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Medical Devices

February 2015 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2015
 
 
DEVICE: BWMINI EEG, BWMINIHST, BWMINI PSG
NEUROVIRTUAL USA, INC.            510(k) NO: K131335(Traditional)
ATTN: EDUARDO  FARIA              PHONE NO : 786 693-8200 
2315 NW 107TH AVE STE 1M27        SE DECISION MADE: 03-FEB-15
DORAL FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PJ'S SERENITY
LIMERICK, INC.                    510(k) NO: K132220(Traditional)
ATTN: PATRICIA  KELLY             PHONE NO : 818 566-3060 103
2150 N. GLENOAKS BLVD.            SE DECISION MADE: 20-FEB-15
BURBANK CA  91504                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CARRICELL
ETEX CORPORATION                  510(k) NO: K132868(Traditional)
ATTN: MICHAEL  STRUNK, PHD.       PHONE NO : 617 577-0706 
675 MASSACHUSETTS AVE             SE DECISION MADE: 20-FEB-15
CAMBRIDGE MA  02139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FIBERION OPHTHALMIC ENDOLASER PROBE
EMTRON ELEKTRONIK VE MEKANIK SANAY510(k) NO: K133019(Traditional)
ATTN: MEHMET  MELEK               PHONE NO : 90 212257 1787 
BEBEK YOLU SOKAGI 23/3 ETILER     SE DECISION MADE: 20-FEB-15
ISTANBUL  TR 34337                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
SCHUTZ-DENTAL GMBH                510(k) NO: K133268(Traditional)
ATTN: MICHAEL  WIERZ              PHONE NO : 49 600 3814367 
DIESELSTRASSE 5-6                 SE DECISION MADE: 12-FEB-15
ROSBACH, HESSEN  DE DE 61191      510(k) STATEMENT
                                                    
