| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K142402 |
08/27/2014 |
BigEasy Non-Rebreathing Valve |
12th Man Technologies, Inc. |
Alex Stenzler |
| K142112 |
08/04/2014 |
4WEB SPINAL IMPLANT PRODUCTS |
4WEB, INC. |
RICH JANSEN |
| K142415 |
08/28/2014 |
Hi-Torque JET Guide Wire Family |
ABBOTT VASCULAR INC. |
JANET BENSON |
| K142391 |
08/27/2014 |
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) |
ACON LABORATORIES, INC. |
QIYI XIE |
| K142355 |
08/25/2014 |
Vaginal Tactile Imager |
Advanced Tactile Imaging, Inc. |
Vladimir Egorov |
| K142122 |
08/04/2014 |
RADAR VASCULAR COMPRESSION DEVICE |
ADVANCED VASCULAR DYNAMICS |
MATTHEW SEMLER |
| K142150 |
08/05/2014 |
AIS MODULIFT VBR SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K142315 |
08/19/2014 |
MINOP Disposable Introducer 26F |
AESCULAP, INC. |
KATHY RACOSKY |
| K142184 |
08/08/2014 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
SHAEANN CAVANAGH |
| K142316 |
08/19/2014 |
IMPAX Agility |
AGFA HEALTHCARE N.V. |
Jodi Coleman |
| K142284 |
08/18/2014 |
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE |
ALCON LABORATORIES, INC. |
ALICIA PLESNARSKI |
| K142347 |
08/22/2014 |
Amedica Valeo II Interbody Fusion Device |
Amedica Corp |
William D Jordan |
| K142264 |
08/15/2014 |
Valeo C Spacer System, Valeo II C IBF Device |
Amedica Corp. |
William D Jordan |
| K142333 |
08/21/2014 |
SMART LABEL, PROPOFOL |
AMERICAN I.V. PRODUCTS, INC dba AIV, INC |
SHANNON HOUCHEN |
| K142285 |
08/18/2014 |
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz |
AmeriWater |
Brian R Bowman |
| K142256 |
08/14/2014 |
Applied BioPhotonics Phototherapy System ABPT1003 |
APPLIED BIOPHOTONICS LTD. |
ERIC HSIEH |
| K142427 |
08/29/2014 |
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 |
APPLIED MEDICAL RESOURCES |
AEREE LEE |
| K142336 |
08/21/2014 |
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System |
ARKRAY FACTORY INC. |
Kazuya Yorimitsu |
| K142327 |
08/20/2014 |
smARTrack Feeding Tube System |
ART Healthcare Ltd. |
Liron Elia |
| K142413 |
08/28/2014 |
TITAN Modular Total Shoulder System |
Ascension Orthopedics |
Frederic Testa |
| K142124 |
08/04/2014 |
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM |
ASEPTICO, INC. |
CHERIE TREGONING |
| K142120 |
08/04/2014 |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
ATRICURE, INC. |
JONATHAN MCELWEE |
| K142203 |
08/11/2014 |
Atricure Cryo Module System; cryoICE cryoablation probe |
ATRICURE, INC. |
Jonathan McElwee |
| K142147 |
08/05/2014 |
EEVA SYSTEM |
AUXOGYN, INC. |
JULIA S ANASTAS |
| K142261 |
08/14/2014 |
Ultraverse 035 PTA Balloon Dilatation Catheter |
Bard Peripheral Vascular, Inc. |
Mario Thomas |
| K142425 |
08/29/2014 |
Uroflowmeter |
BE TECHNOLOGIES, INC. |
Edward Belotserkovsky |
| K142346 |
08/22/2014 |
Urine/CSF Albumin, Urine/CSF Albumin Calibrator |
Beckman Coulter Ireland Inc. |
Anne-Marie Shine |
| K142373 |
08/25/2014 |
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst |
BECKMAN COULTER, INC. |
Ryan Severson |
| K142362 |
08/25/2014 |
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. |
BECKMAN COULTER, INC. |
RYAN SEVERSON |
| K142170 |
08/07/2014 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP |
Becton, Dickinson and Company |
MONICA E GIGUERE |
| K142363 |
08/25/2014 |
NUSTAT, NUSTAT XR |
Beeken Biomedical |
Richard Kendall |
| K142340 |
08/21/2014 |
Infrared Therapy System |
Beijing Huatai Healthcare Technology Co., Ltd. |
Bingxian Zheng |
| K142219 |
08/12/2014 |
GammaBeam 100 |
Best Theratronics Limited |
Mike de van der Schueren |
| K142099 |
08/01/2014 |
CUTANEOUS ELECTRODES |
BIO PROTECH, INC. |
Terry Kim |
