| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K133436 |
11/08/2013 |
FLASH AR; FLASH AR QUICK |
3M DEUTSCHLAND GMBH |
DESI SOEGIARTO |
| K133400 |
11/06/2013 |
FLASH BITE |
3M ESPE AG |
RUEDIGER FRANKE |
| K130185 |
01/25/2013 |
4WEB OSTEOTOMY BONE WEDGE |
4-WEB, INC. |
RICH JANSEN, PHARM, D. |
| K130157 |
01/23/2013 |
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K133675 |
11/29/2013 |
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K130113 |
01/16/2013 |
PICCOLO LACTATE TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K130200 |
01/28/2013 |
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM |
ABAXIS, INC. |
DENNIS M BLEILE, PHD |
| K130094 |
01/10/2013 |
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM |
ABBOTT DIABETES CARE |
DAVID G LAMBERT |
| K133469 |
11/12/2013 |
ACUMED SUTURE ANCHOR SYSTEM |
ACUMED, LLC |
LINO TSAI |
| K130013 |
01/02/2013 |
X4 SYSTEM |
ADVANCED BRAIN MONITORING INC. |
ADRIENNE LENZ |
| K130007 |
01/02/2013 |
SLEEP PROFILER |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
| K133443 |
11/12/2013 |
MARATHON NO STING LIQUID SKIN PROTECTANT |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
ROSE GUANG |
| K130165 |
01/23/2013 |
PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 |
ADVANCED PLANIMETRIC SERVICES, LLC |
MARTIN WENDELKEN |
| K133360 |
11/01/2013 |
AERONEB SOLO; AERONEB SOLO ADAPTER |
AEROGEN LTD |
MARTIN CREHAN |
| K133394 |
11/05/2013 |
AIRSTRIP REMOTE PATIENT MONITORING |
AIRSTRIP TECHNOLOGIES, LP |
ROBERT A MILLER |
| K133450 |
11/11/2013 |
AIRSTRIP REMOTE PATIENT MONITORING |
AIRSTRIP TECHNOLOGIES, LP |
ROBERT A MILLER |
| K133411 |
11/07/2013 |
ALERE BINAXNOW INFLUENZA A & B CARD |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
Angela Drysdale |
| K133637 |
11/07/2013 |
ALERE INFLUENZA A & B TEST |
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
Angela Drysdale |
| K130097 |
01/15/2013 |
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS |
AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED |
MIKE HOFTMAN |
| K130152 |
01/22/2013 |
HYDRASOLVE LIPOPLASTY SYSTEM |
ANDREW TECHNOLOGIES, LLC |
HERBERT CRANE |
| K133561 |
11/20/2013 |
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH |
ANGIODYNAMICS, INC. |
Lorraine M Hanley |
| K130150 |
01/22/2013 |
TCM MASSAGER |
ANHUI JINJIANQIAO MED-TECH CO,. LTD. |
FIELD FU |
| K133393 |
11/05/2013 |
GELPOINT PATH TRANSANAL ACCESS PLATFORM |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K130192 |
01/25/2013 |
NEXTSTEP RETROGRADE |
ARROW INTERNATIONAL, INC. |
GWEN TASCHNER |
| K130129 |
01/17/2013 |
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM |
ARTHREX, INC. |
COURTNEY SMITH |
| K130196 |
01/28/2013 |
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR |
ARTHROCARE CORP. |
LAURA KASPEROWICZ |
| K133606 |
11/25/2013 |
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL |
ARTHROCARE CORPORATION |
MITCHELL DHORITY |
| K130050 |
01/09/2013 |
TITAN REVERSE SHOULDER SYSTEM |
ASCENSION ORTHOPEDIC |
SUSAN WALTON |
| K133462 |
11/12/2013 |
DUOCENTRIC REVERSED SHOULDER PROSTHESIS |
ASTON MEDICAL |
CATHERINE GLOSTER |
| K130131 |
01/18/2013 |
EDRAIN CHEST DRAINAGE SYSTEM |
ATRIUM MEDICAL CORP. |
CHRISTINA CALDERWOOD |
| K130142 |
01/22/2013 |
FLIXENE IFG VASCULAR GRAFT |
ATRIUM MEDICAL CORPORATION |
MEGAN MCCAGH, RAC, CTBS |
| K133521 |
11/15/2013 |
AZE PHOENIX SOFTWARE |
AZE, LTD. |
KARL DIEDRICH, AZE |
| K133632 |
11/26/2013 |
PERICAN ULTRA |
B.BRAUN MEDICAL, INC |
LISA GIAQUINTO |
| K133375 |
11/04/2013 |
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR |
BANYAN MEDICAL, LLC. |
TAMMY HEALEY |
| K130103 |
01/15/2013 |
CORONIS FUSION 6MP |
BARCO N.V. |
LIEVEN DE WANDEL |
| K133663 |
11/29/2013 |
NIO COLOR 2MP |
BARCO N.V. |
|
| K133569 |
11/20/2013 |
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM |
BARD PERIPHERAL VASCULAR, INC. |
TIFFINI DIAGE |
| K133486 |
11/13/2013 |
STELLARIS PC VISION ENHANCEMENT SYSTEM |
BAUSCH & LOMB |
TIMOTHY W CAPEHART |
| K130245 |
01/31/2013 |
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K130122 |
01/17/2013 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER |
BECKMAN COULTER, INC |
AMANDA BROWN |
| K130020 |
01/03/2013 |
ACCESS TOTAL BHCG (5TH IS) |
BECKMAN COULTER, INC. |
GERALDINE L BAGLIEN |
| K130197 |
01/28/2013 |
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 |
Becton, Dickinson and Company |
JOHN ROBERTS |
| K130172 |
01/24/2013 |
BELIMED STEAM STERILIZER MST-V |
BELIMED, INC. |
JAY UPCHURCH |
| K133608 |
11/25/2013 |
TRINIA |
BICON, LLC |
RICHARD WU |
| K133441 |
11/12/2013 |
ONESTEP CPR II MULTI-FUNCTION ELECTRODE |
BIO-DETEK, INC. |
SHANNON DUHAMEL |
| K130162 |
01/23/2013 |
LIQUID ASSAYED MULTIQUAL PREMIUM |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K130053 |
01/15/2013 |
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI |
BIO-RAD LABORATORIES, INC. |
Juang Wang |
| K130158 |
01/23/2013 |
M-SCAN |
BIO-RESEARCH ASSOCIATES, INC. |
JOHN RADKE |
| K133520 |
11/15/2013 |
HAMMERLOCK 2 |
BIOMEDICAL ENTERPRISES, INC |
JOE SOWARD |
| K124067 |
01/02/2013 |
VITEK MS |
BIOMERIEUX, INC. |
NANCY WEAVER |
| DEN130013 |
01/02/2013 |
VITEK MS |
BIOMERIEUX, INC. |
Nancy Weaver |
| K130033 |
01/04/2013 |
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO |
BIOMET MANUFACTURING CORP. |
ELIZABETH WRAY |
| K133518 |
11/15/2013 |
MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
KIMBERLY MCCOY |
| K130063 |
01/10/2013 |
ARCOS TROCHANTER BUTTON |
BIOMET, INC. |
BECKY EARL |
| K130126 |
01/17/2013 |
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM |
BIOMET, INC. |
TRACY B JOHNSON |
| K130067 |
01/10/2013 |
MRNA APPLIANCE |
BIOMODELING SOLUTIONS, LLS |
COLETTE COZEAN, PH.D. |
| K133522 |
11/15/2013 |
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM |
BIONIME COPORATION |
