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Medical Devices

July 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2014
 
 
DEVICE: EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
Boston Scientific Corporation     510(k) NO: K133110(Traditional)
ATTN: RENEE  MITCHELL             PHONE NO : 763 494-1405 
ONE SCIMED PLACE                  SE DECISION MADE: 02-JUL-14
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BLOSSOM SALINE DELIVERY ASSIST DEVICE
MARZ MEDICAL, INC                 510(k) NO: K131692(Traditional)
ATTN: MARY  PASCUAL GALLUP        PHONE NO : 510 441-4017 
2500 HOSPITAL DRIVE BUILDING 9    SE DECISION MADE: 10-JUL-14
MOUNTAIN VIEW CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
STRYKER CORPORATION               510(k) NO: K140400(Traditional)
ATTN: SORAYA  KING                PHONE NO : 201 760-8296 
2 PEARL COURT                     SE DECISION MADE: 01-JUL-14
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PORCINE ANORGANIC BONE MINERAL
COLLAGEN MATRIX, INC.             510(k) NO: K140714(Traditional)
ATTN: PEGGY  HANSEN               PHONE NO : 201 405-1477 
15 THORNTON ROAD                  SE DECISION MADE: 16-JUL-14
OAKLAND NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: V-PRO STERILIZATION TRAY/ STERILIZATION MAT
STERIS Corporation                510(k) NO: K140494(Traditional)
ATTN: TONY  PIOTRKOWSKI           PHONE NO : 440 392-7437 
5960 Heisley Road                 SE DECISION MADE: 25-JUL-14
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
STERIS Corporation                510(k) NO: K140499(Traditional)
ATTN: BILL  BRODBECK              PHONE NO : 440 392-7690 
5960 Heisley Road                 SE DECISION MADE: 17-JUL-14
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
JUNO DENTISTRY LP                 510(k) NO: K140512(Traditional)
ATTN: ROGER  MASTRONY             PHONE NO : 203 298-0438 
848-1/2 DERBY AVE                 SE DECISION MADE: 02-JUL-14
ORANGE CT  06477                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
STERIS Corporation                510(k) NO: K140515(Abbreviated)
ATTN: BILL  BRODBECK              PHONE NO : 440 392-7695 
5960 Heisley Road                 SE DECISION MADE: 17-JUL-14
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LIAISON XL ANALYZER
DIASORIN, INC.                    510(k) NO: K141116(Traditional)
ATTN: Mari  Meyer                 PHONE NO : 651 351-5635 
1951 NORTHWESTERN AVE.            SE DECISION MADE: 25-JUL-14
STILLWATER MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
CHOICE SPINE, LP                  510(k) NO: K140142(Traditional)
ATTN: KIM  FINCH                  PHONE NO : 865 246-3333 
306 ERIN DRIVE                    SE DECISION MADE: 16-JUL-14
KNOXVILLE TN  37919-2141          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
CEDARS-SINAI MEDICAL CENTER       510(k) NO: K141652(Special)
ATTN: GEOFF  POLLARD              PHONE NO : 310 423-4663 
8700 BEVERLY BOULEVARD            SE DECISION MADE: 22-JUL-14
LOS ANGELES CA  90048-1869        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EQUALIZER OCCLUSION BALLOON CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K140273(Traditional)
ATTN: DIANE  NELSON               PHONE NO : 
ONE SCIMED PLACE                  SE DECISION MADE: 22-JUL-14
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
NEUROINVENT INC.                  510(k) NO: K140200(Traditional)
ATTN: CHAO-SHENT  CHAO            PHONE NO : 886 227935 961 
5F,NO.123,ANMEI ST.,NEIHU DISTRICTSE DECISION MADE: 18-JUL-14
TAIPEI CITY  TW 11484             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALMA DIODE TABLETOP LASER
ALMA LASERS LTD.                  510(k) NO: K140005(Traditional)
ATTN: KATHY  MAYNOR               PHONE NO : 352 586-3113 
26 REBECCA CT                     SE DECISION MADE: 18-JUL-14
HOMOSASSA FL  34446               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EXCIA TOTAL HIP SYSTEM
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K140915(Special)
ATTN: JULIE T WING                PHONE NO : 610 984-9147 
3773 Corporate Parkway            SE DECISION MADE: 21-JUL-14
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OPTILITE C1 INACTIVATOR KIT
THE BINDING SITE GROUP LTD        510(k) NO: K141100(Traditional)
ATTN: MARIANNE  SENDER            PHONE NO : 440 121456 9500 
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 18-JUL-14
BIRMINGHAM, WEST MIDLANDS  GB B15 510(k) STATEMENT
                                                    
 
DEVICE: VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
VITAL CONNECT INC.                510(k) NO: K141167(Traditional)
ATTN: SAM  MOSTAFAVI              PHONE NO : 408 963-4620 
900 E. HAMILTON AVE., SUITE 500   SE DECISION MADE: 29-JUL-14
CAMPBELL CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
EV3 INC                           510(k) NO: K141118(Special)
ATTN: LAURA J LIND                PHONE NO : 763 398-7247 
3033 Campus Drive Suite N550      SE DECISION MADE: 18-JUL-14
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
Guangzhou Wondfo Biotech Co., Ltd.510(k) NO: K141532(Traditional)
ATTN: Joe  Shia                   PHONE NO : 240 505-7880 
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 14-JUL-14
GAITHERSBURG MD  20878            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENCOMPASS
PANORAMIC CORP.                   510(k) NO: K141130(Traditional)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234-1735 
8870 RAVELLO CT                   SE DECISION MADE: 30-JUL-14
NAPLES FL  34114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
DEPUY MITEK, A JOHNSON AND JOHNSON510(k) NO: K140324(Traditional)
ATTN: YAYOI  FUJIMAKI             PHONE NO : 508 828-3541 
325 Paramount Drive               SE DECISION MADE: 07-JUL-14
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SKYHAWK LATERAL PLATE SYSTEM
ORTHOFIX INC.                     510(k) NO: K140260(Traditional)
ATTN: TROY  BROOKS                PHONE NO : 214 937-2047 
3451 PLANO PARKWAY                SE DECISION MADE: 02-JUL-14
LEWISVILLE TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
TITAN SPINE, LLC                  510(k) NO: K140055(Traditional)
ATTN: CHRISTINE  SCIFERT          PHONE NO : 901 831-8035 
3416 ROXEE RUN COVE               SE DECISION MADE: 02-JUL-14
BARTLETT TN  38133                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
ICON ORTHOPEDIC CONCEPTS, LLC DBA 510(k) NO: K140876(Traditional)
ATTN: JAN  TRIANI                 PHONE NO : 201 543-9388 
6 MARS COURT, UNIT 6-3            SE DECISION MADE: 22-JUL-14
BOONTON NJ  07005                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
MEDIVATORS                        510(k) NO: K140753(Special)
ATTN: KINNARI  SHAH               PHONE NO : 763 553-3369 
14605 28TH AVE. N.                SE DECISION MADE: 15-JUL-14
MINNEAPOLIS MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RANGE/MESA/DENALI SPINAL SYSTEM
K2M, INC.                         510(k) NO: K140765(Traditional)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777-3155 
751 MILLER DR.,SE                 SE DECISION MADE: 10-JUL-14
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AESCULAP OPTILENE NONABSORBABLE SUTURE
AESCULAP, INC.                    510(k) NO: K133890(Traditional)
ATTN: KATHY A RACOSKY             PHONE NO : 610 984-9291 
3773 Corporate Parkway            SE DECISION MADE: 15-JUL-14
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SIS HERNIA GRAFT
COOK BIOTECH, INC.                510(k) NO: K133306(Traditional)
ATTN: PERRY W GUINN               PHONE NO : 765 497-3355 
1425 INNOVATION PLACE             SE DECISION MADE: 23-JUL-14
WEST LAFAYETTE IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MIROCAM CAPSULE ENDOSCOPE SYSTEM
INTROMEDIC CO., LTD               510(k) NO: K134005(Traditional)
ATTN: JINYOUNG  LEE               PHONE NO : 822 801 9300 
STE 1104, E&C VENTURE DREAM TOWER SE DECISION MADE: 09-JUL-14
GURO-GU , SEOUL  KR 152-719       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
PJUR GROUP LUXEMBOURG SA          510(k) NO: K133233(Traditional)
ATTN: CANDACE  CEDERMAN           PHONE NO : 503 201-2485 
722 ARJEAN DRIVE                  SE DECISION MADE: 18-JUL-14
WILMINGTON NC  28411              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
PHILIPS ULTRASOUND, INC.          510(k) NO: K141369(Third Party - Traditional)
ATTN: SARASWATHI  DEORA           PHONE NO : 
22100 BOTHELL EVERETT HWY.        SE DECISION MADE: 02-JUL-14
BOTHELL WA  98021                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: FINGERTIP PULSE OXIMETER
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K140682(Traditional)
ATTN: LEI  CHEN                   PHONE NO : 86 108 8798300 
NO. 9 SHUANGYUAN ROAD, BADACHU HI-SE DECISION MADE: 17-JUL-14
BEIJING  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TRAXCESS 14 GUIDEWIRE
MICROVENTION, INC.                510(k) NO: K133725(Traditional)
ATTN: Naomi  Gong                 PHONE NO : 714 247-8000 
1311 VALENCIA AVE                 SE DECISION MADE: 31-JUL-14
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FLEXI-LUME LED SYSTEM
EPIC MEDICAL CONCEPTS & INNOVATION510(k) NO: K140281(Abbreviated)
ATTN: ALEX  WALLER                PHONE NO : 913 432-5321 
6950 SQUIBB RD, STE 300           SE DECISION MADE: 24-JUL-14
MISSION KS  66202                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
FOTONA D.D.                       510(k) NO: K132806(Traditional)
ATTN: STOJAN  TROST               PHONE NO : 386 150 09100 
STEGNE 7,                         SE DECISION MADE: 11-JUL-14
LJUBLJANA  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RESTORIS POROUS PARTIAL KNEE SYSTEM
MAKO SURGICAL CORP.               510(k) NO: K133811(Traditional)
ATTN: TERRY  POWELL               PHONE NO : 703 562-9800 252
575 EIGHTH AVE, SUITE 1212        SE DECISION MADE: 08-JUL-14
