| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K133769 |
12/11/2013 |
3B RESMART BPAP 25A, BMC RESMART BPAP 25A |
3B MEDICAL, INC |
ALEX LUCIO |
| K133776 |
12/12/2013 |
A-DEC/W&H ELECTRIC HANDPIECE MOTOR |
A-DEC, INC. |
BONNIE DUNDAS |
| K130255 |
02/01/2013 |
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS |
ABBOTT LABORATORIES |
JUDITH R WALLACH |
| K130284 |
02/05/2013 |
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
QIYI XIE |
| K133789 |
12/12/2013 |
DOLPHIN NEUROSTIM OTC |
ACUMED MEDICAL LTD. |
RICHARD KEEN |
| K130329 |
02/11/2013 |
SURGISEAL TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
| K130474 |
02/25/2013 |
SURGISEAL TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
| K133963 |
12/24/2013 |
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
| K130525 |
02/28/2013 |
OCCLUSION PERFUSION CATHETER |
ADVANCED CATHETER THERAPIES, INC. |
CHRIS HENZA |
| K130263 |
02/04/2013 |
STERRAD 50/100S/200 TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K133898 |
12/20/2013 |
NIOX VERO AIRWAY INFLAMMATION MONITOR |
AEROCRINE AB |
Susanne Parks |
| K133802 |
12/13/2013 |
AIS MODULIFT VBR SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K130291 |
02/06/2013 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K133890 |
12/20/2013 |
AESCULAP OPTILENE NONABSORBABLE SUTURE |
AESCULAP, INC. |
KATHY A RACOSKY |
| K130313 |
02/07/2013 |
CYTOSCAN(R) DX |
AFFYMETRIX, INC. |
ERIC FUNG |
| DEN130018 |
12/18/2013 |
CYTOSCAN(R) DX |
Affymetrix, Inc. |
ERIC FUNG |
| K133851 |
12/19/2013 |
ALERE PBP2A SA/CONS CULTURE COLONY TEST |
ALERE SCARBOROUGH, INC |
DANIELLE A BRIGGEMAN |
| K130401 |
02/19/2013 |
ALERTWATCH: OR |
ALERTWATCH LLC |
DONNA-BEA TILLMAN |
| K130409 |
02/19/2013 |
ALIVECOR HEART MONITOR |
ALIVECOR, INC. |
MICHAEL RIGHTER |
| K133991 |
12/26/2013 |
ISY |
ALTATEC GMBH |
LINDA SCHULZ |
| K130504 |
02/27/2013 |
ASA ORAL APPLIANCES |
AMERICAN SLEEP ASSOCIATION |
KAREN E WARDEN, PHD |
| K133783 |
12/12/2013 |
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION |
AMERIWATER |
BRIAN R BOWMAN |
| K133685 |
12/02/2013 |
0.9% SODIUM CHLORIDE FLUSH SYRINGE |
AMUSA |
ALEX FERRI |
| K133770 |
12/11/2013 |
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE |
ANCHOR INNOVATION MEDICAL (A.I.M.) |
KAREN M BECKER, PH.D. |
| K133790 |
12/09/2013 |
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM |
ANDON HEALTH CO., LTD |
YI LIU |
| K133998 |
12/26/2013 |
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K130510 |
02/27/2013 |
ARTHREX COMPRESSION PLATES |
ARTHREX, INC. |
IVETTE GALMEZ |
| K133854 |
12/19/2013 |
ARTHREX IBALANCE TKA SYSTEM |
ARTHREX, INC. |
LEON BROWN, II |
| K130458 |
02/22/2013 |
KNOTLESS FIBERTAK SUTURE ANCHOR |
ARTHREX, INC. |
CHRISTINA FLORES |
| K133727 |
12/06/2013 |
Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU |
ARTHROCARE CORPORATION |
MITCHELL DHORITY |
| K133835 |
12/18/2013 |
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K133924 |
12/23/2013 |
ENDOLUMINAL OCCLUSION SYSTEM (EOS) |
ARTVENTIVE MEDICAL GROUP, INC |
Roberta Hines |
| K133865 |
12/19/2013 |
ASAHI GAIA FIRST, SECOND, THIRD |
ASAHI INTECC CO., LTD. |
CANDACE CEDERMAN |
| K133891 |
12/20/2013 |
MULTIPULSE TM+1470 |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K130520 |
02/28/2013 |
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR |
ASHITAKA FACTORY OF TERUMO CORP. |
EILEEN DORSEY |
| K133742 |
12/09/2013 |
XQ-1 INCUBATOR |
AT MEDICAL UAB |
THOMAS PEDERSEN |
| K130521 |
02/28/2013 |
ISOLATOR LINEAR PEN |
ATRICURE, INC. |
REBECCA WALTERS |
| K130514 |
02/27/2013 |
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT |
AUDIFON-USA INC. |
JANE E PERRONE |
| K130417 |
02/19/2013 |
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S |
AUDIFON-USA INC. |
JANE E PERRONE |
| K133967 |
12/24/2013 |
INTERBODY CAGE SYSTEM |
AURORA SPINE |
JUSTIN EGGLETON |
| K133981 |
12/26/2013 |
AVACEN 100 |
AVACEN INC. |
THOMAS G MUEHLABUER |
| K133764 |
12/11/2013 |
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL |
AVERY DENNISON BELGIE, BVBA |
LISA BARTAKOVICS |
| K130498 |
02/26/2013 |
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
BACTERIN INTERNATIONAL INC. |
HOWARD L SCHRAYER |
| K133994 |
12/26/2013 |
SIVR56-T KIT |
BARCO N.V. |
LIEVEN DE WANDEL |
| K133984 |
12/26/2013 |
CORONIS 5MP |
BARCO NV |
LIEVEN DE WANDEL |
| K133948 |
12/23/2013 |
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT |
BARD PERIPHERAL VASCULAR, INC. |
SARAH MCCARTNEY |
| K133743 |
12/09/2013 |
BAXANO SURGICAL MIS SPINAL SYSTEM |
BAXANO SURGICAL, INC. |
KRISTEN ALLEN |
| K133801 |
12/13/2013 |
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY |
BAXTER HEALTHCARE CORPORATION |
THOMAS SAMPOGNA |
| K130265 |
02/04/2013 |
CONTOUR NEXT EZ BLOOD GLUCOSE METER |
BAYER HEALTHCARE LLC |
JENNIFER GREGORY |
| K130373 |
02/14/2013 |
NAVIOS FLOW CYTOMETER SYSTEM |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K130253 |
02/01/2013 |
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K130268 |
02/04/2013 |
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
EMILY HOWARD |
| K133975 |
12/26/2013 |
MSA100 PEAK FLOW METER |
BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD |
MIKE GU |
| K133915 |
12/23/2013 |
GALAXY CO2 LASER SYSTEM |
BEIJING TOPLASER TECHNOLOGY CO., LTD. |
ZHANG XIAOSONG |
| K133873 |
12/20/2013 |
TRIBALL INCENTIVE SPIROMETER |
BESMED HEALTH BUSINESS CORP. |
PAUL DRYDEN |
| K133774 |
12/12/2013 |
ATOVEN |
BIO-MED U.S.A., INC. |
YOUNG CHI |
| K134013 |
12/30/2013 |
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K133960 |
12/24/2013 |
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K133884 |
12/20/2013 |
BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM |
BIODENTA SWISS AG |
DAVID EILER |
| K130465 |
02/25/2013 |
EPIC 10S |
BIOLASE TECHNOLOGY, INC. |
COLLEEN BOSWELL |
| K130324 |
02/08/2013 |
STATSEAL DISC |
BIOLIFE, LLC |
CLAUDIA MASSELINK |
| K133844 |
12/18/2013 |
SPEED TRIAD |
BIOMEDICAL ENT., INC. |
JOE SOWARD |
| K133780 |
12/12/2013 |
SPEED XL |
BIOMEDICAL ENT., INC. |
JOE SOWARD |
| K133817 |
12/16/2013 |
VITEK 2 AST - YEAST FLUCONAZOLE |
BIOMERIEUX, INC. |
JOCELYN JENNINGS |
| K133952 |
12/23/2013 |
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE |
BIOMERIEUX, INC. |
CHARLENE FERRAND |
| K133939 |
12/23/2013 |
MODIFIED DISTAL RADIUS PLATING SYSTEM |
BIOMET |
SUZANA OTANO |
