| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K143258 |
11/13/2014 |
PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) |
4WEB,INC. |
JESSEE HUNT |
| K143269 |
11/13/2014 |
Delivery Analysis |
ACCURAY INCORPORATED |
Keith Picker |
| K143207 |
11/07/2014 |
Revitive IX (OTC) |
Actegy, Ltd |
Angela Glover |
| K143394 |
11/26/2014 |
Acumed Small Fragment Base Set |
ACUMED LLC |
Nathan Wolf |
| K143385 |
11/26/2014 |
Acumed Ankle Plating System |
Acumed, llc |
Nathan Wolf |
| K143276 |
11/14/2014 |
Acumed Small Bone IM Nail System |
Acumed, LLC |
Nathan Wolf |
| K143204 |
11/07/2014 |
AOS Clavicle Intramedullary Device |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ANNA HWANG |
| K143397 |
11/26/2014 |
ICIS View |
Agfa HealthCare N.V. |
JODI COLEMAN |
| K143354 |
11/24/2014 |
Natrelle 133 Plus Tissue Expander |
ALLERGAN, INC. |
Bruce Krattenmaker |
| K143149 |
11/03/2014 |
Arsenal Spinal Fixation System |
ALPHATEC SPINE, INC. |
RENEE MURPHY |
| K143337 |
11/20/2014 |
CONELOG Titanium base CAD/CAM |
ALTATEC GMBH |
DENNIS PAPPAS |
| K143372 |
11/25/2014 |
AWARE |
AMBIENT CLINICAL ANALYTICS |
ALLEN BERNING |
| K143308 |
11/18/2014 |
GelPOINT Transvaginal Access Platform |
APPLIED MEDICAL RESOURCES |
Frans VandenBroek |
| K143139 |
11/03/2014 |
Arthrex Fracture System |
ARTHREX, INC. |
David Rogers |
| K143235 |
11/10/2014 |
RF20000a Controller, FLOW 50 Wand |
ARTHROCARE CORPORATION |
Ashley J Dawson |
| K143157 |
11/03/2014 |
Coronis Fusion 4MP LED |
BARCO NV |
LIEVEN DE WANDEL |
| K143150 |
11/03/2014 |
CO2 monitoring line with and without in-line filter |
BESMED HEALTH BUSINESS CORP. |
WINNIE CHUNG |
| K143379 |
11/25/2014 |
Liquichek Maternal Serum II Control |
Bio-Rad Laboratories |
Elizabeth Platt |
| K143178 |
11/04/2014 |
FilmArray 2.0 System |
BioFire Diagnostics, LLC |
Kristen Kanack, PhD |
| K143171 |
11/04/2014 |
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 |
Biofire Diagnostics, LLC. |
Kristen Kanack, PhD |
| K143188 |
11/05/2014 |
3.Omm Biomet Cannulated Screw System |
BIOMET MANUFACTURING CORP. |
VICTORIA SCHEITLIN |
| K143336 |
11/20/2014 |
Biomet Microfixation OmniMax MMF System |
BIOMET MICROFIXATION |
Lauren Jasper |
| K143192 |
11/06/2014 |
Vanguard 360 Revision Knee System |
Biomet, Inc. |
Jason Heckaman |
| K143387 |
11/26/2014 |
GE333 Blood Glucose Monitoring System |
Bionime Coporation |
Tino Lee |
| K143292 |
11/17/2014 |
TheraCal DC |
Bisco Inc |
Michelle Schiltz-Taing |
| K143298 |
11/17/2014 |
Ultrasound Scanner System bk2300 |
BK MEDICAL APS |
RANDI HAUERBERG |
| K143267 |
11/13/2014 |
TempTraq TT-100 |
Blue Spark Technologies Inc. |
Jennifer Cartledge |
| K143193 |
11/06/2014 |
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters |
BOSTON SCIENTIFIC |
Anna Deraney |
| K143280 |
11/14/2014 |
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens |
Brien Holden Vision Pty Ltd. |
Randall May |
| K143151 |
11/03/2014 |
Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) |
BSN MEDICAL GMBH |
MARTIN SPENGLER |
| K143380 |
11/25/2014 |
Phasix ST Mesh |
C. R. Bard Inc |
Tony John |
| K143208 |
11/10/2014 |