NEW YORK NY  10018                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
EXPANDING ORTHOPEDICS, INC.       510(k) NO: K133813(Traditional)
ATTN: MEREDITH  MAY               PHONE NO : 719 337-7579 
4628 NORTHPARK DRIVE              SE DECISION MADE: 15-JUL-14
COLORADO SPRINGS CO  80918        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BIOFOAM BONE WEDGE
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K140531(Traditional)
ATTN: VAL  MYLES                  PHONE NO : 901 290-5162 
1023 CHERRY ROAD                  SE DECISION MADE: 09-JUL-14
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KIMGUARD ONE-STEP STERILIZATION WRAP
KIMBERLY-CLARK HEALTH CARE        510(k) NO: K141071(Traditional)
ATTN: THOMAS  KOZMA, PH.D.        PHONE NO : 770 587-8393 
1400 HOLCOMB BRIDGE ROAD          SE DECISION MADE: 28-JUL-14
ROSWELL GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
INTUITIVE SURGICAL, INC.          510(k) NO: K140553(Traditional)
ATTN: DAWN  CHANG                 PHONE NO : 408 523-2347 
1266 KIFER RD                     SE DECISION MADE: 25-JUL-14
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
ARROW INTERNATIONAL, INC (SUBSIDIA510(k) NO: K141618(Special)
ATTN: ELIZABETH  DUNCAN           PHONE NO : 610 378-0131 
2400 BERNVILLE ROAD               SE DECISION MADE: 08-JUL-14
READING PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ODISSEY TISSUE OXIMETER
VIOPTIX, INC.                     510(k) NO: K141234(Traditional)
ATTN: GREG  HOLLAND               PHONE NO : 949 262-0411 
3722 AVE. SAUSALITO               SE DECISION MADE: 01-JUL-14
IRVINE CA  92606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
PJUR GROUP,LUXEMBOURG S.A.        510(k) NO: K133336(Traditional)
ATTN: CANDACE  CEDERMAN           PHONE NO : 503 201-2485 
722 ARJEAN DR.                    SE DECISION MADE: 24-JUL-14
WILMINGTON NC  28411              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
FRESENIUS MEDICAL CARE, NORTH AMER510(k) NO: K133299(Traditional)
ATTN: DENISE M OPPERMANN          PHONE NO : 781 699-4044 
920 WINTER ST.                    SE DECISION MADE: 07-JUL-14
WALTHAM MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
HEALGEN SCIENTIFIC, LLC           510(k) NO: K141647(Traditional)
ATTN: Joe  Shia                   PHONE NO : 301 505-7880 
504 EAST DIAMNOND AVE. SUITE F    SE DECISION MADE: 17-JUL-14
GAITHERSBURG MD  20877            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CT MIDLINE
MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K141151(Traditional)
ATTN: TIMOTHY  HOLWICK            PHONE NO : 215 256-4201 
1499 DELP DR.                     SE DECISION MADE: 08-JUL-14
HARLEYSVILLE PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
ZIMMER DENTAL INC.                510(k) NO: K133551(Traditional)
ATTN: MELISSA  BURBAGE            PHONE NO : 760 929-4110 
1900 ASTON AVE.                   SE DECISION MADE: 18-JUL-14
CARLSBAD CA  92008-7308           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
ARTHROSURFACE, INC.               510(k) NO: K133835(Traditional)
ATTN: DAWN J WILSON               PHONE NO : 508 520-3003 
28 FORGE PARKWAY                  SE DECISION MADE: 03-JUL-14
FRANKLIN MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
EXACTECH, INC.                    510(k) NO: K140302(Traditional)
ATTN: PATRICK  HUGHES             PHONE NO : 352 327-4762 
2320 N.W. 66TH CT.                SE DECISION MADE: 30-JUL-14
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM
ZONARE MEDICAL SYSTEMS, INC.      510(k) NO: K141641(Third Party - Traditional)
ATTN: DAN  BRADFORD               PHONE NO : 650 316-3113 
420 NORTH BERNARDO AVENUE         SE DECISION MADE: 18-JUL-14
MOUNTAIN VIEW CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
X-SPINE SYSTEMS, INC              510(k) NO: K133947(Traditional)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847-8410 
452 Alexandersville Rd            SE DECISION MADE: 29-JUL-14
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
Siemens Healthcare Diagnostics Inc510(k) NO: K141444(Abbreviated)
ATTN: DONNA  VELASQUEZ            PHONE NO : 310 645-8200 7403
5210 PACIFIC CONCOURSE DRIVE      SE DECISION MADE: 09-JUL-14
LOS ANGELES CA  90045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IFUSE IMPLANT SYSTEM
SI-BONE, INC.                     510(k) NO: K141049(Traditional)
ATTN: ROXANNE  DUBOIS             PHONE NO : 408 207-0700 
3055 OLIN AVE SUITE 2200          SE DECISION MADE: 23-JUL-14
SAN JOSE CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: G-TL
VITROLIFE, INC.                   510(k) NO: K133568(Traditional)
ATTN: MARK  LARMAN                PHONE NO : 303 762-1933 
3601 SOUTH INCA ST.               SE DECISION MADE: 16-JUL-14
ENGLEWOOD CO  80110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
PT. SMART GLOVE INDONESIA         510(k) NO: K133699(Traditional)
ATTN: KHON  PU FOO                PHONE NO : 616 17 940100 
JL. PELITA RAUYA NO. 5-7,KIM STAR,SE DECISION MADE: 18-JUL-14
MEDAN, NORTH SUMATER  ID 20362    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
NEOCOIL, LLC                      510(k) NO: K133670(Abbreviated)
ATTN: MICHEAL  LEIGH              PHONE NO : 262 374-1250 
N27 W23910A PAUL RD.              SE DECISION MADE: 24-JUL-14
PEWAUKEE WI  53072                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: THE BELMONT RAPID INFUSER
BELMONT INSTRUMENT CORPORATION    510(k) NO: K141654(Special)
ATTN: URAIWAN P LABADINI          PHONE NO : 978 663-0212 
780 BOSTON ROAD                   SE DECISION MADE: 18-JUL-14
BILLERICA MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EXAMINATION GLOVES
HL RUBBER INDUSTRIES SDN BHD      510(k) NO: K140316(Traditional)
ATTN: NOORZALIZA  AHMAD           PHONE NO : 606 481108 788 
LOT 10, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 11-JUL-14
KUALA PILAH, NEGERI SEMBILAN  MY 7510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DRE VENTURA
DRE MEDICAL, INC.                 510(k) NO: K132903(Traditional)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498-2155 
1800 WILLIAMSON CT.               SE DECISION MADE: 01-JUL-14
LOUISVILLE KY  40026              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
COVIDIEN                          510(k) NO: K140813(Traditional)
ATTN: Daniel  Campion             PHONE NO : 508 452-4135 
15 HAMPSHIRE STREET               SE DECISION MADE: 15-JUL-14
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INTRODUCER, MODEL ADELANTE MAGNUM
Oscor Inc.                        510(k) NO: K140917(Traditional)
ATTN: LAURA  SOBRIN               PHONE NO : 727 937-2511 
3816 DE SOTO BLVD.                SE DECISION MADE: 09-JUL-14
PALM HARBOR FL  34683             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NUVIS ARTHROSCOPE
INTEGRATED ENDOSCOPY, INC.        510(k) NO: K140903(Traditional)
ATTN: ANIL  BHALANI               PHONE NO : 949 777-6749 
23141 ARROYO VISTA, STE 100       SE DECISION MADE: 17-JUL-14
RANCHO SANTA MARGARITA CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COROENT XL-F SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K140479(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 320-4549 
7475 LUSK BLVD                    SE DECISION MADE: 28-JUL-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CADWELL SPIKE AND SEIZURE DETECTOR
CADWELL                           510(k) NO: K140552(Traditional)
ATTN: JINESH  JAIN                PHONE NO : 509 735-6481 
909 N. KELLOGG ST.                SE DECISION MADE: 23-JUL-14
KENNEWICK WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: H&H EMERGENCY CRICOTHYROTOMY KIT
H&H MEDICAL CORPORATION           510(k) NO: K133528(Traditional)
ATTN: J. Lawrence  Stevens        PHONE NO : 508 926-8330 
290 TURNPIKE RD. SUITE 200        SE DECISION MADE: 03-JUL-14
WESTBOROUGH MA  01581             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
Boston Scientific Corporation     510(k) NO: K134031(Traditional)
ATTN: VICKY L HAGENS              PHONE NO : 763 494-1522 
ONE SCIMED PLACE                  SE DECISION MADE: 21-JUL-14
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE:  RS80A DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD          510(k) NO: K141620(Third Party - Traditional)
ATTN: PARK  KYEONG-MI             PHONE NO : 
42, TEHERAN-RO 108-GIL            SE DECISION MADE: 02-JUL-14
GANGNAM-GU, SEOUL  KR 135-280     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K140770(Traditional)
ATTN: OLGA  LEWIS                 PHONE NO : 858 320-5257 
7475 LUSK BLVD                    SE DECISION MADE: 25-JUL-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NEUROPACE BURR HOLE COVER
NEUROPACE INC                     510(k) NO: K141368(Special)
ATTN: ISABELLA R ABATI            PHONE NO : 650 237-2700 
455 N. BERNARDO AVE               SE DECISION MADE: 11-JUL-14
MOUNTAIN VIEW CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MILESTONE SPINAL SYSTEM
WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K133053(Traditional)
ATTN: Diana  Hong                 PHONE NO : 86 21 22815850 
PO BOX 120-119                    SE DECISION MADE: 15-JUL-14
SHANGHAI  CN 200120               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EEVA DISH (WITH 12 MICROWELLS)
AUXOGYN, INC.                     510(k) NO: K141663(Special)
ATTN: JULIA S ANASTAS             PHONE NO : 650 763-3875 
1490 O'BRIEN DRIVE, SUITE A       SE DECISION MADE: 22-JUL-14
MENLO PARK CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VOLUSON P6, VOLUSON P8
GE HEALTHCARE                     510(k) NO: K141675(Special)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721-4214 
9900 Innovation Drive             SE DECISION MADE: 25-JUL-14
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CAMERA ENABLED PROBE
TRICE MEDICAL, INC.               510(k) NO: K141119(Traditional)