| K130310 |
02/07/2013 |
CERTAIN BELLATEK PROVISIONAL ABUTMENTS |
BIOMET 3I |
JACQUELYN A HUGHES, RAC |
| K130390 |
02/15/2013 |
COMPREHENSIVE CONVERTIBLE GLENOID |
BIOMET MANUFACTURING, INC. |
PATRICIA SANDBORN BERES |
| K130309 |
02/07/2013 |
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM |
BIOMET MICROFIXATION |
CHRISTINE SCIFERT |
| K133746 |
12/09/2013 |
POLARIS SPINAL SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY, MS, RAC |
| K133940 |
12/23/2013 |
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) |
BIOMET UK LTD. |
JASON HECKAMAN |
| K130428 |
02/20/2013 |
COVAMESH |
BIOMUP S.A. |
VALERIE CENTIS |
| K130322 |
02/08/2013 |
SPM-300 |
BIONET CO., LTD. |
MARC GOODMAN |
| K130298 |
02/07/2013 |
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM |
BIOPRO, INC. |
AL LIPPINCOTT |
| K133950 |
12/23/2013 |
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) |
BIORETEC LTD. |
MINNA RASANEN |
| K133733 |
12/06/2013 |
WINSIX Implant System |
BIOSAF IN S.R.L. |
MAURIZIO PANTALEONI |
| K133916 |
12/23/2013 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K134037 |
12/31/2013 |
PREMVIA |
BIOTIME, INC. |
DAVID C FURR |
| K133684 |
12/02/2013 |
ULTRABLOX |
BLOXR CORPORATION |
RAI CHOWDHARY |
| K130483 |
02/25/2013 |
BOEHRINGER GASTRIC SIZING TUBE |
BOEHRINGER LABORATORIES, LLC |
CHRISTOPHER RADL, ENGINEERING |
| K130391 |
02/15/2013 |
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT |
BOSTON SCIENTIFIC CORP. |
VICKY L HAGENS |
| K130484 |
02/25/2013 |
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER |
BOSTON SCIENTIFIC CORP. |
ANDREW NGUYEN |
| K133700 |
12/03/2013 |
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS |
Boston Scientific Corporation |
ELENA NIEVES |
| K133987 |
12/26/2013 |
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES |
Boston Scientific Corporation |
JANIS F TARANTO |
| K130382 |
02/14/2013 |
HEARTSTRING III PROXIMAL SEAL SYSTEM |
Boston Scientific Corporation |
MARK DINGER |
| K133933 |
12/23/2013 |
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER |
Boston Scientific Corporation |
ASHLEY SANTOS |
| K133750 |
12/09/2013 |
OCCLUDER OCCLUSION BALLOON CATHETER |
Boston Scientific Corporation |
CHRISTINE SHOEMAKER |
| K134031 |
12/31/2013 |
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER |
Boston Scientific Corporation |
VICKY L HAGENS |
| K134054 |
12/31/2013 |
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR |
BOVIE MEDICAL CORPORATION |
RICHARD A KOZLOFF |
| K130294 |
02/06/2013 |
BRAEMAR CARDIOKEY HOLTER RECORDER |
BRAEMAR MANUFACTURING LLC |
KENT SAYLER |
| K133697 |
12/03/2013 |
BREAST-MED TISSUE MARKER |
BREAST-MED, INC. |
MICHAEL NELSON |
| K133852 |
12/19/2013 |
APOLLO BALLOON DILATATION CATHETER |
BROSMED MEDICAL |
STEPHEN LEE |
| K134040 |
12/31/2013 |
BTL-9000; BTL-9000 RADIOFREQUENCY MODULE |
BTL INDUSTRIES LTD |
MICHAIL M PANKRATOV |
| K130366 |
02/13/2013 |
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT |
C.R. BARD, INC. |
Joni Creal |
| K133856 |
12/19/2013 |
POWERGLIDE MIDLINE CATHETER |
C.R. BARD, INC. |
CASEY COOMBS |
| K134010 |
12/30/2013 |
CABOCHON SYSTEM |
CABOCHON AESTHETICS, INC. |
BEN F BRIAN, PH.D. |
| K134038 |
12/31/2013 |
CAMBER SPINE DIAGON OBLIQUE CAGE |
CAMBER SPINE |
DANIEL A PONTECORVO |
| K133693 |
12/03/2013 |
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS |
CANON, INC. |
DIANE RUTHERFORD |
| K130288 |
02/05/2013 |
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE |
CARDIAC INSIGHT, INC. |
DEBORAH SHEFFIELD |
| K130404 |
02/19/2013 |
TIBURON SURGICAL DRAPE |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K134044 |
12/31/2013 |
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM |
CARDIOTEK, B.V. |
MELISSA WALKER |
| K133999 |
12/27/2013 |
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS, INC. |
BLAIR BUTH |
| K133925 |
12/23/2013 |
VYNTUS/ SENTRYSUITE PRODUCT LINE |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K130464 |
02/22/2013 |
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR |
CARESTREAM HEALTH,INC. |
CAROLYN WAGNER |
| K133823 |
12/17/2013 |
NUFACE MINI DEVICE |
Carol Cole Company |
Rand Daoud |
| K130411 |
02/19/2013 |
740 SELECT |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K133879 |
12/20/2013 |
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K134004 |
12/27/2013 |
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE |
CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS |
LOLITA D FORBES |
| K130307 |
02/07/2013 |
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE |
CELONOVA BIOSCIENCES, INC. |
NICOLE BARBER |
| K133869 |
12/20/2013 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT |
CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) |
HYE-JOO KIM |
| K133758 |
12/11/2013 |
CENTERVUE MACULAR INTEGRITY ASSESSMENT |
CENTERVUE SPA |
ROGER GRAY |
| K130461 |
02/22/2013 |
STALIF X |
CENTINEL SPINE INC. |
JUSTIN EGGLETON |
| K134011 |
12/30/2013 |
GENERAL SPINAL SYSTEM |
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
Diana Hong |
| K130439 |
02/21/2013 |
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING |
CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD |
FIELD FU |
| K130481 |
02/25/2013 |
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK |
CIRCADIANCE LLC |
RYAN T KASUN |
| K133870 |
12/20/2013 |
FLUID LEVEL MONITOR |
COLEMAN LABORATORIES |
LE-JUN YIN |
| K130482 |
02/25/2013 |
COMBAT READY CLAMP |
COMBAT MEDICAL SYSTEMS, LLC |
Calley Herzog |
| K133703 |
12/03/2013 |
PHYSIOGLOVE ET SYSTEM |
COMMWELL R&D LTD. |
JONATHON KAHAN |
| K133919 |
12/23/2013 |
CONSENSUS VITALITE TIBIAL INSERT |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW M HULL |
| K130360 |
02/13/2013 |
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION |
CONSTANT CARE, LLC |
SETH A MAILHOT |
| K130420 |
02/19/2013 |
SOLEA |
CONVERGENT DENTAL, INC |
Carrie Hetrick |
| K133788 |
12/12/2013 |
COOK HOLMIUM LASER FIBER |
COOK INCORPORATED |
DAVID CHADWICK |
| K130293 |
02/06/2013 |
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
DAVID E CHADWICK |
| K130444 |
02/21/2013 |
H-30 HOLMIUM LASER SYSTEM |
COOK, INC. |
SUSANNE GALIN |
| K133843 |
12/18/2013 |
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER |
CORDIS CORPORATION |
KIM FONDA |
| K130343 |
02/11/2013 |
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS |
CORIN U.S.A. |
DIANA L MARTONE |