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit |
C.R. Bard, Inc |
Laurie Sang |
| K143199 |
11/06/2014 |
Capillus 272 Pro |
Capillus, LLC |
Frances Pina Brea |
| K143234 |
11/10/2014 |
MaxZero Administration Sets |
CAREFUSION |
LARRY WALKER |
| K143275 |
11/14/2014 |
IOLMaster700 |
Carl Zeiss Meditec, Inc. |
Christine Dunbar |
| K143392 |
11/26/2014 |
Quattro Bolt Tenodesis Screw |
CAYENNE MEDICAL, INC |
Shima Hashemian |
| K143247 |
11/12/2014 |
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) |
CENTRAL MEDICARE SDN BHD |
TH Chong |
| K143302 |
11/17/2014 |
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 |
CEPHEID |
KERRY J FLOM |
| K143356 |
11/24/2014 |
NovoStitch Plus Meniscal Repair System |
Ceterix Orthopaedics, Inc. |
Michael Hendricksen |
| K143396 |
11/26/2014 |
omni TRAX Active Patient Tracker |
CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions |
Amanda Stahle |
| K143182 |
11/05/2014 |
Speedicath Compact Male |
COLOPLAST A/S |
Brian Schmidt |
| K143415 |
11/28/2014 |
Air Bubble Based Infuser (ABBI) |
CooperSurgical, Inc |
James Keller |
| K143412 |
11/28/2014 |
ADROIT Guiding Catheter |
CORDIS CORPORATION |
BABU PERIASAMY |
| K143161 |
11/03/2014 |
Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) |
COVIDIEN |
Sharon McDermott |
| K143263 |
11/13/2014 |
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets |
COVIDIEN |
KARIN DESJARDINS |
| K143317 |
11/19/2014 |
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) |
Currie Medical Specialties, Inc. |
Owen J. Bry |
| K143143 |
11/03/2014 |
PATHWAY ELIF |
CUSTOM SPINE, INC. |
Mahmoud Abdelgany |
| K143378 |
11/25/2014 |
AQUARIUS Gastrostomy Replacement Tube |
DEGANIA SILICONE LTD |
Zoya Lee |
| K143310 |
11/18/2014 |
MoisturemeterD |
DELFIN TECHNOLOGIES LTD. |
Theodore Sullivan |
| K143362 |
11/24/2014 |
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister |
Devon Medical Products |
John Siegel |
| K143318 |
11/19/2014 |
DR Systems Zero Download 3D Viewer (Z3D) |
DR Systems, Inc |
Kimberly J Meade |
| K143290 |
11/17/2014 |
DBSWIN and VistaEasy Imaging Software |
Durr Dental AG |
Oliver Lange |
| K143325 |
11/20/2014 |
OC-Light S FIT |
EIKEN CHEMICAL CO. LTD |
Yoshinori Ota |
| K143261 |
11/13/2014 |
2.3MP Color LCD Monitor, RadiForce MX242W |
EIZO CORPORATION |
Hiroaki Hashimoto |
| K143365 |
11/24/2014 |
Eminent Foot Plate System |
Eminent Spine |
Dave Freehill |
| K143242 |
11/12/2014 |
Rebel 3DKNEE System |
ENCORE MEDICAL, L.P. |
Teffany Hutto |
| K143169 |
11/04/2014 |
MyGlucoHealth Wireless System |
ENTRA HEALTH SYSTEMS |
RICHARD STROBRIDGE |
| K143186 |
11/05/2014 |
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector |
ERBE USA, INC. |
JOHN TARTAL |
| K143306 |
11/18/2014 |
ERBE WaterJet Model ERBEJET« 2 System with HybridAPC Probe |
ERBE USA, INC. |
JOHN TARTAL |
| K143402 |
11/28/2014 |
Extremity Medical Calcaneal Osteotomy Device |
EXTREMITY MEDICAL LLC |
Brian Smekal |
| K143228 |
11/10/2014 |
Ancora LLC Interbody Fusion Device |
FRONTIER MEDICAL DEVICES, INC. |
ERIC SEABORG |
| K143140 |
11/03/2014 |
G-Premio BOND |