Feng-Yu Lee |
| K133642 |
11/27/2013 |
RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK |
BIOPHOR DIAGNOSTICS, INC. |
Nathaniel G Butlin |
| K130065 |
01/10/2013 |
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE |
BIOSONIC TECHNOLOGIES, LLC |
SHEPARD G BENTLEY |
| K133509 |
11/14/2013 |
EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO |
Biotest Medical Corp. |
ROBERT NAWY |
| K130161 |
01/23/2013 |
PASSEO-35 |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K133413 |
11/07/2013 |
IDSS SLC |
BLACK DIAMOND VIDEO |
RAGUNATH MUNIANDY |
| K130243 |
01/31/2013 |
ILAB ULTRASOUND IMAGING SYSTEM |
BOSTON SCIENTIFIC CORP. |
LORI R SMITH |
| K133566 |
11/20/2013 |
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS |
BOSTON SCIENTIFIC CORP. |
MAYLIN TRUESDELL |
| K130121 |
01/17/2013 |
SHORT PORT BLUNT TIP TROCAR |
Boston Scientific Corporation |
MARK DINGER |
| K130004 |
01/02/2013 |
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM |
Boston Scientific Corporation |
JANIS TARANTO |
| K130037 |
01/07/2013 |
BREATHE CPAP SYSTEM |
BREATHE TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K133385 |
11/05/2013 |
LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE |
BRONCUS MEDICAL INC |
ROBIN BUSH |
| K130101 |
01/15/2013 |
BYTECH |
BYTECH DONGTAI CO., LTD. |
CHU XIAOAN |
| K133470 |
11/12/2013 |
BARD RITECATH INTERMITTENT CATHETER |
C.R. BARD, INC. |
MICHELE DAVIS |
| K133456 |
11/12/2013 |
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER |
C.R. BARD, INC. |
ELIZABETH PETERSON |
| K133508 |
11/14/2013 |
RESOLUTIONMD MOBILE |
CALGARY SCIENTIFIC, INC. |
KYLE PETERSON |
| K133529 |
11/15/2013 |
CAMBER SPINE COVERIS CERVICAL CAGE |
CAMBER SPINE |
DANIEL A PONTECORVO |
| K133366 |
11/01/2013 |
ORTHROS POSTERIOR STABILIZATION SYSTEM |
CAMBER SPINE |
DANIEL A PONTECORVO |
| K130036 |
01/07/2013 |
COSENSE CO MONITOR |
Capnia, Inc. |
Julie Blacklock |
| K130061 |
01/10/2013 |
PICCOLO COMPOSITE PLATE SYSTEM |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K130208 |
01/28/2013 |
BERNOULLI ENTERPRISE SOFTWARE |
CARDIOPULMONARY CORP. |
UREY KANG |
| K133399 |
11/06/2013 |
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS INCORPORATED |
BLAIR BUTH |
| K130124 |
01/17/2013 |
CATALYST II AND III |
CARDIVA MEDICAL, INC. |
MICHAEL A DANIEL |
| K133532 |
11/18/2013 |
ALARIS SYSTEM WITH GUARDRAILS SUITE MX |
CAREFUSION 303, INC. |
CHRISTINE CATON |
| K133442 |
11/12/2013 |
BONE SUPPRESSION SOFTWARE |
CARESTREAM HEALTH, INC. |
CAROLYN WAGNER |
| K133476 |
11/12/2013 |
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION |
CARL ZEISS MEDITEC AG |
SARAH HARRINGTON |
| K133519 |
11/15/2013 |
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR |
CAROLINA LIQUID CHEMISTRIES CORP. |
Melissa F Thompson |
| K130027 |
01/03/2013 |
DISPOSABLE NEUTRAL ELECTRODE GP202 |
CATHAY MANUFACTURING CORP. |
ZHANG HUI |
| K133412 |
11/07/2013 |
S200, S300 |
CEFLA S.C. |
BERTHOIN CLAUDE |
| K133447 |
11/12/2013 |
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES |
CELONOVA BIOSCIENCES, INC. |
NICOLE BARBER |
| K130180 |
01/25/2013 |
CLEANSER ROOT CANAL |
CERKAMED WOJCIECH PAWLOWSKI |
KINGA WIERUCKA |
| K133525 |
11/15/2013 |
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM |
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
Diana Hong |
| K130046 |
01/08/2013 |
CLEARSPEC SINGLE USE VAGINAL SPECULUM |
CLEARSPEC LLC |
IRA DUESLER |
| K130194 |
01/28/2013 |
ACCULIF XL CAGE |
COALIGN INNOVATIONS, INC. |
JUSTIN EGGLETON |
| K133625 |
11/26/2013 |
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & |
Codman & Shurtleff, Inc. |
HANNAH FOLEY |
| K133600 |
11/25/2013 |
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR |
COEUR, INC. |
DEBRA F MANNING |
| K130137 |
01/18/2013 |
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER |
COLTENE/WHALEDENT |
EDWARD A KROLL |
| K130019 |
01/03/2013 |
J-SCREW COMPRESSION SCREW |
COMPETITIVE ENGINEERING INC. |
DAVID M DAVIS |
| K133464 |
11/12/2013 |
MODIFIED TREVO PROVUE RETRIEVER |
CONCENTRIC MEDICAL, INC. |
SARAH MEYER |
| K133560 |
11/20/2013 |
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
| K133465 |
11/12/2013 |
CONSURE STOOL MANAGEMENT SYSTEM |
CONSURE MEDICAL PVT LTD. |
ALAN DONALD |
| K130006 |
01/02/2013 |
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS |
COOK BIOTECH INCORPORATED |
NICK X WANG |
| K133597 |
11/22/2013 |
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY |
COOK, INC. |
SEAN SPENCE |
| K133634 |
11/26/2013 |
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET |
COOK, INC. |
SEAN SPENCE |
| K133627 |
11/26/2013 |
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS |
COOPERVISION, INC. |
ANNETTE NELSON |
| K133369 |
11/01/2013 |
TIGER SPINE SYSTEM |
CORELINK LLC |
J D WEBB |
| K130128 |
01/17/2013 |
TRINITY ACETABULAR SYSTEM |
CORIN MEDICAL |
LUCINDA GERBER |
| K133599 |
11/25/2013 |
CORGRIP |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K130089 |
01/14/2013 |
CROSSTREES PVA POD |
CROSSTREES MEDICAL, INC. |
JANICE M HOGAN |
| K133372 |
11/01/2013 |
CROSSTREES PVA POD |
CROSSTREES MEDICAL, INC. |
JANICE HOGAN |
| K130168 |
01/24/2013 |
CL10009 IR LASER |
CURAE'LASE INC. |
M. JOYCE HEINRICH |
| K133367 |
11/01/2013 |
ORTHOVIS PREOPERATIVE PLAN |
CUSTOM ORTHOPAEDIC SOLUTIONS |
JUSTIN BAKER |
| K133473 |
11/12/2013 |
ILUMINAGE SKIN SMOOTHING LASER |
CYNOSURE, INC. |
KEVIN O'CONNELL |
| K133364 |
11/01/2013 |
PICOSURE WORKSTATION |
CYNOSURE, INC. |
Connie Hoy |
| K130135 |
01/18/2013 |
DANA REUSABLE BI TEST PACK |
DANA PRODUCTS, INC. |
HARRY BALA |
| K130244 |
01/31/2013 |
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM |
DELBIO INCORPORATION |
NICKY PAN |
| K130083 |
01/14/2013 |
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE |
DEMETECH CORP. |
ANTHONY J DIMERCURIO |