 
DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
FUKUDA DENSHI USA, INC.           510(k) NO: K134046(Traditional)
ATTN: DOUG  BLAKELY               PHONE NO : 425 881-7737 
17725 N.E. 65TH ST., BLDG. C      SE DECISION MADE: 12-FEB-15
REDMOND WA  98052-4911            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BODY COMPOSITION ANALYZER
JAWON MEDICAL CO., LTD.           510(k) NO: K140045(Traditional)
ATTN: W S PARK                    PHONE NO : 2 626 49001 
LIFE-OFFICETEL 320,40,63-RO YOUNGDSE DECISION MADE: 18-FEB-15
SEOUL  KR 150-731                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENGSTROM CARESTATION, ENGSTROM PRO
DATEX-OHMEDA, INC.                510(k) NO: K140575(Traditional)
ATTN: TRISHIA  DWYER              PHONE NO : 608 221-1515 
3030 OHMEDA DR. P.O. BOX 7550     SE DECISION MADE: 03-FEB-15
MADISON WI  53718                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ULTRASONIC POCKET DOPPLER
EDAN INSTRUMENTS, INC.            510(k) NO: K140579(Traditional)
ATTN: QUEENA  CHEN                PHONE NO : 867 552 6858736 
NANHAI RD 1019 NO. SHEKOU, NANSHANSE DECISION MADE: 06-FEB-15
SHENZHEN, GUANGDONG  CN 518067    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
BRAINREADER APS                   510(k) NO: K140828(Traditional)
ATTN: METTE  MUNCH                PHONE NO : 452 987 2000 
SKAGENVEJ 21                      SE DECISION MADE: 04-FEB-15
EGAA  DK 8250                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
DEPUY (IRELAND)                   510(k) NO: K140881(Traditional)
ATTN: NANCY  FRIDDLE              PHONE NO : 574 371 4923 
LOUGHBEG RINGASKIDDY              SE DECISION MADE: 13-FEB-15
CO. CORK  IE --                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
STANMORE INC.                     510(k) NO: K140900(Special)
ATTN: SAMANTHA  SHELLEY           PHONE NO : 442 082386 427 
10 CORDAGE ROAD PARK CIRCLE, SUITESE DECISION MADE: 12-FEB-15
PLYMOUTH MA  02360                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NUROS BONE GRAFT SUBSTITUTE
ORIENTAL RESOURCES DEVELOPMENT LIM510(k) NO: K140913(Traditional)
ATTN: MICHAEL  LEE                PHONE NO : 886 228 096995 
NO.45 MINSHENG ROAD DANSHUI TOWN  SE DECISION MADE: 17-FEB-15
NEW TAIPEI CITY  TW 251           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
ULTIMED INCORPORATED              510(k) NO: K140949(Traditional)
ATTN: MARY BETH  HENDERSON        PHONE NO : 952 595-5580 
5353 WAYZATA BLVD., SUITE 505     SE DECISION MADE: 09-FEB-15
MINNEAPOLIS MN  55416             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TI NASAL MASK
RESPIRONICS, INC.                 510(k) NO: K140980(Abbreviated)
ATTN: SHAYLEE  MASILUNAS          PHONE NO : 724 387-7729 
1001 MURRY RIDGE LN.              SE DECISION MADE: 10-FEB-15
MURRYSVILLE PA  15668             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K140990(Traditional)
ATTN: TINA  WU                    PHONE NO : 443 352-3909 
62 FOREST ST., STE 300            SE DECISION MADE: 27-FEB-15
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
INTERSURGICAL INCORPORATED        510(k) NO: K141087(Traditional)
ATTN: MICHAEL  ZALEWSKI           PHONE NO : 315 451-2900 202
417 ELECTRONICS PARKWAY           SE DECISION MADE: 12-FEB-15
LIVERPOOL NY  13088               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
ALLIANCE PARTNERS, LLC.           510(k) NO: K141123(Traditional)
ATTN: TIM  LOHNES                 PHONE NO : 203 922-0105 
80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 27-FEB-15
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
TTBIO CORP.                       510(k) NO: K141183(Abbreviated)
ATTN: SHU-CHING  LEE              PHONE NO : 886 4 23595958 
2F, NO.7, 6TH ROAD INDUSTRY PARK  SE DECISION MADE: 27-FEB-15
TAICHUNG, ROC  TW  40755          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
Lin-Zhi International, Inc.       510(k) NO: K141205(Traditional)
ATTN: BERNICE  LIN                PHONE NO : 408 732-3856 
670 ALMANOR AVE                   SE DECISION MADE: 13-FEB-15
SUNNYVALE CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM
LIFE SPINE, INC                   510(k) NO: K141222(Traditional)
ATTN: RANDY  LEWIS                PHONE NO : 847 884-6117 
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 12-FEB-15
HOFFMAN ESTATES IL  60169         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
LIFE SPINE, INC                   510(k) NO: K141246(Traditional)
ATTN: RANDY  LEWIS                PHONE NO : 847 884-6117 
2401 W. HASSELL RD SUITE 1535     SE DECISION MADE: 22-FEB-15
HOFFMAN ESTATES IL  60169         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
INOVA DIAGNOSTICS, INC.           510(k) NO: K141274(Traditional)
ATTN: Roger  Albesa               PHONE NO : 858 5869900 1391
9900 OLD GROVE RD.                SE DECISION MADE: 13-FEB-15
SAN DIEGO CA  92131-1638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BUSSE EXTENSION SET
BUSSE HOSPITAL DISPOSABLES        510(k) NO: K141285(Traditional)
ATTN: MUHAMAD  ANSARI             PHONE NO : 631 435-4711 254
75 ARKAY DRIVE                    SE DECISION MADE: 19-FEB-15
HAUPPAUGE NY  11788-3707          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COGNISION EEG/EP SYSTEM
NEURONETRIX SOLUTIONS             510(k) NO: K141316(Traditional)
ATTN: CHERYL  FISHER              PHONE NO : 408 410-5920 
816 CONGRESS AVENUE, SUITE 1400   SE DECISION MADE: 13-FEB-15
AUSTIN TX  78701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
INOVA DIAGNOSTICS, INC.           510(k) NO: K141328(Traditional)
ATTN: GABRIELLA  LAKOS            PHONE NO : 858 586-9900 1393
9900 OLD GROVE ROAD               SE DECISION MADE: 12-FEB-15
SAN DIEGO CA  92131-1638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
PHADIA US INC.                    510(k) NO: K141375(Traditional)
ATTN: MANUELA  CONSTANZE HOG      PHONE NO : 497 614 7805173 
MUNZINGER STRASSE 7               SE DECISION MADE: 13-FEB-15
FREIBURG IM BREISGAU  DE 79111    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BIOS KING BIOCELLULOSE FILM
CORELEADER BIOTECH CO., LTD.      510(k) NO: K141382(Traditional)
ATTN: YA-WEN  KUO                 PHONE NO : 886 226 968880 
19F NO. 100, SEC 1 XINTAI 5TH RD, SE DECISION MADE: 10-FEB-15
NEW TAIPEI CITY  TW 22102         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EASY OUT
FEET FOR LIFE PODIATRY CENTER     510(k) NO: K141401(Traditional)
ATTN: MICHAEL  HORWITZ            PHONE NO : 314 9830303 
8637 DELMAR BLVD.                 SE DECISION MADE: 20-FEB-15
SAINT LOUIS MO  63124             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ORAGENE DX OGD-500.001
DNA GENOTEK, INC.                 510(k) NO: K141410(Traditional)
ATTN: DAN  FULLERTON              PHONE NO : 613 723 5757 
2 BEAVERBROOK ROAD                SE DECISION MADE: 19-FEB-15
OTTAWA  CA K2K 1L1                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PMMA BLOCK
RIZHAO HUGE DENTAL INDUSTRY CO., L510(k) NO: K141421(Abbreviated)
ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182 
ROOM 302, NO. 21 BLDG, KAIYU GARDESE DECISION MADE: 09-FEB-15
WENZHOU, ZHEJIANG  CN 325000      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SORRENTO BONE GRAFT SUBSTITUTE
HAIDER BIOLOGICS, LLC             510(k) NO: K141429(Traditional)
ATTN: GUSTAVO R PRADO             PHONE NO : 858 202-1505 
9930 MESA RIM DRIVE               SE DECISION MADE: 23-FEB-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SATURN 5 LASER
RESEARCH INSTRUMENTS LTD.         510(k) NO: K141434(Traditional)
ATTN: DAVID  LANDSDOWNE           PHONE NO : 441 326 372753 
BICKLAND WATER INDUSTRIAL PARK    SE DECISION MADE: 18-FEB-15