GC AMERICA, INC. |
Dr. Mark Heiss |
| K143361 |
11/24/2014 |
Mammo Workstation |
GE HEALTHCARE |
Mounir Zaouali |
| K143251 |
11/12/2014 |
SIGNA Creator, SIGNA Explorer |
GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) |
GLEN SABIN |
| K143389 |
11/26/2014 |
3.0T GEM RT Open Array |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
Candice C Mandera |
| K143345 |
11/21/2014 |
SIGNA Pioneer |
GE HEALTHCARE JAPAN CORPORATION |
Toru Shimizu |
| K143270 |
11/13/2014 |
Optima XR646 |
GE HUALUN MEDICAL SYSTEMS CO. LTD |
Kenny Ma |
| K143368 |
11/25/2014 |
GenIQ |
GE MEDICAL SYSTEMS, LLC. |
Jenny Wong |
| K143156 |
11/03/2014 |
Sentinella 102; Sentinella 102 Horus |
GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- |
Jose Montes |
| K143245 |
11/12/2014 |
GPC Intramedullary Nailing Systems |
GPC MEDICAL LIMITED |
Vikas Narang |
| K143312 |
11/18/2014 |
Portrait GBS Assay |
GREAT BASIN CORPORATION |
Chuck Owen |
| K143287 |
11/17/2014 |
Fluidshield* Surgical Mask with Expanded Chamber |
Halyard Health, Inc. |
Roberto F. Refeca |
| K143219 |
11/10/2014 |
NIRO-200NX |
Hamamatsu Photonics K.K. |
SUSUMU SUZUKI |
| K143183 |
11/05/2014 |
Maxima XTEND Handpiece Maintenance System |
HANDPIECE HEADQUARTERS |
Timothy Ropchan |
| K143227 |
11/10/2014 |
Magellan Robotic System, Magellan Robotic Catheter 10Fr |
HANSEN MEDICAL, INC. |
TODD MILHOLLAND |
| K143419 |
11/28/2014 |
Patient Examination Gloves |
HARTALEGA NGC SDN. BHD. |
Kuan Mun Leong |
| K143187 |
11/05/2014 |
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) |
Healgen Scientific LLC |
Jianqiu Fang |
| K143414 |
11/28/2014 |
Hill-Rom Wireless Connectivity Module |
HILL-ROM |
ANN WATERHOUSE |
| K143339 |
11/20/2014 |
Mini me |
ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) |
BOBAE KIM |
| K143324 |
11/19/2014 |
IDS-iSYS CTX-I Calibration Verifiers |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
ROMA YOUNG |
| K143420 |
11/28/2014 |
SYMBIS Surgical System |
IMRIS, Inc. |
Sanjay Shah |
| K143323 |
11/19/2014 |
OS2-V Varisation Staple |
IN2Bones SAS |
MORGANE GRENIER |
| K143213 |
11/10/2014 |
INOmax DSIR Plus MRI |
INO Therapeutics/Ikaria |
Robert Bovy |
| K143301 |
11/17/2014 |
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit |
Integrated Healing Technologies |
Ian Baird |
| K143217 |
11/10/2014 |
12 mm & Stapler Bladeless Obturators |
INTUITIVE SURGICAL, INC. |
Manish Patel |
| K143369 |
11/25/2014 |
MRidium 3860+ MRI infusion Pump/ Monitoring System |
IRADIMED CORPORATION |
FRANCIS X CASEY |
| K143154 |
11/03/2014 |
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) |
IRIDEX CORPORATION |
PAUL H HARDIMAN |
| K143241 |
11/12/2014 |
MDT Navigable Brain Biopsy Cannula |
IZI MEDICAL PRODUCTS LLC |
Qiang Cao |
| K143142 |
11/03/2014 |
JDENTALCARE Implant System |
J DENTAL CARE S.r.l |
Giacomo Grandi |
| K143155 |
11/03/2014 |
LISTERINE Sensitivity Defense Mouthrinse |
Johnson & Johnson Healthcare Products, Division of McNeil-PP |
ANGELINA M. HUNT |
| K143334 |
11/20/2014 |
Range/Denali/Mesa Spinal System |
K2M, INC |
NANCY GIEZEN |
| K143350 |
11/24/2014 |
Nile Alternative Fixation |