| K142332 |
08/20/2014 |
BT-400 |
Bio-Med USA |
Young Chi |
| K142204 |
08/11/2014 |
Bioceptive Suction Cervical Retractor |
Bioceptive Inc. |
Steward B. Davis, M.D. |
| K142174 |
08/07/2014 |
BIOMATE DENTAL IMPLANT SYSTEM |
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. |
WAYNE CHEN |
| K142292 |
08/18/2014 |
Speed, Speed Shift, Speed Titan, Speed Arc |
BioMedical Enterprises, Inc. |
Joe Soward |
| K142097 |
08/01/2014 |
SELEC-3 I.V.ADMINISTRATION SET |
BIOMEDIX, INC. |
MYRA J BENDER |
| K142295 |
08/18/2014 |
Sirius Femoral Stem, Size 30A |
Biomet, Inc. |
Jason Dugger |
| K142432 |
08/29/2014 |
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit |
BIONESS, INC. |
Robert Schulz, RAC |
| K142129 |
08/04/2014 |
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET |
BIOPHOR DIAGNOSTICS, INC. |
NATAHANIEL G BUTLIN |
| K142293 |
08/18/2014 |
Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls |
BIOPHOR DIAGNOSTICS, INC. |
Nathaniel G. Butlin |
| K142276 |
08/15/2014 |
MCS Bone Graft |
BIOSTRUCTURES, LLC |
John Brunelle, Ph.D. |
| K142379 |
08/26/2014 |
Passeo-35 PTA Catheter |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K142337 |
08/21/2014 |
Blackford Analysis Registration Product Family |
BLACKFORD ANALYSIS LTD |
Gordon McNeilly |
| K142259 |
08/14/2014 |
Direxion Torqueable Microcatheter |
BOSTON SCIENTIFIC CORP. |
Mark Lanz |
| K142108 |
08/04/2014 |
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| DEN140025 |
08/20/2014 |
BrainScope Ahead 100 |
BRAINSCOPE COMPANY, INC |
Michael E. Singer |
| K142267 |
08/15/2014 |
Sherlock 3CG Tip Positioning System Stylet |
C.R.Bard, Inc. |
Bryan Stone |
| K142372 |
08/25/2014 |
Pico Way Laser System |
CANDELA CORPATION |
Ruthie Amir |
| K142225 |
08/13/2014 |
Pilot Elite Diode Laser |
CAO Group, Inc. |
Robert K Larsen |
| K142223 |
08/13/2014 |
Pilot Pro Diode Laser |
CAO GROUP, INC. |
ROBERT K. LARSEN |
| K142226 |
08/13/2014 |
Pilot Ultra Diode Laser |
CAO GROUP, INC. |
ROBERT K. LARSEN |
| K142399 |
08/27/2014 |
DualCap IV Pole Strips(Disinfectant Caps for Male Luers) |
CATHETER CONNECTIONS, INC. |
Donald d Soloman |
| K142396 |
08/27/2014 |
Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests |
Chemtron Biotech, Inc. |
Jane Zhang |
| K142216 |
08/12/2014 |
Tranberg CLS Thermal Therapy System |
Clinical Laserthermia Systems AB |
Lars-Erik Eriksson |
| K142429 |
08/29/2014 |
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable |
Codman & Shurtleff, Inc |
Hannah Foley |
| K142193 |
08/11/2014 |
COGENT MED-LIF XL |
COGENT SPINE LLC |
JUDE PAGANELLI |
| K142325 |
08/20/2014 |
Veenstra Instruments VDC-506 Dose Calibrator |
Comecer Netherlands b.v. |
Gert Jan Klok |
| K142404 |
08/27/2014 |
iTotal Posterior Stabilized (PS) Knee Replacement System |
ConforMIS Inc. |
Amita Shah |
| K142161 |
08/06/2014 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
| K142134 |
08/04/2014 |
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES |
CONMED CORPORATION, LARGO |
JOY LOVETT |
| K142357 |
08/25/2014 |
DuraSheath Introducer Sheath System |
CONTRACT MEDICAL INTERNATIONAL GMBH |
JAN KLOBOUCNIK |
| K142301 |
08/18/2014 |
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath |
COOK VASCULAR, INC. |
Thomas J. Kardos |
| K142094 |
08/01/2014 |
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM |
COPAN ITALIA S.P.A. |
TINA WU |
| K142294 |
08/18/2014 |
FlexiMarc Marker |
CORTEX MANUFACTURING, INC. |
Andrew Jones |
| K142128 |
08/04/2014 |
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR |
COVIDIEN |
SHANNON GREEN |
| K142335 |
08/21/2014 |
RapidVac Smoke Evacuator System |
COVIDIEN |
JOSE MARQUEZ |
| K142296 |