FALMOUTH CORNWALL  GB TR 11 4TA   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
BD Biosciences                    510(k) NO: K141468(Traditional)
ATTN: Terrance  Thiel             PHONE NO : 408 9544150 
2350 Qume Dr.                     SE DECISION MADE: 27-FEB-15
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
EUROSETS S.R.L.                   510(k) NO: K141492(Traditional)
ATTN: MARIO  GENNARI              PHONE NO : 39 53573 1216 
VIA G. PUCCINI, 1                 SE DECISION MADE: 06-FEB-15
MEDOLLA, MODENA  IT I-43036       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: T-8000 THEROZONE UNIT
THEROZONE USA, INC.               510(k) NO: K141504(Traditional)
ATTN: Rebecca K Pine              PHONE NO : 760 809-5178 
2701 OCEAN PARK BLVD, SUITE 108   SE DECISION MADE: 24-FEB-15
SANTA MONICA CA  90405            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MCC Para-Fix CARY BLAIR MEDIUM
MEDICAL CHEMICAL CORPORATION      510(k) NO: K141506(Traditional)
ATTN: KRIS J KONTIS               PHONE NO : 800 424-9394 
19430 VAN NESS AVE                SE DECISION MADE: 25-FEB-15
TORRANCE CA  90501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: V-GUIDE FOR VENTRICULOSTOMIES
ARC SURGICAL LLC.                 510(k) NO: K141559(Traditional)
ATTN: CRAIG  PAGAN                PHONE NO : 321 728-0125 102
1135 W NASA BLVD STE 500          SE DECISION MADE: 27-FEB-15
MELBOURNE FL  32901               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER
MEGADYNE MEDICAL PRODUCTS, INC.   510(k) NO: K141587(Traditional)
ATTN: RONDA  MAGNESON             PHONE NO : 801 5769669 
11506 SOUTH STATE ST.             SE DECISION MADE: 18-FEB-15
DRAPER UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: THD REVOLUTION
THD SPA                           510(k) NO: K141657(Traditional)
ATTN: MAURIZIO  PANTALEONI        PHONE NO : 393 48 4435155 
VIA A. BONETTI 3/A                SE DECISION MADE: 24-FEB-15
IMOLA, BO  IT 40026               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FERTILIGENT SLOW RELEASE IUI CATHETER KIT
FERTILIGENT, LTD                  510(k) NO: K141666(Traditional)
ATTN: BABACAR  DIOUF              PHONE NO : 317 872-0074 3512
5610 W 82ND ST                    SE DECISION MADE: 03-FEB-15
INDIANAPOLIS IN  46278            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AESCULAP ORTHOPILOT NEXT GENERATION
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K141694(Special)
ATTN: JULIE  TOM WING             PHONE NO : 610 984-9147 
3773 Corporate Parkway            SE DECISION MADE: 24-FEB-15
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MEDEOR MATRIX WOUND DRESSING
KENSEY NASH CORPORATION DBA DSM BI510(k) NO: K141738(Traditional)
ATTN: BRIANNA  JORDAN             PHONE NO : 484 713-2608 
735 PENNSYLVANIA DRIVE            SE DECISION MADE: 17-FEB-15
EXTON PA  19341                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SYPHER SPACER SYSTEM
BIOGENNIX, LLC                    510(k) NO: K141798(Traditional)
ATTN: MEREDITH  MAY, MS, RAC      PHONE NO : 719 337-7579 
4628 NORTHPARK DRIVE              SE DECISION MADE: 19-FEB-15
COLORADO SPRINGS CO  80918        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
Immunalysis Corporation           510(k) NO: K141803(Traditional)
ATTN: joseph  Ginete              PHONE NO : 909 482-0840 
829 TOWNE CENTER DR.              SE DECISION MADE: 12-FEB-15
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OPTIMUS NEURO SYSTEM
OSTEONIC CO., LTD.                510(k) NO: K141911(Traditional)
ATTN: Priscilla  Chung            PHONE NO : 714 202-5789 
2651 E CHAPMAN AVE. STE 110       SE DECISION MADE: 10-FEB-15
FULLERTON CA  92831               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IRIS INTELLIGENT RETINAL IMAGING SYSTEM
INTELLIGENT RETINAL IMAGING SYSTEM510(k) NO: K141922(Traditional)
ATTN: RYAN  BOUCHARD              PHONE NO : 978 685-8900 
300 BRICKSTONE SQUARE             SE DECISION MADE: 27-FEB-15
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ECHOSTAR COMFORT 1.5T MRI
ALLTECH MEDICAL SYSTEMS AMERICA, I510(k) NO: K141945(Traditional)
ATTN: MICHAELEEN  DOM             PHONE NO : 440 424-2240 
28900 FOUNTAIN PARKWAY            SE DECISION MADE: 03-FEB-15
SOLON OH  44139                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DIGITAL ELECTROCARDIOGRAPH
SHENZHEN BIOCARE BIO-MEDICAL EQUIP510(k) NO: K141946(Traditional)
ATTN: Diana  Hong                 PHONE NO : 86 21 22815850 
P.O. BOX 120-119                  SE DECISION MADE: 13-FEB-15
SHANGHAI  CN 200120               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 12SL ECG ANALYSIS PROGRAM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K141963(Traditional)
ATTN: KRISTIN  PABST              PHONE NO : 414 721-3104 
9900 WEST INNOVATION DRIVE        SE DECISION MADE: 05-FEB-15
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
WRP ASIA PACIFIC SDN. BHD.        510(k) NO: K141982(Traditional)
ATTN: SARALA DEVI  JAYARAMAN      PHONE NO : 60 387 061486 
LOT 1, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 05-FEB-15
SALAK TINGGI, SEPANG SELANGOR  MY 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GALILEO NT
EB NEURO, S.P.A.                  510(k) NO: K142064(Traditional)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 228-8719 
9001 WESLEYAN RD, STE 200         SE DECISION MADE: 13-FEB-15
INDIANAPOLIS IN  46268            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PROCOTYL L-O ACETABULAR SYSTEM
MICROPORT ORTHOPEDICS INC.        510(k) NO: K142119(Traditional)
ATTN: BYRON  LEDBETTER            PHONE NO : 901 290-5943 
5677 AIRLINE RD                   SE DECISION MADE: 27-FEB-15
ARLINGTON TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
COVIDIEN                          510(k) NO: K142128(Traditional)
ATTN: SHANNON  GREEN              PHONE NO : 508 261-8587 
15 HAMPSHIRE STREET               SE DECISION MADE: 23-FEB-15
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SEEGENE ANYPLEX II HSV-1/2 ASSAY
SEEGENE                           510(k) NO: K142156(Traditional)
ATTN: FRAN  WHITE                 PHONE NO : 978 927-3808 
180 Cabot Street                  SE DECISION MADE: 13-FEB-15
Beverly MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MEDENTIKA ABUTMENT SYSTEM
MEDENTIKA GMBH                    510(k) NO: K142167(Traditional)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792-1235 
12264 El Camino Real, Suite 400   SE DECISION MADE: 20-FEB-15
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LIGHTMED TRUSCAN 577
LIGHTMED CORP.                    510(k) NO: K142172(Traditional)
ATTN: ANGEL  HSIEH                PHONE NO : 886 226 881726 
NO.1-1, LANE1,PAO-AN ST. SEC.3 SHUSE DECISION MADE: 27-FEB-15
NEW TAIPEI CITY  TW 23861         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PROROOT MTA WHITE, PROROOT MTA GRAY
DENTSPLY INTERNATIONAL INC.       510(k) NO: K142178(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 487-1332 
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 26-FEB-15
YORK PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NuVasive X-CORE(R) Expandable VBR System
NUVASIVE, INC.                    510(k) NO: K142205(Traditional)
ATTN: OLGA  LEWIS                 PHONE NO : 858 320 5257 
7475 LUSK BLVD.                   SE DECISION MADE: 20-FEB-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Heated Eye Pad
Digital Heat Corporation          510(k) NO: K142228(Traditional)
ATTN: John   Devine               PHONE NO : 512 5607184 
5626 S. Captain Kidd Ct. Unit B   SE DECISION MADE: 09-FEB-15
Tempe  AZ  85283                  510(k) STATEMENT
                                                    
