| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K142402 |
03/23/2015 |
BigEasy Non-Rebreathing Valve |
12th Man Technologies, Inc. |
Alex Stenzler |
| K143207 |
03/23/2015 |
Revitive IX (OTC) |
Actegy, Ltd |
Angela Glover |
| K133789 |
03/04/2015 |
DOLPHIN NEUROSTIM OTC |
ACUMED MEDICAL LTD. |
RICHARD KEEN |
| K143443 |
03/25/2015 |
VEGA Knee System, Columbus Total Knee System |
Aesculap Implants Systems, LLC |
Julie Tom Wing |
| K143114 |
03/10/2015 |
Sense4Baby System Model B+ (MSA) |
AIRSTRIP TECHNOLOGIES, INC. |
ROBERT ANDREW MILLER |
| K141757 |
03/31/2015 |
ALERE I STREP A |
ALERE SCARBOROUGH, INC |
Angela Drysdale |
| K141237 |
03/13/2015 |
HARMONY LITE |
ALMA INC. |
KATHY MAYNOR |
| K143580 |
03/18/2015 |
PeriCoach |
ANALYTICA LTD |
GEOFF DALY |
| K142983 |
03/04/2015 |
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating |
ANGIOSCORE, INC. |
Kimberley Kline |
| K143517 |
03/27/2015 |
Voyant Open Sealer-Divider Device |
APPLIED MEDICAL RESOURCES |
Jessica Cho |
| K141159 |
03/11/2015 |
KONUS DENTAL IMPLANT SYSTEM |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH |
LINDA SAYLOR |
| K141981 |
03/09/2015 |
ASAHI FUBUKI 043 / ASAHI FUBUKI |
ASAHI INTECC CO., LTD. |
CANDACE CEDERMAN |
| K143519 |
03/10/2015 |
The MeDioStar NeXT Family |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K141536 |
03/06/2015 |
VIEWING CLIENT MOBILE |
AXON MEDICAL TECHNOLOGIES CORP. |
CHAS YU |
| K140943 |
03/05/2015 |
MASTRO PLUS BALLOON IN-DEFLATION DEVICE |
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. |
MIKE GU |
| K143492 |
03/04/2015 |
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece |
Bien-Air Surgery SA |
Judith Clerc |
| K142332 |
03/20/2015 |
BT-400 |
Bio-Med USA |
Young Chi |
| K143379 |
03/13/2015 |
Liquichek Maternal Serum II Control |
Bio-Rad Laboratories |
Elizabeth Platt |
| K142448 |
03/24/2015 |
VARIANT II TURBO HbA1c Kit - 2.0 |
Bio-Rad Laboratories, Inc. |
Jackie Buckley |
| K141975 |
03/05/2015 |
WATERLASE IPLUS S |
BIOLASE, INC. |
COLLEEN BOSWELL |
| K142174 |
03/20/2015 |
BIOMATE DENTAL IMPLANT SYSTEM |
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. |
WAYNE CHEN |
| K143697 |
03/30/2015 |
Biomet Proximal Humerus Plating System |
Biomet Manufacturing |
Julie Largent |
| K142634 |
03/12/2015 |
Biomet Spine Fusion System |
BIOMET SPINE, LLC. |
Mike Medina |
| K150503 |
03/25/2015 |
Echo Bi-Metric Microplasty Line Extension |
BIOMET, INC. |
AMY WALRIVEN |
| K143503 |
03/19/2015 |
BioMonitor |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K142337 |
03/19/2015 |
Blackford Analysis Registration Product Family |
BLACKFORD ANALYSIS LTD |
Gordon McNeilly |
| K143668 |
03/20/2015 |
Navio |
BLUE BELT TECHNOLOGIES, INC. |
RICHARD G CONFER |
| K142677 |
03/27/2015 |
MALDI Biotyper CA System |
BRUKER DALTONICS, INC |
Ken Hirakawa |
| K141785 |
03/31/2015 |
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
BSD MEDICAL CORP. |
DIXIE TOOLSON SELLS |
| K143109 |
03/06/2015 |
XP300 |
BTL INDUSTRIES, INC |
Jan Zarsky |
| K142818 |
03/31/2015 |
Phasix Mesh |
C.R. Bard |
Steve Keenan |
| K142706 |
03/25/2015 |
Modified ONFLEX Mesh |
C.R. Bard Inc. |