08/18/2014 |
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula |
Covidien |
Danielle Mueller |
| K142298 |
08/18/2014 |
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff |
Covidien |
Kelsey Lee |
| K142364 |
08/25/2014 |
Barrx RFA Self Sizing Balloon Catheter |
Covidien llc |
Rachel Silva |
| K142198 |
08/11/2014 |
BNX Fine Needle Aspiration System |
Covidien LLC |
Saket Bhatt |
| K142428 |
08/29/2014 |
Shock Pulse-SE Lithotripsy System CYBERWAND II |
CYBERSONICS, INC. |
Jeff Vaitekunas |
| K142376 |
08/26/2014 |
Palomar Icon Aesthetic System |
CYNOSURE, INC. |
Allyson Connor |
| K142329 |
08/20/2014 |
BBS REVOLUTION |
dBMEDx INC. |
DAVE SHINE |
| K142106 |
08/01/2014 |
DECISIO HEALTH PATIENT DASHBOARD |
DECISIO HEALTH, INC. |
RONALD S WARREN |
| K142313 |
08/19/2014 |
OneQ-SL Implant System |
DENTIS CO. LTD. |
Jeong Seop Keun |
| K142178 |
08/08/2014 |
PROROOT MTA WHITE, PROROOT MTA GRAY |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
| K142185 |
08/08/2014 |
EXPEDIUM VERSE SPINE SYSTEM |
DEPUY SPINE, INC. |
CATHERINE KILSHAW |
| K142168 |
08/06/2014 |
NATURE'S BOND 600 AND NATURE'S BOND 603 |
DEVON MEDICAL PRODUCTS, INC. |
Ruth Wu |
| K142132 |
08/04/2014 |
POOL NORM |
Diagnostics Stago S.A.S. |
MARIE COMPAGNON-RIOBE |
| K142228 |
08/13/2014 |
Heated Eye Pad |
Digital Heat Corporation |
John Devine |
| K142229 |
08/13/2014 |
Laparoscopic FMsealer |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
| K142426 |
08/29/2014 |
EBI External Implant System |
EBI Inc |
Mi Sook Kim |
| K142107 |
08/01/2014 |
ECHO TRUE 3D VIEWER |
ECHO PIXEL INC. |
SERGIO AGUIRRE |
| K142173 |
08/07/2014 |
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE |
ECOLAB, INC. |
JENNIFER WILLNER |
| K142199 |
08/11/2014 |
Ascendra Balloon Aortic Valvaloplasty Catheter |
EDWARDS LIFESCIENCES |
Susan Reynolds |
| K142398 |
08/27/2014 |
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
| K142410 |
08/28/2014 |
Elliquence Electrodes |
ELLIQUENCE LLC |
Paul D Buhrke |
| K142319 |
08/20/2014 |
SCIg60 Infuser, Infuset |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K142194 |
08/11/2014 |
CytoSure Urinary Access System |
Emmy Medical |
Christine G Santagate |
| K142155 |
08/06/2014 |
ENDOCHOICE WATER BOTTLE CAP SYSTEM |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K142113 |
08/04/2014 |
ESOPHYX2 HD |
ENDOGASTRIC SOLUTIONS, INC. |
MICHAEL A DANIEL |
| K142252 |
08/14/2014 |
XprESS Multi-Sinus Dilation Tool |
ENTELLUS MEDICAL, INC. |
Karen E. Peterson |
| K142245 |
08/13/2014 |
EpiAccess System |
EpieP, Inc. |
Pamela Bunes |
| K142207 |
08/11/2014 |
TransferMan 4m Micromanipulator |
EPPENDORF AG |
CORNELIA HILDEBRANDT |
| K142421 |
08/28/2014 |
G-scan Brio |
ESAOTE, S.P.A. |
Donatella Ragghianti |
| K142306 |
08/19/2014 |
Flower Upper Extremity Plating Set |
Flower Orthopedics Corporation |
Gary Barnett |
| K142365 |
08/25/2014 |
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack |
FOCUS DIAGNOSTICS |
Sharon Young |
| K142160 |
08/06/2014 |
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM |
GE HEALTHCARE |
BRYAN BEHN |
| K142288 |
08/18/2014 |
MAC 800 Resting ECG Analysis System |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
Sun YanLi |
| K142323 |
08/20/2014 |
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System |
GE MEDICAL SYSTEMS ISRAEL LTD. |
Bryan Behn |
| K142361 |
08/25/2014 |
Discovery MR750 3.0T |
GE MEDICAL SYSTEMS, LLC |
Jenny Wong |
| K142383 |
08/26/2014 |
Optima XR200amx, Optima XR220amx |
GE Medical Systems, LLC |
Chris Paulik |
| K142098 |
08/01/2014 |
SIGNA PET/MR |
GE MEDICAL SYSTEMS, LLC |
ROBIN MARTIN |
| K142291 |
08/18/2014 |