 
DEVICE: PREMIUM, SHELTA Implant Systems
SWEDEN & MARTINA S.P.A.           510(k) NO: K142242(Traditional)
ATTN: GLORIANNA  ZANGIACOMI       PHONE NO : 39 049 9124300 
VIA VENETO, 10                    SE DECISION MADE: 02-FEB-15
DUE CARRARE  IT 35020             510(k) STATEMENT
                                                    
 
DEVICE: CLEO PATIENT MONITOR 
INFINIUM MEDICAL                  510(k) NO: K142244(Traditional)
ATTN: SULEYMAN  BILGUTAY          PHONE NO : 727 531 8434 
12151 62ND STREET NORTH # 5       SE DECISION MADE: 06-FEB-15
LARGO FL  33773                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope
Urologix, Inc.                    510(k) NO: K142248(Traditional)
ATTN: Georgiann  Keyport          PHONE NO : 1 763 4751400 
14405 21st Avenue North           SE DECISION MADE: 20-FEB-15
Minneapolis  MN  55447            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula
Covidien                          510(k) NO: K142296(Traditional)
ATTN: Danielle  Mueller           PHONE NO : 1 303 3052603 
6135 Gunbarrel Ave                SE DECISION MADE: 24-FEB-15
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
Covidien                          510(k) NO: K142298(Traditional)
ATTN: Kelsey   Lee                PHONE NO : 1 303 3052760 
6135 Gunbarrel Avenue             SE DECISION MADE: 13-FEB-15
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Talos-C(HA) Cervical Intervertebral Body Fusion Devices
MEDITECH SPINE, LLC               510(k) NO: K142345(Traditional)
ATTN: JASON  GROMEK               PHONE NO : 678 974 5287 
1447 PEACHTREE ST NE SUITE 44     SE DECISION MADE: 22-FEB-15
ATLANTA GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Osstell IDx
OSSTELL AB                        510(k) NO: K142358(Traditional)
ATTN: KARIN  BREDING              PHONE NO : 46 31340 8254 
STAMPGATAN 14                     SE DECISION MADE: 19-FEB-15
GOTHENBURG  SE 41101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ivWatch Model 400
ivWatch, LLC                      510(k) NO: K142374(Traditional)
ATTN: Javier   Garriz             PHONE NO : 855 4892824 7016
469 McLaws Circle                 SE DECISION MADE: 13-FEB-15
Williamsburg VA  23185            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
BIONESS, INC.                     510(k) NO: K142432(Traditional)
ATTN: Robert  Schulz, RAC         PHONE NO : 1 661 9025270 
25103 RYE CANYON LOOP             SE DECISION MADE: 20-FEB-15
VALENCIA CA  91355                510(k) STATEMENT
                                                    