Mariya Buharin |
| K142711 |
03/20/2015 |
ONFLEX Mesh |
C.R. Bard Inc. |
Mariya Buharin |
| K150529 |
03/30/2015 |
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System |
C.R. Bard, Inc |
Reily Inman |
| K142873 |
03/12/2015 |
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners |
C.R.Bard Inc. |
Christine Lloyd |
| K142916 |
03/04/2015 |
SVED Wound Treatment System |
CARDINAL HEALTH |
Tatyana Bogdan |
| K142990 |
03/04/2015 |
Insta-Gard Surgical and Procedure Face Mask |
Cardinal Health 200, LLC |
Lavenia Ford |
| K142959 |
03/20/2015 |
Vyntus Walk |
CAREFUSION GERMANY 234 GMBH |
Elmar Niedermeyer |
| K141837 |
03/11/2015 |
DRX-EVOLUTION |
CARESTREAM HEALTH,INC. |
CAROLYN L WAGNER |
| K143473 |
03/25/2015 |
Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles |
CAYENNE MEDICAL, INC |
Shima Hashemian |
| K150573 |
03/25/2015 |
ebb Complete Tamponade System |
CLINICAL INNOVATIONS, LLC |
Tom Haueter |
| K142907 |
03/25/2015 |
Baha 5 Sound Processor |
COCHLEAR AMERICAS |
Sean Bundy |
| K142464 |
03/05/2015 |
Entriport |
CONMED CORPORATION |
Anna D'Lima |
| K143725 |
03/04/2015 |
Consensus Knee System Modular Tibial Baseplate |
Consensus Orthopedics, Inc |
Matthew M Hills |
| K141322 |
03/27/2015 |
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER |
COOK INCORPORATED |
STEVEN LAWRIE |
| K133788 |
03/18/2015 |
COOK HOLMIUM LASER FIBER |
COOK INCORPORATED |
DAVID CHADWICK |
| K142294 |
03/26/2015 |
FlexiMarc Marker |
CORTEX MANUFACTURING, INC. |
Andrew Jones |
| K143100 |
03/05/2015 |
NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta |
Cossington Ltd |
Diana Mandell Horwitz, Ph.D.,RAC |
| K143134 |
03/05/2015 |
NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System |
Cossington Ltd |
Diana Mandell Horwitz |
| K141518 |
03/05/2015 |
Nellcor Bedside Respiratory Patient Monitoring System |
COVIDIEN |
JAMIE THOMAS |
| K143598 |
03/12/2015 |
Lapro-Clip Auto Suture Reusable Long Clip Applier |
Covidien LLC |
Rebecca Magnanimo |
| K142865 |
03/26/2015 |
Nellcor Bedside SpO2 Patient Monitoring System |
Covidien LLC |
Megan Fessenden |
| K142808 |
03/09/2015 |
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners |
CR BARD INC |
Andrew Harrell |
| K142545 |
03/20/2015 |
SonoFlow Sonohysterography and Sonohysterosalpingography Device |
CrossBay Medical, Inc. |
Piush Vidyarthi |
| K142886 |
03/18/2015 |
DMRC Self-Cure Bracket Adhesive One Step and Primer |
DANVILLE MATERIALS, LLC. |
Dong Hua |
| K142531 |
03/20/2015 |
F1-Modular Pedicle Screw System |
Degen Medical |
Craig Black |
| K150196 |
03/26/2015 |
DD cubeX2 |
DENTAL DIREKT GMBH |
UWE GREITENS |
| K141385 |
03/27/2015 |
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) |
DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON |
JEFFREY DOW |
| K150375 |
03/11/2015 |
LIAISON VZV IgG, LIAISON Control VZV IgG |
DiaSorin Inc. |
John Walter |
| K140213 |
03/25/2015 |
DISPOSABLE ENDOSCOPIC CANNULA |
DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD |
LONG YANG |
| K143318 |
03/10/2015 |
DR Systems Zero Download 3D Viewer (Z3D) |
DR Systems, Inc |
Kimberly J Meade |
| K142877 |
03/13/2015 |