| K130186 |
01/25/2013 |
DENTEK EASY BRUSH WITH FLUORIDE |
DENTEK ORAL CARE, INC. |
LINDA GILES |
| K130216 |
01/29/2013 |
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT |
DENTSPLY IMPLANT |
LINDA K SCHULZ |
| K130169 |
01/24/2013 |
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
| K130105 |
01/15/2013 |
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
JULIE VAFIDES |
| K130163 |
01/23/2013 |
D-LUX |
DIADENT GROUP INTERNATIONAL |
GIL JUN, HONG |
| K133448 |
11/15/2013 |
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY |
DIAGNOSTIC HYBRIDS, INC. |
RONALD H LOLLAR |
| K130090 |
01/14/2013 |
STA COMPACT MAX |
DIAGNOSTICA STAGO, INCORPORATED |
CARLO D'ALESSANDRO |
| K133410 |
11/07/2013 |
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET |
DIAZYME LABORATORIES |
Abhijit Datta |
| K133434 |
11/08/2013 |
GENESIS II |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K133661 |
11/29/2013 |
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K133517 |
11/15/2013 |
NEMUS 2 SYSTEM |
EB NEURO, S.P.A. |
ALLISON SCOTT, RAC |
| K130070 |
01/11/2013 |
4MP COLOR LCD MONITOR, RADIFORCE RX440 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K133565 |
11/20/2013 |
LEKSELL GAMMA KNIFE PERFEXION |
ELEKTA INSTRUMENT AB |
MATILDA FORSBERG |
| K133405 |
11/06/2013 |
MINNIE |
ELETTRONICA VALSERIANA SRL |
SERGIO GHERSINI |
| K130110 |
01/16/2013 |
MEDDUSA BIPOLAR SYSTEM |
ELLIQUENCE LLC |
OSCAR R PAREDES |
| K133536 |
11/18/2013 |
EMERGE MEDICAL BONE PLATE SYSTEM |
EMERGE MEDICAL |
MICHELLE POTVIN |
| K133541 |
11/18/2013 |
EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM |
EMERGE MEDICAL |
MICHELLE POTVIN |
| K133452 |
11/12/2013 |
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM |
EMERGE MEDICAL |
MICHELLE POTVIN |
| K130048 |
01/08/2013 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K130099 |
01/15/2013 |
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K133425 |
11/08/2013 |
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT |
ENGINEERED MEDICAL SOLUTIONS CO. LLC. |
RYAN SAVAGE |
| K133563 |
11/20/2013 |
PATHASSIST LIGHT SEEKER |
Entellus Medical, Inc. |
GARRETT P AHLBORG |
| K133584 |
11/21/2013 |
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM |
EOSHEALTH, INC. |
Carrie Hetrick |
| K133537 |
11/18/2013 |
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K133389 |
11/05/2013 |
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K133647 |
11/27/2013 |
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| DEN130047 |
11/18/2013 |
PROLONG |
ERGON MEDICAL LTD. |
BARRY PEARCE |
| K133490 |
11/13/2013 |
G-SCAN BRIO |
ESAOTE S.P.A. |
ALLISON S COTT |
| K130068 |
01/11/2013 |
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) |
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M |
KEN SEISE |
| K130178 |
01/25/2013 |
INSPIRATION VENTILATOR SYSTEM 5I/7I |
EVENT MEDICAL LTD |
RICK WATERS |
| K133446 |
11/12/2013 |
HEPARIN LOCK / FLUSH SYRINGES |
Excelsior Medical Corporation |
JOHN LINFANTE |
| K130120 |
01/17/2013 |
EXTREMITY MEDICAL IP FUSION SYSTEM |
EXTREMITY MEDICAL, LLC |
BRIAN SMEKAL |
| K133636 |
11/26/2013 |
EXTREMITY MEDICAL HAMMERTOE DEVICE |
EXTREMITY MEDICAL, LLC. |
BRIAN SMEKAL |
| K133573 |
11/20/2013 |
FIAGON NAVIGATION SYSTEM |
FIAGON GMBH |
DIRK MUCHA |
| K133403 |
11/06/2013 |
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS |
FIRESTONE OPTICS, INC. |
MARTIN DALSING |
| K133638 |
11/27/2013 |
GEKO |
FIRSTKIND LIMITED |
SHEILA HEMEON-HEYER |
| K133666 |
11/29/2013 |
RT016 INSPIRATORY FILTER |
FISHER & PAYKEL HEALTHCARE LTD. |
ELIZABETH GOLDSTEIN |
| K133516 |
11/15/2013 |
CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER |
FLEXICARE |
CHRISTOPHER WATKINS |
| K130171 |
01/24/2013 |
FLIGHT 60 VENTILATOR |
FLIGHT MEDICAL INNOVATIONS LTD. |
SHOSHANA FRIEDMAN |
| K133621 |
11/25/2013 |
SIMPLEXA HSV 1&2 DIRECT |
FOCUS DIAGNOSTICS |
SHARON YOUNG |
| DEN130049 |
11/25/2013 |
SIMPLEXA HSV 1&2 DIRECT |
FOCUS DIAGNOSTICS |
SHARON YOUNG |
| K133588 |
11/21/2013 |
FORA CARE BLOOD PRESSURE MONITORING SYSTEM |
FORA CARE INC. |
Sharon Peng |
| K130001 |
01/02/2013 |
CARE SU01A SUCTION ASPIRATOR |
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
GANG WU |
| K133454 |
11/12/2013 |
SONOSITE EDGE ULTRASOUND SYSTEM |
FUJIFILM SONOSITE,INC. |
PATRICIA LIAU |
| K130173 |
01/24/2013 |
SONOSITE MAXX SERIES ULTRASOUND SYSTEM |
FUJIFILM SONOSITE,INC. |
SCOTT PAULSON |
| K130039 |
01/07/2013 |
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K130190 |
01/28/2013 |
PIXEL 3 SYSTEM |
GAUSS SURGICAL, INC. |
PEGGY MCLAUGHLIN |
| K130069 |
01/11/2013 |
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 |
GE HEALTHCARE |
NING WEN |
| K133533 |
11/18/2013 |
LOGIQ E |
GE HEALTHCARE |
BRYAN BEHN |
| K133431 |
11/08/2013 |
VENUE 50 |
GE HEALTHCARE |
BRYAN BEHN |
| K133576 |
11/20/2013 |
MONITOR B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
ROBERT CASARSA |
| K130155 |
01/22/2013 |
MUSE CARDIOLOGY INFORMATION SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
KRISTIN PABST |
| K133649 |
11/27/2013 |
HEPATIC VCAR |
GE MEDICAL SYSTEMS SCS |
HUY DOAN |
| K133664 |
11/29/2013 |
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN |
CHRIS PAULIK |
| K133640 |
11/27/2013 |
ASIR-V |
GE MEDICAL SYSTEMS, LLC |
HUY DOAN |
| K130115 |
01/16/2013 |
DISCOVERY MR750W 3.0T |
GE MEDICAL SYSTEMS, LLC |
MICHELLE HUETTNER |
| K133657 |
11/27/2013 |
DISCOVERY PET/CT 710 |
GE MEDICAL SYSTEMS, LLC |
DAVID DUERSTELER |
| K133605 |
11/25/2013 |
BD MAX MRSA XT, BD MAX INSTRUMENT |
GENEOHM SCIENCES CANADA, INC. |
PATRICIA DIONNE |
| K130088 |
01/14/2013 |
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K130082 |
01/14/2013 |
GENPRIME DRUGS OF ABUSE READER SYSTEM |
GENPRIME, INC |
Maureen Garner |
| K133482 |
11/13/2013 |
SILC FIXATION SYSTEM |