GMX Series Medical Air/Oxygen Blender |
GENTEC (SHANGHAI) CORPORATION |
Dongjian Lin |
| K142218 |
08/12/2014 |
Coalition AGX Plate and Coalition AGX Spacer |
GLOBUS MEDICAL INC. |
Kelly Baker |
| K142409 |
08/27/2014 |
Vinyl Co-Polymer Powder Free Examination Gloves |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
DENG ZHANYONG |
| K142088 |
08/01/2014 |
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K142369 |
08/25/2014 |
Urinary Incontinence System |
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD |
Chiping Ma |
| K142164 |
08/06/2014 |
MANIPULATOR; MANIPULATOR PRO |
GYNETECH PTY. LTD. |
KEVIN MACDONALD |
| K142350 |
08/22/2014 |
PK J-HOOK |
GYRUS ACMI INC. |
NEIL KELLY |
| K142289 |
08/18/2014 |
PK Spatula |
Gyrus ACMI Inc. |
Neil Kelly |
| K142154 |
08/06/2014 |
PK NEEDLE |
GYRUS ACMI, INC. |
NEIL KELLY |
| K142423 |
08/28/2014 |
EyeSuite Imaging |
HAAG-STREIT AG |
Oscar Banz |
| K142270 |
08/15/2014 |
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE |
HARTALEGA SDB. BHD. |
KUAN KAM HON |
| K142280 |
08/15/2014 |
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
Jianqiu Fang |
| K142348 |
08/22/2014 |
OsteoSeal Bone Hemostat |
HEMOSTASIS, LLC |
Bernard Horwath |
| K142157 |
08/06/2014 |
PALACOS R+G PRO |
HERAEUS MEDICAL GMBH |
ASTRID MARX |
| K142368 |
08/25/2014 |
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI ALOKA MEDICAL, LTD. |
ANGELA VAN ARSDALE |
| K142433 |
08/29/2014 |
Hospira Extension Set |
Hospira, Inc. |
David Blonski |
| K142367 |
08/25/2014 |
Hospira Primary Sets |
HOSPIRA, INC. |
CATHERINE KANG |
| K142300 |
08/18/2014 |
Arrow GPSCath Balloon Dialation Catheter (150 cm) |
HOTSPUR TECHNOLOGIES, INC., |
ERICK ANKERUD |
| K142418 |
08/28/2014 |
I.T.S. Hand Locking Plates System - HLS |
I.T.S. GmbH |
Al Lippincott |
| K142135 |
08/04/2014 |
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION |
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC |
JAN TRIANI |
| K142351 |
08/22/2014 |
25-Hydroxy Vitamin Ds EIA |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
Mick Henderson |
| K142244 |
08/13/2014 |
CLEO PATIENT MONITOR |
INFINIUM MEDICAL |
SULEYMAN BILGUTAY |
| K142192 |
08/11/2014 |
Insightra Freedom Ventral Hernia Repair System |
Insightra Medical |
Neerav Parikh |
| K142238 |
08/13/2014 |
MAYFIELD Skull Clamp |
INTEGRA LIFESCIENCES CORPORATION |
Brian Hoy |
| K142414 |
08/28/2014 |
Miltex N-Tralig Intraligamentary Syringe |
INTEGRA LIFESCIENCES CORPORATION |
Judith E. O'Grady |
| K142389 |
08/27/2014 |
Variolink Esthetic |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K142374 |
08/26/2014 |
ivWatch Model 400 |
ivWatch, LLC |
Javier Garriz |
| K142344 |
08/22/2014 |
DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System |
IZI MEDICAL PRODUCTS LLC |
QIANG CAO |
| K142360 |
08/25/2014 |
Everest Spinal System |
K2M, Inc |
Nancy Giezen |
| K142212 |
08/12/2014 |
Pyrenees Cervical Plate System |
K2M, Inc |
Nancy Giezen |
| K142179 |
08/08/2014 |
D-KAT Z-YPE |
KEELER LTD. |
EUGENE R VAN ARSDALE |
| K142330 |
08/20/2014 |
Kobold Ring and Tandem Applicator Set |
KOBOLD, LLC |
Spencer Fillmore |
| K142197 |
08/11/2014 |
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 |
KONICA MINOLTA INC. |
SHIGEYUKI KOJIMA |
| K142393 |
08/27/2014 |
PREDICATE III GUIDEWIRE |
LAKE REGION MEDICAL |
MATHEW PEXA |
| K142397 |
08/27/2014 |
Predicate III Guidewire |
Lake Region Medical |
Mathew Pexa |
| K142246 |
08/14/2014 |
LightStim for Acne/ LightStim for Acne Mini |
LED INTELLECTUAL PROPERTIES, LLC |
Steve Marchese |
| K142359 |
08/25/2014 |
Vasc Band hemostat |
Lepu Medical Technology (Beijing) Co., LTD |
Kim Xiangdan |
| K142253 |