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
DANIELLE SLEEGERS |
| K142426 |
03/27/2015 |
EBI External Implant System |
EBI Inc |
Mi Sook Kim |
| K143695 |
03/30/2015 |
CENTRAL MONITORING SYSTEM |
EDAN INSTRUMENTS INC |
QUEENA CHEN |
| K141278 |
03/24/2015 |
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
John McIntyre |
| K143365 |
03/30/2015 |
Eminent Foot Plate System |
Eminent Spine |
Dave Freehill |
| K143645 |
03/04/2015 |
EsophyX« Z Fastener Delivery Device |
ENDOGASTRIC SOLUTIONS, INC. |
DARREN CROW |
| DEN130047 |
03/20/2015 |
PROLONG |
ERGON MEDICAL LTD. |
BARRY PEARCE |
| K142822 |
03/26/2015 |
PLIASURE Polyglycolide Synthetic Absorbable Suture |
ETHICON, Inc. |
Susan Lin |
| K142732 |
03/04/2015 |
T3 Software |
Etiometry, Inc. |
Dimitar Baronov |
| K150491 |
03/26/2015 |
ER36 Series OAE Test System |
ETYMOTIC RESEARCH, INC. |
Steve Iseberg |
| K150309 |
03/04/2015 |
Extremity Medical Calcaneal Osteotomy Device |
EXTREMITY MEDICAL, LLC |
Brian Smekal |
| K141460 |
03/20/2015 |
FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR |
FINAPRES MEDICAL SYSTEMS BV |
IR. PAUL KOSTERS |
| K143646 |
03/05/2015 |
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit |
Fisher & Paykel Healthcare Ltd |
Elizabeth Goldstein |
| K142776 |
03/23/2015 |
Flow-Screw |
Flow-FX, LLC |
PATRICK J. SWEENEY |
| K143651 |
03/18/2015 |
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack |
FOCUS DIAGNOSTICS, INC. |
Sharon Young |
| K142778 |
03/20/2015 |
ARROW Reverse Shoulder long keel and short keel glenoid base |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K150030 |
03/16/2015 |
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor |
Fukuda Denshi USA, Inc. |
Doug Blakely |
| K143108 |
03/27/2015 |
HealthGuard-15 |
FUTREX, INC. |
Carole Rosenthal |
| K143564 |
03/05/2015 |
Visual-ICE Cryoablation System, Software Revision 1.3.1 |
GALIL MEDICAL INC. |
AMY MCKINNEY |
| K142801 |
03/12/2015 |
Triton Canister System |
Gauss Surgical, Inc. |
Peggy McLaughlin |
| K143361 |
03/26/2015 |
Mammo Workstation |
GE HEALTHCARE |
Mounir Zaouali |
| K143389 |
03/06/2015 |
3.0T GEM RT Open Array |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
Candice C Mandera |
| K150193 |
03/24/2015 |
Customer Remote Console (CRC) |
GE MEDICAL SYSTEMS, LLC |
John W. Jaeckle |
| K150085 |
03/02/2015 |
GE EchoPAC |
GE VINGMED ULTRASOUND AS |
Bryan Behn |
| K150087 |
03/04/2015 |
Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System |
GE VINGMED ULTRASOUND AS |
BRYAN BEHN |
| K141961 |
03/26/2015 |
GENADYNE SPIRO FOAM DRESSING KIT |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN MING GOH |
| K142218 |
03/31/2015 |
Coalition AGX Plate and Coalition AGX Spacer |
GLOBUS MEDICAL INC. |
Kelly Baker |
| K143287 |
03/24/2015 |
Fluidshield* Surgical Mask with Expanded Chamber |
Halyard Health, Inc. |
Roberto F. Refeca |
| K143095 |
03/24/2015 |
MiniStim MS-IVB Peripheral Nerve Stimulator |
Halyard Health, Inc. |
Lindsey Hedlund |
| K143419 |
03/06/2015 |
Patient Examination Gloves |
HARTALEGA NGC SDN. BHD. |
Kuan Mun Leong |
| K150096 |
03/04/2015 |
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