GLOBE MEDICAL, INC. |
CHRISTINA KICHULA |
| K133567 |
11/20/2013 |
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL INC. |
CHRISTINA KICHULA |
| K133678 |
11/29/2013 |
CONFIRM BIOACTIVE |
GLOBUS MEDICAL, INC. |
CHRISTINA KICHULA |
| K133655 |
11/27/2013 |
RADIANCE V2 |
GMV SOLUCIONES GLOBALES INTERNET S.A.U. |
ALBERT KOSTER |
| K133619 |
11/25/2013 |
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K133618 |
11/25/2013 |
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K130055 |
01/09/2013 |
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K133528 |
11/15/2013 |
H&H EMERGENCY CRICOTHYROTOMY KIT |
H&H MEDICAL CORPORATION |
J. Lawrence Stevens |
| K130235 |
01/30/2013 |
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY |
HANS BIOMED CORP. |
PATSY J TRISLER, JD, RAC |
| K130191 |
01/25/2013 |
MINT |
HANSBIOMED CORPORATION |
APRIL LEE |
| K133552 |
11/19/2013 |
MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT |
Hansen Medical |
HASSAN LABAY |
| K130034 |
01/07/2013 |
UNI-PICC |
HEALTH LINE INTERNATIONAL CORPORATION |
NOLA BENSTOG |
| DEN130045 |
11/04/2013 |
HEARTFLOW FFRCT |
HEARTFLOW |
Dustin Michaels |
| K130141 |
01/22/2013 |
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA B AMMIRATI, RAC, MT (ASCP) |
| K130038 |
01/07/2013 |
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE |
HL RUBBER INDUSTRIES SDN BHD |
NOORZALIZA AHMAD |
| K133676 |
11/29/2013 |
ABX PENTRA MICRO ALB CONTROL L/H |
HORIBA ABX SAS |
CAROLINE FERRER |
| K133602 |
11/25/2013 |
ADD-VANTAGE ADDAPTOR |
HOSPIRA, INC. |
KAREN KEENER |
| K130008 |
01/02/2013 |
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING |
I.T.S. GMBH |
AL LIPPINCOTT |
| K130059 |
01/10/2013 |
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP |
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. |
ELISSA BURG |
| K133620 |
11/25/2013 |
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM |
IMAGING SCIENCES INTERNATIONAL |
RUTH PUI |
| K133669 |
11/29/2013 |
MEDINAUT KYPHOPLASTY SYSTEM |
IMEDICOM |
Priscilla Chung |
| K133617 |
11/25/2013 |
JAZZ SYSTEM |
IMPLANET S.A. |
JANICE M HOGAN |
| K130224 |
01/29/2013 |
ICT |
IMRIS, INC. |
Daniel Biank |
| K130181 |
01/25/2013 |
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K133459 |
11/12/2013 |
ELITE IBF |
INNOVA SPINAL TECHNOLOGIES, LLC |
RICH JANSEN, PHARM. D. |
| K133542 |
11/18/2013 |
PURACYN PLUS SKIN AND WOUND |
INNOVACYN, INC. |
FRED L MA |
| K133390 |
11/05/2013 |
NDX DORSAL APPLIANCE |
INSTITUTE FOR QUALITY RESOURCE MANAGEMENT |
LEAH AMIR, MS, MHA |
| K133523 |
11/15/2013 |
STAPIX SUPERELASTIC IMPLANT BONE STAPLES |
INSTRATEK, INC. |
Jeff Seavey |
| K133582 |
11/21/2013 |
HEMOSIL D-DIMER HS 500 CONTROL |
INSTRUMENTATION LABORATORY |
CAROL MARBLE |
| K133407 |
11/06/2013 |
GEM PREMIER 4000 |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K133607 |
11/25/2013 |
V8 TRANSLUMINAL BAV CATHETER |
INTERVALVE, INC |
JULIE BODMER |
| K133583 |
11/21/2013 |
OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 |
INTERVENTIONAL SPINE, INC. |
JANE METCALF |
| K130140 |
01/22/2013 |
INTRA-LOCK OP DENTAL IMPLANT |
INTRA-LOCK INTERNATIONAL |
DIANA TAYLOR |
| K133613 |
11/25/2013 |
INTRA-LOCK DENTAL IMPLANTS |
INTRA-LOCK INTERNATIONAL, INC. |
MARY L JEAN |
| K133493 |
11/14/2013 |
SINGLE USE STERILE SYRINGE WITH NEEDLE |
JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO.,LT |
HELEN NAN |
| K130232 |
01/29/2013 |
ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM |
JINXINBAO ELECTRONIC CO.,LTD |
HELEN NAN |
| K130231 |
01/29/2013 |
NON-CONTACT INFRARED THERMOMETER |
JINXINBAO ELECTRONIC CO.,LTD |
HELEN NAN |
| K133510 |
11/14/2013 |
NEODENT IMPLANT SYSTEM |
JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA |
KEVIN A THOMAS |
| K133511 |
11/14/2013 |
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
| K133614 |
11/25/2013 |
ALEUTIAN IBF SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K133494 |
11/14/2013 |
CHESAPEAKE SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K133402 |
11/06/2013 |
K2M MODULAR HOOKS |
K2M, INC. |
KAREN E WARDEN |
| K130056 |
01/09/2013 |
PATIENT MONITOR |
LD TECHNOLOGY LLC |
ALBERT MAAREK |
| K133363 |
11/01/2013 |
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM |
LDR SPINE, USA, INC. |
MEREDITH MAY |
| K130016 |
01/01/2013 |
LIFESPAN EPTFE VASCULAR GRAFT |
LEMAITRE VASCULAR, INC. |
XIANG ZHANG |
| K130202 |
01/28/2013 |
IRIS ANTERIOR CERVICAL PLATE |
LIFE SPINE, INC |
RANDY LEWIS |
| K133564 |
11/20/2013 |
MODIFICATION TO NAUTILUS SPINAL SYSTEM |
LIFE SPINE, LLC. |
RANDY LEWIS |
| K130164 |
01/23/2013 |
FIBERLASE ENDURE CO2 FIBER |
LUMENIS LTD. |
YORAM LEVY |
| K130195 |
01/28/2013 |
SCANNING LASERLINK |
LUMENIS, INC. |
JACE R MCLANE |
| K130028 |
01/03/2013 |
RESURFX 1565NM LASER MODULE |
LUMENIS, LTD. |
YORAM LEVY |
| K130189 |
01/25/2013 |
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
| DEN130003 |
01/11/2013 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
| K130213 |
01/29/2013 |
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE |
LUMIQUICK DIAGNOSTICS, INC. |
Feng-Yu Lee |
| K130199 |
01/28/2013 |
CLARITY LPC LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
| K133550 |
11/19/2013 |
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT |
MAINE STANDARDS COMPANY LLC |
JAMES W CHAMPLIN |
| K133598 |
11/22/2013 |
CARDIOHELP SYSTEM |
MAQUET CARDIOPULMONARY AG |
HELDER A SOUSA |
| K133466 |
11/12/2013 |
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) |
MAUNA KEA TECHNOLOGIES |
MICHAEL A DANIEL |
| K133540 |
11/18/2013 |
FLOCAP |
MAXTEC, INC. |
PAUL DRYDEN |
| K133534 |
11/18/2013 |
MCKESSON CARDIOLOGY ECG MOBILE |
MCKESSON ISRAEL LTD. |
PAUL SUMNER |
| K133630 |
11/26/2013 |
GMK SHORT STEM |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K133460 |
11/12/2013 |