K2M, Inc. |
Nancy Giezen |
| K143164 |
11/03/2014 |
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set |
KIMBERLY-CLARK CORPORATION |
MARIA E WAGNER |
| K143177 |
11/04/2014 |
KleenGel Dispenser |
KleenGel, LLC |
Suzanne Mair |
| K143332 |
11/20/2014 |
Fast Sphyg by Koven |
KOVEN TECHNOLOGY, INC. |
HEATHER BELL |
| K143271 |
11/13/2014 |
CastleLoc-P Anterior Cervical Plate System |
L&K BIOMED Co., Ltd |
Ki-Hyang Kim |
| K143360 |
11/24/2014 |
LnK Cervical Interbody Fusion Cage System |
L&K BIOMED Co., Ltd |
Yerim An |
| K143279 |
11/14/2014 |
LnK Anterior Cervical Plate System |
L&K BIOMED Co., Ltd. |
Ki-Hyang Kim |
| K143278 |
11/14/2014 |
LnK Posterior Cervical Fixation System |
L&K BIOMED Co., Ltd. |
An Yerim |
| K143363 |
11/24/2014 |
VENUS Spinal Fixation System |
L&K BIOMED Co., Ltd. |
Ki-Hyang Kim |
| K143152 |
11/03/2014 |
TM-ABI system |
LD TECHNOLOGY LLC |
Albert Maarek |
| DEN140033 |
11/10/2014 |
Companion |
LGCH, INC |
Mike Girouard |
| K143249 |
11/12/2014 |
SOLSTICE OCT System |
LIFE SPINE, INC |
Randy Lewis |
| K143277 |
11/14/2014 |
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), |
Lifestyle Safety Products (Hui Zhou) Co., Ltd. |
Lee Hong Chong |
| K143359 |
11/24/2014 |
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector |
LifeWatch Technologies Ltd. |
Asher Kassel |
| K143256 |
11/13/2014 |
SMR Modular Glenoid |
Limacorporate S.P.A. |
Stephen J. Peoples |
| K143145 |
11/03/2014 |
SafeAir Smoke Pencil |
LiNA Medical ApS |
Anne Klitgard |
| K143191 |
11/06/2014 |
IntelliSense Drill |
McGinley Innovations |
Joseph McGinley |
| K143238 |
11/12/2014 |
C3 Wave |
MEDCOMP (MEDICAL COMPONENTS) |
Courtney Nix |
| K143304 |
11/18/2014 |
Sickbay Clinical Platform |
Medical Informatics Corp |
Ralph Krog |
| K143257 |
11/13/2014 |
KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System |
MEDICATECH USA |
George Makar |
| K143147 |
11/03/2014 |
Gemini Bonded Sterilization Wrap |
MEDLINE INDUSTRIES, INC. |
Matt Clausen |
| K143322 |
11/19/2014 |
Medline Natural Lubricating Liquid |
MEDLINE INDUSTRIES, INC. |
JENNIFER MASON |
| K143175 |
11/04/2014 |
AEx Generator; PlasmaBlade T |
MEDTRONIC ADVANCED ENERGY |
Deep Pal |
| K143141 |
11/03/2014 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
Gregory Maschek |
| K143375 |
11/25/2014 |
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments |
MEDTRONIC SOFAMOR DANEK USA, INC |
Becky Ronner |
| K143316 |
11/19/2014 |
Attain Hybrid Guide Wire |
Medtronic, Inc. |
Mia Hunt |
| K143203 |
11/07/2014 |
AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe |
MEDWAVES INCORPORATED |
TED ORMSBY |
| K143232 |
11/10/2014 |
Universal Digital Interface 2W, UDI 2W |
MERIDIAN MEDICAL SYSTEMS, LLC |
Larry Cornell |
| K143255 |
11/13/2014 |
Prelude SNAP Splittable Sheath Introducer |
MERIT MEDICAL SYSTEMS, INC. |
Alina Stubbs |
| K143341 |
11/21/2014 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K143366 |
11/24/2014 |
ADVANCE Porous Coated Spiked Tibial Base |
MicroPort Orthopedics Inc. |
Caroline Fryar |
| K143222 |
11/10/2014 |
FIREFLY Pedicle Screw Navigation Guide |