08/14/2014 |
SOLSTICE OCT System |
LIFE SPINE, INC |
Randy Lewis |
| K142326 |
08/20/2014 |
HP Tissue Matrix |
LifeCell Corporation |
Mira Leiwant |
| K142172 |
08/07/2014 |
LIGHTMED TRUSCAN 577 |
LIGHTMED CORP. |
ANGEL HSIEH |
| K142139 |
08/05/2014 |
SMR 40MM GLENOSPHERE |
LIMACORPORATE S.P.A. |
STEPHEN PEOPLES |
| K142386 |
08/27/2014 |
Operating Room Light Handle Adapter |
Litex Manufacturing, Inc. |
Noel Gharibian |
| K142215 |
08/12/2014 |
Power Twin21-50/Power Twin21-100 |
LIVETEC GMBH |
Klaus Reichebach |
| K142420 |
08/28/2014 |
Patient Positioning Devices |
MACROMEDICS BV |
C de Keijzer |
| K142394 |
08/27/2014 |
Masimo Root Monitoring System and Accesories |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K142125 |
08/04/2014 |
New Medax Biopsy Systems |
MEDAX SRL UNIPERSONALE |
Stefano Cavalieri |
| K142167 |
08/06/2014 |
MEDENTIKA ABUTMENT SYSTEM |
MEDENTIKA GMBH |
LINDA SCHULZ |
| K142258 |
08/14/2014 |
PolyCatch Retrieval Device |
Medi-Globe Corporation |
Scott Karler |
| K142303 |
08/18/2014 |
NeumoFilt Ergo/Neumo Filt BiteOn |
Medical Respiratory Devices S.L. |
Jose Alberto Hernandez |
| K142163 |
08/06/2014 |
MALE CIRCUMCISION KITS:RAPIDECLAMP |
MEDICFIT TECHNOLOGY SDN BHD |
JIGAR SHAH |
| K142345 |
08/22/2014 |
Talos-C(HA) Cervical Intervertebral Body Fusion Devices |
MEDITECH SPINE, LLC |
JASON GROMEK |
| K142096 |
08/01/2014 |
T-PIECE RESUSCITATOR |
MERCURY MEDICAL |
PAUL DRYDEN |
| K142265 |
08/15/2014 |
ONE Snare Endovascular Microsnare System |
MERIT MEDICAL SYSTEMS, INC. |
Mark Mullaney |
| K142162 |
08/06/2014 |
MERITS TRANSFORMER POWER SCOOTER, S941 |
MERITS HEALTH PRODUCTS CO., LTD. |
VINCENT CHEN |
| K142119 |
08/04/2014 |
PROCOTYL L-O ACETABULAR SYSTEM |
MICROPORT ORTHOPEDICS INC. |
BYRON LEDBETTER |
| K142105 |
08/01/2014 |
ELI 380 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC |
AMY YANG |
| K142342 |
08/21/2014 |
NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Nacrous Plastic Co., Ltd |
WANG LI |
| K142104 |
08/01/2014 |
NANOFUSE DBM |
NANOTHERAPEUTICS, INC. |
DORIS SNOW |
| K142275 |
08/15/2014 |
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens |
NEO VISION CO., LTD. |
Kyung Hwa Kim |
| K142419 |
08/28/2014 |
Mini and Micro Fragments Reconstruction System-NEOFIX |
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
Mariana de Oliveira Quinzani |
| K142388 |
08/27/2014 |
Neo Total Knee System |
New Era Orthopedics, LLC |
Craig Corrance |
| K142286 |
08/18/2014 |
NS3000 Holmium Laser System |
New Star Lasers, Inc. |
Natalie Vollrath |
| K142260 |
08/14/2014 |
NobelActive |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K142424 |
08/29/2014 |
DR300 HOLTER MONITOR |
NORTH EAST MONITORING INC. |
SHERRY STEELE |
| K142220 |
08/12/2014 |
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) |
NOVA BIOMEDICAL CORPORATION |
Paul W. MacDonald |
| K142111 |
08/04/2014 |
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE |
NOVATSEP |
GILLES AUDIC |
| K142439 |
08/29/2014 |
Martinez Prostate Template Set |
Nucletron BV |
Rudolf Vos |
| K142205 |
08/11/2014 |
NuVasive X-CORE(R) Expandable VBR System |
NUVASIVE, INC. |
OLGA LEWIS |
| K142299 |
08/18/2014 |
CoRoent Small Interlock System |
NUVASIVE, INCORPORATED |
Cynthia Adams |
| K142328 |
08/20/2014 |
nvc |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
BRIAN KIESER |
| K142201 |
08/11/2014 |
OMNI Interface Acetabular System |
OMNLIFE SCIENCE |
Vani Sindwani |
| K142209 |
08/11/2014 |
Pulse oximeter NBM-200 |
ORSENSE LTD |
Aharon Weinstein |
| K142146 |
08/05/2014 |
IBIS PEDICLE SCREW SYSTEM |
ORTHO DEVELOPMENT CORP. |
MIKE ENSIGN |
| K142339 |
08/21/2014 |
HEMASORB Resorbable Hemostatic Bone Putty |