ATTN: TIFFINI  DIAGE              PHONE NO : 707 799-6732 
1000 CONTINENTAL DRIVE, SUITE 240 SE DECISION MADE: 29-JUL-14
KING OF PRUSSIA PA  19406         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COROENT SMALL INTERBODY SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K140921(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 320-4549 
7475 LUSK BOULEVARD               SE DECISION MADE: 28-JUL-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SYVEK RADIAL BAND
MARINE POLYMER TECHNOLOGIES       510(k) NO: K132293(Traditional)
ATTN: SERGIO  FINKIELSZTEIN       PHONE NO : 781 270-3200 
107 WATER STREET                  SE DECISION MADE: 31-JUL-14
DANVERS MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SILVER DENTAL ARREST
COOLEY CONSULTING, INC.           510(k) NO: K102973(Traditional)
ATTN: WILLIAM  COOLEY             PHONE NO : 513 522-3797 
531 CHISHOLM TRAIL                SE DECISION MADE: 31-JUL-14
WYOMING OH  45215                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
BIOSENSE WEBSTER, INC.            510(k) NO: K133916(Traditional)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839-8597 
3333 DIAMOND CANYON RD            SE DECISION MADE: 01-JUL-14
DIAMOND BAR CA  91765             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
SYBRONENDO                        510(k) NO: K140685(Traditional)
ATTN: COURTNEY  CLARK             PHONE NO : 714 516-7426 
1717 W.COLLINS AVENUE             SE DECISION MADE: 02-JUL-14
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
COMED MEDICAL SYSTEMS CO., LTD    510(k) NO: K131721(Traditional)
ATTN: J. HARVEY  KNAUSS           PHONE NO : 832 675-9281 
11874 SOUTH EVELYN CIRCLE         SE DECISION MADE: 22-JUL-14
HOUSTON TX  77071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
PONTIS ORTHOPAEEICS, LLC          510(k) NO: K141711(Special)
ATTN: LEONARD  GORDON             PHONE NO : 415 567-8935 
2299 POST STREET, SUITE 103       SE DECISION MADE: 24-JUL-14
SAN FRANCISCO CA  94115           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POD SYSTEM
PENUMBRA, INC.                    510(k) NO: K141134(Special)
ATTN: CHARLES  DENAULT            PHONE NO : 510 748-3302 
1351 HARBOR BAY PARKWAY           SE DECISION MADE: 03-JUL-14
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
WELCH ALLYN                       510(k) NO: K141582(Special)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685-2609 
4341 STATE STREET ROAD            SE DECISION MADE: 11-JUL-14
SKANEATELES FALLS NY  13153       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
IN2BONES SAS                      510(k) NO: K132912(Traditional)
ATTN: NORMAN F ESTRIN, PH.D.      PHONE NO : 301 279-2899 
9109 COPENHAVER DR.               SE DECISION MADE: 30-JUL-14
POTOMAC MD  20854                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TATTOOSTAR EFFECT COMBO
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K131757(Traditional)
ATTN: ANTJE  KATZER               PHONE NO : 49 364 17700309 
BRUESSELER STR. 10                SE DECISION MADE: 17-JUL-14
JENA  DE 07747                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: X-REPAIRSL
SYNTHASOME, INC.                  510(k) NO: K141499(Special)
ATTN: ANTHONY  RATCLIFFE          PHONE NO : 858 490-9400 
3030 BUNKER HILL ST. SUITE 308    SE DECISION MADE: 02-JUL-14
SAN DIEGO CA  92109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CASPIAN OCT SPINAL SYSTEM
K2M, INC.                         510(k) NO: K133288(Traditional)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777-3155 
751 MILLER DR.,SE                 SE DECISION MADE: 01-JUL-14
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
SHENZHEN MINDRAY BIO-MEIDCAL ELECT510(k) NO: K132036(Abbreviated)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995-8391 
800 MACARTHUR BLVD.               SE DECISION MADE: 01-JUL-14
MAHWAH NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MR SYRINGE DUAL PACK
COEUR, INC.                       510(k) NO: K140469(Traditional)
ATTN: ERIN  RHEINSCHELD           PHONE NO : 615 547-7923 
100 PHYSICIANS WAY SUITE 200      SE DECISION MADE: 28-JUL-14
LEBANON TN  37090                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORPORATION  510(k) NO: K141778(Special)
ATTN: KIRSTEN  STOWELL FRANCO     PHONE NO : 610 404-3367 
100 DENNIS DRIVE                  SE DECISION MADE: 30-JUL-14
READING PA  19606                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ORTHO SOLUTIONS ULTOS PLATING SYSTEM
ORTHO SOLUTIONS LIMITED           510(k) NO: K141784(Traditional)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492-5858 
3150 EAST 200TH STREET            SE DECISION MADE: 23-JUL-14
PRIOR LAKE MN  55372              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AP EXPANDABLE XLIF SYSTEM
NUVASIVE, INC.                    510(k) NO: K140162(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 320-4549 
7475 LUSK BLVD                    SE DECISION MADE: 02-JUL-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SKINTACT
LEONHARD LANG GMBH                510(k) NO: K140500(Traditional)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549-6035 
P.O. BOX 560                      SE DECISION MADE: 29-JUL-14
STILLWATER MN  55082-0560         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PLIF LITE AND TLIF LITE
SINTEA PLUSTEK                    510(k) NO: K132907(Traditional)
ATTN: RICH  JANSEN                PHONE NO : 612 281-5505 
11821 BRAMBLE COVE DRIVE          SE DECISION MADE: 24-JUL-14
FT. MYERS FL  33905               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
WELLDOC, INC                      510(k) NO: K141273(Special)
ATTN: DIVYA  KALLAMADI            PHONE NO : 443 692-3100 
1501 SAINT PAUL STREET SUITE 118  SE DECISION MADE: 08-JUL-14
BALTIMORE MD  21202               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
HMICRO, INC.                      510(k) NO: K140096(Traditional)
ATTN: KIM  TOMPKINS               PHONE NO : 408 981-4889 
4984 EL CAMINO REAL #200          SE DECISION MADE: 24-JUL-14
LOS ALTOS CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
CERAGEM MEDISYS INC.              510(k) NO: K140141(Special)
ATTN: DANA  MOON                  PHONE NO : 82 41 5298427 
16 JEONGIAL-GIL, SEONGGEO-EUP, SEOSE DECISION MADE: 03-JUL-14
CHEONAN, CHUNGCHEONGNAM-DO  KR 331510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PICOSURE WORKSTATION
CYNOSURE, INC.                    510(k) NO: K133364(Traditional)
ATTN: Connie  Hoy                 PHONE NO : 781 993-2414 
5 CARLISLE ROAD                   SE DECISION MADE: 22-JUL-14
WESTFORD MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
PHILIPS MEDICAL SYSTEMS DMC GMBH  510(k) NO: K141736(Special)
ATTN: GEROLD  SCHWARZ             PHONE NO : 49 405078 1116 
ROENTGENSTRASSE 24-26             SE DECISION MADE: 25-JUL-14
HAMBURG  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZQUIET-SA
SLEEPING WELL, LLC                510(k) NO: K140777(Traditional)
ATTN: WILLIAM  MCLAIN             PHONE NO : 717 656-9656 
342 E. MAIN STREET, STE 207       SE DECISION MADE: 25-JUL-14
LEOLA PA  17540                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
VR MEDICAL                        510(k) NO: K132709(Traditional)
ATTN: LEE  PAN, PHD               PHONE NO : 861 378 8975958 
90 GAOXIN ROAD, ZHOUZHUANG        SE DECISION MADE: 30-JUL-14
KUN SHAN, JIANGSU  CN 215325      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SUCTION LIPOPLASTY ACCESSORIES
INEX                              510(k) NO: K132353(Traditional)
ATTN: RAYMOND  PATEL              PHONE NO : 330 344 741995 
ZA LA GOBETTE 60540 PUISEUX LE HAUSE DECISION MADE: 30-JUL-14
PUISEUX LE HAUBERGER  FR 60540    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
QUALITY ELECTRODYNAMICS, LLC.     510(k) NO: K140998(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 484-2964 
700 BETA DRIVE STE 100            SE DECISION MADE: 11-JUL-14
MAYFIELD VILLAGE OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALPINE HIP STEM; ALPINE HA HIP STEM
ORTHO DEVELOPMENT                 510(k) NO: K141001(Traditional)
ATTN: MIKE  ENSIGN                PHONE NO : 801 553-9991 
12187 S. BUSINESS PARK DR.        SE DECISION MADE: 30-JUL-14
DRAPER UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DESARA BLUE OV, DESARA BLUE SS
CALDERA MEDICAL                   510(k) NO: K140843(Special)
ATTN: VICKI  GAIL                 PHONE NO : 818 483-7602 
5171 Clareton Dr                  SE DECISION MADE: 01-JUL-14
Agoura Hills CA  91301            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
SYNERGY BIOMEDICAL, INC.          510(k) NO: K140844(Traditional)
ATTN: RANDY  PREBULA              PHONE NO : 202 637-6548 
555 THIRTEENTH ST, N.W.           SE DECISION MADE: 16-JUL-14
WASHINGTON DC  20009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
Tornier SAS                       510(k) NO: K140082(Traditional)
ATTN: AYMEN  AZAIEZ               PHONE NO : 33 4 76613500 
161 RUE LAVOISIER                 SE DECISION MADE: 18-JUL-14
MONTBONNOT SAINT MARTIN  FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: K2M MODULAR HOOKS
K2M, INC.                         510(k) NO: K133402(Traditional)
ATTN: KAREN E WARDEN              PHONE NO : 440 729-8457 
PO BOX 566                        SE DECISION MADE: 30-JUL-14
CHESTERLAND OH  44026-2141        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BABYMEG BIOMAGNETOMETER SYSTEM
TRISTAN TECHNOLOGIES INC          510(k) NO: K133419(Traditional)
ATTN: EUGENE  HIRSCHKOFF          PHONE NO : 619 992-6301 
3365 CALLE MARGARITA              SE DECISION MADE: 21-JUL-14
ENCINITAS CA  92024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MICROPUNCTURE INTRODUCER SET
COOK INCORPORATED                 510(k) NO: K133114(Traditional)
ATTN: DAVID  LEHR, RAC            PHONE NO : 812 335-3575 