 
DEVICE: 3S Safety Syringe with/without Needle
Sincere Medical Device Co., Ltd.  510(k) NO: K142435(Traditional)
ATTN: Garfield  Wang              PHONE NO : 86 135 64751751 
Rm 218, 2F., No.183, Zhouzi St.   SE DECISION MADE: 20-FEB-15
Taipei  TW 114                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3S Safety Insulin Syringe
Sincere Medical Device Co., Ltd.  510(k) NO: K142436(Traditional)
ATTN: Garfield  Wang              PHONE NO : 86 135647 51751 
Rm 218, 2F., No.183, Zhouzi St.   SE DECISION MADE: 19-FEB-15
Taipei City  TW 114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System 
MERETE MEDICAL GMBH               510(k) NO: K142451(Traditional)
ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 4930 779980 114 
ALT-LANKWITZ 102                  SE DECISION MADE: 09-FEB-15
BERLIN  DE 12247                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ebony PTA 0.014 RX Peripheral Dilatation Catheter
NATEC MEDICAL LTD                 510(k) NO: K142459(Traditional)
ATTN: Xavier de  Buchere          PHONE NO : 230 466 3054
MAEVA CENTRE BUILDING EBENE BUSINESE DECISION MADE: 03-FEB-15
REDUIT  MU 72201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
GE Healthcare                     510(k) NO: K142472(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 414 6766120 
9900 W Innovation Dr              SE DECISION MADE: 10-FEB-15
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Master Caution Device MCD
HealthWatch Ltd.                  510(k) NO: K142476(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 972 77 5434541 
6 Hasadna Street                  SE DECISION MADE: 17-FEB-15
Kfar Saba  IL 44424               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MEGNA BREAST PUMPS
WUXI XINZHONGRUI BABY SUPPLIES CO.510(k) NO: K142479(Traditional)
ATTN: ANNE  CHEN                  PHONE NO : 86 510 81155000 
NO.117 XINHUA ROAD, MEICUN, NEW DISE DECISION MADE: 24-FEB-15
WUXI CITY  CN 214000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MAGNIFY and MAGNIFY-S Spacers
GLOBUS MEDICAL INC.               510(k) NO: K142498(Traditional)
ATTN: KELLY J BAKER               PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 26-FEB-15
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: U50 Diagnostic Ultrasound System
EDAN INSTRUMENTS, INC.            510(k) NO: K142511(Third Party - Traditional)
ATTN: CHERRY   SUN                PHONE NO : 0755 26856469 
3/F-B, NANSHAN MEDICAL   NANHAI RDSE DECISION MADE: 20-FEB-15
SHEKOU, NANSHAN SHENZHEN   CN 5180510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Spinal System
EISERTECH, LLC                    510(k) NO: K142576(Traditional)
ATTN: Lukas  Eisermann            PHONE NO : 888 2622817 101
13795 Blaisdell Place, Suite 102  SE DECISION MADE: 26-FEB-15
Poway CA  92064                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vienna System
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K142597(Traditional)
ATTN: Chuck  Smith                PHONE NO : 914 6673999 
521 HOMESTEAD AVE.                SE DECISION MADE: 19-FEB-15
MOUNT VERNON NY  10550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PANAVIA SA Cement Plus Handmix
KURARAY NORITAKE DENTAL, INC.     510(k) NO: K142623(Traditional)
ATTN: Michio  Takigawa            PHONE NO : 81 36701 1706 
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 26-FEB-15
Chiyoda ku  JP 1000004            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K142680(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42642 2694 
2951 ISHIKAWA-CHO                 SE DECISION MADE: 08-FEB-15
HACHIOJI-SHI  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
SIAM SEMPERMED CORP., LTD         510(k) NO: K142685(Special)
ATTN: ANAN  PRUKSANUSAK           PHONE NO : 66 74 344663 
10 SOI 10 PHETKASEM RD.           SE DECISION MADE: 11-FEB-15
HATYAI  TH 90110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZywieAI Software Library
Zywie, Inc.                       510(k) NO: K142693(Traditional)
ATTN: Latha  Ganeshan             PHONE NO : 678 9921941 
12000 Findley Road, Suite 360     SE DECISION MADE: 20-FEB-15
Johns Creek GA  30097             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VCARE
CONMED CORPORATION                510(k) NO: K142716(Traditional)
ATTN: ANNA  D'LIMA                PHONE NO : 315 6243439 
525 FRENCH ROAD                   SE DECISION MADE: 10-FEB-15
UTICA NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HEARTWAY Electrically Powered Wheelchairs
HEARTWAY Medical Products Co., Ltd510(k) NO: K142731(Traditional)
ATTN: Dr. Ke-Min  Jen             PHONE NO : 886 4 23580357 
No.6 Road 25, Taichung Industrial SE DECISION MADE: 27-FEB-15
Taichung City  TW 40850           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ThinkMed Intermittent Catheter with/without Hydrophilic Coating
ThinkMed Medical Technology Co., L510(k) NO: K142767(Traditional)
ATTN: Garfield  Wang              PHONE NO : 86 1 3564751751 
No.4 Building, 322 Hongyang Road, SE DECISION MADE: 03-FEB-15
Kunshan  CN 215341                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Polysmith Sleep System
Neurotronics, Inc.                510(k) NO: K142774(Traditional)
ATTN: David  Pezet                PHONE NO : 1 815 3729955 
3600 NW 43rd Street, Suite F1     SE DECISION MADE: 18-FEB-15
Gainesville FL  32606             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Neuwater TM (HydrocynTM aqua)
Vigilenz Medical Devices          510(k) NO: K142775(Traditional)
ATTN: Shudipta  Choudhury         PHONE NO : 011 604 5023501 
2A, LPBM 2, Taman Perindustrian BuSE DECISION MADE: 13-FEB-15
Bukit Minyak  MY 14100            510(k) STATEMENT
                                                    
 
DEVICE: Biomet Microfixation Thoracic Fixation System
BIOMET MICROFIXATION              510(k) NO: K142823(Traditional)
ATTN: Lauren  Jasper              PHONE NO : 1 904 7419259 
1520 TRADEPORT DRIVE              SE DECISION MADE: 25-FEB-15
JACKSONVILLE FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Unimed Disposable and Reusable SPO2 Sensors
UNIMED MEDICAL SUPPLIES INC.      510(k) NO: K142832(Traditional)
ATTN: Xinmei  Tan                 PHONE NO : 86 755 26695165 
NO.37, YANSHAN ROAD, SHEKOU       SE DECISION MADE: 06-FEB-15
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EAZY PRIMER
Parkell, Inc.                     510(k) NO: K142848(Traditional)
ATTN: David  Mott                 PHONE NO : 631 2491134 145
300 Executive Drive               SE DECISION MADE: 24-FEB-15
Edgewood NY  11717                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
Careplus (M) SDN BHD              510(k) NO: K142858(Traditional)
ATTN: Lim Kwee   Shyan            PHONE NO : 60 6677 2781 
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 09-FEB-15
Negeri Sembilan Darul Khusus  MY  510(k) STATEMENT
                                                    
 
DEVICE: DMRC Light Cure Orthodontic Adhesive System
Daville Materials LLC             510(k) NO: K142880(Traditional)
ATTN: Dong  Hua                   PHONE NO : 925 9730710 
3420 Fostoria Way Suite A-200     SE DECISION MADE: 04-FEB-15
San Ramon CA  94583               510(k) STATEMENT
                                                    
 
DEVICE: DMRC Dual Cure Orthodontic Band Cement
DANVILLE MATERIALS, LLC.          510(k) NO: K142881(Traditional)
ATTN: Dong  Hua                   PHONE NO : 1 925 9730710 
3420 Fostoria Way Ste A200        SE DECISION MADE: 13-FEB-15
SAN RAMON CA  94583               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: G7 Freedom and Offset Liners, Freedom Head, Size 32
Biomet, Inc.                      510(k) NO: K142882(Traditional)
ATTN: Becky  Earl                 PHONE NO : 574 2676639 
56 East Bell Drive                SE DECISION MADE: 10-FEB-15
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fingertip Pulse Oximeter
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K142888(Traditional)
ATTN: Lei  Chen                   PHONE NO : 86 10 88798300 6020
No.9 Shuangyuan Road, Badachu Hi-tSE DECISION MADE: 20-FEB-15
BEIJING  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TCS Blend
Thermoplastic Comfort Systems, Inc510(k) NO: K142894(Traditional)
ATTN: Marilin  Posca              PHONE NO : 562 4262970 
2619 Lime Avenue                  SE DECISION MADE: 03-FEB-15
Signal Hill CA  90755             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
SHASER, INC.                      510(k) NO: K142924(Traditional)
ATTN: ANTHONY  BURNS              PHONE NO : 1 781 9952246 
10 MAGUIRE RD BUILDING ONE        SE DECISION MADE: 13-FEB-15
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Endoscope Sterilization Tray
INTUITIVE SURGICAL, INC.          510(k) NO: K142937(Traditional)
ATTN: Nadine  Nasr                PHONE NO : 408 5232100 
1266 KIFER ROAD                   SE DECISION MADE: 24-FEB-15
SUNNYVALE CA  94086-5206          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit 
Integrated Healing Technologies   510(k) NO: K142956(Traditional)
ATTN: Ian  Baird                  PHONE NO : 615 4682491 
103 Forrest Crossing Blvd, Suite 1SE DECISION MADE: 24-FEB-15
Franklin TN  37064                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
BECKMAN COULTER, INC.             510(k) NO: K142985(Special)
ATTN: Eimear  Carr                PHONE NO : 353 65 3831482 
250 S. KREAMER BOULEVARD          SE DECISION MADE: 26-FEB-15
BREA CA  92821                    510(k) STATEMENT
                                                    