ORTHOCON, LLC |
Howard L Schrayer |
| K142152 |
08/06/2014 |
CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM |
ORTHOFIX, INC. |
NATALIA VOLOSEN |
| K142148 |
08/05/2014 |
ORTHOHELIX STAPLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
BRIAN HOCKETT |
| K142141 |
08/05/2014 |
STARBAND, STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
DAVID L.HOOPER |
| K142090 |
08/01/2014 |
REBOSSIS |
ORTHOREBIRTH CO., LTD. |
KEVIN A.THOMAS |
| K142358 |
08/25/2014 |
Osstell IDx |
OSSTELL AB |
KARIN BREDING |
| K142321 |
08/19/2014 |
Benchmark Intracranial Access System |
PENUMBRA, INC. |
Michaela Mahl |
| K142273 |
08/15/2014 |
EmboGuide |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
Liselotte Kornmann |
| K142126 |
08/04/2014 |
EP NAVIGATOR REL. 5.0 |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LISELOTTE KORNMANN |
| K142430 |
08/29/2014 |
LIFEPAK 15 monitor/defibrillator |
PHYSIO-CONTROL, INC. |
Sylvia Lemke |
| K142438 |
08/29/2014 |
Nerve Monitoring Cable System |
Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) |
Sarah McIntyre |
| K142408 |
08/28/2014 |
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
POLYMED THERAPEUTICS, INC |
FRANK LUO |
| K142302 |
08/18/2014 |
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis |
Polymer Technology Systems, Inc. |
Jack Rogers |
| K142282 |
08/15/2014 |
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) |
PRECEPTIS MEDICAL |
KEITH LELAND |
| K142378 |
08/26/2014 |
Interspinous Plate System |
Precision Spine, Inc. |
Michael C. Dawson |
| K142118 |
08/04/2014 |
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE |
PRISMATIK DENTALCRAFT, INC. |
BRANDON SHEPARD |
| K142115 |
08/04/2014 |
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT |
PRISMATIK DENTALCRAFT, INC. |
BRANDON SHEPARD |
| K142190 |
08/08/2014 |
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs |
PT MEDISAFE TECHNOLOGIES |
Anil Taneja |
| K142366 |
08/25/2014 |
Puritan OptiTranz Liquid Stuart Collection and Transport System |
PURITAN MEDICAL PRODUCTS LLC |
Mehdi Karamchi |
| K142222 |
08/13/2014 |
NewTom 5G |
QR S.r.l. |
Lorenzo Bortolotti |
| K142384 |
08/26/2014 |
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) |
QUALIMED SRL |
Tereza Uhrova |
| K142262 |
08/14/2014 |
AUTION CHECK PLUS |
QUANTIMETRIX CORP. |
KALYNA SNYLYK |
| K142181 |
08/08/2014 |
RANDOX ALDOLASE CALIBRATION SERUM |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K142123 |
08/04/2014 |
REACH ACCESS TELEMEDICINE DOSE CALCULATOR |
REACH HEALTH, INC. |
BETH DESTASIO |
| K142304 |
08/18/2014 |
Viberect Penile Vibratory Stimulation Device |
REFLEXONIC, LLC |
Kambiz Tajkarimi |
| K142269 |
08/15/2014 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M Berry |
| K142217 |
08/12/2014 |
Reliance Interspinous Plate System |
Reliance Medical Systems, LLC |
Jeremy Alsup |
| K142095 |
08/01/2014 |
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM |
Renovis Surgical Technologies, Inc. |
Sharyn Orton |
| K142211 |
08/12/2014 |
OT EQUATOR |
Rhein '83 SRL |
Claudia Nardi |
| K142127 |
08/04/2014 |
ELECSYS ESTRADIOL III CALCHECK 5 |
Roche Diagnostics |
KELLI TURNER |
| K142133 |
08/04/2014 |
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM |
Roche Diagnostics |
Sarah Baumann |
| K142089 |
08/01/2014 |
ACCU-CHEK AVIVA EXPERT SYSTEM |
ROCHE DIAGNOSTICS CORPORATION |
Greg Mondics |
| K142422 |
08/28/2014 |
cobas Cdiff Test |
ROCHE MOLECULAR SYSTEMS, INC. |
Wilk von Gustedt |
| K142159 |
08/06/2014 |
DISPOSABLE PRE-GELLED SURFACE ELECTRODE |
ROCHESTER ELECTRO MEDICAL, INC. |
WAYNE GLOVER |
| K142352 |
08/22/2014 |
CardiacLinx |
