd                   SE DECISION MADE: 28-MAR-14
SCOTTSDALE AZ 85260               510(k) STATEMENT

DEVICE: DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
INTUITIVE SURGICAL, INC.          510(k) NO: K131861(TRADITIONAL)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523 2100   
1266 KIFER ROAD                   SE DECISION MADE: 28-MAR-14
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL COUGH
LUNG ASSIST, INC.                 510(k) NO: K132988(TRADITIONAL)
ATTN: LEWIS  WARD                 PHONE NO : 303 530 3279   
4655 KIRKWOOD COURT               SE DECISION MADE: 28-MAR-14
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOCAP
MAXTEC, INC.                      510(k) NO: K133540(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
6526 SOUTH COTTONWOOD ST.         SE DECISION MADE: 28-MAR-14
SALT LAKE CITY UT 84107           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K133560(TRADITIONAL)
ATTN: AMITA  SHAH                 PHONE NO : 781 345 9164   
28 Crosby Dr                      SE DECISION MADE: 28-MAR-14
Bedford MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
BIOMET UK LTD.                    510(k) NO: K133940(TRADITIONAL)
ATTN: JASON  HECKAMAN             PHONE NO : 574 374 3707   
56 EAST BELL DRIVE                SE DECISION MADE: 28-MAR-14
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROSTAR TMS THERAPY SYSTEM
NEURONETICS                       510(k) NO: K133408(TRADITIONAL)
ATTN: JUDY P WAYS, PH.D.          PHONE NO : 610 640 4202   
3222 PHOENIXVILLE PIKE            SE DECISION MADE: 28-MAR-14
MALVERN PA 19355 1245             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORONIS 5MP
BARCO NV                          510(k) NO: K133984(TRADITIONAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 32 56 233459
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 28-MAR-14
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: PEEK FUSION IMPLANT
MTP SOLUTIONS LLC                 510(k) NO: K133515(TRADITIONAL)
ATTN: ROBERT  HOY                 PHONE NO : 614 448 6358   
124 SOUTH 600 WEST, SUITE 100     SE DECISION MADE: 28-MAR-14
LOGAN UT 84321                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTREMITY MEDICAL HAMMERTOE DEVICE
EXTREMITY MEDICAL, LLC.           510(k) NO: K133636(TRADITIONAL)
ATTN: BRIAN  SMEKAL               PHONE NO : 973 588 8980   
300 INTERPACE PKWY, STE 410       SE DECISION MADE: 28-MAR-14
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
HITACHI ALOKA MEDICAL,LTD. (HITACH510(k) NO: K134016(TRADITIONAL)
ATTN: ANGELA  VANARSDALE          PHONE NO : 203 269 5088   
10 FAIRFIELD BLVD.                SE DECISION MADE: 28-MAR-14
WALLINGFORD CT 06492 7502         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXERA 2 ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K140201(TRADITIONAL)
ATTN: GRACE  LI                   PHONE NO : 650 261 8039   
740 BAY ROAD                      SE DECISION MADE: 28-MAR-14
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
PURICORE INC.                     510(k) NO: K131848(TRADITIONAL)
ATTN: ART  MORSE                  PHONE NO : 484 321 2700   
508 LAPP RD.                      SE DECISION MADE: 31-MAR-14
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
RTI SURGICAL, INC.                510(k) NO: K132850(TRADITIONAL)
ATTN: ESTHER  CARBON              PHONE NO : 386 418 8888   
11621 Research Cir                SE DECISION MADE: 31-MAR-14
ALACHUA FL 32615                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES SYNSONIC ULNA NAIL
SYNTHES (USA)                     510(k) NO: K131984(TRADITIONAL)
ATTN: THOMAS N SHEA               PHONE NO : 610 719 6809   
1302 WRIGHTS LANE EAST            SE DECISION MADE: 31-MAR-14
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIROMATRIX BIOLOGICAL MESH
MIROMATRIX MEDICAL INC.           510(k) NO: K134033(TRADITIONAL)
ATTN: STEPHEN  RHODES             PHONE NO : 301 579 3700   
400 N. WASHINGTON ST., STE 100    SE DECISION MADE: 31-MAR-14
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K140505(ABBREVIATED)
ATTN: FATIMA  PACHECO             PHONE NO : 914 524 2450   
511 BENEDICT AVENUE               SE DECISION MADE: 31-MAR-14
TARRYTOWN NY 10591 5097           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICEROD CX CRYOABLATION NEEDLE
GALIL MEDICAL LTD.                510(k) NO: K140584(SPECIAL)
ATTN: LYNNE  DAVIES               PHONE NO : 651 287 5098   
4364 ROUND LAKE ROAD              SE DECISION MADE: 31-MAR-14
ARDEN HILLS MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
CARDIOTEK, B.V.                   510(k) NO: K134044(TRADITIONAL)
ATTN: MELISSA  WALKER             PHONE NO : 636 405 7498   
1324 CLARKSON CLAYTON CENTER #332 SE DECISION MADE: 31-MAR-14
BALLWIN MO 6301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
PINNACLE SPINE GROUP, LLC         510(k) NO: K133721(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
1601 ELM ST STE 1930              SE DECISION MADE: 31-MAR-14
Dallas TX 75201                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITE IBF
INNOVA SPINAL TECHNOLOGIES, LLC   510(k) NO: K133459(TRADITIONAL)
ATTN: RICH  JANSEN, PHARM. D.     PHONE NO : 612 281 5505   
11821 BRAMBLE COVE DRIVE          SE DECISION MADE: 06-MAR-14
FT. MYERS FL 33905                510(k) STATEMENT

DEVICE: FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
CORDIS CORP.                      510(k) NO: K130981(TRADITIONAL)
ATTN: KIM  FONDA                  PHONE NO : 510 248 2480   
6500 PASEO PADRE PARKWAY          SE DECISION MADE: 12-MAR-14
FREMONT CA 94555                  510(k) STATEMENT


                                                 TOTAL 510(k)s THIS PERIOD   255                                     
                                                 TOTAL WITH SUMMARIES        238                                     
                                                 TOTAL WITH STATEMENTS        17