| K133701 |
12/03/2013 |
NUVANT MCT SYSTEM |
CORVENTIS, INC. |
CHERYL SWANSON |
| K133889 |
12/20/2013 |
PREMIUM |
COUSIN BIOTECH S.A.S. |
FRANCK PELLETIER |
| K130320 |
02/08/2013 |
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW |
COVIDIEN |
ELIZABETH MALO |
| K133938 |
12/23/2013 |
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY |
COVIDIEN |
JOSE MARQUEZ |
| K133821 |
12/16/2013 |
EMPRINT ABLATION SYSTEM |
Covidien LLC |
HEATHER V NIGRO |
| K133762 |
12/11/2013 |
ENDO GIA(TM) EXTRA LONG ADAPTER |
Covidien LLC |
DEBRA PEACOCK |
| K130357 |
02/13/2013 |
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH |
Covidien LLC |
KRISTEN SWANSON |
| K130435 |
02/21/2013 |
VERSAPORT V2 BLADELESS OPTICAL TROCAR |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
SARAH RIZK |
| K133945 |
12/23/2013 |
CUTERA PICOSECOND LASER SYSTEM |
CUTERA, INC. |
BRADLEY RENTON |
| K133739 |
12/09/2013 |
TRUSCULPT |
CUTERA, INC. |
BRADLEY RENTON |
| K130315 |
02/08/2013 |
IPULSE HAIR REMOVAL SYSTEM |
CYDEN LIMITED |
DAVID BRODERICK |
| K130431 |
02/21/2013 |
COMPRESSYN BAND |
DALLEN MEDICAL, INC. |
AL MEMMOLO |
| K133858 |
12/19/2013 |
TENSYN BAND |
DALLEN MEDICAL, INC. |
AL MEMMOLO |
| K130349 |
02/12/2013 |
FREEMIE BREAST COLLECTION SYSTEM |
DAO HEALTH |
DAN GARBEZ |
| K130476 |
02/25/2013 |
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE |
DENTAL MORELLI |
LILIAN LLULL |
| K130455 |
02/22/2013 |
430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES |
DENTALEZ GROUP, STARDENTAL DIVISION |
JIM WATKINS |
| K133834 |
12/17/2013 |
DEPUY GLOBAL UNITE SHOULDER SYSTEM |
DEPUY (IRELAND) |
KELLIE MYERS |
| K133794 |
12/13/2013 |
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
TATYANA KORSUNSKY |
| K134055 |
12/31/2013 |
ADX4000W |
DEXCOWIN CO., LTD |
Claude Berthoin |
| K133751 |
12/09/2013 |
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
| K130511 |
02/27/2013 |
CITRISOL ACID CONCENTRATE |
DIASOL, INC. |
MONICA ABELES |
| K130321 |
02/08/2013 |
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS |
DIASORIN |
CAROL DEPOUW |
| K130469 |
02/25/2013 |
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 |
DIASORIN, INC. |
KELLY SAUER |
| K133803 |
12/16/2013 |
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
| K130344 |
02/11/2013 |
DORNIER MEDILAS UROPULSE |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K133786 |
12/12/2013 |
DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID |
DORNOCH MEDICAL SYSTEMS, INC. |
LARRY SMITH |
| K133886 |
12/20/2013 |
PERSEUS A500 |
DRAEGER MEDICAL GMBH |
BETH ZIS |
| K134002 |
12/27/2013 |
6MP COLOR LCD MONITOR, RADIFORCE RX650 |
EIZO CORPORATION |
TOSHIMINE HIRAKI |
| K130336 |
02/11/2013 |
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K133895 |
12/20/2013 |
DEKA SMARTXIDE LASER SYSTEM |
EL.EN. S.P.A |
GEORGE CHO |
| K130301 |
02/07/2013 |
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) |
ELIMEDICAL DEVICES (FUJIAN) INC. |
Diana Hong |
| K130274 |
02/04/2013 |
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
JOHN O'TOOLE |
| K130365 |
02/13/2013 |
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K133747 |
12/09/2013 |
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM |
ENDOCHOICE, INC. |
DANIEL HOEFER |
| K133734 |
12/09/2013 |
SEAL SINGLE-USE BIOPSY VALVE |
ENDOCHOICE, INC. |
JANNA BABSON |
| K130501 |
02/27/2013 |
INTENSIF |
ENDYMED MEDICAL LTD |
YORAM LEVY |
| K130503 |
02/27/2013 |
PATHASSIST LED LIGHT FIBER |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K130354 |
02/12/2013 |
MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) |
ENTRIGUE SURGICAL, INC. |
GABRIELE G NIEDERAUER |
| K130395 |
02/15/2013 |
STEREOS WORKSTATION |
EOS IMAGING INC. |
JOHN J SMITH |
| K133718 |
12/04/2013 |
ZERONA |
ERCHONIA CORPORATION |
Kevin Walls |
| K133722 |
12/05/2013 |
ASTHMA MONITOR AM3 |
ERESEARCH TECHNOLOGY |
RICHARD A MILLER |
| K133905 |
12/23/2013 |
6200 / 6250 ULTRASOUND SYSTEM |
ESAOTE S.P.A. |
Allison Scott |
| K133864 |
12/19/2013 |
DERMABOND PRINEO SKIN CLOSURE SYSTEM |
ETHICON, INC. |
DONNA MARSHALL |
| K130434 |
02/21/2013 |
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC |
EXACTECH, INC. |
PATRICK HUGHES |
| K130524 |
02/28/2013 |
BREATHID HP SYSTEM |
EXALENZ BIOSCIENCE LTD. |
CLAY ANSELMO |
| K133775 |
12/12/2013 |
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING |
EXCITON TECHNOLOGIES INC. |
MELANIE USSYK |
| K133813 |
12/16/2013 |
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE |
EXPANDING ORTHOPEDICS, INC. |
MEREDITH MAY |
| K130339 |
02/11/2013 |
CLINICAL ALERT NOTIFICATION |
EXTENSION , INC |
TIM GEE |
| K130453 |
02/22/2013 |
EXCELSIOR |
EYEKOR, LLC. |
MAUREEN O'CONNELL |
| K130283 |
02/05/2013 |
EVRF SYSTEM |
F CARE SYSTEMS NV |
E. J SMITH |
| K130375 |
02/14/2013 |
SELF-RETAINING BICANALICULUS INTUBATON SET II |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
BARBARA S FANT |
| K134001 |
12/27/2013 |
FIREFLY |
FIRSTKIND LIMITED |
SHEILA HEMEON-HEYER |
| K130328 |
02/11/2013 |
F&P SIMPLUS FULL FACE MASK |
FISHER & PAYKEL HEALTHCARE LIMITED |
SUE CHO |
| K133872 |
12/20/2013 |
ARIA WIFI SMART SCALE |
FITBIT, INC. |
Diane Horwitz |
| K133930 |
12/23/2013 |
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET |
FLOWER ORTHOPEDICS CORPORATION |
GARY BARNETT |
| K130507 |
02/27/2013 |
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER |
FOOTPRINT MEDICAL INC. |
CLYDE N BAKER |
| K133976 |
12/26/2013 |
FUJIFILM ENDOSCOPIC CO2 REGULATOR |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
GINA WALLJASPER |
| K130383 |
02/14/2013 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K133972 |
12/26/2013 |
ASPIRE CRISTALLE |
FUJIFILM MEDICAL SYSTEMS, USA INC. |
PETER ALTMAN |
| K134046 |
12/31/2013 |
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR |
FUKUDA DENSHI USA, INC. |
DOUG BLAKELY |
| K133957 |
12/23/2013 |
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE |
GALEMED CORP. |
PAUL DRYDEN |
| K133807 |
12/16/2013 |
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| DEN130015 |
02/04/2013 |
PIXEL 3 SYSTEM |
GAUSS SURGICAL, INC. |
PEGGY MCLAUGHLIN |
| K133836 |
12/18/2013 |
OPTIGLAZE COLOR |
GC AMERICA INC. |
MARK HEISS |
| K133824 |
12/17/2013 |
CERASMART |
GC AMERICA, INC. |
MARK HEISS |
| K133922 |
12/23/2013 |
GENTLECARE AR APPLICATOR |
GC MEDTECH, LLC |
GREGORY MATHISON |
| K133882 |
12/20/2013 |