750 DANIELS WAY                   SE DECISION MADE: 03-JUL-14
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POROUS COATED COMPREHENSIVE FRACTURE STEMS
BIOMET MANUFACTURING CORP.        510(k) NO: K140652(Traditional)
ATTN: BRIAN  KINCAID              PHONE NO : 574 3711088 
56 EAST BELL DRIVE                SE DECISION MADE: 03-JUL-14
WARSAW IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
RAYENCE CO., LTD                  510(k) NO: K141566(Special)
ATTN: DAVE  KIM                   PHONE NO : 713 467-2607 
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 16-JUL-14
HOUSTON TX  77025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PEDILOC FRAGMENT SYSTEM
ORTHOPEDIATRICS, CORP.            510(k) NO: K140431(Traditional)
ATTN: MARK  FOX                   PHONE NO : 574 268-6379 
2850 FRONTIER DRIVE               SE DECISION MADE: 29-JUL-14
WARSAW IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MARATHON NO STING LIQUID SKIN PROTECTANT
ADVANCED MEDICAL SOLUTIONS (PLYMOU510(k) NO: K133443(Traditional)
ATTN: ROSE  GUANG                 PHONE NO : 44 416068 63500 
WESTERN WOOD WAY LANGAGE SCIENCE PSE DECISION MADE: 10-JUL-14
PLYMOUTH, DEVON  GB PL7 5BG       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
MAUNA KEA TECHNOLOGIES            510(k) NO: K133466(Traditional)
ATTN: MICHAEL A DANIEL            PHONE NO : 415 407-0223 
8 SNOWBERRY COURT                 SE DECISION MADE: 25-JUL-14
ORINDA CA  94563                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VICTUS FEMTOSECOND LASER PLATFORM
TECHNOLAS PERFECT VISION GMBH     510(k) NO: K140615(Traditional)
ATTN: BETTY M JOHNSON             PHONE NO : 714 273-8254 
PO BOX 17190                      SE DECISION MADE: 15-JUL-14
ANAHEIM CA  92817-7190            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
COLOPLAST A/S                     510(k) NO: K140523(Special)
ATTN: BRIAN  SCHMIDT              PHONE NO : 612 302-4987 
1601 WEST RIVER ROAD N            SE DECISION MADE: 24-JUL-14
MINNEAPOLIS MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARTHROSCOPIC ENERGY SYSTEM
CONMED CORPORATION                510(k) NO: K140578(Traditional)
ATTN: DIONNE  SANDERS             PHONE NO : 727 399-5564 
525 FRENCH RD.                    SE DECISION MADE: 23-JUL-14
UTICA NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BENDA WEDGE
CENTRIX, INC.                     510(k) NO: K140144(Traditional)
ATTN: GREG  MOREAU                PHONE NO : 203 567-7444 
770 RIVER RD.                     SE DECISION MADE: 08-JUL-14
SHELTON CT  06484-5458            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MEGA BIG BOY CONDOM
OKAMOTO U.S.A., INC.              510(k) NO: K140379(Abbreviated)
ATTN: JEFFREY N GIBBS             PHONE NO : 202 737-4288 
700 THIRTEENTH STREET, N.W. SUITE SE DECISION MADE: 01-JUL-14
WASHINGTON DC  20005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CORMATRIX ECM FOR VASCULAR REPAIR
CORMATRIX CARDIOVASCULAR, INC.    510(k) NO: K140789(Traditional)
ATTN: BRYAN  BROSSEAU             PHONE NO : 470 514-4036 
1100 OLD ELLIS ROAD               SE DECISION MADE: 15-JUL-14
ROSWELL GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CDI BLOOD PARAMETER MONITORING SYSTEM 500
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K133658(Traditional)
ATTN: Kevin  Kong                 PHONE NO : 734 663-4145 
6200 JACKSON RD.                  SE DECISION MADE: 25-JUL-14
ANN ARBOR MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OKAMOTO STUDDED CONDOM
OKAMOTO U.S.A., INC.              510(k) NO: K141256(Abbreviated)
ATTN: JOSEPH W CORMIER, JD, PHD   PHONE NO : 202 737-7553 
700 THIRTEENTH STREET, N.W. SUITE SE DECISION MADE: 23-JUL-14
WASHINGTON DC  20005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KANGLI
SUZHOU KANGLI ORTHOPAEDICS INSTRUM510(k) NO: K133840(Traditional)
ATTN: ALICE  GONG                 PHONE NO : 862 164 957283 
503 ROOM, 8 BUILDING, 600 LIU ZHOUSE DECISION MADE: 29-JUL-14
SHANGHAI  CN 200233               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COBRA FUNDUS CAMERA
C.S.O. S.R.L.                     510(k) NO: K132987(Traditional)
ATTN: Claude  Berthoin            PHONE NO : 386 672-2630 
110 EAST GRANADA BLVD, STE 209    SE DECISION MADE: 03-JUL-14
ORMOND BEACH FL  32716            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
FACET TECHNOLOGIES, LLC           510(k) NO: K141749(Special)
ATTN: JENNIFER  REGISTER          PHONE NO : 770 590-6455 7705
112 TOWN PARK DR. SUITE 300       SE DECISION MADE: 29-JUL-14
KENNESAW GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
BETTER CARE PLASTIC TECHNOLOGY CO.510(k) NO: K140816(Traditional)
ATTN: KATHY  LIU                  PHONE NO : 909 590-1611 
3973 SCHAEFER AVE                 SE DECISION MADE: 08-JUL-14
CHINO CA  91710                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VELOXTM INTERBODY FUSION SYSTEM
U&I CORP.                         510(k) NO: K140864(Traditional)
ATTN: JI YEA  LEE                 PHONE NO : 82 31 8520102 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 22-JUL-14
Uijeongbu-si  KR 480-859          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FLENTS PLASTIC EYE WASH CUP
APOTHECARY PRODUCTS, INC.         510(k) NO: K140409(Traditional)
ATTN: JAMES  JENKINS              PHONE NO : 952 808-8364 
11750 12TH AVE. SOUTH             SE DECISION MADE: 09-JUL-14
BURNSVILLE MN  55337              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COLONGLIDE LUBRICANT
PEDIATRIC PHARMACEUTICALS INC.    510(k) NO: K141028(Special)
ATTN: ROBERT M HARRIS             PHONE NO : 732 739-2018 
2137 ROUTE 35                     SE DECISION MADE: 24-JUL-14
HOLMDEL NJ  07733                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARROW GPSCATH BALLOON DILATATION CATHETER
HOTSPUR TECHNOLOGIES,INC SUBSIDIAR510(k) NO: K140351(Traditional)
ATTN: ERIC  ANKERUD, JD           PHONE NO : 978 302-9467 
880 Maude Ave Ste A               SE DECISION MADE: 02-JUL-14
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GANTRY BEAM LINE
ION BEAM APPLICATIONS S.A.        510(k) NO: K132919(Traditional)
ATTN: BRUCE D ARMON               PHONE NO : 215 972-7985 
1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 10-JUL-14
PHILADELPHIA PA  19102            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
Immunalysis Corporation           510(k) NO: K141406(Traditional)
ATTN: joseph  Ginete              PHONE NO : 909 482-0840 
829 TOWNE CENTER DR.              SE DECISION MADE: 01-JUL-14
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
DEPUY MITEK, A JOHNSON AND JOHNSON510(k) NO: K140643(Traditional)
ATTN: YAYOI  FUJIMAKI             PHONE NO : 508 828-3541 
325 Paramount Drive               SE DECISION MADE: 08-JUL-14
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
PT. MEDISAFE TECHNOLOGIES         510(k) NO: K133689(Traditional)
ATTN: ANIL  TANEJA                PHONE NO : 626 130 007134 
JL.BATANG KUIS GG.TAMBAK REJO DESASE DECISION MADE: 03-JUL-14
MEDAN, NORTH SUMATERA  ID 20362   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EZ-IO INTRAOSSEOUS INFUSION SYSTEM
VIDACARE LLC                      510(k) NO: K141117(Traditional)
ATTN: DIANA F MONTEZ, BSN, RN     PHONE NO : 210 375-8500 
4350 LOCKHILL SELMA RD.           SE DECISION MADE: 08-JUL-14
SHAVANO PARK TX  78249            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SENSILIGHT MINI
EL GLOBAL TRADE LTD.              510(k) NO: K140527(Traditional)
ATTN: SHLOMIT  SEGMAN             PHONE NO : 972 9788 9069 
TZORAN 4TH ST.                    SE DECISION MADE: 31-JUL-14
NETANYA  IL 42504                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CONSENSUS VITALITE TIBIAL INSERT
CONSENSUS ORTHOPEDICS, INC.       510(k) NO: K133919(Traditional)
ATTN: MATTHEW M HULL              PHONE NO : 916 355-7100 
1115 WINDFIELD WAY, SUITE 100     SE DECISION MADE: 14-JUL-14
EL DORADO HILLS CA  95762-9623    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
MEDTRONIC NAVIGATION, INC.        510(k) NO: K133444(Traditional)
ATTN: KAYE  WAITE                 PHONE NO : 720 890-2182 
826 COAL CREEK CIR.               SE DECISION MADE: 25-JUL-14
LOUISVILLE CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NOBELPROCERA OVERDENTURE BAR
NOBEL BIOCARE USA, LLC            510(k) NO: K132749(Traditional)
ATTN: PHUONG  NGUYEN SON          PHONE NO : 714 282-4800 7830
22715 SAVI RANCH PKWY.            SE DECISION MADE: 24-JUL-14
YORBA LINDA CA  92887             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDOLED
OLYMPUS WINTER & IBE GMBH         510(k) NO: K133311(Traditional)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 986-3147 
3500 CORPORATE PARKWAY            SE DECISION MADE: 30-JUL-14
CENTER VALLEY PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FLOW-NAIL
FLOW-FX, LLC                      510(k) NO: K140601(Traditional)
ATTN: MICHELLE  MCDONOUGH         PHONE NO : 202 552-5800 
1331 H STREET NW, 12TH FLOOR REGULSE DECISION MADE: 02-JUL-14
WASHINGTON DC  20005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
BIOMET MANUFACTURING CORP.        510(k) NO: K141219(Traditional)
ATTN: JARED  COOPER               PHONE NO : 574 372-1941 
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 18-JUL-14
WARSAW IN  46581-0587             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K141228(Traditional)
ATTN: ANNA  HWANG                 PHONE NO : 310 533-9966 
3203 KASHIWA STREET               SE DECISION MADE: 08-JUL-14
TORRANCE CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
INFOPIA CO., LTD                  510(k) NO: K141750(Special)
ATTN: Priscilla  Chung            PHONE NO : 714 202-5789 
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 24-JUL-14
FULLERTON CA  92833               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
ARROW INTERNATIONAL, INC.         510(k) NO: K141051(Special)