APTUS CANNULATED COMPRESSION SCREWS |
MEDARTIS AG |
ALLISON KOMIYAMA |
| K130123 |
01/17/2013 |
BASIC AND DOMINANT FLEX SUCTION PUMPS |
MEDELA AG |
ADRIENNE LENZ |
| K130210 |
01/29/2013 |
MEDELA THOPAZ |
MEDELA AG |
MARKUS BUETLER |
| K130080 |
01/14/2013 |
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL |
MEDICA CORPORATION |
Photios Makris |
| K133428 |
11/08/2013 |
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO |
MEDIKRO OY |
MIKKO ELORANTA |
| K130221 |
01/29/2013 |
HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM |
MEDIMECCA CO., LTD. |
Priscilla Chung |
| K130179 |
01/25/2013 |
MP VIAL ADAPTER 13MM |
MEDIMOP MEDICAL PROJECTS, LTD. |
ILANIT GOLDGRABER |
| K130132 |
01/18/2013 |
BABYLANCE HEEL INCISION DEVICE |
MEDIPURPOSE PTE. LTD. |
JULIE STEPHENS |
| K133665 |
11/29/2013 |
MALLEABLE SUCTION INSTRUMENTS |
MEDTRONIC NAVIGATION, INC. |
CHARLES M COPPERBERG |
| K133444 |
11/12/2013 |
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM |
MEDTRONIC NAVIGATION, INC. |
KAYE WAITE |
| K133577 |
11/21/2013 |
CLYDESDALE(R) SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC |
LEE GRANT |
| K130177 |
01/25/2013 |
ANATOMIC PEEK CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LEE GRANT |
| K133653 |
11/27/2013 |
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
JULIE BASSETT |
| K133650 |
11/27/2013 |
CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
GREGORY MASCHEK |
| K133645 |
11/27/2013 |
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BECKY RONNER |
| K133539 |
11/18/2013 |
TOTAL ACROSS |
MEDTRONIC VASCULAR |
DIANA JOHNSON |
| K133673 |
11/29/2013 |
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K130076 |
01/14/2013 |
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS |
MERZ DENTAL GMBH |
|
| K130100 |
01/15/2013 |
COMINED STANDARD SOLUTION |
MESA LABORATORIES, INC. |
JAMIE LOUIE |
| K130229 |
01/29/2013 |
PALM BLADDER SCANNER |
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. |
HELEN NAN |
| K133554 |
11/19/2013 |
SURGICAL LIGHT HANDLE COVER |
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY |
ANDY ROLLER |
| K133626 |
11/26/2013 |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K130073 |
01/11/2013 |
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS |
MIKRON MAKINA SANAYI VE TICARET LTD STI |
OMAR DIKER |
| K133624 |
11/26/2013 |
COMPASS CT, COMPASS CT PORT |
MIRADOR BIOMEDICAL |
JUSTIN HULVERSHORN |
| K130003 |
01/02/2013 |
XIRALITE FLOURESCENCE IMAGING SYSTEM X4 |
MIVENION GMBH |
MALTE BAHNER |
| K130040 |
01/07/2013 |
MEPITEL AG |
MOLNLYCKE HEALTH CARE |
ANGELA L BUNN |
| K133515 |
11/15/2013 |
PEEK FUSION IMPLANT |
MTP SOLUTIONS LLC |
ROBERT HOY |
| K133453 |
11/12/2013 |
IOVERA |
MYOSCIENCE INC |
BIJESH CHANDRAN |
| K130010 |
01/03/2013 |
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY |
NANOSTRING TECHNOLOGIES |
SYLVA KRIZAN, PHD |
| K133609 |
11/25/2013 |
THE DOME S6C |
NDS SURGICAL IMAGING |
JIM LENG |
| K130198 |
01/28/2013 |
NEO DENTA ZIRCONIA |
NEO GROUP LIMITED |
MIKE ADAMS |
| K133422 |
11/08/2013 |
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE |
NEOCOIL, LLC |
KATIE GONZALEZ |
| K133670 |
11/29/2013 |
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE |
NEOCOIL, LLC |
MICHEAL LEIGH |
| K133592 |
11/22/2013 |
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM |
NEODENT USA, INC. |
CHRISTOPHER KLACZYK |
| K130228 |
01/29/2013 |
SUITEHEART |
NEOSOFT, LLC |
JACKIE SCHWABE |
| K130117 |
01/16/2013 |
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS |
NETWORK MEDICAL PRODUCTS, LTD. |
ALISON MARCH |
| K130233 |
01/30/2013 |
NEUROSTAR TMS THERAPY SYSTEM |
NEURONETICS |
JUDY P WAYS, PH.D. |
| K133408 |
11/06/2013 |
NEUROSTAR TMS THERAPY SYSTEM |
NEURONETICS |
JUDY P WAYS, PH.D. |
| K133373 |
11/01/2013 |
CLEARVIEW |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YUEHUI |
| K130114 |
01/16/2013 |
PAINMASTER MCT PATCH |
NEWMARK, INC. |
CHERITA JAMES |
| K133475 |
11/12/2013 |
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS |
NEXXT SPINE LLC |
ERIC LINTULA |
| K133507 |
11/14/2013 |
GUIDOSS |
NIBEC CO LTD |
DANIEL NAM |
| K130238 |
01/31/2013 |
NIHON KOHDEN AE-918P NEURO UNIT |
NIHON KOHDEN CORP. |
NATALIE KENNEL |
| K130049 |
01/08/2013 |
MONOJECT 12ML SYRINGE |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD-MCLEOD |
| K130057 |
01/09/2013 |
ESPIN |
NLT SPINE LTD |
JOHN J SMITH |
| K133377 |
11/04/2013 |
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE |
NOBEL BIOCARE AB |
PHUONG NGUYEN |
| K133506 |
11/14/2013 |
NORAS OR HEAD HOLDER FLEXIBILITY |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
| K130023 |
01/03/2013 |
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR |
NP MEDICAL, INC. |
ROBERT J BARD, JD, RAC, CQE |
| K130242 |
01/31/2013 |
MAVEN PRO |
NSEQUENCE |
RHONDA ALEXANDER, MS, MPA |
| K133530 |
11/15/2013 |
NUVASIVE EMG ENDOTRACHEAL TUBE |
NUVASIVE, INCORPORATED |
JEREMY MARKOVICH |
| K130234 |
01/30/2013 |
NUVON VITALS CHARTING SYSTEM |
NUVON, INC. |
JONATHAN S KAHAN |
| K133547 |
11/19/2013 |
NXSTAGE SYSTEM ONE WITH NXVIEW |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K133562 |
11/20/2013 |
CATARHEX 3 |
OERTLI INSTRUMENTE AG |
KARIN ROHR |
| K133538 |
11/18/2013 |
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE |
OLYMPUS CORPORATION OF THE AMERICAS |
SHERI L MUSGNUNG |
| K130058 |
01/09/2013 |
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 |
OLYMPUS MEDICAL SYSTEMS CORP. |
DAPHNEY GERMAIN-KOLAWOLE |
| K133381 |
11/04/2013 |
OMNI ARC MONOBLOCK HIP STEM |
OMNILIFE SCIENCE |
CHRISTINA FLORES |
| K133379 |
11/04/2013 |
HEM-7311 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K133383 |
11/04/2013 |
HEM-7320 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K133387 |
11/05/2013 |
ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED |
ORIGIO A/S |
TOVE KJAER |
| K133449 |
11/12/2013 |
KASM KNEE ARTICULATING SPACER MOLDS |
ORTHO DEVELOPMENT CORP. |
MIKE ENSIGN |
| K133386 |
11/05/2013 |
OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM |
ORTHO DEVELOPMENT CORP. |
MIKE ENSIGN |
| K130176 |
01/25/2013 |
FIREBIRD SPINAL FIXATION SYSTEM |
ORTHOFIX |
JACKI GEREN |
| K130217 |
01/29/2013 |
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
| K130104 |
01/15/2013 |
GUIDEWIRE, PURSUER SERIES |
Oscor Inc. |
MILA DOSKOCIL |
| K133527 |
11/15/2013 |
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT |
OSSTEM GERMANY GMBH |
PATRICK LIM |
| K130174 |
01/24/2013 |
DVTCARE CA5 |
OSSUR AMERICAS INC |
JOHN LINDAHL |
| K133437 |
11/07/2013 |
1ST MTP PLATE |
OSTEOMED |
BLESSON ABRAHAM |
| K130201 |
01/28/2013 |
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM |
OTOTRONIX, LLC |
BERNARD HORWATH |
| K133514 |
11/15/2013 |
XCAGE INTERBODY FUSION SYSTEM |
OUROBOROS MEDICAL |
JOHN TO |
| K133397 |
11/06/2013 |
P-POD |
P-POD |
LINDA BRADDON |
| K133544 |
11/18/2013 |
OP300 |
PALODEX GROUP OY |
TERHO TURKUMAKI |
| K130087 |
01/14/2013 |
PANPAC WORD/BARTHOLIN CATHETER |
Panpac Medical Corporation |
Yen-Ming Pan |
| K133432 |
11/05/2013 |
SHERPA PAK CARDIAC TRANSPORT SYSTEM |
PARAGONIX TECHNOLOGIES, INC. |
LEO BASTA |
| K130206 |
01/28/2013 |
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K133404 |
11/06/2013 |
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH |
PHADIA AB |
MARTIN R MANN |
| K130091 |
01/15/2013 |
PULMOSAL |
PHARMACARIBE |
PAUL DRYDEN |
| K130159 |
01/23/2013 |
QLAB QUANTIFICATION SOFTWARE HEART MODEL |
PHILIPS HEALTHCARE |
PENNY GRECO |
| K133674 |
11/29/2013 |
PHILIPS IQON SPECTRAL CT |
PHILIPS HEALTHCARE (CLEVELAND) |
CATHERINE M CONNELL |
| K130153 |
01/22/2013 |
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST |
PHILIPS MEDICAL SYSTEMS |
MARK PUOPOLO |
| K133659 |
11/27/2013 |
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING |
PHILIPS MEDICAL SYSTEMS |
JOHN PARDO |
| K133603 |
11/25/2013 |
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION |
PHILIPS MEDICAL SYSTEMS |
SUSAN QUICK |
| K133526 |
11/15/2013 |
MDIXON-QUANT |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
SUSAN QUICK |
| K130021 |
01/03/2013 |
PHILIPS HERCEPTEST DIGITAL SCORE |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
DIRK VOSSEN |
| K133623 |
11/26/2013 |
C-PLUS |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K133455 |
11/12/2013 |
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY DOWNS |
| K133374 |
11/01/2013 |
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I |
SARAH MCINTYRE |
| K133579 |
11/21/2013 |
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS |
PONTIS ORTHOPAEDICS, LLC |
LEONARD GORDON |
| K133483 |
11/13/2013 |
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE |
PORTABLE THERAPEUTIX |
Sharyn Orton, Ph.D. |
| K133524 |
11/15/2013 |
PVMED DDR 2430T |
PORTAVISION MEDICAL LLC |
TERRY ANCAR |
| K133629 |
11/26/2013 |
ANGIOJET ULTRA AVX THROMBECTOMY SET |
POSSIS MEDICAL, INC. |
GEORGE LUCAS |
| K133474 |
11/12/2013 |
BIOSIGN FLU A + B, STATUS FLU A & B |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K133502 |
11/14/2013 |
5000Z FIREFLY SYSTEM |
PRIZM MEDICAL, INC. |
CARL BEAURLINE |
| K133546 |
11/19/2013 |
STARLITE-OM, LIGHT EFFECTS, THIBIANT |
PS ADVANCED ENGINEERING |
CD FEAK |
| K130223 |
01/29/2013 |
RMGI FILL |
PULPDENT CORPORATION |
KENNETH J BERK |
| K133382 |
11/04/2013 |
QB TEST |
QBTECH AB |
HANS BOSTROM |
| K133503 |
11/14/2013 |
AMPLIVUE GBS ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K130144 |
01/22/2013 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
Martin Gabler |
| K130236 |
01/30/2013 |
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 |
RADIOMETER MEDICAL APS |
Martin Gabler |
| K133423 |
11/08/2013 |
REST ASSURED EXTRA COMFORT NITE PROTECTOR |
RANIR LLC |
PAULA BOJSEN |
| K133409 |
11/07/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA |
RAYENCE CO., LTD |
DAVE KIM |
| K130079 |
01/14/2013 |
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER |
REFLECTANCE MEDICAL INC |
Nandini Murthy |
| K130237 |
01/31/2013 |
PONTIC PAINT |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAULA WENDLAND |
| K130002 |
01/02/2013 |
SURECALL LABOR MONITOR |
REPRODUCTIVE RESEARCH TECHNOLOGIES, LP |
J. HARVEY KNAUSS |
| K124065 |
01/02/2013 |
FERRISCAN R2-MRI ANALYSIS SYSTEM |
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD |
GREG HOLLAND |
| DEN130012 |
01/02/2013 |
FERRISCAN R2-MRI ANALYSIS SYSTEM |
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD |
GREG HOLLAND |
| K130170 |
01/24/2013 |
EXSPIRON 1XI |
RESPIRATORY MOTION, INC. |
JENNY FREEMAN, MD |
| K130077 |
01/14/2013 |
REMSTAR SE |
RESPIRONICS, INC. |
FRANK KADI |
| K133635 |
11/26/2013 |
EASYPOINT NEEDLE |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
| K130218 |
01/30/2013 |
XSTAT |
REVMEDX, INC. |
JOHN J SMITH |
| DEN130016 |
01/30/2013 |
XSTAT |
REVMEDX, INC. |
JOHN J SMITH |
| K130220 |
01/29/2013 |
MR CONDITIONAL PRESSON ELECTRODE |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES M MEWBORNE |
| K133330 |
11/01/2013 |
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN |
Roche Diagnostics |
Susan Hollandbeck |
| K130138 |
01/18/2013 |
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Justin Davis |
| K133496 |
11/14/2013 |
X TWIN SYSTEM |
ROESYS GMBH |
JOCHEN DYSZBALIS |
| K130125 |
01/17/2013 |
MTA CEMENTS |
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN |
CHRISTIAN BOETTCHER |
| K130014 |
01/02/2013 |
A1C GEAR SYSTEM |
Sakae Corporation |
ERICA B AMMIRATI |
| K133505 |
11/14/2013 |
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
PARK KYEONG-MI |
| K133418 |
11/07/2013 |
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM |
SEASPINE, INC. |
JEFF BRITTAN |
| K130130 |
01/17/2013 |
ATG/SM-OSA APPLIANCES |
SELANE PRODUCTS, INC. |
CAROLYN PRIMUS |
| K133362 |
11/01/2013 |
SGS DENTAL IMPLANT |
SGS INTERNATIONAL LTD |
DANIELA LEVY |
| K130015 |
01/03/2013 |
SHASER V-MINI HAIR REMOVAL SYSTEM |
SHASER, INC. |
SARAH HACKETT |
| K130041 |
01/08/2013 |
SHEATHES STERILE ULTRASOUND GEL |
SHEATHING TECHNOLOGIES, INC. |
JENNIFER DOWNING |
| K133478 |
11/12/2013 |
POWDER FREE POLYETHYLENE EXAMINATION GLOVES |
SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD |
KATHY LIU |
| K133668 |
11/29/2013 |
AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL |
SHOULDER OPTIONS, INC. |
JOHN KAPITAN |
| K133512 |
11/15/2013 |
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE K ENNIS |
| K133601 |
11/25/2013 |
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY |
Siemens Healthcare Diagnostics Inc. |
PHILIP LIU |
| K133491 |
11/13/2013 |
ADVIA CENTAUR TESTOSTERONE (TSTO) |
Siemens Healthcare Diagnostics Inc. |
MATTHEW GEE |
| K133580 |
11/21/2013 |
ARTIS ONE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K133435 |
11/08/2013 |
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K133654 |
11/27/2013 |
SCENIUM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MARIA EBIO |
| K133424 |
11/08/2013 |
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K133589 |
11/22/2013 |
SOMATOM FORCE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K133590 |
11/22/2013 |
SOMATOM PERSPECTIVE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K133677 |
11/29/2013 |
SYNGO CT SINGLE SOURCE DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K133648 |
11/27/2013 |
SYNGO, CT DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K133644 |
11/27/2013 |
SYNGO.VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO, RAC |
| K133401 |
11/06/2013 |
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K133643 |
11/27/2013 |
SYNGO, CT LIVER ANALYSIS |
SIEMENS MEDICAL SOLUTIONS, INC. |
KIMBERLY MANGUM |
| K133646 |
11/27/2013 |
ADMIRE |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K133370 |
11/04/2013 |
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE |
SIGNATURE ORTHOPAEDICS PTY LIMITED |
DECLAN BRAZIL |
| K130225 |
01/29/2013 |
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE |
SILVERBAY LLC, D/B/A QUASAR BIO-TECH |
ROBERT WAGNER |
| K130147 |
01/22/2013 |
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL) |
SMALL BONE INNOVATIONS, INC. |
JOHN MINIER |
| K133662 |
11/29/2013 |
SMITH & NEPHEW CANNULATED CAPTURED SCREW |
SMITH & NEPHEW, INC. |
KATHERINE MARCACCIO |
| K130193 |
01/25/2013 |
FRAXEL DUAL 1550/1927 LASER SYSTEM |
SOLTA MEDICAL, INC. |
Raymond Lee |
| DEN130046 |
11/14/2013 |
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE |
SOMNA THERAPEUTICS, LLC |
James S. Miller |
| K130025 |
01/03/2013 |
SONENDO ENDOTHERAPY SYSTEM |
SONENDO, INC. |
DAN W MILLER |
| K130119 |
01/16/2013 |
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K130209 |
01/29/2013 |
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K133586 |
11/21/2013 |
VISI MOBILE MONITIORING SYSTEM |
SOTERA WIRELESS, INC |
EBEN GORDON |
| K133472 |
11/12/2013 |
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) |
SOUFLON PHARMACEUTICALS LTD |
CHRISTOPHER SMEJKAL |
| K130112 |
01/16/2013 |
CAPNO MODULE, 92517 |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K130207 |
01/28/2013 |
SPACELABS HEALTHCARE CARDIOEXPRESS |
SPACELABS HEALTHCARE LTD. |
THOMAS KROENKE |
| K133631 |
11/26/2013 |
LEXIPLIANT DILATOR SHEATH SET |
SPECTRANETICS CORPORATION |
STACEY A STRAND |
| K130066 |
01/10/2013 |
SPECTRUM SPINE SPINOUS PROCESS DEVICE |
SPECTRUM SPINE IP HOLDINGS, LLC |
RICH JANSEN |
| K133557 |
11/19/2013 |
JULIET LL LATERAL LUMBAR CAGE |
SPINEART |
FRANCK PENNESI |
| K133371 |
11/01/2013 |
RAMPART-L |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K133575 |
11/20/2013 |
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM |
SPINEVISION, S.A. |
J.D. WEBB |
| K130211 |
01/29/2013 |
AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS |
SPS MEDICAL SUPPLY CORP. |
MICHAEL G NOLAN |
| K133587 |
11/21/2013 |
PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 |
ST. JUDE MEDICAL SYSTEMS AB |
ERDULFO DE PERALTA |
| K133481 |
11/13/2013 |
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) |
ST. JUDE MEDICAL, INC. |
Michael McSweeney |
| K133152 |
11/22/2013 |
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT |
STANMORE IMPLANTS WORLDWIDE LTD. |
GERARD J PRUD'HOMME |
| K133396 |
11/06/2013 |
VDRIVE WITH V-SONO |
STEREOTAXIS, INC. |
DIANE HORWITZ, PH.D. RAC |
| K133414 |
11/07/2013 |
REPROCESSED CLOSURE SYSTEM |
STERILMED, INC. |
JASON SKRAMSTED |
| K130160 |
01/23/2013 |
VERIFY PROCESS INDICATOR FOR RELIANCE EPS |
STERIS Corporation |
MARCIA L BENEDICT |
| K133549 |
11/19/2013 |
STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR |
STERITEC PRODUCTS MFG., CO., INC. |
JONATHAN RUTIGLIANO |
| K130183 |
01/25/2013 |
SFI BAR ABUTMENTS |
STERNGOLD DENTAL LLC |
MARIA RAO |
| K130222 |
01/29/2013 |
STRAUMANN DENTAL IMPLANT SYSTEM |
STRAUMANN USA, LLC |
JENNIFER M JACKSON, MS |
| K133421 |
11/08/2013 |
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW |
STRAUMANN USA, LLC |
CHARLOTTE RINGLEB |
| K133398 |
11/06/2013 |
STRYKER PEDIATRIC MANDIBLE DISTRACTOR |
Stryker |
Manish Patel |
| K133461 |
11/12/2013 |
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM |
Stryker |
JULIE SCHOELL |
| K133671 |
11/29/2013 |
ICONIX ALL SUTURE ANCHORS |
STRYKER CORP. |
KELLY KUCHARCZYK |
| K133672 |
11/29/2013 |
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY |
STRYKER SUSTAINABILITY SOLUTIONS |
SCOTT ENGLISH |
| K133578 |
11/21/2013 |
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
STRYKER SUSTAINABILITY SOLUTIONS |
JILL CLARK |
| K133440 |
11/12/2013 |