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
ROBERT CASARSA |
| K133705 |
12/03/2013 |
REVOLUTION CT |
GE MEDICAL SYSTEMS, LLC |
HELEN PENG |
| K133695 |
12/03/2013 |
TITAN 11 |
GEMSS MEDICAL SYSTEMS CO., LTD |
DAVE KIM |
| K130470 |
02/25/2013 |
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT |
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
PATRICIA DIONNE |
| K130374 |
02/14/2013 |
OMNI-VUE 2 SYSTEM |
GENESIS DIGITAL IMAGING, INC. |
CARL ALLETTO |
| K133911 |
12/23/2013 |
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM |
GENESYS SPINE |
BRIAN J BERGERON |
| K130317 |
02/08/2013 |
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM |
GENESYS SPINE |
WILLIAM W SOWERS |
| K130419 |
02/19/2013 |
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K130516 |
02/27/2013 |
CARDIODAY |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
BERT SCHADOW |
| K130478 |
02/25/2013 |
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS |
GLOBE MEDICAL, INC. |
SARAH MARIE FITZGERALD |
| K130392 |
02/15/2013 |
KINEX BIOACTIVE |
GLOBUS MEDICAL INC. |
SARAH MARIE FITZGERALD |
| K133766 |
12/11/2013 |
HUMICARE D900 |
GRUENDLER GMBH |
JIM CASSI |
| K130311 |
02/08/2013 |
TRANSTEK BODY FAT ANALYZER |
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
LEO WANG |
| K133968 |
12/26/2013 |
WONDFO MULTI-DRUG URINE TEST CUP, PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K133966 |
12/24/2013 |
MODEL-BASED RSA SOFTWARE |
HALIFAX BIOMEDICAL, INC. |
DANIEL KAMM |
| K133719 |
12/05/2013 |
PDE-NEO |
HAMAMATSU PHOTONICS, K.K. |
JEFFREY K SHAPIRO |
| K130517 |
02/27/2013 |
EZ TRANSPORT CHAIR |
HARRIS MEDICAL, LLC |
JAMES WASON, PH.D. |
| K133953 |
12/23/2013 |
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M |
HARTALEGA SDN BHD |
NURUL AISYAH KONG BT ABDULLAH |
| K130473 |
02/22/2013 |
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) |
HARTALEGA SDN BHD |
NURUL AISYAH KONG BT ABDULLAH |
| K133956 |
12/23/2013 |
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K133848 |
12/18/2013 |
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK |
HEARTVISTA, INC. |
JAMES J ROGERS |
| K130512 |
02/27/2013 |
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS |
HEINZ KURZ GMBH MEDIZINTECHNIK |
KRISTINA BITZER |
| K133800 |
12/13/2013 |
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI |
HGI INDUSTIRES |
CONNIE ARAPS, PHD |
| K130308 |
02/07/2013 |
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM |
HITACHI ALOKA MEDICAL, LTD. |
ANGELA VANARSDALE |
| K134016 |
12/30/2013 |
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
ANGELA VANARSDALE |
| K130277 |
02/04/2013 |
SINGLE ENERGY (SE) FEMUR EXAMS |
HOLOGIC, INC. |
EILEEN M BOYLE |
| K133881 |
12/20/2013 |
MACY CATHETER |
HOSPI CORPORATION |
IGAL LADABAUM |
| K130397 |
02/19/2013 |
ARROW GPSCATH BALLOON DILATATION CATHETER |
HOTSPUR TECHNOLOGIES |
ERIC ANKERUD, JD |
| K130361 |
02/13/2013 |
THERMOFINDER; THERMOCARE |
HUBDIC CO., LTD |
MATT HANSEN |
| K130338 |
02/11/2013 |
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS |
IMPEDIMED LIMITED |
John j Smith, M.D., J.D. |
| K133692 |
12/02/2013 |
IMRI 1.5T AND IMRI 3T S |
IMRIS, INC. |
Sanjay Shah |
| K130306 |
02/07/2013 |
INCITE ANCHORED CERVICAL INTERBODY DEVICE |
INCITE INNOVATION LLC |
JOHN KIRWAN |
| K133826 |
12/17/2013 |
INTONEMV |
INCONTROL MEDICAL, LLC |
JESSICA ANDRESHAK |
| K134020 |
12/30/2013 |
INTONEMV |
INCONTROL MEDICAL, LLC |
JESSICA ANDRESHAK |
| K133753 |
12/09/2013 |
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR |
INFOBIONIC, INC. |
CARRIE NEUBERGER |
| K130295 |
02/06/2013 |
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. |
INFOPIA CO., LTD |
Priscilla Chung |
| K133897 |
12/20/2013 |
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER |
Infraredx, Inc. |
STEVEN J CHARTIER |
| K133932 |
12/23/2013 |
INION FREEDOMPIN |
INION OY |
KATI MARTTINEN |
| K133810 |
12/16/2013 |
VC150 VITAL SIGNS MONITOR |
INNOKAS YHTYMA |
Tiina Kotipalo |
| K130312 |
02/07/2013 |
IROOT FM |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
| K133690 |
12/02/2013 |
TRUE SPINAL FUSSION SYSTEM |
INNOVATIVE SURGICAL DESIGNS |
ED MORRIS |
| K130506 |
02/27/2013 |
IMSE P-TLIF |
INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION |
JOHN MORAN |
| K133754 |
12/09/2013 |
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER |
INTEGRA LIFESCIENCES CORPORATION |
ELIZABETH MCMENIMAN |
| K134047 |
12/31/2013 |
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS |
INTEGRA LIFESCIENCES CORPORATION |
RUTHANNE VENDY |
| K130389 |
02/15/2013 |
MAYFIELD INFINITY XR2 SKULL CLAMP |
INTEGRA LIFESCIENCES CORPORATION |
JANET KAY |
| K130249 |
02/01/2013 |
INTEGRITY SPINAL CARE SYSTEM 3.0 |
INTEGRITY LIFE SCIENCES |
JAMES J GIBSON |
| K130290 |
02/06/2013 |
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE |
INTEL-GE CARE INNOVATIONS LLC |
MAUREEN GLYNN |
| K133759 |
12/11/2013 |
INTELLIJOINT HIP |
INTELLIJOINT SURGICAL INC. |
BRANDON GINGRICH |
| K134005 |
12/27/2013 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
JINYOUNG LEE |
| K133845 |
12/18/2013 |
8MM TROCAR KIT |
INTUITIVE SURGICAL |
BRANDON HANSEN |
| K133942 |
12/23/2013 |
ENDOSCOPE STERILIZATION TRAY |
INTUITIVE SURGICAL |
BRANDON HANSEN |
| K130266 |
02/04/2013 |
ENDOWRIST ONE VESSEL SEALER |
INTUITIVE SURGICAL, INC. |
CRYSTAL ONG |
| K133853 |
12/19/2013 |
VIEWFLEX XTRA ICE CATHETER |
IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY |
JENNIFER CORREA |
| K133859 |
12/19/2013 |
WATCH-PAT200U (WP200U) |
ITAMAR MEDICAL LTD |
JONATHAN KAHAN, ESQ |
| K130436 |
02/21/2013 |
MULTILINK HYBRID ABUTMENT CEMENT |
IVOCLAR VIVADENT AG |
DONNA MARIE HARTNETT |
| K130456 |
02/22/2013 |
WUNDER PREGNANCY TEST |
JAMES NGUYEN |
JAMES NGUYEN, M.D. |
| K130447 |
02/21/2013 |
SPEEDY FLAP SYSTEM |
Jeil Medical Corporation |
Jieun Kim |
| K133696 |
12/03/2013 |
NEODENT IMPLANT SYSTEM |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
KEVIN A THOMAS |
| K133686 |
12/02/2013 |
21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
| K130330 |
02/11/2013 |
RANGE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K133944 |
12/23/2013 |
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K133815 |
12/16/2013 |
INTESS CERVICAL CAGE SYSTEM |
KALITEC DIRECT, LLC |
J.D. WEBB |
| K134043 |
12/31/2013 |
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER |
KAZ USA, INC (A SUBSIDIARY OF KAZ INC) |
RAJ KASBEKAR |
| K133716 |
12/05/2013 |
TRC-PASTE |
KM CORPORATION |
Priscilla Chung |
| K133730 |
12/06/2013 |
CO PILOT/REGIUS UNITEA |
KONICA MINOLTA INC. |
RUSSELL MUNVES |
| K133755 |
12/09/2013 |
KOWA SL-17 |
KOWA CO. LTD. |
HIROYUKI KOIDE |
| K130371 |
02/14/2013 |
CLEARFIL MAJESTY ES FLOW |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K130341 |
02/11/2013 |
STRAWBERRY, STRAWBERRY & CREAM |
LASER LIPO LIMITED |
Ian Cobley |
| K133997 |
12/27/2013 |
LG SMARTHEALTH |
LG ELECTRONICS |
DIANE SUDDUTH |
| K133717 |
12/05/2013 |
LONGBOW SPACER SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K133710 |
12/04/2013 |
LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K130305 |
02/05/2013 |
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE |
LINA MEDICAL APS |
RICHARD GILLIS |
| K133934 |
12/23/2013 |
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) |
LINKS MEDICAL PRODUCTS, INC. |
James Smith |
| K130497 |
02/26/2013 |
D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
JONATHAN WERNER |
| K133849 |
12/19/2013 |
VANTERA CLINICAL ANALYZER |
LIPOSCIENCE |
SUZETTE WARNER |
| K134036 |
12/31/2013 |
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT |
LOKTAL MEDICAL ELECTRONICS IND. COM. LTDA- EPP |
Carrie Hetrick |
| K130518 |
02/27/2013 |
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER |
LUTHER NEEDLESAFE PRODUCTS, INC. |
Rebecca K Pine |
| K133811 |
12/16/2013 |
RESTORIS POROUS PARTIAL KNEE SYSTEM |
MAKO SURGICAL CORP. |
TERRY POWELL |
| K133729 |
12/06/2013 |
WOUND DRESSING WITH MANUKA HONEY |
MANUKA HEALTH NEW ZEALAND LTD. |
DAVID BECHTEL |
| K130300 |
02/07/2013 |
HEATER-COOLER UNIT HCU 40 |
MAQUET CARDIOPULMONARY AG |
HELDER A SOUSA |
| K133958 |
12/24/2013 |
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 |
MAQUET CRITICAL CARE AB |
LIA LIEBGOLD |
| K130513 |
02/27/2013 |
VOLISTA 400; VOLISTA 600 |
MAQUET SAS |
TOSIN YEDESS |
| K133796 |
12/13/2013 |
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), |
MARVAO MEDICAL DEVICES, LTD. |
CHRISTINE NICHOLS, RAC |
| K130385 |
02/15/2013 |
COMPRESSIBLE LIMB SLEEVE SYSTEM |
MAXSTAR INDUSTRIAL CO. LTD. |
DANIEL NAM |
| K130345 |
02/11/2013 |
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING |
MAYER LABORATORIES, INC. |
DAVID P MAYER |
| K130299 |
02/07/2013 |
GMK HINGE |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K133914 |
12/23/2013 |
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE |
MEDCOM GMBH |
LUCA SALVATORE |
| K133763 |
12/11/2013 |
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K133907 |
12/23/2013 |
VSP SYSTEM |
MEDICAL MODELING INC. |
JONATHAN S KAHAN |
| K130377 |
02/14/2013 |
KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM |
MEDICATECH USA |
DANIEL KAMM, P.E. |
| K133906 |
12/23/2013 |
C-JAWS CERVICAL COMPRESSIVE STAPLE |
MEDICREA INTERNATIONAL |
JOHN J SMITH |
| K130441 |
02/21/2013 |
FALLER STYLET |
MEDIONICS INTERNATIONAL, INC. |
MAHESH AGARWAL |
| K133724 |
12/06/2013 |
MINNCARE HD |
MEDIVATORS, INC. |
KINNARI SHAH |
| K130319 |
02/08/2013 |
MEDLINE CANNULATED SCREW |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K133941 |
12/23/2013 |
MITEK ARTHROSCOPES |
MEDOS INTERNATIONAL SARL |
SUSAN KAGAN |
| K130381 |
02/14/2013 |
ANGIOJET ULTRA POWER PULSE KIT |
MEDRAD, INC. |
AMRA RACIC |
| K130467 |
02/25/2013 |
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE |
MEDSHAPE, INC |
KENNETH M DUPONT, PH.D. |
| K134009 |
12/30/2013 |
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL |
MEDTEK LIGHTING |
SUSAN ANTHONEY-DE WET |
| K133903 |
12/20/2013 |
BIO-PROBE TRANSDUCER (ADULT) |
MEDTRONIC INC. |
RAHUL SHAH |
| K133904 |
12/20/2013 |
CD HORIZON SPINAL SYSTEM GROWTH ROD SET |
MEDTRONIC SOFAMOR DANEK USA |
LEE GRANT |
| K130335 |
02/11/2013 |
MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RYAN MASSEY |
| K133726 |
12/06/2013 |
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA MAGNESON |
| K130400 |
02/19/2013 |
MERETEC CS, CORTICAL SCREWS |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K133714 |
12/05/2013 |
TRU FLU |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K130259 |
02/01/2013 |
BEARING NSPVA EMBOLIZATION PARTICLES |
MERIT MEDICAL SYSTEMS, INC. |
LINDA VARROSO |
| K134015 |
12/27/2013 |
M-PM-DISC |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
| K134008 |
12/30/2013 |
MD-FLEX HEAVY BODY |
META BIOMED, INC. |
BLIX WINSTON |
| K133683 |
12/02/2013 |
MICR02 OSA DEVICE |
MICRODENTAL, INC. |
LAURA SHEPPARD |
| K133725 |
12/06/2013 |
TRAXCESS 14 GUIDEWIRE |
MICROVENTION, INC. |
Naomi Gong |
| K133779 |
12/12/2013 |
CP RELIEF WAND |
MID-AMERICA MEDICAL INNOVATIONS, LLC. |
NORM SCHROEDER |
| K130269 |
02/04/2013 |
ECAT SCINTRON PET |
MIE GMBH |
THOMAS KUEHL |
| K130393 |
02/15/2013 |
MIRADA RTX |
MIRADA MEDICAL LTD. |
GWILYM OWEN |
| K134033 |
12/31/2013 |
MIROMATRIX BIOLOGICAL MESH |
MIROMATRIX MEDICAL INC. |
STEPHEN RHODES |
| K134006 |
12/27/2013 |
DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE |
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED |
THOMAS CHAN TSZ FUNG |
| K133806 |
12/16/2013 |
M1 CAPNOGRAPHY MASK |
MONITOR MASK, INC. |
STUART R GOLDMAN |
| K133937 |
12/23/2013 |
HEARTSCAN SOFTWARE |
MORPHEUS IMAGING, INC |
JOHN AXERIO-CILIES |
| K133989 |
12/26/2013 |
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K130346 |
02/11/2013 |
SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION |
NATUS NEUROLOGY INCORPORATED |
SHANE T SAWALL |
| K133708 |
12/04/2013 |
MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR |
NEC DISPLAY SOLUTIONS, LTD. |
TONY HSU |
| K133995 |
12/26/2013 |
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE |
NEUROSOFT LTD |
ENRICO BISSON |
| K130399 |
02/19/2013 |
CERTUS 140 CERTUSURGGT SURGICAL TOOL |
NEUWAVE MEDICAL, INC. |
DAN KOSEDNAR |
| K130416 |
02/19/2013 |
NEXUS TKO-6P LUER ACTIVATED DEVICE |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
| K133951 |
12/23/2013 |
SMARTTOUCH |
NEXUS6, LTD. |
GARTH SUTHERLAND |
| K130254 |
02/01/2013 |
PROW FUSION |
NLT SPINE LTD |
JONATHAN KAHAN |
| K133731 |
12/06/2013 |
NOBELACTIVE WIDE PLATFORM (WP) |
NOBELBIOCARE AB |
PHUONG NGUYEN |
| K133910 |
12/23/2013 |
NORDICBRAINEX |
NORDICNEUROLAB |
CHANDANA GURUNG BHANDARI |
| K130368 |
02/14/2013 |
AUTOLITH TOUCH; URO TOUCH |
NORTHGATE TECHNOLOGIES INC. |
CASEY KUREK |
| K133738 |
12/09/2013 |