ATTN: FRANK  PELC                 PHONE NO : 610 378-0131 
2400 BERNVILLE RD.                SE DECISION MADE: 07-JUL-14
READING PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PROCTIGARD
ACCESS PHARMACEUTICALS, INC       510(k) NO: K140558(Traditional)
ATTN: JEFFREY B DAVIS             PHONE NO : 212 786-6205 
1325 AVENUE OF THE AMERICA, 27TH FSE DECISION MADE: 16-JUL-14
NEW YORK NY  10019                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INSTAFIX SHAPE MEMORY FIXATION SYSTEM
OT MEDICAL                        510(k) NO: K141550(Special)
ATTN: WILLIAM  RHODA              PHONE NO : 484 588-2063 
1000 CONTINENTAL DRIVE, SUITE 240 SE DECISION MADE: 11-JUL-14
KING OF PRUSSIA PA  19406         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ELCAM STOPCOCKS AND MANIFOLDS
ELCAM MEDICAL ACAL                510(k) NO: K141254(Special)
ATTN: NATASHA  BRANZBURG          PHONE NO : 972 772568 625 
KIBBUTZ BARAM                     SE DECISION MADE: 30-JUL-14
MP MEROM HAGALIL  IL 1386000      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ASCEND
NEUROMETRIX, INC.                 510(k) NO: K140333(Traditional)
ATTN: RAINER  MAAS                PHONE NO : 781 314-2781 
62 FOURTH AVE.                    SE DECISION MADE: 03-JUL-14
WALTHAM MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HIVOX SELF ADHESIVE ELECTRODE GEL PADS
HIVOX BIOTEK, INC.                510(k) NO: K131720(Traditional)
ATTN: Ke-Min  Jen                 PHONE NO : 886 285 112668 
8 F., NO. 98, SHINDE RD, SANCHONG SE DECISION MADE: 25-JUL-14
NEW TAIPEI CITY  TW 24158         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EDWARDS TRANSFEMORAL BALLOON CATHETER
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K140241(Traditional)
ATTN: ERIC  CARRIER               PHONE NO : 949 250-6443 
ONE EDWARDS WAY                   SE DECISION MADE: 03-JUL-14
IRVINE CA  92663                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
3M HEALTH CARE                    510(k) NO: K140250(Traditional)
ATTN: KRISTIN  TOTUSHEK           PHONE NO : 651 736-6117 
3M CENTER, 2510 CONWAY AVE. BLDG 2SE DECISION MADE: 25-JUL-14
ST. PAUL MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MCKESSON RADIOLOGY
MCKESSON MEDICAL IMAGING COMPANY  510(k) NO: K140909(Traditional)
ATTN: PAUL  SUMNER                PHONE NO : 404 338-3556 
5995 WINWARD PARKWAY              SE DECISION MADE: 02-JUL-14
ALPHARETTA GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALTERA SPACER
GLOBUS MEDICAL INC.               510(k) NO: K140411(Traditional)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930-1800 
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 01-JUL-14
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
BIOMET, INC.                      510(k) NO: K140902(Traditional)
ATTN: AMY L WALRIVEN              PHONE NO : 574 372-6660 
56 EAST BELL DR. BOX 587          SE DECISION MADE: 03-JUL-14
WARSAW IN  46581-0587             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
REGULATORY TECHNOLOGY SERVICES LLC510(k) NO: K141838(Third Party - Traditional)
ATTN: MARK  JOB                   PHONE NO : 763 682-4139 
1394 25TH STREET NW               SE DECISION MADE: 25-JUL-14
BUFFALO MN  55313                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
BOSTON SCIENTIFIC CORP.           510(k) NO: K140726(Traditional)
ATTN: TARA  PAUL                  PHONE NO : 508 683-4296 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 21-JUL-14
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LEVO TINNITUS MASKING SOFTWARE DEVICE
OTOHARMONICS CORP                 510(k) NO: K140845(Traditional)
ATTN: YARMELA  PAVLOVIC           PHONE NO : 267 675-4618 
1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 18-JUL-14
PHILADELPHIA PA  19103            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OARTRAC SYSTEM
RADIADYNE                         510(k) NO: K141154(Traditional)
ATTN: STUART R GOLDMAN            PHONE NO : 512 327-9997 
816 CONGRESS AVE. SUITE 1400      SE DECISION MADE: 22-JUL-14
AUSTIN TX  78701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ABX PENTRA MICRO ALB CONTROL L/H
HORIBA ABX SAS                    510(k) NO: K133676(Abbreviated)
ATTN: CAROLINE  FERRER            PHONE NO : 334 671 41843 
PARC EUROMEDECINE RUE DU CADUCEE  SE DECISION MADE: 11-JUL-14
MONTPELLIER  FR 34184             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DIGIARC 100AU+
BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K141672(Special)
ATTN: JUNE  LI                    PHONE NO : 861 067892 3558968 
B2-2 NEW CITY INDUSTRIAL PARK, NO.SE DECISION MADE: 31-JUL-14
BEIJING  CN 100023                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Abbott Vascular                   510(k) NO: K141678(Special)
ATTN: JESSICA  KAO                PHONE NO : 408 845-0696 
3200 Lakeside Drive               SE DECISION MADE: 22-JUL-14
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: C-JAWS CERVICAL COMPRESSIVE STAPLE
MEDICREA INTERNATIONAL            510(k) NO: K133906(Traditional)
ATTN: JOHN J SMITH                PHONE NO : 202 637-3638 
555 THIRTEENTH STREET NW          SE DECISION MADE: 24-JUL-14
WASHINGTON DC  20004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BELTER BLOOD PRESSURE METER
SHENZHEN BELTER HEALTH MEASUREMENT510(k) NO: K134029(Traditional)
ATTN: PANG  MING                  PHONE NO : 867 55 61869839 
702, 704 BLOCK C, TSINGHUA UNIS SCSE DECISION MADE: 25-JUL-14
SHENZHEN, GUANGDONG  CN 518057    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
ICU MEDICAL, INC.                 510(k) NO: K140129(Traditional)
ATTN: KRISTIN  CASPER             PHONE NO : 801 264-1313 
4455 ATHERTON DRIVE               SE DECISION MADE: 02-JUL-14
SALT LAKE CITY UT  84123          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INFX-8000V, V5.30
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133535(Traditional)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 669-7896 
2441 MICHELLE DRIVE               SE DECISION MADE: 23-JUL-14
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
HOSPIRA, INC.                     510(k) NO: K141102(Special)
ATTN: TOM  GUTIERREZ              PHONE NO : 858 391-1142 
275 NORTH FIELD DR.               SE DECISION MADE: 08-JUL-14
LAKE FOREST IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LEADERFLEX
VYGON                             510(k) NO: K141026(Traditional)
ATTN: JILLIAN  MIKOVICH           PHONE NO : 800 473-5414 
2750 MORRIS ROAD, SUITE A200      SE DECISION MADE: 30-JUL-14
LANSDALE PA  19446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OPEN FMSEALER
DOMAIN SURGICAL, INC.             510(k) NO: K141484(Traditional)
ATTN: CURTIS  JENSEN              PHONE NO : 801 924-4950 
1370 SOUTH 2100 EAST              SE DECISION MADE: 30-JUL-14
SALT LAKE SITY UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ISOSEED
ECKERT & ZIEGLER BEBIG GMBH       510(k) NO: K140849(Abbreviated)
ATTN: SVEN  LANGER                PHONE NO : 49 30 941084734 
ROBERT-ROSSLE STR.10              SE DECISION MADE: 02-JUL-14
BERLIN  DE 13125                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MELUNA CLASSIC/SPORT MENSTRUAL CUP
MELUNA                            510(k) NO: K140626(Traditional)
ATTN: YOLANDA  SMITH              PHONE NO : 888 729-9674 
1468 HARWELL AVE                  SE DECISION MADE: 10-JUL-14
CROFTON MD  21114                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POLYSYN SURGICAL SUTURE
SURGICAL SPECIALTIES CORP.        510(k) NO: K141625(Special)
ATTN: PAUL  AMUDALA               PHONE NO : 610 404-3367 
100 DENNIS DR.                    SE DECISION MADE: 18-JUL-14
READING PA  19606                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VARIAX ELBOW PLATING SYSTEM
Stryker Trauma AG                 510(k) NO: K141677(Traditional)
ATTN: ELIJAH N WREH               PHONE NO : 201 831-5691 
325 Corporate Drive               SE DECISION MADE: 22-JUL-14
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
TOUCHSTONE INTERNATIONAL MEDICAL S510(k) NO: K141367(Traditional)
ATTN: JO  QIAO                    PHONE NO : 86 512629 91985 
21A SCIENCE PLAZA, INTRENATIONAL SSE DECISION MADE: 25-JUL-14
SUZHOU, JIANGSU  CN 215021        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BIOSURE HEALICOIL PK INTERFERENCE SCREW
Smith & Nephew, Inc               510(k) NO: K140879(Traditional)
ATTN: VIVEK  MUKHATYAR            PHONE NO : 978 749-1043 
150 MINUTEMAN DR.                 SE DECISION MADE: 21-JUL-14
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
SPECTRANETICS CORPORATION         510(k) NO: K140775(Traditional)
ATTN: AMANDA  JOHNSON             PHONE NO : 719 477-2000 
9965 FEDERAL DRIVE                SE DECISION MADE: 23-JUL-14
COLORADO SPRINGS CO  80921-3617   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDOSIZE
THERENVA SAS                      510(k) NO: K141475(Third Party - Traditional)
ATTN: CEMIL  GOKSU                PHONE NO : 33 299 283751 
2 RUE HENRI LE GUILLOUX           SE DECISION MADE: 31-JUL-14
RENNES  FR 35000                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
VILEX, INC.                       510(k) NO: K132820(Traditional)
ATTN: ABRAHAM  LAVI               PHONE NO : 941 373-3987 
7214 LAKE FOREST GLEN             SE DECISION MADE: 23-JUL-14
LAKEWOOD RANCH FL  34202          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
IMPLANTECH ASSOCIATES INC.        510(k) NO: K141027(Traditional)
ATTN: STEPHEN  MEADE              PHONE NO : 805 339-9415 
6025 NICOLLE ST., SUITE B         SE DECISION MADE: 10-JUL-14
VENTURA CA  93003                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AZUL PERSONAL LUBRICANT
CHURCH & DWIGHT CO., INC.         510(k) NO: K141034(Traditional)
ATTN: JOSEPH  CICONE              PHONE NO : 609 806-1994 
500 CHARLES EWING BLVD            SE DECISION MADE: 21-JUL-14