Mighty Oak Medical Inc |
Heidi Frey |
| K143348 |
11/21/2014 |
BC-3600 Auto Hematology Analyzer |
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Tan Chuanbin |
| K143233 |
11/10/2014 |
Mitsar-EEG |
MITSAR CO., LTD |
Semchenkov Ales |
| K143252 |
11/13/2014 |
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) |
NEEDLETECH PRODUCTS, INC. |
Dennis Shay |
| K143344 |
11/21/2014 |
NeoMed NeoConnect Enteral Syringes with ENFit Connector |
NEOMED, INC. |
TONY LAIR |
| K143327 |
11/20/2014 |
Neoss Ti Reinforced Membrane |
Neoss Ltd |
Karin Darle Olsson |
| K143230 |
11/10/2014 |
Palladian Lumbar Pedicle Screw System |
Neurostructures, Inc. |
Moti Altarac |
| K143197 |
11/06/2014 |
Nice1 |
NICE RECOVERY SYSTEMS, LLC |
MICHAEL ROSS |
| K143351 |
11/24/2014 |
iCase Contact Lens Case |
Novabay Pharmaceuticals, Inc |
Charles Francavilla |
| K143229 |
11/10/2014 |
Nexis osteosynthesis compressive screws |
NOVASTEP |
Gilles Audic |
| K143146 |
11/03/2014 |
Nexis osteosynthesis snap-off screws |
NOVASTEP |
Gilles Audic |
| K143388 |
11/26/2014 |
Affix IIS Spinous Process Plate System |
NuVasive, Incorporated |
Olga Lewis |
| K143313 |
11/19/2014 |
NxStage Therapeutic Plasma Exchange (TPE) Cartridge |
NxStage Medical, Inc. |
Randall J Covill |
| K143153 |
11/03/2014 |
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V |
OLYMPUS MEDICAL SYSTEMS CORP. |
Toshiyuki Nakajima |
| K143303 |
11/18/2014 |
Single Use Biliary Balloon Dilator |
OLYMPUS MEDICAL SYSTEMS CORP. |
Sheri Musgnung |
| K143338 |
11/20/2014 |
Argulated Locking Plates |
OSTEOMED L.P. |
Anita Zacherl |
| K143395 |
11/26/2014 |
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. |
Julian Rutherford |
| K143244 |
11/12/2014 |
The Panthera Anti-Snoring Device |
Panthera Dental Inc. |
Guy Bernard Bantsiele |
| K143355 |
11/24/2014 |
The Simple Locking IntraMedullary (SLIM) System |
PEGA MEDICAL INC. |
Ariel R Dujovne |
| K143202 |
11/07/2014 |
ANGIO-PRESS DVT Compression Device Model Name: IPCS |
Pegasus Medical Supply, Inc. |
PAO-MING SHIH |
| K143218 |
11/10/2014 |
Penumbra Smart Coil |
Penumbra, Inc. |
Charles DeNault |
| K143180 |
11/04/2014 |
F3 |
PERMOBIL AB |
JAN ASTROM |
| K143253 |
11/13/2014 |
O-MAR |
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. |
JAN VAN DE KERKHOF |
| K143349 |
11/24/2014 |
Gynomunal |
POLICHEM S.A. |
Daria Mari |
| K143248 |
11/12/2014 |
Reform Pedicle Screw System |
PRECISION SPINE, INC. |
MICHAEL C. DAWSON |
| K143383 |
11/25/2014 |
Q6 Edge EM |
Pride Mobility Product Corporation |
Kimberly Elmes |
| K143330 |
11/20/2014 |
BruxZir Anterior |
PRISMATIK DENTALCRAFT, INC. |
Armin Zehtabchi |
| K143353 |
11/24/2014 |
Hahn Tapered Implant System |
PRISMATIK DENTALCRAFT, INC. |
Brandon Shepard |
| K143206 |
11/07/2014 |
AmpliVue Bordetella Assay |
QUIDEL CORPORATION |
RONALD H. LOLLAR |
| K143329 |
11/20/2014 |
AmpliVue Trichomonas Assay |
QUIDEL CORPORATION |
RONALD H LOLLAR |
| K143307 |
11/18/2014 |
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector |
RAYNER INTRAOCULAR LENSES LTD. |
Juliette Cook |
| K143272 |
11/14/2014 |
ApneaLink Air |
RESMED GERMANY INC. |