NOVOFINE PLUS 32G 4 MM |
NOVO NORDISK INC. |
RICK SPRING |
| K130413 |
02/19/2013 |
PINPOINTE FOOTLASER |
NUVOLASE, INC. |
KATHY MAYNOR |
| K134019 |
12/30/2013 |
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO |
NXSTAGE MEDICAL, INC. |
LAURA F PLATH |
| K130460 |
02/22/2013 |
NXSTAGE DOSING CALCULATOR |
NXSTAGE MEDICAL, INC. |
NNAMDI NWACHUKWU |
| K130281 |
02/05/2013 |
OAK RIDGE PRODUCTS SHARP CONTAINER |
OAK RIDGE PRODUCTS, LLC |
TIBOR B KOVARI |
| K134026 |
12/30/2013 |
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT |
OLYMPUS MEDICAL SYSTEMS CORP. |
DAPHNEY GERMAIN-KOLAWOLE |
| K130489 |
02/25/2013 |
ELECTRODE, FLEXIBLE SUCTION COAGULATOR |
OPTIM, LLC. |
JEFF BARRETT, CEO |
| K134039 |
12/31/2013 |
DAYTONA ICG (P200TICG) |
OPTOS PLC |
RANDY PREBULA |
| K133892 |
12/20/2013 |
IVUE 500 |
OPTOVUE, INC. |
MICHAEL J SARRASIN |
| K133912 |
12/23/2013 |
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO |
ORIGIO A/S |
TOVE KJAER |
| K133707 |
12/04/2013 |
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS |
ORIGIO A/S |
TOVE KJAER |
| K130387 |
02/15/2013 |
ORTHOALIGN PLUS SYSTEM |
ORTHALIGN, INC |
AMY WALTERS |
| K133875 |
12/20/2013 |
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA |
ORTHO KINEMATICS, INC. |
JOHN J SMITH |
| K130332 |
02/11/2013 |
VITROS CHEMISTRY PRODUCTS TRIG SLIDES |
Ortho-Clinical Diagnostics, Inc. |
GAOZHEN HANG |
| K130446 |
02/21/2013 |
FASTBRACES CERAMIC BRACKETS |
ORTHODONTIC DESIGN AND PRODUCTION, INC. |
RICHARD MERRELL |
| K130380 |
02/14/2013 |
ORTHOSENSOR KNEE BALANCER |
ORTHOSENSOR, INC. |
KIMBERLEE WASHBURN |
| K133827 |
12/17/2013 |
A-LINK Z |
OSTEO VASIVE LLC |
KEVIN A THOMAS |
| K130412 |
02/19/2013 |
OSTEOMED EXTREMIFUSE SYSTEM |
OSTEOMED |
PIEDAD PENA |
| K133691 |
12/02/2013 |
EXTRIMILOCK ANKLE PLATING SYSTEM |
OSTEOMED LP |
BLESSON ABRAHAM |
| K133861 |
12/19/2013 |
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM |
OSTIAL CORPORATION |
JAKE WOLENBERG |
| K130443 |
02/21/2013 |
I-MAX TOUCH 3D |
OWANDY |
Claude Berthoin |
| K133809 |
12/16/2013 |
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE |
OXFORD PERFORMANCE MATERIALS |
LEIGH AYRES |
| K130297 |
02/06/2013 |
SCANORA 3DX |
PALODEX GROUP OY |
MATTI TULIKOURA |
| K130250 |
02/01/2013 |
QYAG LASER SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
NICOLE BROWN |
| K130462 |
02/22/2013 |
PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT |
PALTOP ADVANCED DENTAL SOLUTIONS LTD |
TAL HAMMER-TOPAZ |
| K130273 |
02/04/2013 |
PANPAC VAGINAL DILATORS |
Panpac Medical Corporation |
Yen-Ming Pan |
| K133980 |
12/27/2013 |
PANTHEON ELECTROSTIMULATOR |
PANTHEON RESEARCH |
YOLANDA SMITH |
| K133694 |
12/03/2013 |
SHERPA PAK TRANSPORTER |
PARAGONIX TECHNOLOGIES, INC. |
LEO BASTA |
| K133757 |
12/11/2013 |
GFS II STANDARD, GFS II LARGE, GFS MIMI |
PARCUS MEDICAL, LLC |
PAUL VAGTS |
| K133901 |
12/20/2013 |
PARI-PATH SURGICAL NAVIGATION SYSTEM |
PARITIC INC |
KEVIN BARRETT |
| K130247 |
02/01/2013 |
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K133793 |
12/13/2013 |
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE |
PERSYST DEVELOPMENT CORPORATION |
DARI DARABBEIGI |
| K130519 |
02/27/2013 |
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS |
PHILIPS LIGHTING COMPANY |
JAMES R CYRE |
| K133961 |
12/24/2013 |
SURESIGNS VS3, SURESIGNS VS4 |
PHILIPS MEDICAL SYSTEMS |
GREG LI |
| K130278 |
02/05/2013 |
MR PERMEABILITY |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
SUSAN QUICK |
| K133819 |
12/16/2013 |
VERADIUS |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
RUOJUAN ZHANG |
| K130499 |
02/26/2013 |
IU22 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
JESSICA STENBERG |
| K133833 |
12/17/2013 |
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
MARK JOB |
| K130454 |
02/22/2013 |
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR |
PHYSIO-CONTROL, INC. |
MICHELLE ACKERMANN |
| K133993 |
12/26/2013 |
CAAS WORKSTATION |
PIE MEDICAL IMAGING |
Florie Daniels |
| K133721 |
12/05/2013 |
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K130286 |
02/05/2013 |
STREAMLINE MIS SPINAL FIXATION SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY M DOWNS |
| K133785 |
12/12/2013 |
TRITIUM STERNAL CABLE PLATE SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY DOWNS |
| K130427 |
02/20/2013 |
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC. |
SARAH MCINTYRE |
| K130353 |
02/12/2013 |
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) |
PIPELINE ORTHOPEDICS |
TERRY POWELL |
| K130351 |
02/12/2013 |
NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER |
PIVOT MEDICAL INC. |
Jon Cook |
| K134017 |
12/30/2013 |
GIGALASER |
POWERMEDIC APS |
M. JOYCE HEINRICH |
| K133921 |
12/23/2013 |
PRECEPTIS TYMPANOSTOMY TUBE INSERTER |
PRECEPTIS MEDICAL |
KEITH LELAND |
| K133850 |
12/19/2013 |
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K133857 |
12/19/2013 |
BRELLA-SPEC(TM) VAGINAL SPECULUM |
PROA MEDICAL, INC. |
VICTORIA NADERSHAHI |
| K134052 |
12/31/2013 |
RADIANCE 330 PROTON THERAPY SYSTEM |
ProTom International, Inc. |
JOHN J SMITH, MD, JD |
| K133689 |
12/02/2013 |
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K133699 |
12/03/2013 |
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES |
PT. SMART GLOVE INDONESIA |
KHON PU FOO |
| K130450 |
02/22/2013 |
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE |
PURNA BINA SDN BHD |
ROBERT HILL |
| K130487 |
02/25/2013 |
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE |
PYNG MEDICAL CORP. |
Michele Tyler |
| K133936 |
12/23/2013 |
ARTUS C. DIFFICILE QS-RGQ MDX KIT |
QIAGEN, GMBH |
Kimberly Mapp |
| K130442 |
02/21/2013 |
NEWTOM VGI AND NEWTOM 5G |
QR S.R.L. |
BERTHOIN CLAUDE |
| K130256 |
02/01/2013 |
MDK MULTI-APPLICATIONS PLATFORM |
Quanta System SpA |
Maurizio Bianchi |
| K130398 |
02/19/2013 |
SOFIA(R) RSV FIA |
QUIDEL CORP. |
JOHN D TAMERIUS, PH.D. |
| K133883 |
12/20/2013 |
LYRA DIRECT STREP ASSAY |
QUIDEL CORPORATION |
RONALD H LOLLAR |
| K130415 |
02/19/2013 |
HIGH METABOLITE QUALICHECK |
RADIOMETER MEDICAL APS |
Martin Gabler |
| K130337 |
02/11/2013 |
RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| DEN130051 |
12/13/2013 |
PEDIATRIC VISION SCANNER |
REBISCAN, INC. |
JUSTIN G SHAKA |
| K133923 |
12/23/2013 |
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET |
REFLECTANCE MEDICAL INC |
Nandini Murthy |