Jianqiu Fang |
| K142709 |
03/27/2015 |
samaritan PAD 450P |
HEARTSINE TECHNOLOGIES, INC. |
Paul Phillips |
| K143414 |
03/10/2015 |
Hill-Rom Wireless Connectivity Module |
HILL-ROM |
ANN WATERHOUSE |
| K143537 |
03/06/2015 |
Sirius Starmobile tiara |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
| K142734 |
03/02/2015 |
TRILLIUM Oval MR System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
Doug Thistlethwaite |
| K141944 |
03/13/2015 |
HOME ACCESS AIC TEST |
HOME ACCESS HEALTH CORP. |
Sandra D White |
| K150175 |
03/31/2015 |
HeatLux Pro I |
HOME SKINOVATIONS LTD. |
Ahava Stein |
| K143087 |
03/04/2015 |
Hospira Blood Set |
HOSPIRA, INC. |
Charles Neitzel |
| K140954 |
03/23/2015 |
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
Diana Hong |
| K142769 |
03/20/2015 |
Fetal Doppler |
iCare Newlife Technologies, Inc. |
BO XIAO |
| K142781 |
03/31/2015 |
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA |
IMMCO DIAGNOSTICS, INC. |
Kevin Lawson |
| K150275 |
03/09/2015 |
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls |
Immunalysis Corporation |
Joseph Ginete |
| K143324 |
03/30/2015 |
IDS-iSYS CTX-I Calibration Verifiers |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
ROMA YOUNG |
| K150180 |
03/16/2015 |
InTone |
INCONTROL MEDICAL, LLC. |
JESSICA ANDRESHAK |
| K140806 |
03/23/2015 |
IBS IMPLANT SYSTEM |
INNOBIOSURG CO., LTD |
CHARLIE MACK |
| K141655 |
03/05/2015 |
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS |
INOVA DIAGNOSTICS, INC. |
GRABRIELLA LAKOS |
| K143301 |
03/03/2015 |
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit |
Integrated Healing Technologies |
Ian Baird |
| K142766 |
03/12/2015 |
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear |
INTEROJO INC. |
Si-Chul Rho |
| K143663 |
03/17/2015 |
MiroCam Capsule Endoscope System |
INTROMEDIC CO., LTD |
Jinyoung Lee |
| K142344 |
03/20/2015 |
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System |
IZI MEDICAL PRODUCTS LLC |
QIANG CAO |
| K141825 |
03/03/2015 |
IDEAL Locking Plate System |
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT |
ALICE GONG |
| K150325 |
03/31/2015 |
Range/Denali/Mesa Spinal System |
K2M, Inc |
Nancy Giezen |
| K143104 |
03/25/2015 |
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X |
KETTENBACH GMBH & CO KG |
Katja Simon |
| K142782 |
03/09/2015 |
KIMGUARD ONE-STEP Sterilization Wrap |
Kimberly-Clark Health Care |
Thomas Kozma |
| K143279 |
03/20/2015 |
LnK Anterior Cervical Plate System |
L&K BIOMED Co., Ltd. |
Ki-Hyang Kim |
| K141181 |
03/31/2015 |
NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES |
LED TECHNOLOGIES, LLC |
SUSAN ANTHONEY-DEWET |
| K143010 |
03/20/2015 |
LENSAR Laser System - fs 3D |
LENSAR, INC. |
MOHINDER MERCHEA |
| K150368 |
03/24/2015 |
Tarsa-Link Wedge Fixation System |
Life Spine |
Randy Lewis |
| K150390 |
03/16/2015 |
Nautilus Spinal System |
LIFE SPINE, INC. |
RANDY LEWIS |
| K142561 |
03/20/2015 |
LM-9300 ELMA Lithotripter |
LITE-MED INC. |
WALT HSU |
| K142420 |
03/27/2015 |
Patient Positioning Devices |
MACROMEDICS BV |
C de Keijzer |
| K150307 |
03/10/2015 |
RESTORIS Multicompartmental Knee System |
MAKO SURGICAL CORP. |
Jonathan Reeves |
| K150410 |
03/20/2015 |
RESTORIS POROUS PARTIAL KNEE SYSTEM |
MAKO SURGICAL CORPORATION |
JONATHAN REEVES |
| K143567 |
03/31/2015 |
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for l |
MARVAO MEDICAL DEVICES, LTD. |
CHRISTOPHER DAVEY |
| K143453 |
03/02/2015 |
Mpact Double Mobility System |
Medacta International |
Adam Gross |
| K143662 |
03/12/2015 |
Bissinger Monopolar Forceps and Cables |
MEDAGENT, INC |
Franz Menean |
| K143485 |
03/04/2015 |
iGuide 2.1 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
| K142798 |
03/25/2015 |
PASS LP Spinal System |
MEDICREA INTERNATIONAL S.A. |
Audrey VION |
| K142068 |
03/10/2015 |
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE |
MEDOVATIONS, INC. |
LAURA BOLL |
| K141833 |
03/25/2015 |
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION |
MEDTRONIC NAVIGATION, INC. |
CHRISTOPHER PERMAN |
| K150291 |
03/27/2015 |
TYRX Neuro Absorbable Antibacterial Envelope |
MEDTRONIC TYRX, INC. |
Regina Novak |
| K143083 |
03/25/2015 |
Bio-Medicus Pediatric Cannula and Introducers |
MEDTRONIC, INC |
BRUCE BACKLUND |
| K143073 |
03/25/2015 |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface |
Medtronic, Inc. |
Jessica Sixberry |
| K143316 |
03/11/2015 |
Attain Hybrid Guide Wire |
Medtronic, Inc. |
Mia Hunt |
| K150422 |
03/20/2015 |
EOPA 3D Arterial Cannula |
MEDTRONIC, INC. |
Chelsea L Pioske |
| K143032 |
03/29/2015 |
eMotion Faros ECG Mobile |
MEGA ELECTRONICS LTD. |
Taneli Vaaraniemi |
| K141042 |
03/19/2015 |
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES |
MERCATOR MEDICAL (THAILAND) LTD. |
Kevin Walls |
| K141493 |
03/20/2015 |
PROXIMAL HUMERUS PLATING SYSTEM |
Miami Device Solutions |
PETER J MINCIELI |
| K142449 |
03/26/2015 |
Headway 27 Microcatheter |
MICRO VENTION, INC. |
Cynthia Valenzuela |
| K141455 |
03/16/2015 |
EASYDRILL AUTOSTOP CRANIAL PERFORATOR |
MICROMAR IND. COM. LTD. |
DEEP PAL |
| K150366 |
03/27/2015 |
SOFIA 6F Catheter |
MICROVENTION, INC. |
NAOMI GONG |
| K141847 |
03/26/2015 |
AVANCE FOAM DRESSING KITS |
MOLNLYCKE HEALTH CARE US, LLC |
ANGELA L BUNN, RAC |
| K140477 |
03/23/2015 |
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES |
MOLNLYCKE HEALTH CARE US, LLC |
CURTIS D TRUESDALE |
| K150234 |
03/31/2015 |
Myriad Prostate Caddy┐ Immobilization Rectal Balloon Item #9901,3301 |
Myriad Medical, LLC |
Frank Bimbo |
| K143036 |
03/30/2015 |
Ebony PTA 0.035 Peripheral Dilatation Catheter |
Natec Medical Ltd |
Xavier De Buchere |
| K150448 |
03/19/2015 |
NMI PICC III and NMI PICC IV |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K150527 |
03/31/2015 |
Xcela Power Injectable PICC |
NAVILYST MEDICAL, INC. |
Wanda Carpinella |
| K141715 |
03/25/2015 |
GLOVE PORT |
NELIS |
PETER CHUNG |
| K150225 |
03/16/2015 |
NovaGold High Performance Guidewire |
NEOMETRICS, INC. |
Dave Liebl |
| K143703 |
03/18/2015 |
NICAL SMART MICRO CR system for intraoral dental images |
NICAL SPA |
ROBERTO NICCOLUCCI |
| K130238 |
03/04/2015 |
NIHON KOHDEN AE-918P NEURO UNIT |
NIHON KOHDEN CORP. |
NATALIE KENNEL |
| K150052 |
03/26/2015 |