Sandra Grunwald |
| K143405 |
11/28/2014 |
Option (TM) ELITE Vena Cava Filter 100cm System |
REX MEDICAL, LP |
Erich Bressler |
| K143284 |
11/17/2014 |
Elecsys Estradiol III Calcheck |
ROCHE DIAGNOSTICS |
Kelli Turner |
| K143342 |
11/21/2014 |
Elecsys T-Uptake Calset |
Roche Diagnostics |
Kelli Turner |
| K143335 |
11/20/2014 |
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) |
Roosin Medical Devices Co., Ltd |
Chengyu Shen |
| K143418 |
11/28/2014 |
STRONG Dental Handpieces |
Saeshin Precision Co., Ltd. |
Choi Sae Kwan |
| K143411 |
11/28/2014 |
TRAUS ENDO |
SAESHIN PRECISION CO., LTD. |
Sae Kwan Choi |
| K143264 |
11/13/2014 |
H60 V2.00 Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
Kyeong-Mi Park |
| K143221 |
11/10/2014 |
Schoelly Laparoscope |
Schoelly Fiberoptic Gmbh |
Sandra Baumann |
| K143398 |
11/26/2014 |
Plato MICROCATH 27B Microcatheter |
SCIENTIA VASCULAR , LLC |
Sharon Rockwell |
| K143382 |
11/25/2014 |
DentiAnn Smart Sil |
SeilGlobal Co., Ltd. |
Pack Seong Uk |
| K143160 |
11/03/2014 |
FOXTROT NC PTCA Balloon Catheter |
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD |
JINGWEN LI |
| K143268 |
11/13/2014 |
TENS AND POWERED MUSCLE STIMULATOR |
SHENZHEN AS-TEC TECHNOLOGY CO., LTD |
CONNIE LI |
| K143195 |
11/06/2014 |
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
Yanhong Bai |
| K143196 |
11/06/2014 |
syngo.CT Lung CAD |
SIEMENS AG MEDICAL SOLUTIONS |
JAMES E KUHN JR. |
| K143376 |
11/25/2014 |
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
FATIMA PACHECO |
| K143194 |
11/06/2014 |
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
FATIMA PACHECO |
| K143352 |
11/24/2014 |
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Sara Kastrup |
| K143373 |
11/25/2014 |
IMMULITE« 2000 Calcitonin Calibration Verification Material , IMMULITE« 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
DONNA VELASQUEZ |
| K143254 |
11/13/2014 |
eSie Apps Suite |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NANCY BURKE |
| K143409 |
11/28/2014 |
SOMATOM Definition AS Open (VA48) |
Siemens Medical Solutions USA, Inc. |
Eve Davis |
| K143400 |
11/28/2014 |
SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Kimberly Mangum |
| K143401 |
11/28/2014 |
SOMATOM Definition Edge |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K143416 |
11/28/2014 |
SOMATOM Definition Flash (VA48) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Eve Davis |
| K143319 |
11/19/2014 |
Syngo X-workplace SW VD10 |
Siemens Medical Solutions, Inc |
Patricia D. Jones |
| K143205 |
11/07/2014 |
Viscoelastic Injector |
Sight Sciences, Inc. |
Paul Badawl |
| K143184 |
11/05/2014 |
Evolve UniPolar Head |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K143172 |
11/04/2014 |
ACL SMART System |
SMITH & NEPHEW, INC. |
SAMIR IBRAHIM |
| K143226 |
11/10/2014 |
Visionaire Disposable Instruments |
SMITH & NEPHEW, INC. |
Shereen Bienz |
| K143386 |
11/26/2014 |
Progrip Laparoscopic Self-Fixating Mesh |
SOFRADIM PRODUCTION |
Eric Jague |
| K143214 |
11/10/2014 |
SCARLET« AC-T Secured Anterior Cervical Cage |
SPINEART |
Franck PENNESI |