| K133990 |
12/27/2013 |
IEVA REHABILITATIVE POSITIONAL DEVICE |
REMENDIUM LABS, LLC |
YOLANDA LORIE |
| K130282 |
02/05/2013 |
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT |
REMINGTON MEDICAL, INC. |
CAITLIN SENTER, MS, RAC |
| K133973 |
12/26/2013 |
TEMPUS PRO WITH ENHANCED FEATURES |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD |
LEIGH CORNOCK |
| K134014 |
12/30/2013 |
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
LEIGH CORNOCK |
| K133988 |
12/26/2013 |
TEMPUS PRO EXTENDED FEATURES |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
LEIGH CORNOCK |
| K133868 |
12/20/2013 |
ASTRAL VENTILATOR |
RESMED LTD. |
JIM CASSI |
| K133986 |
12/26/2013 |
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY |
RESONANCE INNOVATIONS LLC |
RANDALL JONES |
| K130457 |
02/22/2013 |
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL |
RESONANCE INNOVATIONS LLC |
RANDALL JONES |
| K130378 |
02/14/2013 |
RESPIGUIDE DELIVERY SYSTEM |
RESPICARDIA |
BONNIE LABOSKY |
| K134003 |
12/27/2013 |
RHINIX NASAL FILTER |
RHINIX APS |
METTE MUNCH |
| K130287 |
02/05/2013 |
MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
| K130423 |
02/20/2013 |
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RON HASELHORST |
| K133741 |
12/09/2013 |
ACCU-CHEK Performa Blood Glucose Monitoring System |
Roche Diagnostics |
NATHAN CARRINGTON |
| K133862 |
12/19/2013 |
ACCU-CHEK AVIVA PLUS SYSTEM |
ROCHE DIAGNOSTICS CORPORATION |
KHONE SAYSANA |
| K130379 |
02/14/2013 |
ROLLINS 7 OXYGEN MASK |
ROLLINS MEDICAL SOLUTIONS, INC. |
E. J SMITH |
| K133893 |
12/20/2013 |
STERISPINE LC CAGE |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K130342 |
02/11/2013 |
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
| K130331 |
02/11/2013 |
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
| K133740 |
12/09/2013 |
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
| K133682 |
12/02/2013 |
SCHOELLY ARTHROSCOPE |
SCHOLLY FIBEROPTIC GMBH |
PAMELA PAPINEAU, RAC |
| K130500 |
02/26/2013 |
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT |
SEBIA |
KAREN ANDERSON |
| K133782 |
12/12/2013 |
NOVA FA DR SYSTEM |
SEDECAL SA |
DANIEL KAMM, P.E. |
| K134029 |
12/31/2013 |
BELTER BLOOD PRESSURE METER |
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
PANG MING |
| K133985 |
12/26/2013 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Diana Hong |
| K133965 |
12/24/2013 |
OTC EMS STIMULATOR |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
QILIAN LIU |
| K133929 |
12/23/2013 |
HEALTH EXPERT ELCTRONIC STIMULATOR |
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED |
LI YANG |
| K130325 |
02/08/2013 |
ARM AUTOMATIC BLOOD PRESSURE MONITOR |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
IVY CHEN |
| K133728 |
12/06/2013 |
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE |
Siemens Healthcare Diagnostics Inc. |
LAURA J DUGGAN, PH.D. |
| K133816 |
12/16/2013 |
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL |
Siemens Healthcare Diagnostics Inc. |
Ernest Joseph |
| K130276 |
02/05/2013 |
DIMENSION EXL WITH LM SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
PAMELA A JURGA |
| K130262 |
02/01/2013 |
MAGNETOM ESSENZA WITH SYNGO MR D14 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K133680 |
12/02/2013 |
ENCORE SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K133838 |
12/18/2013 |
STERILIZATION POUCH/ROLL MADE WITH TYVEK |
SIGMA MEDICAL SUPPLIES CORP. |
UTA SHIH |
| K130402 |
02/19/2013 |
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE |
SINTEA PLUSTEK, LLC |
RICH JANSEN |
| K130479 |
02/25/2013 |
ILIZAROV DRILL TIP WIRES |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K130394 |
02/15/2013 |
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 |
SMITHS MEDICAL ASD, INC. |
PAULA CORDERO |
| K133752 |
12/09/2013 |
SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT |
SONENDO, INC. |
DAN MILLER |
| K133702 |
12/03/2013 |
PRESTO BREAST BIOPSY DEVICE |
SONTINA MEDICAL, LLC |
ROBERT PELIKS |
| K130433 |
02/21/2013 |
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K133959 |
12/24/2013 |
PODIATRY X-RAY SYSTEM |
SOURCE-RAY, INC. |
Daniel Kamm |
| K134022 |
12/30/2013 |
BASE IT |
SPIDENT CO., LTD. |
LENA PAK |
| K134021 |
12/30/2013 |
ESTEMP IMPLANT, ESTEMP CLEAR |
SPIDENT CO., LTD. |
LENA PAK |
| K130279 |
02/05/2013 |
REFORM PEDICLE SCREW SYSTEM |
SPINAL USA |
MEREDITH MAY |
| K130445 |
02/21/2013 |
VAULT ALIF SYSTEM |
SPINAL USA |
J.D. WEBB |
| K130267 |
02/04/2013 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K130396 |
02/19/2013 |
RAMPART O AND RAMPART P |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K130302 |
02/07/2013 |
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT |
SPINEVISION, S.A. |
HELENE PLAS |
| K130252 |
02/01/2013 |
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER |
ST. JUDE MEDICAL |
COLLEEN CANAN |
| K130257 |
02/01/2013 |
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER |
ST. JUDE MEDICAL |
COLLEEN CANAN |
| K130408 |
02/19/2013 |
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT |
STERNGOLD DENTAL LLC |
MARIA RAO |
| K133791 |
12/13/2013 |
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] |
STERNGOLD DENTAL LLC |
MARIA RAO |
| K130424 |
02/20/2013 |
STIMEL-03 |
STIMEL LTD |
RAYMOND J KELLY IV |
| K130430 |
02/20/2013 |
IVAS 10MM AND 15MM BALLOON CATHETER |
STRYKER CORPORATION |
CHRISTINA MCKEE |
| K133974 |
12/26/2013 |
VARIAX DISTAL RADIUS PLATING SYSTEM |
STRYKER LEIBINGER GMBH |
ELIJAH N WREH |
| K130334 |
02/11/2013 |
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM) |
Stryker Trauma AG |
ESTELA CELI |
| K130426 |
02/20/2013 |
SUMITOMO PROTON THERAPY SYSTEM |
SUMITOMO HEAVY INDUSTRIES, LTD |
RONALD S WARREN |
| K133979 |
12/26/2013 |
TENS |
SUNMAS (H.K.) TRADING LIMITED |
Diana Hong |
| K133795 |
12/13/2013 |
SUMMED INFLATION DEVICE KIT |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
JAMES QI ZHANG |
| K133855 |
12/19/2013 |
BREEZY ELEGANCE |
SUNRISE MEDICAL (US) LLC |
LAURIE H ROBERTS |
| K133781 |
12/12/2013 |
DECLIPSESPECT LAPAROSCOPY |
SURGICEYE GMBH |
MORITZ HOYER |
| K133840 |
12/18/2013 |
Kangli Locking Plate System |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
ALICE GONG |
| K130451 |
02/22/2013 |
NEUROQ 3.6 |
SYNTERMED, INC. |
KENNETH VAN TRAIN |
| K133698 |
12/03/2013 |
SYNAPSE SYSTEM |
SYNTHES USA PRODUCTS LLC |