Ross Medical Technology, Inc |
ALEXANDER CHIU |
| K142243 |
08/13/2014 |
LessRay with Tracking |
SAFERAY SPINE, LLC |
Michael Alrutz |
| K142416 |
08/28/2014 |
Luma Wrap |
Salter Labs |
Aurelia Browndridge |
| K142249 |
08/14/2014 |
SCHOELLY SINUSCOPE |
SCHOELLY FIBEROPTIC GMBH |
SANDRA BAUMANN |
| K142180 |
08/08/2014 |
TELESENSE |
SCOTTCARE CORPORATION |
SNEHRAJ MERCHANT |
| K142156 |
08/06/2014 |
SEEGENE ANYPLEX II HSV-1/2 ASSAY |
SEEGENE |
FRAN WHITE |
| K142241 |
08/13/2014 |
LARIAT sulture Delivery Device |
SENTREHEART INC. |
Kit Cariquitan |
| K142263 |
08/14/2014 |
Applanation Tonometer |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. |
Weida Zhan |
| K142186 |
08/08/2014 |
DIODE LASER HAIR REMOVAL SYSTEM |
SHENZHEN GSD TECH. CO., LTD. |
Diana Hong |
| K142341 |
08/21/2014 |
X-RAY TV SYSTEM SONIALVISION G4 |
SHIMADZU CORP. |
TOSHIO KADOWAKI |
| K142434 |
08/29/2014 |
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K142395 |
08/27/2014 |
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Shelly Pearce |
| K142436 |
08/29/2014 |
3S Safety Insulin Syringe |
Sincere Medical Device Co., Ltd. |
Garfield Wang |
| K142435 |
08/29/2014 |
3S Safety Syringe with/without Needle |
Sincere Medical Device Co., Ltd. |
Garfield Wang |
| K142091 |
08/01/2014 |
PARIETENE MACROPOROUS MESH |
SOFRADIM PRODUCTION |
JENNIFER BRENNAN |
| DEN140024 |
08/18/2014 |
cNEP Airway |
Sommetrics |
Richard Rose |
| K142221 |
08/12/2014 |
MEMO 3D ReChord |
SORIN GROUP ITALIA S.R.L |
MAURO ERCOLANI |
| K142116 |
08/04/2014 |
LLD EZ |
SPECTRANETICS, INC. |
PHAROAH GARMA |
| K142101 |
08/01/2014 |
ABACUS (TM) SPACER SYSTEM |
SPINE WAVE, INC. |
ROAIDA JOHNSON |
| K142277 |
08/15/2014 |
JULIET PO |
SPINEART |
Franck Pennesi |
| K142213 |
08/12/2014 |
VIA SPINOUS PROCESS FIXATION SYSTEM |
SPINEOLOGY, INC. |
TIM CRABTREE |
| K142272 |
08/15/2014 |
SNaP Wound Care System |
SPIRACUR, INC. |
Lawrence Hu |
| K142235 |
08/13/2014 |
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter |
St. Jude Medical |
ZACHARY PRICE |
| K142239 |
08/13/2014 |
CPS Direct MediGuide Enabled outer catheter |
St. Jude Medical |
Geena George |
| K142254 |
08/14/2014 |
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector |
St. Jude Medical |
Geena George |
| K142130 |
08/04/2014 |
ORAL BOND |
STEINER LABORATORIES |
GREGORY G STEINER |
| K142109 |
08/04/2014 |
STERILUCENT STERILIZATION CONTAINER SYSTEM |
STERILUCENT, INC |
PETER KALKBRENNER |
| K142407 |
08/28/2014 |
Straight Stud Attachment |
Sterngold Dental, LLC |
Maria Rao |
| K142381 |
08/26/2014 |
Xia 3 Spinal System |
STRYKER CORP. |
GARRY T HAYECK |
| K142237 |
08/13/2014 |
Aviator Anterior Cervical Plate (ACP) System |
Stryker Corporation |
Soraya King |
| K142251 |
08/14/2014 |
AVS AS PEEK Spacer |
Stryker Corporation |
Garry T Hayeck |
| K142114 |
08/04/2014 |
XIA 4.5 SPINAL SYSTEM |
STRYKER CORPORATION |
GARRY T HAYECK, PH.D. |
| K142310 |
08/19/2014 |
Stryker Infrared Fluorescence (IRF) Imaging System |
Stryker Endoscopy |
Golnaz Moeini |
| K142142 |
08/05/2014 |
QUALITY REPORTS |
SUN NUCLEAR CORPORATION |
JAMES LUKER |
| K142431 |
08/29/2014 |
WaterProof PROFILER |
SUN NUCLEAR CORPORATION |
NOEL DOWNEY |
| K142100 |
08/01/2014 |
AIXPLORER |
SUPERSONIC IMAGINE |
AURELIE GRUENER |
| K142290 |
08/18/2014 |
KangLi pedical screw spinal system |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
Jin Hua Huang |
| K142242 |
08/13/2014 |
PREMIUM, SHELTA Implant Systems |
SWEDEN & MARTINA S.P.A. |
GLORIANNA ZANGIACOMI |
| K142309 |
08/19/2014 |
GEM Flow COUPLER Device and System |
Synovis Life Technologies, Inc. |
Troy Thome |
| K142371 |
08/25/2014 |
Luminesse PMMA |
TALLADIUM, INC. |