 
DEVICE: DD Bio Z, DD Bio ZX(square), DD BioZX(square) color
DENTAL DIREKT OF AMERIKA UG (HAFTU510(k) NO: K142987(Abbreviated)
ATTN: Gerhard de  Boer            PHONE NO : 49 5225 863190 
PAPPELWEG 6                       SE DECISION MADE: 11-FEB-15
SPENGE  DE 32139                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
LifeGlobal Group, LLC             510(k) NO: K142991(Traditional)
ATTN: Michael D. Cecchi           PHONE NO : 1 203 453 1700
393 Soundview Road                SE DECISION MADE: 17-FEB-15
Guilford CT  06437                510(k) STATEMENT
                                                    
 
DEVICE: StaXx(R) XD System
SPINE WAVE, INC.                  510(k) NO: K142996(Traditional)
ATTN: Roaida  Johnson             PHONE NO : 203 9449494 
3 ENTERPRISE DRIVE SUITE 210      SE DECISION MADE: 19-FEB-15
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
BioFire Diagnostics, LLC          510(k) NO: K143005(Traditional)
ATTN: Kristen  Kanack             PHONE NO : 801 7366354 330
390 Wakara Way                    SE DECISION MADE: 19-FEB-15
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Hospira Primary Sets
Hospira, Inc.                     510(k) NO: K143015(Traditional)
ATTN: Anju  Kurian                PHONE NO : 224 2126141 
375 North Field Drive             SE DECISION MADE: 25-FEB-15
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Digital Diagnostic X-ray System (GC80)
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K143029(Traditional)
ATTN: KIM  CHULSIN                PHONE NO : 82 31 2007661 
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 04-FEB-15
SUWON-SI  KR 443742               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CAAS A-Valve
PIE MEDICAL IMAGING B.V.          510(k) NO: K143044(Traditional)
ATTN: Florie  Daniels             PHONE NO : 31 43 3281328 
PHILIPSWEG 1                      SE DECISION MADE: 06-FEB-15
MAASTRICHT  NL 6227 AJ            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LYNC intramedullary implant
NOVASTEP                          510(k) NO: K143049(Traditional)
ATTN: Gilles  Audic               PHONE NO : 33 29933 8650 
Espace performance Alphasis - BatiSE DECISION MADE: 19-FEB-15
Saint Gregoire  FR 35769          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla
YTY INDUSTRY (MANJUNG) SDN. BHD.  510(k) NO: K143055(Traditional)
ATTN: Arivalagan  Subramaniam     PHONE NO : 60 567 92288 
LOT 1422-1424, BATU 10 LEKIR      SE DECISION MADE: 12-FEB-15
SITIAWAN  MY 32020                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PuraDerm Gel
3-D Matrix, Inc.                  510(k) NO: K143058(Traditional)
ATTN: Lisa  Spirio                PHONE NO : 781 3739020 
200 West St. Ste 14               SE DECISION MADE: 13-FEB-15
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENROUTE Transcarotid Neuroprotection System
SILK ROAD MEDICAL, INC            510(k) NO: K143072(Traditional)
ATTN: Richard M Ruedy             PHONE NO : 1 408 7209002 
735 NORTH PASTORIA AVE            SE DECISION MADE: 09-FEB-15
SUNNYVALE CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
BioFire Diagnostics, LLC          510(k) NO: K143080(Traditional)
ATTN: Kristen  Kanack             PHONE NO : 801 7366354 330
390 Wakara Way                    SE DECISION MADE: 17-FEB-15
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
STRYKER ORTHOPAEDICS              510(k) NO: K143085(Traditional)
ATTN: Denise  Daugert             PHONE NO : 201 8315413 
325 Corporate Drive               SE DECISION MADE: 09-FEB-15
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GastriSail Gastric Positioning System
COVIDIEN                          510(k) NO: K143088(Traditional)
ATTN: Debbie  Peacock             PHONE NO : 203 4926935 
60 MIDDLETOWN AVE.                SE DECISION MADE: 25-FEB-15
NORTH HAVEN CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Tensyn Plug
DALLEN MEDICAL, INC.              510(k) NO: K143092(Traditional)
ATTN: Al  Memmolo                 PHONE NO : 1 949 2180030 
1046 Calle Recodo Ste G           SE DECISION MADE: 11-FEB-15
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Picosure Workstation
CYNOSURE, INC.                    510(k) NO: K143105(Traditional)
ATTN: Kelli  McMillan             PHONE NO : 1 781 9932454 
5 CARLISLE ROAD                   SE DECISION MADE: 23-FEB-15
WESTFORD MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Codman Certas Plus Programmable Valve; Codman Certas Toll Kit
MEDOS INTERNATIONAL SARL          510(k) NO: K143111(Traditional)
ATTN: Michelle  Godin             PHONE NO : 
CHEMIN-BLANC 38                   SE DECISION MADE: 19-FEB-15
LE LOCLE  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Volcano iFR Harvest Software (Offline)
Volcano Corporation               510(k) NO: K143122(Special)
ATTN: Neeta  Sharma               PHONE NO : 858 7204187 
3721 Valley Centre Dr Ste 500     SE DECISION MADE: 20-FEB-15
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Synergetics PHOTON EX
Synergetics                       510(k) NO: K143123(Third Party - Traditional)
ATTN: Dan  Regan                  PHONE NO : 1 636 7945013 
3845 Corporate Centre Drive       SE DECISION MADE: 24-FEB-15
O'Fallon MO  63368                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Renovis S141 Lumbar Interbody Cage System
Renovis Surgical Technologies     510(k) NO: K143126(Traditional)
ATTN: Josh  Brown                 PHONE NO : 909 5572360 
1901 W. Lugonia Ave., Ste 340     SE DECISION MADE: 06-FEB-15
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style 
DISPO-MED (MALAYSIA) SDN BHD      510(k) NO: K143127(Traditional)
ATTN: NC  LEOW                    PHONE NO : 603 67304966 
21, JALAN TEKNOLOGI 3/5A, PUSAT TESE DECISION MADE: 13-FEB-15
PETALING JAYA , SELANGOR DARUL EHS510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Kossan International Sdn. Bhd.    510(k) NO: K143131(Traditional)
ATTN: Cho Sow Fong                PHONE NO : 603 32910516 
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 12-FEB-15
Klang  MY 42100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Spring Coil Guidewire
NeoMetrics, Inc.                  510(k) NO: K143135(Traditional)
ATTN: Gene  Champeau              PHONE NO : 763 5594440 
2605 Fernbrook Lane, Suite J      SE DECISION MADE: 20-FEB-15
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nexis osteosynthesis snap-off screws
NOVASTEP                          510(k) NO: K143146(Traditional)
ATTN: Gilles  Audic               PHONE NO : 33 299 338650 
Espace performance Alphasis - BatiSE DECISION MADE: 06-FEB-15
Saint Gregoire  FR 35769          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CO2 monitoring line with and without in-line filter
BESMED HEALTH BUSINESS CORP.      510(k) NO: K143150(Traditional)
ATTN: WINNIE  CHUNG               PHONE NO : 011 886 222903959 
NO.5, LANE116, WU-KONG 2ND RD     SE DECISION MADE: 05-FEB-15
NEW TAIPEI CITY  TW TAIWAN        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACL SMART System
SMITH & NEPHEW, INC.              510(k) NO: K143172(Traditional)
ATTN: SAMIR  IBRAHIM              PHONE NO : 1 978 7491000 
150 MINUTEMAN RD.                 SE DECISION MADE: 04-FEB-15
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Maxima XTEND Handpiece Maintenance System
HANDPIECE HEADQUARTERS            510(k) NO: K143183(Traditional)
ATTN: Timothy  Ropchan            PHONE NO : 1 714 5790175 
620 S. PLACENTIA AVE.             SE DECISION MADE: 17-FEB-15
PLACENTIA CA  92870               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IntelliSense Drill
McGinley Innovations              510(k) NO: K143191(Traditional)
ATTN: Joseph  McGinley            PHONE NO : 1 307 3156419 
2435 King Blvd, Suite 230         SE DECISION MADE: 20-FEB-15
Casper WY  82604                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vanguard 360 Revision Knee System
Biomet, Inc.                      510(k) NO: K143192(Traditional)
ATTN: Jason  Heckaman             PHONE NO : 574 3713707 
56 East Bell Drive                SE DECISION MADE: 12-FEB-15
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MIS Z-Pedicle Screw System
Z-Medical GmbH & Co. KG           510(k) NO: K143200(Traditional)
ATTN: ALEXANDER  HENNINGER        PHONE NO : 49 7462 945540 
Gansacker 38                      SE DECISION MADE: 03-FEB-15
TUTTLINGEN  DE                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SonicFill 2
SYBRON DENTAL SPECIALTIES         510(k) NO: K143209(Traditional)
ATTN: KERRI  CASINO               PHONE NO : 714 5167634 
1717 W. COLLINS AVENUE            SE DECISION MADE: 05-FEB-15
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SCARLET® AC-T Secured Anterior Cervical Cage
SPINEART                          510(k) NO: K143214(Traditional)
ATTN: Franck   PENNESI            PHONE NO : 41 22 5701246 
lnternational Center Cointrin 20 rSE DECISION MADE: 23-FEB-15
GENEVA  CH 1215                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Visionaire Disposable Instruments
SMITH & NEPHEW, INC.              510(k) NO: K143226(Traditional)
ATTN: Shereen  Bienz              PHONE NO : 901 3996325 
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 12-FEB-15
CORDOVA TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ancora LLC Interbody Fusion Device
FRONTIER MEDICAL DEVICES, INC.    510(k) NO: K143228(Traditional)
ATTN: ERIC  SEABORG               PHONE NO : 1 906 2321200 
512 FOURTH STREET                 SE DECISION MADE: 26-FEB-15
GWINN MI  49841                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nexis osteosynthesis compressive screws
NOVASTEP                          510(k) NO: K143229(Traditional)
ATTN: Gilles  Audic               PHONE NO : 33 299 338650 
Espace performance Alphasis - BatiSE DECISION MADE: 06-FEB-15
Saint Gregoire  FR 35769          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Palladian Lumbar Pedicle Screw System
Neurostructures, Inc.             510(k) NO: K143230(Traditional)
ATTN: Moti  Altarac               PHONE NO : 800 3526103 
16 Technology Dr. Suite 165       SE DECISION MADE: 25-FEB-15
Irvine CA  32918                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SIGNA Creator, SIGNA Explorer 
GE HEALTHCARE (GE MEDICAL SYSTEMS,510(k) NO: K143251(Traditional)
ATTN: GLEN  SABIN                 PHONE NO : 262 5216848 
3200 N. GRANDVIEW BLVD.           SE DECISION MADE: 04-FEB-15
WAUKESHA WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System
MEDICATECH USA                    510(k) NO: K143257(Traditional)
ATTN: George  Makar               PHONE NO : 1 949 6792881 
50 MAXWELL                        SE DECISION MADE: 06-FEB-15
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider 
STERILMED, INC.                   510(k) NO: K143260(Traditional)
ATTN: NICOLE  BOSER               PHONE NO : 763 4882050 
11400 73rd Ave N                  SE DECISION MADE: 23-FEB-15
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Optima XR646
GE HUALUN MEDICAL SYSTEMS CO. LTD 510(k) NO: K143270(Traditional)
ATTN: Kenny  Ma                   PHONE NO : 0086 10 59347159 
NO.1, YONG CHANG NORTH ROAD ECONOMSE DECISION MADE: 18-FEB-15
BEIJING  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Acumed Small Bone IM Nail System
Acumed, LLC                       510(k) NO: K143276(Traditional)
ATTN: Nathan  Wolf                PHONE NO : 503 2071502 
5885 NW Cornelius Pass Road       SE DECISION MADE: 05-FEB-15
Hillsboro OR  97124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
Zimmer Spine, Inc.                510(k) NO: K143297(Traditional)
ATTN: Donna M. Semlak             PHONE NO : 952 8575643 
7375 Bush Lake Road               SE DECISION MADE: 12-FEB-15
Minneapolis MN  55439             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
CEPHEID                           510(k) NO: K143302(Traditional)
ATTN: KERRY J FLOM                PHONE NO : 408 4008460 
904 CARIBBEAN DRIVE               SE DECISION MADE: 12-FEB-15
SUNNYVALE CA  94089-1189          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Single Use Biliary Balloon Dilator
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K143303(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 426 422694 
2951 ISHIKAWA-CHO                 SE DECISION MADE: 27-FEB-15
HACHIOJI  JP 192-8507             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Progressive Orthopaedic Total Hip System
The Progressive Orthopaedic Compan510(k) NO: K143314(Traditional)
ATTN: SCOTT  KEISER               PHONE NO : 561 4404460 
801 US Highway 1, Suite B         SE DECISION MADE: 27-FEB-15
North Palm Beach FL  33408        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Syngo X-workplace SW VD10
Siemens Medical Solutions, Inc    510(k) NO: K143319(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 448 3536
51 Valley Stream Parkway          SE DECISION MADE: 24-FEB-15
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OS2-V Varisation Staple
IN2Bones SAS                      510(k) NO: K143323(Traditional)
ATTN: MORGANE  GRENIER            PHONE NO : 33 4 72292626 
28 CHEMIN DU PETIT BOIS           SE DECISION MADE: 26-FEB-15
ECULLY  FR 63130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CONELOG Titanium base CAD/CAM 
ALTATEE GmbH                      510(k) NO: K143337(Traditional)
ATTN: DENNIS  PAPPAS              PHONE NO : 49 7044 94450 
Maybachstrasse 5                  SE DECISION MADE: 17-FEB-15
Wimsheim  DE D-71299              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nile Alternative Fixation
K2M, Inc.                         510(k) NO: K143350(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 703 7773155 
751 Miller Drive SE               SE DECISION MADE: 25-FEB-15
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
Devon Medical Products            510(k) NO: K143362(Special)
ATTN: John  Siegel                PHONE NO : 866 4460092 
1100 First Avenue, Suite 202      SE DECISION MADE: 03-FEB-15
King of Prussia PA  19406         510(k) STATEMENT
                                                    