EWING NJ  08628                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: WIRELESS THERMOMETER
RAIING MEDICAL COMPANY            510(k) NO: K132761(Traditional)
ATTN: WU  WEI                     PHONE NO : 861 064 118658 
21 Huoju St                       SE DECISION MADE: 08-JUL-14
Beijing  CN 102200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: APERIO EPATHOLOGY EIHC IVD SYSTEM
LEICA BIOSYSTEMS IMAGING, INC.    510(k) NO: K141109(Traditional)
ATTN: CHRISTINE  KISHI            PHONE NO : 760 539-1100 1194
1360 PARK CENTER DRIVE            SE DECISION MADE: 29-JUL-14
VISTA CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC                 510(k) NO: K141112(Special)
ATTN: CAROL  TIFFANY              PHONE NO : 763 494-1106 
ONE SCIMED PLACE                  SE DECISION MADE: 16-JUL-14
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
ZIMMER DENTAL INC.                510(k) NO: K141120(Traditional)
ATTN: MELISSA  BURBAGE            PHONE NO : 760 929-4110 
1900 ASTON AVE.                   SE DECISION MADE: 29-JUL-14
CARLSBAD CA  92008-7308           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PFX SPINOUS PROCESS FIXATION SYSTEM
INNOVASIS, INC.                   510(k) NO: K132765(Traditional)
ATTN: MARSHALL  MCCARTY           PHONE NO : 801 261-2236 
614 EAST 3900 SOUTH               SE DECISION MADE: 14-JUL-14
SALT LAKE CITY UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HARD PACK SYRINGE
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K141359(Special)
ATTN: Diana  Hong                 PHONE NO : 86 21 22815850 
P.O. BOX 120-119                  SE DECISION MADE: 25-JUL-14
SHANGHAI  CN 200120               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VERADIUS
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K133819(Abbreviated)
ATTN: RUOJUAN  ZHANG              PHONE NO : 310 6316 85825 
VEENPLUIS 4-6                     SE DECISION MADE: 10-JUL-14
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
SIGNATURE ORTHOPAEDICS PTY LIMITED510(k) NO: K133370(Traditional)
ATTN: DECLAN  BRAZIL              PHONE NO : 61 2 94285181 
7 Sirius Road LANE COVE           SE DECISION MADE: 22-JUL-14
NSW  AU 2066                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SPHYGMOMANOMETER
SUZHOU JJ METER CO., LTD.         510(k) NO: K141392(Traditional)
ATTN: LONG  YANG                  PHONE NO : 86 755 86664986 
R1508, EAST BLDG, YIHAI PLAZA CHUASE DECISION MADE: 02-JUL-14
SHENZHEN, GUANGDONG  CN 518054    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: L'DISQ
U & I CORPORATION                 510(k) NO: K132797(Traditional)
ATTN: GYEONG-JE  KWON             PHONE NO : 82 31 8520102 
20, SANDAN-RO, 76BEON-GIL (RD)    SE DECISION MADE: 30-JUL-14
UIJEONGBU-SI, GYEONGGI-DO  KR 480-510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARTHREX PIP DART
ARTHREX, INC.                     510(k) NO: K141577(Special)
ATTN: DAVID L ROGERS              PHONE NO : 239 643-5553 
1370 CREEKSIDE BLVD.              SE DECISION MADE: 18-JUL-14
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NAVIO
BLUE BELT TECHNOLOGIES, INC.      510(k) NO: K140596(Traditional)
ATTN: RICHARD G CONFER            PHONE NO : 412 683-3844 
2828 LIBERTY AVENUE SUITE 100     SE DECISION MADE: 02-JUL-14
PITTSBURGH PA  15222              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
CONMED CORPORATION                510(k) NO: K140658(Traditional)
ATTN: SANDY  LECLAIR              PHONE NO : 315 624-3435 
525 FRENCH RD.                    SE DECISION MADE: 10-JUL-14
UTICA NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
ANDON HEALTH CO., LTD             510(k) NO: K140121(Special)
ATTN: LIU  YI                     PHONE NO : 862 260 526161 
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 02-JUL-14
TIANJIN  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SYNGO, CT DUAL ENERGY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133648(Traditional)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448-4912 
51 VALLEY STREAM PKWY.            SE DECISION MADE: 07-JUL-14
MALVERN PA  19355-1406            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
PRAXAIR HEALTHCARE SERVICES       510(k) NO: K132778(Traditional)
ATTN: TINA  WU, PH.D.             PHONE NO : 443 352-3909 
62 FOREST STREET, STE 300         SE DECISION MADE: 07-JUL-14
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INTELLIJOINT HIP
INTELLIJOINT SURGICAL INC.        510(k) NO: K133759(Traditional)
ATTN: BRANDON  GINGRICH           PHONE NO : 519 342 3178 X2104 
60 BATHURST DR.                   SE DECISION MADE: 23-JUL-14
WATERLOO ONTARIO  CA N2V 2A9      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARGEN PMMA
THE ARGEN CORPORATION             510(k) NO: K140894(Traditional)
ATTN: CRAIG  JOLICOEUR            PHONE NO : 858 455-7900 471
5855 OBERLIN DRIVE                SE DECISION MADE: 31-JUL-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K141417(Special)
ATTN: LESLIE  FITCH               PHONE NO : 901 867-4120 
1023 CHERRY ROAD                  SE DECISION MADE: 09-JUL-14
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM
CONMED CORPORATION                510(k) NO: K140459(Traditional)
ATTN: LISA  ANDERSON              PHONE NO : 315 624-3371 
525 FRENCH RD.                    SE DECISION MADE: 11-JUL-14
UTICA NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AVREO INTERWORKS SYSTEM
AVREO, INC.                       510(k) NO: K141556(Special)
ATTN: ALISON  MCKEE               PHONE NO : 866 286-8082 
4050 Azalea Dr                    SE DECISION MADE: 02-JUL-14
N Charleston SC  29405            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
SMITHS MEDICAL ASD, INC.          510(k) NO: K141193(Traditional)
ATTN: TOM  BLISS                  PHONE NO : 651 628-7145 
1265 GREY FOX ROAD                SE DECISION MADE: 25-JUL-14
ST. PAUL MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ETEX MIXING AND DELIVERY SYSTEM
ETEX CORPORATION                  510(k) NO: K141245(Traditional)
ATTN: ANDY  SOMAN                 PHONE NO : 617 871-6342 
675 MASSACHUSETTS AVE 12TH FLOOR  SE DECISION MADE: 09-JUL-14
CAMBRIDGE MA  02139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
HAGER & MEISINGER GMBH            510(k) NO: K132214(Traditional)
ATTN: WIEBKE  STOLTEN             PHONE NO : 004 921 312012388 
HANSEMANNSTRASSE 10               SE DECISION MADE: 07-JUL-14
NEUSS  DE D-41468                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ESIE APPS SUITE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141554(Third Party - Traditional)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694-5988 
685 East Middlefield Road         SE DECISION MADE: 11-JUL-14
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
RAYENCE CO., LTD                  510(k) NO: K141563(Special)
ATTN: DAVE  KIM                   PHONE NO : 713 467-2607 
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 16-JUL-14
HOUSTON TX  77025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BIO-CONNEKT WOUND MATRIX
MLM BIOLOGICS, INC.               510(k) NO: K140456(Traditional)
ATTN: GREGG  RITTER               PHONE NO : 352 494-2122 
12085 RESEARCH DRIVE              SE DECISION MADE: 22-JUL-14
ALACHUA FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
Becton, Dickinson and Company     510(k) NO: K141311(Special)
ATTN: JUMA  HOSHINO               PHONE NO : 201 847-4260 
1 Becton Drive                    SE DECISION MADE: 25-JUL-14
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
OXFORD PERFORMANCE MATERIALS      510(k) NO: K133809(Traditional)
ATTN: LEIGH  AYRES                PHONE NO : 860 698-9300 
30 South Satellite Road           SE DECISION MADE: 28-JUL-14
South Windsor CT  06074           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LIBERTY PDX CYCLER
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K141145(Traditional)
ATTN: DENISE M OPPERMANN          PHONE NO : 781 699-4479 
920 Winter Street                 SE DECISION MADE: 30-JUL-14
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
COAG MEDICAL LLC                  510(k) NO: K140313(Traditional)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231-1761 
4486 TIMBERLINE CT.               SE DECISION MADE: 28-JUL-14
VADNAIS HEIGHTS MN  55127         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALTEON 6.5MM BONE SCREWS
EXACTECH, INC.                    510(k) NO: K141797(Special)
ATTN: THOMAS  MCNAMARA            PHONE NO : 352 377-1140 
2320 N.W. 66TH CT.                SE DECISION MADE: 29-JUL-14
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MYLABSIX ULTRASOUND SYSTEM
ESAOTE EUROPE B.V.                510(k) NO: K141486(Third Party - Traditional)
ATTN: Allison  Scott              PHONE NO : 317 228 8719 
PHILIPSWEG 1                      SE DECISION MADE: 11-JUL-14
MAASTRICHT  NL 6227 AJ            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: DELWORKS DR SYSTEM
DEL MEDICAL, INC.                 510(k) NO: K140825(Traditional)
ATTN: DANIEL  KAMM                PHONE NO : 239 234-1735 
8870 RAVELLO CT                   SE DECISION MADE: 17-JUL-14
NAPLES FL  34114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GMK SPHERE EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K140826(Traditional)
ATTN: ADAM  GROSS                 PHONE NO : 805 910-6511 
1556 W CARROLL AVE.               SE DECISION MADE: 15-JUL-14
CHICAGO IL  60607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
COOK VASCULAR, INC.               510(k) NO: K141148(Traditional)
ATTN: THOMAS J KARDOS             PHONE NO : 724 845-8621 2225
1186 MONTGOMERY LANE              SE DECISION MADE: 01-JUL-14
VANDERGRIFT PA  15690             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
SEINOH OPTICAL CO. LTD.           510(k) NO: K141280(Abbreviated)
ATTN: JENNIFER  TING              PHONE NO : 886 2 82823192 