LAURA BLEYENDAAL |
| DEN130019 |
02/28/2013 |
ZANZA-CLICK |
TECNIMED S.R.L. |
Claude Berthoin |
| K130405 |
02/19/2013 |
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET |
TELEFLEX MEDICAL |
LORI PFOHL |
| K133797 |
12/13/2013 |
QMASTER-H/REVO |
TELESYSTEMS CO., LTD. |
Claude Berthoin |
| K130326 |
02/08/2013 |
TEPHAFLEX MELTBLOWN CONSTRUCT |
TEPHA, INC. |
MARY P LEGRAW |
| K130359 |
02/13/2013 |
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
SUZANNE GRENIER |
| K130333 |
02/11/2013 |
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
SUZANNE GRENIER |
| K130280 |
02/05/2013 |
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR |
TERUMO Corporation |
GARRY A COURTNEY, MBA, RAC |
| K130493 |
02/26/2013 |
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR |
TERUMO Corporation |
GARRY A COURTNEY, MBA, RAC |
| K133894 |
12/20/2013 |
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K133867 |
12/20/2013 |
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K133687 |
12/02/2013 |
THD N-ANO ANOSCOPE |
THD SPA |
GUIDO BONAPACE |
| K130285 |
02/05/2013 |
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS |
THE LAGADO CORP. |
Ellen M Beucler |
| K130304 |
02/07/2013 |
LMA FAMILY OF AIRWAYS |
THE LARYNGEAL MASK CO.,LTD. |
PAUL DRYDEN |
| K130403 |
02/19/2013 |
MAGSTIM DOUBLE 70-2 COIL |
THE MAGSTIM COMPANY LTD. |
J. P OUELLETTE |
| K133799 |
12/13/2013 |
THERMEDX FLUID MANAGMENT SYSTEM |
THERMEDX LLC |
JEFF WILLIAMS |
| K133773 |
12/12/2013 |
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM |
Thermo Fisher Scientific |
Cynthia Knapp |
| K133847 |
12/18/2013 |
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
Cynthia Knapp |
| K130275 |
02/04/2013 |
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
Roger De Bock |
| K133949 |
12/23/2013 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
TOP CALIBRE SDN BHD |
ROSNITA MAODIN |
| K130289 |
02/05/2013 |
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA |
TOPCON CORP. |
MAUREEN O'CONNELL |
| K130422 |
02/20/2013 |
PHANTOM FIBER BIOFIBER SUTURE |
TORNIER, INC. |
LAEL J PICKETT |
| K133777 |
12/12/2013 |
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR |
TORNIER, INC. |
Mireille Lemery |
| K133761 |
12/11/2013 |
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
CHARLEMAGNE CHUA |
| K134025 |
12/30/2013 |
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K133832 |
12/17/2013 |
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS |
TOTAL JOINT ORTHOPEDICS, INC. |
BEN CASEY |
| K134051 |
12/31/2013 |
TRANSONIC ELSA SYSTEM |
TRANSONIC SYSTEMS, INC. |
NAVEEN THURAMALLA |
| K134035 |
12/31/2013 |
TRANSONIC HCM 103 SYSTEM |
TRANSONIC SYSTEMS, INC. |
NAVEEN THURAMALLA |
| K130459 |
02/22/2013 |
TRIA FAN SYSTEM |
TRIA BEAUTY, INC. |
JONATHAN KAHAN |
| K130414 |
02/19/2013 |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K133896 |
12/20/2013 |
REJUVALITE MD |
TROPHY SKIN, INC. |
SUSAN ANTHONEY-DEWET |
| K133842 |
12/18/2013 |
TYBER MEDICAL TRAUMA SCREW |
TYBER MEDICAL LLC |
JEFF TYBER |
| K130463 |
02/22/2013 |
UCP HOME DRUG SCREENING TEST; CARDS, CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K134032 |
12/31/2013 |
ULTHERA SYSTEM |
ULTHERA, INC. |
ASHLEY FICKETT |
| K134023 |
12/30/2013 |
2300 SERIES MGO PORTABLE OXYGEN |
ULTRA ELECTRONICS LIMITED PRECISION AIR & LAND SY |
ANDY CHILTON |
| K133712 |
12/05/2013 |
EMBRYOVIEWER SOFTWARE |
UNISENSE FERTILITECH A/S |
Henrik Wahlgren |
| K133736 |
12/09/2013 |
ENDOSCOPIC SUTURE CUTTER |
UNITED STATES ENDOSCOPY GROUP, INC. |
ERIC MAYNARD |
| K130494 |
02/26/2013 |
UNITRON TINNITUS MASKER FEATURE |
UNITRON HEARING |
JIM REITER |
| K130251 |
02/01/2013 |
ESOPHAGUS BOUGIE SET |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K130318 |
02/08/2013 |
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) |
VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED |
CATHERINE MULCAHY |
| K130432 |
02/21/2013 |
PHT-6500, PHT-60CFO |
VATECH CO., LTD. |
DAVE KIM |
| K130515 |
02/27/2013 |
VIRTUOSO SYSTEM FOR IHC ER (SPI) |
VENTANA MEDICAL SYSTEMS, INC. |
ERIKA AMMIRATI |
| K130406 |
02/19/2013 |
DIAGNOSTICPRO EDGE |
VIDAR SYSTEMS CORP. |
CARRIE L BRANCART |
| K133983 |
12/27/2013 |
INTRA. OX HANDHELD TISSUE OXIMETER |
VIOPTIX INC. |
GREG HOLLAND |
| K133837 |
12/18/2013 |
VIORA V-TOTAL |
VIORA LTD. |
YORAM LEVY |
| K133829 |
12/17/2013 |
AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF |
VIVONIC GMBH |
ANDREAS HESSBERGER |
| K130485 |
02/25/2013 |
CONTROL SEAL |
VOCO GMBH |
T. GERKENSMEIER |
| K130486 |
02/25/2013 |
FUTURABOND UNIVERSAL |
VOCO GMBH |
T. GERKENSMEIER |
| K130421 |
02/20/2013 |
MERON APPLICATION CAPSULES |
VOCO GMBH |
T. GERKENSMEIER |
| K133681 |
12/02/2013 |
CRUX SNARE FILTER RETRIEVAL SET |
VOLCANO CORPORATION |
ELISA HEBB |
| K130350 |
02/12/2013 |
PROCELLERA |
VOMARIS INNOVATIONS INC. |
Mary Maijer |
| K130340 |
02/11/2013 |
LOCKING BONE PLATES AND SCREWS |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
Diana Hong |
| K133723 |
12/06/2013 |
OTC PATCH |
WELL-LIFE HEALTHCARE LIMITED |
CHIN-CHIN HSIEH |
| K133713 |
12/05/2013 |
CHARLOTTE (TM) SNAP-OFF SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K133715 |
12/05/2013 |
CHARLOTTE CLAW PLATE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K130376 |
02/14/2013 |
DYNASTY ACETABULAR SYSTEM WITH CERAMIC |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DEAN NACHTRAB |
| K133947 |
12/23/2013 |
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K130438 |
02/21/2013 |
AXLE INTERSPINOUS FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN, M.D. |
| K130410 |
02/19/2013 |
DENTAL UNIT WITH CHAIR |
XIANYANG NORTH WEST MEDICAL INSTRUMENT (GROUP) CO. |
Diana Hong |
| DEN130007 |
02/19/2013 |
AXIOS STENT AND DELIVERY SYSTEM |
XLUMENA, INC |
JANE BEGGS |
| K130468 |
02/25/2013 |
ORBIT INFUSION SET |
YPSOMED AG |
BENJAMIN REINMANN |
| K133735 |
12/09/2013 |
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
| K134045 |
12/31/2013 |
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
JULIE LAMOTHE |
| K133784 |
12/12/2013 |
VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
| K133737 |
12/09/2013 |
ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION |
ZIMMER, INC. |
PAULINE A SHAND |
| K133706 |
12/03/2013 |
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM |
ZL MICRODENT-ATTACHMENT GMBH & CO. KG |
SYNNOVE LINDEMAN |