 
DEVICE: IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K143373(Abbreviated)
ATTN: DONNA  VELASQUEZ            PHONE NO : 310 6458200 7403
5210 Pacific Concourse Drive      SE DECISION MADE: 26-FEB-15
Los Angeles CA  90045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K143375(Special)
ATTN: Becky  Ronner               PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 13-FEB-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PedFuse Pedicle Screw System
SPINEFRONTIER, INC.               510(k) NO: K143377(Special)
ATTN: Manthan J Damani            PHONE NO : 978 2323990 116
500 CUMMINGS CENTER SUITE 3500    SE DECISION MADE: 12-FEB-15
BEVERLY MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sensititre Susceptibility Plates
Thermo Fisher Scientific          510(k) NO: K143381(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 1 800 8718909 322411
1 Thermo Fisher Way               SE DECISION MADE: 19-FEB-15
Oakwood Village OH  440146        510(k) STATEMENT
                                                    
 
DEVICE: DentiAnn Smart Sil
SeilGlobal Co., Ltd.              510(k) NO: K143382(Traditional)
ATTN: Pack  Seong Uk              PHONE NO : 82 51465 5456 
191, Gaejwa-ro, Geumjeong-gu      SE DECISION MADE: 23-FEB-15
Busan  KR 609-845                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
OTODYNAMICS, LTD.                 510(k) NO: K143395(Traditional)
ATTN: Julian  Rutherford          PHONE NO : 44 1707 267540 
30-38 BEACONSFIELD RD.            SE DECISION MADE: 23-FEB-15
HATFIELD, HERTS  GB AL10 8BB      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Extremity Medical Calcaneal Osteotomy Device
EXTREMITY MEDICAL LLC             510(k) NO: K143402(Traditional)
ATTN: Brian  Smekal               PHONE NO : 973 5888980 
300 INTERPACE PARKWAY SUITE 410   SE DECISION MADE: 04-FEB-15
PARSIPPANY NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Air Bubble Based Infuser (ABBI)
CooperSurgical, Inc               510(k) NO: K143415(Traditional)
ATTN: James  Keller               PHONE NO : 203 6019818 
95 Corporate Dr.                  SE DECISION MADE: 26-FEB-15
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ANAX 5.5 Spinal System
U&I Corporation                   510(k) NO: K143417(Traditional)
ATTN: Young-Geun  Kim             PHONE NO : 82 31 8520102 619
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 25-FEB-15
Uijeongbu-si,  KR 480-859         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
i-codi Co., Ltd                   510(k) NO: K143431(Traditional)
ATTN: Yoo Hwan  Park              PHONE NO : 82 105237 4746 
#959-9, Daechon-Dong              SE DECISION MADE: 20-FEB-15
Buk-Gu  KR                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KATANA Zirconia
KURARAY NORITAKE DENTAL, INC.     510(k) NO: K143439(Traditional)
ATTN: Michio  Takigawa            PHONE NO : 81 36701 1706 
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 27-FEB-15
Chiyoda ku  JP 1000004            510(k) STATEMENT
                                                    