6F, NO. 39, LN 224, JIXIAN RD, LUZSE DECISION MADE: 18-JUL-14
NEW TAIPEI CITY  TW 247           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
SURGICAL SPECIALTIES CORP.        510(k) NO: K141558(Special)
ATTN: KIRSTEN  STOWELL FRANCO     PHONE NO : 610 404-3367 
100 DENNIS DR.                    SE DECISION MADE: 11-JUL-14
READING PA  19606                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VARIAX DISTAL RADIUS PLATING SYSTEM
Stryker Leibinger GmbH & Co. KG   510(k) NO: K141430(Traditional)
ATTN: ELIJA  WREH                 PHONE NO : 201 831-5691 
325 Corporate Drive               SE DECISION MADE: 18-JUL-14
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
Boston Scientific Corporation     510(k) NO: K140641(Traditional)
ATTN: KURTIS  HUNSBERGER          PHONE NO : 763 494-1204 
ONE SCIMED PLACE                  SE DECISION MADE: 03-JUL-14
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
STERIS Corporation                510(k) NO: K140487(Traditional)
ATTN: TONY  PIOTRKOWSKI           PHONE NO : 440 392-7437 
5960 Heisley Road                 SE DECISION MADE: 22-JUL-14
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
VASCULAR PATHWAYS, INC.           510(k) NO: K140504(Traditional)
ATTN: BILL  BOLD                  PHONE NO : 
1847 Trade Center Way             SE DECISION MADE: 17-JUL-14
Naples FL  34109                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AMPLIVUE GAS ASSAY
QUIDEL CORPORATION                510(k) NO: K141173(Traditional)
ATTN: Ronald H Lollar             PHONE NO : 740 589-3373 
2005 E State St Suite 100         SE DECISION MADE: 24-JUL-14
ATHENS OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: D2 HEMOSTANTIC DRESSING
Z-MEDICA, LLC                     510(k) NO: K140757(Traditional)
ATTN: SHEILA  WALLIN              PHONE NO : 203 294-0000 
4 FAIRFIELD BLVD.                 SE DECISION MADE: 17-JUL-14
WALLINGFORD CT  06492             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INFANT INCUBATOR
BISTOS CO., LTD.                  510(k) NO: K132543(Traditional)
ATTN: YOUNG  CHI                  PHONE NO : 973 278-5222 
27 NEW ENGLAND DRIVE              SE DECISION MADE: 03-JUL-14
RAMSEY NJ  07446                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Z5C
Z-Systems AG                      510(k) NO: K132881(Traditional)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792-1235 
12264 EL CAMINO REAL STE. 400     SE DECISION MADE: 03-JUL-14
SAN DIEGO CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MERIT SAFETY INTRODUCER NEEDLE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K140513(Traditional)
ATTN: SUSAN  CHRISTENSEN          PHONE NO : 801 208-4789 
1600 WEST MERIT PKWY.             SE DECISION MADE: 09-JUL-14
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SHILLA GROWTH GUIDANCE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K140750(Traditional)
ATTN: LEE  GRANT                  PHONE NO : 800 3963133876 
1800 PYRAMID PLACE                SE DECISION MADE: 17-JUL-14
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
SAPHENA MEDICAL, INC.             510(k) NO: K140603(Traditional)
ATTN: CHERYL  BLAKE               PHONE NO : 949 285-3517 
27392 CAPRICHO                    SE DECISION MADE: 31-JUL-14
MISSION VIEJO CA  92692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CASPIAN SPINAL SYSTEM
K2M, INC.                         510(k) NO: K141284(Special)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777-3155 
751 MILLER DR.,SE                 SE DECISION MADE: 23-JUL-14
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MICR02 OSA DEVICE
MICRODENTAL, INC.                 510(k) NO: K133683(Traditional)
ATTN: LAURA  SHEPPARD             PHONE NO : 925 803-8643 
5601 ARNOLD RD.                   SE DECISION MADE: 24-JUL-14
DUBLIN CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LINSCAN 808, LINSCAN 980
GME (GERMAN MEDICAL ENGINEERING) G510(k) NO: K141063(Traditional)
ATTN: MIKE  JOHNSON, M.D.         PHONE NO : 406 209-3039 
PO BOX 106                        SE DECISION MADE: 15-JUL-14
WILLOW CREEK MT  59760            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
HARTALEGA NGC SDN. BHD.           510(k) NO: K140890(Traditional)
ATTN: NURUL  AISYAH KONG          PHONE NO : 603 328 03888 
DATARAN SD PJU 9                  SE DECISION MADE: 24-JUL-14
BANDAR SRI DAMANSARA, KUALA LUMPUR510(k) STATEMENT
                                                    
 
DEVICE: NORMED VARIO SUBTALAR SCREW
NORMED NEDIZIN TECHNIK GMBH       510(k) NO: K140962(Traditional)
ATTN: DAVID  FURR                 PHONE NO : 512 906-9654 
8708 CAPEHART COVE                SE DECISION MADE: 03-JUL-14
AUSTIN TX  78733                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DCAS I
GP&P CO., LTD.                    510(k) NO: K140869(Traditional)
ATTN: CHARLIE  MACK               PHONE NO : 931 625-4938 
12226 WASHINGTON LANE             SE DECISION MADE: 03-JUL-14
PARKER AZ  85344                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
ENDOSEC CORPORATION               510(k) NO: K132384(Traditional)
ATTN: PIN  YU                     PHONE NO : 650 397-5174 
4546 EL CAMINO REAL, STE 215      SE DECISION MADE: 02-JUL-14
LOS ALTOS CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
GALIL MEDICAL LTD.                510(k) NO: K141485(Special)
ATTN: LYNN  DAVIES                PHONE NO : 651 287-5098 
4364 Round Lake Road              SE DECISION MADE: 02-JUL-14
Arden Hills MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: THE STORK OTC
RINOVUM WOMEN'S HEALTH, INC       510(k) NO: K140186(Traditional)
ATTN: ANDREW  ZELTWANGER          PHONE NO : 724 241-8934 
300 Oxford Dr Suite 330           SE DECISION MADE: 11-JUL-14
Monroeville PA  15146             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140897(Traditional)
ATTN: CORDELL L FIELDS, ESQ.      PHONE NO : 610 219-8518 
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 18-JUL-14
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
FOCUS DIAGNOSTICS                 510(k) NO: K141458(Special)
ATTN: SHARON  YOUNG               PHONE NO : 562 240-6680 
11331 Valley View Street          SE DECISION MADE: 01-JUL-14
CYPRESS CA  90630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VOLUSON S6, VOLUSON S8
GE HEALTHCARE                     510(k) NO: K141639(Special)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721-4214 
9900 Innovation Drive             SE DECISION MADE: 18-JUL-14
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K140417(Traditional)
ATTN: SHWETA  SHARMA              PHONE NO : 800 3963133876 
1800 PYRAMID PLACE                SE DECISION MADE: 09-JUL-14
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
BIOMET, INC.                      510(k) NO: K140883(Traditional)
ATTN: JOHN  HECKAMAN              PHONE NO : 574 371-3707 
56 EAST BELL DR. BOX 587          SE DECISION MADE: 30-JUL-14
WARSAW IN  46581-0587             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K141011(Traditional)
ATTN: DMITRI  FALKNER             PHONE NO : 901 290-5883 
1023 CHERRY ROAD                  SE DECISION MADE: 30-JUL-14
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
ELITECHGROUP                      510(k) NO: K141265(Traditional)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482-5174 
21720 23RD DR SE SUITE 150        SE DECISION MADE: 18-JUL-14
BOTHELL WA  98021                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LINOS MOH HAND PLATING SYSTEM
KLS MARTIN L.P.                   510(k) NO: K141489(Special)
ATTN: JENNIFER  DAMATO            PHONE NO : 800 625-1557 1230
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 24-JUL-14
JACKSONVILLE FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
SHASER, INC.                      510(k) NO: K141583(Special)
ATTN: ANTHONY  BURNS              PHONE NO : 339 927-2599 
10 Maguire Rd Ste 120 BUILDING 1  SE DECISION MADE: 22-JUL-14
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BNA ANALYSIS SYSTEM
EIMINDA LTD.                      510(k) NO: K121119(Traditional)
ATTN: DALIA  DICKMAN              PHONE NO : 972 9 9516476 
16 HAMINHARA ST. BEIT BACHAR      SE DECISION MADE: 25-JUL-14
HERZLIYA  IL 46586                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HUMELOCK II CEMENTED SHOULDER SYSTEM
FX SOLUTIONS                      510(k) NO: K140071(Traditional)
ATTN: JEAN-JACQUES  MARTIN        PHONE NO : 334 745 53555 
1663 RUE DE MAJORNAS              SE DECISION MADE: 28-JUL-14
VIRIAT  FR 01440                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACE CALIBRATOR
SENTINEL CH. SpA                  510(k) NO: K141728(Abbreviated)
ATTN: Patricia  Dupe              PHONE NO : 39 02 34551496 
Via Robert Koch, 2                SE DECISION MADE: 28-JUL-14
Milano  IT 20152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PULSE OXIMETER
NONIN MEDICAL, INC.               510(k) NO: K140785(Traditional)
ATTN: BRODIE  PEDERSEN            PHONE NO : 763 577-3180 
13700 1ST AVE, NORTH              SE DECISION MADE: 07-JUL-14
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
BECKMAN COULTER, INC.             510(k) NO: K140829(Traditional)
ATTN: ANNETTE  HELLIE             PHONE NO : 714 961-4517 
250 S. KRAEMER BLVD. MAIL STOP E1.SE DECISION MADE: 14-JUL-14
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EXPRT REVISION KNEE
ENCORE MEDICAL, L.P.              510(k) NO: K140830(Traditional)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 834-6255 
9800 METRIC BLVD.                 SE DECISION MADE: 11-JUL-14
AUSTIN TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENADEN FLOW
KM CORPORATION                    510(k) NO: K140976(Traditional)
ATTN: Priscilla  Chung            PHONE NO : 714 202-5789 
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 10-JUL-14
FULLERTON CA  92831               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SENSITITRE SUSCEPTIBILITY PLATES