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION |
Stryker Trauma AG |
Elijah Wreh |
| K133451 |
11/12/2013 |
FIXOS SCREW SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K130116 |
01/16/2013 |
SUPERIOR LATERAL VARIAX CLAVICLE PLATE |
Stryker Trauma AG |
ESTELA CELI |
| K130009 |
01/02/2013 |
VARIAX 2 COMPRESSION PLATING SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
| K130078 |
01/14/2013 |
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K133420 |
11/08/2013 |
TRANQUILL BARBED DEVICE |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K133499 |
11/14/2013 |
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA |
SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD. |
ROBERT SEIPLE, RAC |
| K133477 |
11/12/2013 |
TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS |
SYNCHRO MEDICAL |
MARK F SCHENK |
| K130146 |
01/22/2013 |
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM |
SYNTHES (USA) LLC |
STACEY BONNELL |
| K133616 |
11/25/2013 |
MATRIXRIB FIXATION SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
Damon Lees |
| K133593 |
11/22/2013 |
T:SLIM INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
JOHN SHERIDAN |
| K130136 |
01/18/2013 |
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, |
TECHNOMED EUROPE |
PIERRE VREULS |
| K133439 |
11/12/2013 |
PILLING ESOPHAGEAL BOUGIES |
Teleflex Medical, Inc. |
HOLLY KORNEGAY |
| K130043 |
01/08/2013 |
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM |
Teleflex Medical, Inc. |
NATALIE SMITH |
| K133658 |
11/27/2013 |
CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
Kevin Kong |
| K130084 |
01/14/2013 |
MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM |
TGM MEDICAL, INC. |
PRAKASH PAI |
| K133604 |
11/25/2013 |
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS |
THE ANSPACH EFFORT, INC. |
JEANNETTE G DAILEY |
| K130052 |
01/09/2013 |
TONE-A-MATIC |
TONE-A-MATIC INTERNATIONAL, INC. |
ANNIA KORDIUK |
| K133667 |
11/29/2013 |
SLIT LAMP SL-D701 |
TOPCON CORP. |
MAUREEN O'CONNELL |
| K130051 |
01/09/2013 |
611 ANKLE FUSION NAIL |
Tornier SAS |
DAMIEN GUILLAUD |
| K133376 |
11/04/2013 |
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT |
TORNIER, INC. |
JANELL A COLLEY |
| K133553 |
11/19/2013 |
KALARE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K133497 |
11/14/2013 |
AQUILION ONE VISION |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K133535 |
11/18/2013 |
INFX-8000V, V5.30 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
CHARLEMAGNE CHUA |
| K130012 |
01/02/2013 |
WET PLATINUM PERSONAL LUBRICANT |
TRIGG LABORATORIES, INC. |
ERNIE JOHNSON |
| K133633 |
11/26/2013 |
CHOCOLATE PTCA BOLLOON CATHETER |
TRIREME MEDICAL INC |
SHIVA ARDAKANI |
| K133419 |
11/07/2013 |
BABYMEG BIOMAGNETOMETER SYSTEM |
TRISTAN TECHNOLOGIES INC |
EUGENE HIRSCHKOFF |
| K133406 |
11/06/2013 |
CS 8100 3D |
TROPHY |
MARIE PIERRE |
| K130149 |
01/22/2013 |
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K130148 |
01/22/2013 |
FOREIGN BODY HOOD |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K133513 |
11/12/2013 |
MULTI-STAGE SNARE |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K130017 |
01/02/2013 |
VALENTINE STEEL WHEELCHAIR |
VALENTINE INTL. LTD. |
JEN KE-MIN |
| K133572 |
11/20/2013 |
ARIA RADIATION THERAPY MANAGEMENT |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K133501 |
11/14/2013 |
LEADLINER CS LEAD DELIVERY SYSTEM |
VASCULAR SOLUTIONS, INC. |
MIA HUNT |
| K130109 |
01/16/2013 |
ENDOGRAPH DC |
VILLA SISTEMI MEDICALI S.P.A. |
PAOLO CASAGRANDE SANTIN |
| K133568 |
11/20/2013 |
G-TL |
VITROLIFE, INC. |
MARK LARMAN |
| K133641 |
11/27/2013 |
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE |
VOLCANO CORPORATION |
MARCUS GARCIA |
| K133445 |
11/12/2013 |
ANGIOVAC CANNULA |
VORTEX MEDICAL INC |
Lorraine M Hanley |
| K133488 |
11/13/2013 |
PIEZOMED |
W & H DENTALWERK BUERMOOS GMBH |
ANJA LINDNER |
| K130215 |
01/29/2013 |
GORE ACUSEAL VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
| K133652 |
11/27/2013 |
GSP NEONATAL TOTAL GALACTOSE KIT |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. |
JEANETTE SCHIER-PUGSLEY |
| K130074 |
01/14/2013 |
GYMFORM ABS-A-ROUND |
WELL BRAIN INTERNATIONAL, LTD. |
VICTOR K WAI |
| K133615 |
11/25/2013 |
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER |
WELL LEAD MEDICAL CO. LTD |
JOHN OBRIEN |
| K130184 |
01/25/2013 |
ZENOLUX |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K133622 |
11/22/2013 |
MAC 2000 ECG ANALYSIS SYSTEM |
WIPRO GE HEALTHCARE |
DOUGLAS KENTZ |
| K133585 |
11/21/2013 |
INBONE TOTAL ANKLE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K130167 |
01/23/2013 |
PROFEMUR XM DISTAL CENTRALIZER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K130044 |
01/08/2013 |
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN BORMANN |
| K130212 |
01/29/2013 |
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
GARFIELD WANG |
| K130230 |
01/29/2013 |
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
GARFIELD WANG |
| K130108 |
01/16/2013 |
DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS |
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD |
DA ZENG |
| K130030 |
01/04/2013 |
ZAVATION CERVICAL PLATE SYSTEM |
ZAVATION LLC |
JOHN WALKER |
| K133551 |
11/19/2013 |
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K133556 |
11/19/2013 |
VIRAGE OCT SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC. |
HOLLY SEPPANEN |
| K130143 |
01/22/2013 |
PERSONA NATURAL TIBIA BASEPLATES |
ZIMMER, INC. |
NICOLE J MEREDITH |
| K133378 |
11/04/2013 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM |
ZIMMER, INC. |
DAN WILLIMAN |
| K133484 |
11/13/2013 |
ZOLL X SERIES |
ZOLL MEDICAL CORP. |
TANMAY SHUKLA |
| K130092 |
01/15/2013 |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |