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System |
Nipro Diagnostics, Inc |
Simeon Simone |
| K142439 |
03/10/2015 |
Martinez Prostate Template Set |
Nucletron BV |
Rudolf Vos |
| K141665 |
03/13/2015 |
NuVasive CoRoent System |
NUVASIVE, INC. |
JEREMY MARKOVICH |
| K143388 |
03/05/2015 |
Affix IIS Spinous Process Plate System |
NuVasive, Incorporated |
Olga Lewis |
| K143641 |
03/27/2015 |
NuVasive NVM5 System |
NuVasive, Incorporated |
Jeremy Markovich |
| K143313 |
03/20/2015 |
NxStage Therapeutic Plasma Exchange (TPE) Cartridge |
NxStage Medical, Inc. |
Randall J Covill |
| K141595 |
03/16/2015 |
O-TWO E700,O-TWO E600,O-TWO E500 |
O-TWO MEDICAL TECHNOLOGIES, INC. |
David Zhang |
| K141991 |
03/31/2015 |
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP |
OLYMPUS MEDICAL SYSTEMS COPR. |
DAPHNEY GERMAIN-KOLAWOLE |
| K143609 |
03/27/2015 |
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
MARY ANNE PATELLA |
| K142953 |
03/04/2015 |
OCT-Camera |
OptoMedical Technologies GmbH |
Alexander Holzhey |
| K143463 |
03/19/2015 |
IS4/DF4 Port Plug |
Oscor Inc. |
Dorit Segal |
| K150485 |
03/26/2015 |
AVERT Contrast Modulation System |
Osprey Medical, Inc. |
Melanie Hess |
| K141790 |
03/06/2015 |
AQANIFE |
OVESCO ENDOSCOPY AG |
TANJA R LINZER |
| K141717 |
03/09/2015 |
PACSEAL PIT & FISSURE SEALANT |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
| K150322 |
03/06/2015 |
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) |
PAN MEDICAL LTD |
Jennie Budding |
| K143218 |
03/18/2015 |
Penumbra Smart Coil |
Penumbra, Inc. |
Charles DeNault |
| K143180 |
03/27/2015 |
F3 |
PERMOBIL AB |
JAN ASTROM |
| K143014 |
03/25/2015 |
F5 |
PERMOBIL AB |
Jan Astrom |
| K143128 |
03/20/2015 |
mDIXON XD |
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. |
JAN VAN DE KERKHOF |
| K142438 |
03/05/2015 |
Nerve Monitoring Cable System |
Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) |
Sarah McIntyre |
| K143533 |
03/25/2015 |
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE |
PROSIDYAN, INC. |
CHARANPREET S BAGGA |
| K141793 |
03/06/2015 |
PULMONE MINIBOXPFT 2.0 |
PULMONE ADVANCED MEDICAL DEVICES, LTD. |
SUSAN ALPERT |
| K141164 |
03/16/2015 |
ARTEMIS LIGHT ENGINE |
QUEST MEDICAL IMAGING |
MARTIN HEUVELMANS |
| K143329 |
03/17/2015 |
AmpliVue Trichomonas Assay |
QUIDEL CORPORATION |
RONALD H LOLLAR |
| K150150 |
03/27/2015 |
1717SGN / 1717SCN Digital Flat Panel X-ray Detector |
Rayence Co., Ltd |
Kevin Kim |
| K143753 |
03/10/2015 |
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio |
Rayence Co., Ltd |
Kevin Kim |
| K142960 |
03/05/2015 |
Propeller System 2014-R |
Reciprocal Labs |
David Hubanks |
| K142988 |
03/16/2015 |
Sleepware G3 |
RESPIRONICS, INC. |
DANIELA AIZPITARTE |
| K141867 |
03/03/2015 |
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
KHONE SAYSANA |
| K141929 |
03/16/2015 |
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP |
ROCHE DIAGNOSTICS CORPORATION |
CHUNHONG(EMMA) TAO |
| K142352 |
03/12/2015 |
CardiacLinx |
Ross Medical Technology, Inc |
ALEXANDER CHIU |
| K150478 |
03/26/2015 |
A35 Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD. |
KIM JIYOUNG |
