February 2015 510(k) Clearances
510(k) summaries or 510(k) statements for final decisions rendered during the period February 2015.
TOTAL 510(k)s THIS PERIOD 208
TOTAL WITH SUMMARIES 193
TOTAL WITH STATEMENTS 15
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