| K143377 |
11/25/2014 |
PedFuse Pedicle Screw System |
SPINEFRONTIER, INC. |
Manthan J Damani |
| K143159 |
11/03/2014 |
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ?4.0mm, PediGuard Tri Tip ?3.2mm, PediGuard Tri Tip ?2.5mm, PediGuard ?2.5mm XS, PediGuard Curv, PediGuard Curv |
SpineGuard, S.A. |
Stephane Bette |
| K143403 |
11/28/2014 |
Threshold Pedicular Fixation System |
Spineology, Inc. |
Tim Crabtree |
| K143260 |
11/13/2014 |
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider |
STERILMED, INC. |
NICOLE BOSER |
| K143333 |
11/20/2014 |
Revital-Ox RESERT Solution Test Strip |
STERIS Corporation |
Anthony Piotrkowski |
| K143173 |
11/04/2014 |
Stryker CMF MEDPOR Customized Implant |
Stryker |
Julie Schoell |
| K143320 |
11/19/2014 |
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments |
STRYKER CORP. |
Brittney M. Larsen |
| K143399 |
11/28/2014 |
Stryker Footed Attachments and Cutting Accessories |
STRYKER CORP. |
VISHAL KANANI |
| K143163 |
11/03/2014 |
AVS« AL and ALign PEEK Spacers, AVS« PL and UniLIF PEEK Spacers, AVS« TL PEEK Spacer, AVS« Navigator PEEK Spacer, AVS« ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS« Anchor-L Spacer, Aero-AL Lumbar Cage System |
STRYKER CORPORATION |
GARRY T HAYECK |
| K143393 |
11/26/2014 |
Triathlon Tritanium Cone Augments |
STRYKER ORTHOPAEDICS |
Margaret Klippel |
| K143138 |
11/03/2014 |
AxSOS 3 Ti Locking Plate System |
Stryker Trauma AG |
ELIJAH N WREH |
| K143265 |
11/13/2014 |
Acrylic Block |
SUN MEDICAL CO., LTD. |
YUKIHITO YUKIMUNE |
| K143166 |
11/04/2014 |
Medline ReNewal Reprocessed Compression Limb Sleeves |
Surgical Instrument Service and Savings (dba Medline ReNewal |
Richard D. Wynkoop |
| K143404 |
11/28/2014 |
SurgiQuest AirSeal iFS System |
SURGIQUEST, INC. |
Daniel Donovan |
| K143209 |
11/10/2014 |
SonicFill 2 |
SYBRON DENTAL SPECIALTIES |
KERRI CASINO |
| K143198 |
11/06/2014 |
Synapse Transcutaneous Electrical Stimulation Device |
Synapse Electroceutical Limited |
JOHN GILDERSLEEVE |
| K143285 |
11/17/2014 |
Mandible External Fixator - MR Conditional |
Synthes USA Products, LLC |
Susan Lewandowski |
| K143326 |
11/20/2014 |
T.A.G. Dental Implant System |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD |
EREZ ADIV |
| K143185 |
11/05/2014 |
entr? Model PD08-U |
TACTILE SYSTEMS TECHNOLOGY INC |
DANIEL G CHASE |
| K143189 |
11/05/2014 |
t:flex Insulin Delivery System |
Tandem Diabetes Care, Inc. |
John Sheridan |
| K143299 |
11/17/2014 |
Percuvance(R) Percutaneous Surgical System |
Teleflex Medical, Inc. |
Holly Hallock |
| K143314 |
11/19/2014 |
Progressive Orthopaedic Total Hip System |
The Progressive Orthopaedic Company, LLC |
SCOTT KEISER |
| K143236 |
11/12/2014 |
Theranos Herpes Simplex Virus-1 IgG Assay |
THERANOS, INC. |
Brad Arington |
| K143288 |
11/17/2014 |
Sensititre Susceptibility plates |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K143381 |
11/25/2014 |
Sensititre Susceptibility Plates |
Thermo Fisher Scientific |
Cynthia Knapp |
| K143374 |
11/25/2014 |
BLUEPRINT Patient Specific Instrumentation |
TORNIER, SAS |
AYMEN AZAIEZ |