| K143673 |
03/04/2015 |
CMOS Video Nasopharyngoscope System |
Schoelly Fiberoptic Gmbh |
Dr. Sandra Baumann |
| K150158 |
03/09/2015 |
Schoelly Cystoscopes/Hysteroscopes and Accessories |
Schoelly Fiberoptic GmbH |
Sandra Baumann |
| K150469 |
03/23/2015 |
Integra Laminoplasty System |
SEASPINE, INC. |
MICHELLE WILLIS |
| K143094 |
03/05/2015 |
QuantaFlo |
SEMLER SCIENTIFIC, INC. |
BOB MCRAE |
| K142992 |
03/18/2015 |
TULIP Natural Rubber Latex Surgeon's Glove (Powdered) |
SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD |
Xiaoyan Wang |
| K143160 |
03/05/2015 |
FOXTROT NC PTCA Balloon Catheter |
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD |
JINGWEN LI |
| K142892 |
03/25/2015 |
Powder-free Clear Vinyl Patient Examination Gloves |
Shenyi(Shandong) Plastic Products, Co.Ltd |
Tyler Li |
| K142341 |
03/06/2015 |
X-RAY TV SYSTEM SONIALVISION G4 |
SHIMADZU CORP. |
TOSHIO KADOWAKI |
| K142723 |
03/31/2015 |
ADVIA Centaur Cortisol (COR) Assy |
Siemens Healthcare Diagnostics Inc. |
Fatima Pacheco |
| K150192 |
03/29/2015 |
Scenium |
SIEMENS MEDICAL SOLUTIONS USA, INC |
ALAINE MEDIO |
| K143409 |
03/26/2015 |
SOMATOM Definition AS Open (VA48) |
Siemens Medical Solutions USA, Inc. |
Eve Davis |
| K133838 |
03/11/2015 |
STERILIZATION POUCH/ROLL MADE WITH TYVEK |
SIGMA MEDICAL SUPPLIES CORP. |
UTA SHIH |
| K143184 |
03/17/2015 |
Evolve UniPolar Head |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K143096 |
03/24/2015 |
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA |
Smith & Nephew, Inc. |
Jeff Sprague |
| K143386 |
03/13/2015 |
Progrip Laparoscopic Self-Fixating Mesh |
SOFRADIM PRODUCTION |
Eric Jague |
| DEN130046 |
03/06/2015 |
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE |
SOMNA THERAPEUTICS, LLC |
James S. Miller |
| K143601 |
03/18/2015 |
U-Lite |
Sonoscanner SARL |
Bruno Richard |
| K150360 |
03/04/2015 |
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath |
SPECTRANETICS, INC. |
Christopher S McLellan |
| K150285 |
03/05/2015 |
Leva(TM) Spacer System |
SPINE WAVE, INC. |
ROAIDA JOHNSON |
| K143173 |
03/23/2015 |
Stryker CMF MEDPOR Customized Implant |
Stryker |
Julie Schoell |
| K150449 |
03/20/2015 |
LITe Plate System |
STRYKER CORP. |
GARRY T. HAYECK |
| K143616 |
03/05/2015 |
AccuLIF TL and PL Cage |
STRYKER CORPORATION |
Aakash Jain |
| K143546 |
03/19/2015 |
Imbibe Aspirating XIA Taps |
Stryker Corporation |
Soraya King |
| K140356 |
03/20/2015 |
SUMMED HIGH PRESSURE LINE |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
JAMES QI ZHANG |
| K143404 |
03/20/2015 |
SurgiQuest AirSeal iFS System |
SURGIQUEST, INC. |
Daniel Donovan |
| K142001 |
03/18/2015 |
SYNTEC WETALI ORTHODONTIC MINI SCREWS |
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE |
KAVIN CHU |
| K150099 |
03/23/2015 |
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) |
SYNTHES (USA) PRODUCTS, LLC |
NICHOLAS FOUNTOULAKIS |
| K141527 |
03/30/2015 |
DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM |
SYNTHES USA |
ANGELA F LASSANDRO |
| K141524 |
03/12/2015 |
NEURO-AUDIO |
TELEEMG, LLC USA |
BARRY ASHAR |
| K140110 |
03/27/2015 |