Elina Faskhutdinova |
| K142343 |
08/21/2014 |
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) |
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD |
RJ WANG |
| K142103 |
08/01/2014 |
CUFF PILOT, SURE SEAL |
Teleflex Medical, Inc. |
PAUL DRYDEN |
| K142153 |
08/06/2014 |
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML |
Teleflex Medical, Inc. |
JAMES A COCHIE |
| K142138 |
08/05/2014 |
ISO-GARD MASK |
Teleflex Medical, Inc. |
BRIAN GALL |
| K142349 |
08/22/2014 |
TM eCloud ECG Analysis System |
Telemed Solutions, Inc. |
Ken Burns |
| K142183 |
08/08/2014 |
GLIDESHEATH SLENDER |
Terumo Medical Corporation |
Erin Doyle |
| K142151 |
08/06/2014 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
Cynthia Knapp |
| K142338 |
08/21/2014 |
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K142417 |
08/28/2014 |
SP-1PSpecular Microscope |
TOPCON CORPORATION |
Michael Gusel |
| K142182 |
08/08/2014 |
FRIMAP ADAPTER CONNECTOR (MAC) |
TOPERA, INC. |
DENNIS POZZO |
| K142208 |
08/11/2014 |
Monopolar Laparascopic Accessories |
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. |
Weizhong Chen |
| K142248 |
08/14/2014 |
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. |
Georgiann Keyport |
| K142230 |
08/13/2014 |
Apollo Suture Anchor System and Titan Screws |
Valeris Medical |
Daniel Lanois |
| K142268 |
08/15/2014 |
Varian Verification System (VVS) |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
| K142136 |
08/04/2014 |
ACCUCATH MIDLINE CATHETER SYSTEM |
VASCULAR PATHWAYS, INC. |
SCOTT PEASE |
| K142377 |
08/26/2014 |
The OnControl Bone Marrow Biopsy System by Vidacare |
VIDACARE LLC |
DIANA MONTEZ |
| K142093 |
08/01/2014 |
V20 SYSTEM |
VIORA LTD. |
OMRI KESLER |
| K142196 |
08/11/2014 |
Visage Ease Pro |
VISAGE IMAGING GMBH |
Stefan Strowich |
| K142236 |
08/13/2014 |
BioniCare Hand System |
VISION QUEST INDUSTRIES, INC. |
MOHAMED OUERGHI |
| K142353 |
08/21/2014 |
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test |
W.H.P.M., Inc. |
John Wan |
| K142187 |
08/08/2014 |
LINK MP RECONSTRUCTION PROSTHESIS |
WALDEMAR LINK GMBH & CO. KG |
THOMAS MEHLER |
| K142356 |
08/25/2014 |
Connex Spot Monitor,901058 Vital Signs Monitor Core |
WELCH ALLYN, INC. |
Kevin Crossen |
| K142149 |
08/05/2014 |
OXYTOTE INFINITY SERIES VIPR SYSTEMS |
WESTERN/SCOTT FETZER CO. |
DAVID C SIMO |
| K142233 |
08/13/2014 |
zenostar MO, Zenostar T, Zenostar VisualiZr |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
Betina Kistner |
| K142144 |
08/05/2014 |
DISPOSABLE INJECTION NEEDLE |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED |
LIJUAN ZHANG |
| K142385 |
08/27/2014 |
Whisper Pump System |
Wound RX Medical, LLC |
Richard Deslauriers |
| K142117 |
08/04/2014 |
INVISION TOTAL ANKLE REVISION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K142121 |
08/04/2014 |
VALOR HINDFOOT FUSION NAIL SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
| K142297 |
08/18/2014 |
Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set |
XERIDIEM (FORMERLY MRI) |
Jesus Valencia |
| K142283 |
08/15/2014 |
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
Arivalagan Subramaniam |
| K142392 |
08/27/2014 |
Zavation Posterior LEIF |
ZAVATION, LLC |
LAWERENCE WALKER |
| K142271 |
08/15/2014 |
Zavation Z-Link Lumbar |
Zavation, LLC |
Lawrence Walker |
| K142206 |
08/11/2014 |
Dental Unit |
Zhuhai Siger Medical Equipment Co., Ltd |
Huisheng Wang |
| K142403 |
08/27/2014 |
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System |
ZIMMER GMBH |
Roberto Tommasini |
| K142281 |
08/15/2014 |
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM |
ZIMMER, INC. |
PATRICK MCCULLAGH |