| K143294 |
11/17/2014 |
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K143223 |
11/10/2014 |
CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K143225 |
11/10/2014 |
INFX-8000V with Wireless Footswitch |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K143281 |
11/14/2014 |
Ultimax-i |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K143296 |
11/17/2014 |
AIA-PACK C-Peptide Control Set |
Tosoh BioScience, Inc. |
Robert L Wick |
| K143144 |
11/03/2014 |
ST AIA-PACK PROG II Calibrator Set |
Tosoh BioScience, Inc. |
Robert L Wick |
| K143407 |
11/28/2014 |
Klassic HD Hip System |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K143311 |
11/18/2014 |
Pre-vacuum Tabletop Autoclave |
TUTTNAUER USA CO. LTD. |
Robert Basile |
| K143417 |
11/28/2014 |
ANAX 5.5 Spinal System |
U&I Corporation |
Young-Geun Kim |
| K143176 |
11/04/2014 |
UltraLinq |
ULTRALINQ HEALTHCARE SOLUTIONS, INC. |
Stephen Farber |
| K143224 |
11/10/2014 |
TrueBeam-TrueBeam STx-Edge |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K143211 |
11/10/2014 |
myVision Track Model 005 |
VITAL ART AND SCIENCE INCORPORATED |
Michael Bartlett |
| K143212 |
11/10/2014 |
Bifix Temp |
VOCO GMBH |
M. Th. Plaumann |
| K143328 |
11/20/2014 |
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip |
Volcano AtheroMed, Inc. |
Jean Chang |
| K143179 |
11/04/2014 |
The LINK« Endo-Model« Knee System |
Waldemar Link GmbH & Co. KG |
Helmut D. Link |
| K143148 |
11/03/2014 |
Disposable Pressure Manometer (DPM) |
Westmed, Inc. |
DIANA UPP |
| K143220 |
11/10/2014 |
SIDEKICK EZ FRAME External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Leslie Fitch |
| K143158 |
11/03/2014 |
Xenco Medical Lumbar Interbody System |
Xenco Medical, LLC |
Gustavo Prado |
| K143216 |
11/10/2014 |
Assurance Alar / Nasal SpO2 Sensor |
Xhale, Inc. |
Jeffrey Hoebelheinrich |
| K143413 |
11/28/2014 |
J+PRAS YOUNG'S Thread |
Y. Jacobs Medical, Inc. |
Joo Hwan Jeon |
| K143289 |
11/17/2014 |
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
Arivagalan Subramaniam |
| K143190 |
11/05/2014 |
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
| K143200 |
11/06/2014 |
MIS Z-Pedicle Screw System |
Z-Medical GmbH & Co. KG |
ALEXANDER HENNINGER |
| K143346 |
11/21/2014 |
Powder-Free White Vinyl Patient Examination Gloves |
Zibo Changda Plastic Products Company, Limited |
Coco Kou |
| K143340 |
11/21/2014 |
Powder Free Vinyl Patient Examination Gloves, Yellow Color |
Zibo Ling Yun Medical Products Co, Ltd |
Eric Wang |
| K143347 |
11/21/2014 |
Powder-Free Yellow Vinyl Patient Examination Gloves |
Zibo Zhouheng Plastic Products Co. Ltd |
Cherry Xu |
| K143297 |
11/17/2014 |
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. |
Donna M. Semlak |
| K143165 |
11/03/2014 |
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw |
Zimmer, Inc. |
Patrick McCullagh |
| K143321 |
11/19/2014 |
ITST Intertrochanteric/Subtrochanteric Fixation System |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K143331 |
11/20/2014 |
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS |
ZIMMER, INC. |
Patrick McCullagh |