 
DEVICE: NeuroBlate System
MONTERIS MEDICAL, INC.            510(k) NO: K143457(Special)
ATTN: Brooke  Ren                 PHONE NO : 763 2534710 
16305 36th Ave. North Suite 200   SE DECISION MADE: 19-FEB-15
Plymouth MN  55446                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SOFTECH Plus ETCO2 Cannula
TELEFLEX MEDICAL, INC.            510(k) NO: K143469(Special)
ATTN: Brian  Gall                 PHONE NO : 919 5448000 682514
2917 WECK DRIVE                   SE DECISION MADE: 12-FEB-15
RESEARCH TRIANGLE NC  27709       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VERTEX Reconstruction System
Medtronic Sofamor Danek USA, Inc  510(k) NO: K143471(Traditional)
ATTN: Lee  Grant                  PHONE NO : 1 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 06-FEB-15
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
Immunalysis Corporation           510(k) NO: K143500(Traditional)
ATTN: Joseph  Ginete              PHONE NO : 909 4820840 
829 Towne Center Drive            SE DECISION MADE: 06-FEB-15
Pomona CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Infusion Aspiration Catheter System
Inari Medical, Inc.               510(k) NO: K143563(Third Party - Traditional)
ATTN: Eben  Gordon                PHONE NO : 949 5980300 
8 Argonaut Suite 100              SE DECISION MADE: 03-FEB-15
Aliso Vejo CA  92656              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: CD HORIZON Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K143569(Traditional)
ATTN: GREGORY  MASCHEK            PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 12-FEB-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Exactech Ambassador 
EXACTECH, INC.                    510(k) NO: K143576(Traditional)
ATTN: DAWN  DAVISSON              PHONE NO : 352 3771140 
2320 NW 66TH COURT                SE DECISION MADE: 27-FEB-15
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Kirschner Wires, Steinmann Pins
ZIMMER, INC.                      510(k) NO: K143618(Traditional)
ATTN: PATRICK  MCCULLAGH          PHONE NO : 1 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 06-FEB-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Navigated Vertex Select Instruments
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K143628(Traditional)
ATTN: Tejas  Patel                PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 12-FEB-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
Bausch & Lomb Incorporated        510(k) NO: K143632(Traditional)
ATTN: Jessica  Burger             PHONE NO : 1 585 3385665 
1400 North Goodman Street         SE DECISION MADE: 13-FEB-15
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KINETIS Total Knee System
MAKO SURGICAL                     510(k) NO: K143635(Traditional)
ATTN: JONATHAN  REEVES            PHONE NO : 1 954 6280665 
2555 DAVIE RD.                    SE DECISION MADE: 20-FEB-15
FT. LAUDERDALE FL  33317          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K143636(Traditional)
ATTN: Donna  Velasquez            PHONE NO : 310 6458200 7403
5210 Pacific Concourse Drive      SE DECISION MADE: 25-FEB-15
Los Angeles CA  90045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vector PTA Balloon Dilatation Catheter
Vector Corporation LLC            510(k) NO: K143652(Special)
ATTN: Jay  Sturm                  PHONE NO : 1 646 8333700 
1270 Ave of Americas, Suite 302   SE DECISION MADE: 26-FEB-15
New York NY  10020                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
NINEPOINT MEDICAL, INC.           510(k) NO: K143678(Special)
ATTN: SCOTT  BLOOD                PHONE NO : 617 2507190 
ONE KENDALL SQUARE, SUITE B7501   SE DECISION MADE: 06-FEB-15
CAMBRIDGE MA  02139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NeedleCam HD Visualization System
BIOVISION TECHNOLOGIES, LLC       510(k) NO: K143705(Special)
ATTN: DAVID  SANSO                PHONE NO : 303 2379608 
221 CORPORATE CIRCLE UNIT H       SE DECISION MADE: 20-FEB-15
GOLDEN CO  80401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Checkpoint, Checkpoint Head & Neck
NDI Medical, LLC                  510(k) NO: K150005(Special)
ATTN: Robert  Rogers              PHONE NO : 216 3782163 
22901 Millcreek Boulevard, Suite 1SE DECISION MADE: 19-FEB-15
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Baide
Jiangsu Baide Medical Intrument Co510(k) NO: K150009(Traditional)
ATTN: Mr.Kang  Shui               PHONE NO : 86 0512 56987731 
South Side of Dongqi Road         SE DECISION MADE: 25-FEB-15
Zhangjiagang City  CN 215627      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Irritrol, EDS Combo-Rinse
ESSENTIAL DENTAL SYSTESM, INC.    510(k) NO: K150020(Traditional)
ATTN: JEFFREY  WAN                PHONE NO : 201 4879090 
89 LEUNING STREET, SUITE 8        SE DECISION MADE: 25-FEB-15
SOUTH HACKENSACK NJ  07606        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Bissinger Monopolar Cables
GUENTER BISSINGER MEDIZINTECHNIK G510(k) NO: K150024(Traditional)
ATTN: Matthias  Bissinger         PHONE NO : 49 7641 914330 
HANS-THEISEN-STR. 1               SE DECISION MADE: 20-FEB-15
TENINGEN  DE 79331                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zimmer Segmental System XT Components
ZIMMER, INC.                      510(k) NO: K150028(Special)
ATTN: KEITH J. PROCTOR            PHONE NO : 1 574 3724803 
P.O. BOX 708                      SE DECISION MADE: 06-FEB-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PASS LP Spinal System
MEDICREA INTERNATIONAL            510(k) NO: K150049(Special)
ATTN: Audrey  Vion                PHONE NO : 33 472 018787 
14 PORTE DU GRAND LYON            SE DECISION MADE: 10-FEB-15
NEYRON  FR 01700                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACUSON P500 Diagnostic Ultrasound System
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K150050(Third Party - Traditional)
ATTN: Shelly  Pearce              PHONE NO : 650 2790134 
685 East Middlefield Road         SE DECISION MADE: 09-FEB-15
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Excia Total Hip System
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K150062(Special)
ATTN: JULIE TOM WING              PHONE NO : 1 610 9849147 
3773 CORPORATE PARKWAY            SE DECISION MADE: 09-FEB-15
CENTER VALLEY PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MICRONAIL  Distal Radius System
Wright Medical Technology, Inc.   510(k) NO: K150073(Special)
ATTN: Jeanine  Redden             PHONE NO : 1 901 8674522 
1023 Cherry Road                  SE DECISION MADE: 10-FEB-15
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STERISPINE PS Pedicle Screw
SAFE ORTHOPAEDICS                 510(k) NO: K150092(Special)
ATTN: PIERRE  DUMOUCHEL           PHONE NO : 33 013421 5000 
Parc des Bellevues Allee R.LuxemboSE DECISION MADE: 10-FEB-15
Eragny sur Oise  FR 95610         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GM60A-32S & GM60A-40S
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K150097(Traditional)
ATTN: CHULSIN  KIM                PHONE NO : 82 31 2007661 
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 19-FEB-15
SUWON-SI  KR 443742               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Klassic Knee System-Sombrero Patella
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K150105(Special)
ATTN: Chris  Weaber               PHONE NO : 1 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 17-FEB-15
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zimmer Periarticular Plating System 
ZIMMER,INC.                       510(k) NO: K150121(Traditional)
ATTN: PATRICK   MCCULLAGH         PHONE NO : 574 3724656 
P.O.BOX 708                       SE DECISION MADE: 23-FEB-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TOMTEC-ARENA TTA2
TOMTEC IMAGING SYSTEMS, GMBH      510(k) NO: K150122(Traditional)
ATTN: CHRISTINE  KLEIN            PHONE NO : 49 89 32175830 
EDISONSTRASSE 6                   SE DECISION MADE: 13-FEB-15
UNTERSCHLEISSHEIM  DE D-85716     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Laparoscopic Handles with peek Insulation 
Stryker Endoscopy                 510(k) NO: K150127(Third Party - Traditional)
ATTN: Rebecca  Goldberg           PHONE NO : 408 754200 
5900 Optical Court                SE DECISION MADE: 04-FEB-15
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: MD322C8 31.5" Diagnostic Imaging LCD Monitor
NEC DISPLAY SOLUTIONS LTD.        510(k) NO: K150145(Traditional)
ATTN: SATORU  KOTANI              PHONE NO : 81 465 852384 
4-28 MITA 1-CHOME, MINATO-KU,TOKYOSE DECISION MADE: 06-FEB-15
Tokyo  JP 108-0023                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Lubrigyn cream
UNIDERM FARMACEUTICI SRL          510(k) NO: K150147(Special)
ATTN: Giorgio  Chiozza            PHONE NO : 39 065 0930618 
VIALE ENRICO ORTOLANI 211         SE DECISION MADE: 19-FEB-15
ROMA  IT 00125                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Terason uSmart3300 Ultrasound System
TERATECH CORP.                    510(k) NO: K150148(Third Party - Traditional)
ATTN: Steven R Broadstone         PHONE NO : 
77-79 TERRACE HALL RD.            SE DECISION MADE: 20-FEB-15
BURLINGTON MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
W.H.P.M., Inc.                    510(k) NO: K150162(Traditional)
ATTN: John  Wan                   PHONE NO : 1 626 4438480 
5358 Irwindale Ave.               SE DECISION MADE: 26-FEB-15
Irwindale CA  91706               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Extremity Medical Suture Anchor
EXTREMITY MEDICAL LLC             510(k) NO: K150166(Special)
ATTN: Brian  Smekal               PHONE NO : 1 973 5888980 
300 INTERPACE PARKWAY SUITE 410   SE DECISION MADE: 23-FEB-15
PARSIPPANY NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EMMA
INRANGE SYSTEMS, INC.             510(k) NO: K150174(Special)
ATTN: Christopher E Bossi         PHONE NO : 1 814 9401870 
3316 5th Avenue - Suite 100       SE DECISION MADE: 26-FEB-15
Altoona PA  16602                 510(k) STATEMENT
                                                    
 
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K150178(Special)
ATTN: MICHAEL  SCOTT              PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 11-FEB-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K150179(Traditional)
ATTN: BEN  CHEN                   PHONE NO : 86 20 32296069 
WONDFO SCIENTECH PARK, SOUTH CHINASE DECISION MADE: 25-FEB-15
GUANGZHOU  CN 510641              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IntraTemp Solution Warmer
Ecolab Inc.                       510(k) NO: K150190(Special)
ATTN: Michelle  Nivala            PHONE NO : 651 2504167 
370 Wabasha Street North          SE DECISION MADE: 26-FEB-15
St. Paul MN  55102-1390           510(k) STATEMENT
                                                    
 
DEVICE: CD HORIZON Growth Rod Conversion Set
MEDTRONIC SOFAMOR DANEK USA, INCOR510(k) NO: K150200(Special)
ATTN: LEE  GRANT                  PHONE NO : 1 901 3440807 
1800 PYRAMID PLACE                SE DECISION MADE: 25-FEB-15
MEMPHIS TN  38132-3576            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
SPECTRANETICS, INC.               510(k) NO: K150201(Special)
ATTN: Christine  Godleski         PHONE NO : 719 4472000 
9965 Federal Drive                SE DECISION MADE: 27-FEB-15
Colorado Springs CO  80921        510(k) STATEMENT
                                                    
 
DEVICE: NIOX VERO Airway Inflammation Monitor
AEROCRINE AB                      510(k) NO: K150233(Special)
ATTN: Kathleen  Rickard           PHONE NO : 919 7496708 
RASUNDAVAGEN 18, 8TH FLOOR        SE DECISION MADE: 26-FEB-15
SOLNA  SE SE-169 67               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc                    510(k) NO: K150246(Special)
ATTN: Becky  Severson             PHONE NO : 763 5262365 
8200 Coral Sea Street NE          SE DECISION MADE: 18-FEB-15
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Photonica Professional
Ward Photonics LLC                510(k) NO: K150336(Third Party - Traditional)
ATTN: Terry  Ward                 PHONE NO : 800 3925950 
1980 N Atlantic Avenue            SE DECISION MADE: 24-FEB-15
Cocoa Beach FL  32931             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
 
                             TOTAL 510(k)s THIS PERIOD   208                                     
                             TOTAL WITH SUMMARIES        193                                     
                             TOTAL WITH STATEMENTS        15
                                      

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