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET |
TELEFLEX, INC. |
CHET JONES |
| K141938 |
03/23/2015 |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) |
TERUMO BCT, INC.. |
PATTI ARNDT |
| K142649 |
03/24/2015 |
Progressive Orthopedic Total Knee System |
The Progressive Orthopaedic Company, LLC |
Scott Keiser |
| K142338 |
03/02/2015 |
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K143526 |
03/05/2015 |
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) |
Thermo Fisher Scientific |
Cynthia Knapp |
| K143552 |
03/04/2015 |
Simpliciti Shoulder System |
TORNIER, INC. |
Loucinda Bjorklund |
| K150003 |
03/19/2015 |
Aquilion LB, TSX-201A/3, V6.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K142465 |
03/10/2015 |
Aquilion ONE Vision, v7.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K142736 |
03/11/2015 |
XIDF-AWS801, Angio Workstation, v5.31 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K143717 |
03/19/2015 |
Treace Medical Concepts(TMC) Plating System |
Treace Medical Concepts, INc. |
Joe Ferguson |
| K141624 |
03/10/2015 |
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K142236 |
03/23/2015 |
BioniCare Hand System |
VISION QUEST INDUSTRIES, INC. |
MOHAMED OUERGHI |
| K143211 |
03/20/2015 |
myVision Track Model 005 |
VITAL ART AND SCIENCE INCORPORATED |
Michael Bartlett |
| K150258 |
03/05/2015 |
Vitrea, Version 7.0 Medical Image Processing Software |
Vital Images, Inc |
Parthiv Shah |
| K150441 |
03/20/2015 |
Volcano iFR Modality, iFR Scout feature |
VOLCANO CORPORATION |
NEETA SHARMA |
| K142923 |
03/05/2015 |
TraumaCad Mobile Release 1.0 |
Voyant Health Ltd |
Yael Guttentag |
| K150551 |
03/30/2015 |
GORE SEAMGUARD Reinforcement |
W. L. GORE & ASSOCIATES, INC. |
BARBARA L. SMITH |
| K141767 |
03/09/2015 |
ID MILLENNIUM, ID MOMENTS SILICONE |
WESTRIDGE LABORATORIES, INC. |
ALBERT REGO |
| K141085 |
03/27/2015 |
WestTec Procedure Facemask;WestTec Surgical Facemask |
WESTTEC, LLC |
JOHN JENSEN |
| K141740 |
03/05/2015 |
INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
| K142117 |
03/25/2015 |
INVISION TOTAL ANKLE REVISION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K150004 |
03/04/2015 |
SALVATION External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Leslie Fitch |
| K143158 |
03/20/2015 |
Xenco Medical Lumbar Interbody System |
Xenco Medical, LLC |
Gustavo Prado |
| K143216 |
03/17/2015 |
Assurance Alar / Nasal SpO2 Sensor |
Xhale, Inc. |
Jeffrey Hoebelheinrich |
| K141467 |
03/05/2015 |
SURGICAL GOWN |
XUCHANG ZHENGDE ENVIRONSTAR MEDICAL PRODUCTS CO.,L |
MIKE GU |
| K142206 |
03/13/2015 |
Dental Unit |
Zhuhai Siger Medical Equipment Co., Ltd |
Huisheng Wang |
| K143626 |
03/20/2015 |
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele |
Zimmer Spine, Inc. |
Donna M. Semlak |
| K143165 |
03/31/2015 |
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw |
Zimmer, Inc. |
Patrick McCullagh |
| K143331 |
03/04/2015 |
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS |
ZIMMER, INC. |
Patrick McCullagh |
| K150249 |
03/04/2015 |
ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System |
ZONARE MEDICAL SYSTEMS, INC. |
Steve Geerdes |