Thermo Fisher Scientific          510(k) NO: K141000(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 871-8909 322
1 Thermo Fisher Way               SE DECISION MADE: 16-JUL-14
Oakwood Village OH  44146         510(k) STATEMENT
                                                    
 
DEVICE: ACCULIF TL AND PL CAGE
STRYKER CORPORATION               510(k) NO: K141217(Special)
ATTN: KRISTEN  MEANY              PHONE NO : 201 760-8070 
2 PEARL COURT                     SE DECISION MADE: 16-JUL-14
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
Roche Diagnostics                 510(k) NO: K141143(Traditional)
ATTN: KHOA  TRAN                  PHONE NO : 317 521-3409 
9115 HAGUE ROAD                   SE DECISION MADE: 17-JUL-14
INDIANAPOLIS IN  46250-0416       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K141301(Traditional)
ATTN: BRIAN  HOCKETT              PHONE NO : 330 869-9562 
1065 Medina Rd. SUITE 500         SE DECISION MADE: 11-JUL-14
Medina OH  44256                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DYNAMIC NEUROSCREENING DEVICE
PROSENEX                          510(k) NO: K141208(Traditional)
ATTN: WILLIAM G MCLAIN            PHONE NO : 717 656-9656 
342 E. MAIN ST. SUITE 207         SE DECISION MADE: 23-JUL-14
LEOLA PA  17540                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K133784(Traditional)
ATTN: JUDITH  ROSEN               PHONE NO : 973 576-0032 
10 POMEROY RD.                    SE DECISION MADE: 07-JUL-14
PARSIPPANY NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COCOON CONVECTIVE WARMING SYSTEM
CARE ESSENTIALS PTY LTD           510(k) NO: K140635(Traditional)
ATTN: BIBIANA  FRANCO             PHONE NO : 618 7231 0324 
SUITE 2/ 36-38 GLEN OSMOND ROAD   SE DECISION MADE: 25-JUL-14
PARKSIDE, SOUTH AUSTRALIA  AU 5063510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
Siemens Healthcare Diagnostics Inc510(k) NO: K133156(Traditional)
ATTN: PHILIP  LIU                 PHONE NO : 914 524-2443 
511 BENEDICT AVE.                 SE DECISION MADE: 24-JUL-14
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K140572(Traditional)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706-7456 
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 02-JUL-14
GREAT NECK NY  11021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SYSTEM CALIBRATER
BECKMAN COULTER IRELAND INC       510(k) NO: K141388(Abbreviated)
ATTN: DAVID G DAVIS               PHONE NO : 469 236-8180 
250 S. KRAEMER BLVD. E1.SE.01     SE DECISION MADE: 11-JUL-14
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
CANON, INC.                       510(k) NO: K133693(Traditional)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480-9554 
1201 RICHARDSON DRIVE, STE 280    SE DECISION MADE: 01-JUL-14
RICHARDSON TX  75080              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM
OSTIAL CORPORATION                510(k) NO: K133861(Traditional)
ATTN: JAKE  WOLENBERG             PHONE NO : 650 903-9100 
1221 INNSBRUCK DRIVE              SE DECISION MADE: 02-JUL-14
SUNNYVALE CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
KEELER LIMITED                    510(k) NO: K140451(Traditional)
ATTN: EUGENE  VAN ARSDALE         PHONE NO : 610 353-4350 
456 PARKWAY                       SE DECISION MADE: 11-JUL-14
BROOMALL PA  19008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PULSTAR LOGIX PUMP
ALBAHEALTH LLC                    510(k) NO: K141609(Special)
ATTN: SHANE  BRUCE                PHONE NO : 865 354-0410 
425 N GATEWAY AVE.                SE DECISION MADE: 15-JUL-14
ROCKWOOD TN  37854                510(k) STATEMENT
                                                    
 
DEVICE: LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
JEIL MEDICAL CORPORATION          510(k) NO: K141452(Special)
ATTN: Priscilla  Chung            PHONE NO : 714 202-5789 
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 02-JUL-14
FULLERTON CA  92831               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: S9 GREENHILLS
RESMED LTD.                       510(k) NO: K140279(Traditional)
ATTN: JIM  CASSI                  PHONE NO : 858 836-6081 
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 31-JUL-14
SAN DIEGO CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K141605(Special)
ATTN: MICHAEL  SCOTT              PHONE NO : 800 3963133876 
1800 PYRAMID PLACE                SE DECISION MADE: 14-JUL-14
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: REUSABLE GUIDE
KOELIS                            510(k) NO: K141334(Traditional)
ATTN: LAETITIA  GERVAIS           PHONE NO : 334 766375 87 
5 avenue du Grand Sablon          SE DECISION MADE: 11-JUL-14
La Tronche  FR 38700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EDS COMBO-RINSE
ESSENTIAL DENTAL SYSTEMS, INC.    510(k) NO: K140846(Traditional)
ATTN: JEFFREY  WAN                PHONE NO : 201 487-9090 
89 LEUNING STREET SUITE 8         SE DECISION MADE: 25-JUL-14
SOUTH HACKENSACK NJ  07606        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS
ABMEDICA SAS                      510(k) NO: K140101(Traditional)
ATTN: DANIEL  DONOVAN             PHONE NO : 203 799-2400 202
333 QUARRY ROAD                   SE DECISION MADE: 10-JUL-14
MILFORD CT  06460                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
MAQUET CARDIOPULMONARY AG         510(k) NO: K141432(Special)
ATTN: KATRIN  SCHWENKGLENKS       PHONE NO : 011 49 747199730 
KEHLER STRASSE 31                 SE DECISION MADE: 07-JUL-14
RASTATT  DE 76437                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
STERIS Corporation                510(k) NO: K140498(Traditional)
ATTN: BILL  BRODBECK              PHONE NO : 440 392-7690 
5960 Heisley Road                 SE DECISION MADE: 24-JUL-14
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
GEISTLICH PHARMA AG               510(k) NO: K140518(Traditional)
ATTN: DANIEL A KRACOV             PHONE NO : 202 942-5120 
555 twelfth Street, NW            SE DECISION MADE: 18-JUL-14
Washington DC  20004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARTHREX FRACTURE PLATES AND SCREWS
ARTHREX, INC.                     510(k) NO: K141478(Special)
ATTN: DAVID L ROGERS              PHONE NO : 239 643-5553 7192
1370 CREEKSIDE BLVD.              SE DECISION MADE: 08-JUL-14
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
NEOCOIL, LLC                      510(k) NO: K141832(Traditional)
ATTN: MICHAEL  LEIGH              PHONE NO : 262 347-1250 
N27 W23910A PAUL RD.              SE DECISION MADE: 31-JUL-14
PEWAUKEE WI  53072                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
TECHLINK INTERNATIONAL            510(k) NO: K131923(Traditional)
ATTN: TARA  CONRAD                PHONE NO : 305 377-0077 
PO BOX 694125                     SE DECISION MADE: 03-JUL-14
MIAMI FL  33269                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HEARTWAY POWER WHEELCHAIR
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K132856(Traditional)
ATTN: JEN  KE-MIN                 PHONE NO : 886 423 580357 
NO. 6 ROAD 25 TAICHUNG INDUSTRIAL SE DECISION MADE: 15-JUL-14
TAICHUNG CITY, TAIWAN  TW R.O.C. 4510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
QUBYX LIMITED                     510(k) NO: K131601(Traditional)
ATTN: ALICE  KOTYLARENKO          PHONE NO : 33 01 80963820 
80, RUE MARECHAL JOFFRE           SE DECISION MADE: 07-JUL-14
NICE  FR 06000                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET
GENERICA MEDICAL INTERNATIONAL, IN510(k) NO: K133077(Traditional)
ATTN: JIM  BARLEY                 PHONE NO : 949 433-3058 
1910 D ST.                        SE DECISION MADE: 28-JUL-14
LAVERNE CA  91750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
AMERICAN MEDICAL MANUFACTURING, IN510(k) NO: K130097(Traditional)
ATTN: MIKE  HOFTMAN               PHONE NO : 818 701-7171 101
8741 Shirley Ave                  SE DECISION MADE: 22-JUL-14
Northridge CA  91324              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OXIPROBE E (OXIPROBE)
BIO MEDICAL TECHNOLOGIES CO., LTD 510(k) NO: K132516(Traditional)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549-6035 
P.O. BOX 560                      SE DECISION MADE: 30-JUL-14
STILLWATER MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
RITM OKB ZAO                      510(k) NO: K131513(Traditional)
ATTN: LARISA  SHPUNGINA           PHONE NO : 7 8634 623179 
99, PETROVSKAYA                   SE DECISION MADE: 11-JUL-14
TAGANROG  RU 347900               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NOVAPROBE LED LIGHT SOURCE
NOVAPROBE INCORPORATED            510(k) NO: K131226(Traditional)
ATTN: MANISH  INGLE               PHONE NO : 215 259-3673 
2333W. MAIN STREET SUITE 210      SE DECISION MADE: 24-JUL-14
LANSDALE PA  19446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VIMOVE
DORSA VI PTY. LTD                 510(k) NO: K131094(Traditional)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 704 430-8695 
1914 J N PEASE PLACE              SE DECISION MADE: 11-JUL-14
CHARLOTTE NC  28262               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AQUARIUS EXTENSION FEEDING SET
DEGANIA SILICONE, LTD.            510(k) NO: K141631(Special)
ATTN: ZOYA  LEE                   PHONE NO : 972 467 55122 
KIBBUTZ DEGANIA BET               SE DECISION MADE: 28-JUL-14
EMEK HAYARDEN  IL 1513000         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
 
                                                 TOTAL 510(k)s THIS PERIOD   289                                     
                                                 TOTAL WITH SUMMARIES        285                                     
                                                 TOTAL WITH STATEMENTS        4
                                       

 

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