| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K080133 |
01/18/2008 |
MOUNTABLE ENDOSCOPIC BLADE |
A.M. SURGICAL, INC. |
VINCENT PASCALE |
| K083250 |
11/04/2008 |
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS |
AA NEUROMED CORP. |
HERMANN DOLKER |
| K080101 |
01/14/2008 |
AAP CANNULATED SCREW AND DARCO HEADED SCREW |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K083225 |
11/03/2008 |
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM |
ABBOTT DIABETES CARE INC. |
SARAH HARRINGTON |
| K083223 |
11/03/2008 |
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 |
ABBOTT DIABETES CARE INC. |
ARUL STERLIN |
| K080200 |
01/25/2008 |
WATER WORKS DOUCHING DEVICE |
ABBOTT RESEARCH GROUP, INC. |
ROSINA ROBINSON |
| K083377 |
11/14/2008 |
ACCUPEN |
ACCUTOME ULTRASOUND, INC. |
BRIAN T.S. BARRETT |
| K080074 |
01/11/2008 |
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K083419 |
11/19/2008 |
ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 |
ACTHERM, INC. |
RICHARD HSIEH |
| K080100 |
01/14/2008 |
WATCHHALER |
ACTIVAERO AMERICA, INC. |
PAUL DRYDEN |
| K083425 |
11/19/2008 |
FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE |
ADAPTIVE SPECIALTY, LLC |
J.D. WEBB |
| K083354 |
11/13/2008 |
FLORASEAL, MODEL FS350D |
ADHEZION BIOMEDICAL |
RICHARD JONES |
| K083539 |
11/28/2008 |
INFANT CARDIAC ARRAY |
ADVANCED IMAGING RESEARCH, INC. |
RAVI SRINIVASAN |
| K083541 |
11/28/2008 |
NEONATE HEAD AND BODY COILS |
ADVANCED IMAGING RESEARCH, INC. |
RAVI SRINIVASAN |
| K083311 |
11/10/2008 |
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
MATTHEW M HULL |
| K083495 |
11/25/2008 |
MODIFICATION TO: METHA HIP SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
| K083279 |
11/07/2008 |
CALTRIX RESORBABLE BONE VOID FILLER |
AG DIGITAL TECHNOLOGY CORP. |
JENNIFER REICH |
| K083265 |
11/05/2008 |
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 |
AGAMATRIX INC |
CONNIE HERTEL |
| K080252 |
01/31/2008 |
MODIFICATION TO MAMMAPRINT |
AGENDIA BV |
Guido Brink |
| K080013 |
01/03/2008 |
REGISTRATION AND FUSION |
AGFA HEALTHCARE CORPORATION |
TOM HOLBROOK |
| K080073 |
01/11/2008 |
S-TEST CREATININE (CRE) |
ALFA WASSERMANN, INC. |
DAVID SLAVIN |
| K083507 |
11/26/2008 |
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K080063 |
01/10/2008 |
MASS CASUALTY VENTILATOR, MODEL MCV100 |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K083385 |
11/17/2008 |
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K080176 |
01/24/2008 |
ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K083254 |
11/04/2008 |
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K083496 |
11/25/2008 |
CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS |
ALTATEC GMBH |
LINDA K SCHULZ |
| K080069 |
01/10/2008 |
DIMERTEST |
AMERICAN DIAGNOSTICA, INC. |
LEIGH AYRES |
| K080185 |
01/25/2008 |
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K083246 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083248 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083247 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083317 |
11/10/2008 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083318 |
11/10/2008 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083319 |
11/10/2008 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K083395 |
11/17/2008 |
SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K080151 |
01/22/2008 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 |
ANGIOSCORE, INC. |
KARIN J GASTINEAU |
| K080254 |
01/31/2008 |
SCANSCOPE XT SYSTEM |
APERIO TECHNOLOGIES |
JEFF RYBERG |
| K083278 |
11/07/2008 |
AVC A/H5N1 FLU TEST |
ARBOR VITA CORPORTATION |
LINDA ALLISTER |
| K083370 |
11/14/2008 |
D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 |
ARTEGRAFT, INC. |
LAURENCE A POTTER |
| K080111 |
01/16/2008 |
ARTHREX COMPRESSION STAPLE |
ARTHREX, INC. |
SALLY FOUST |
| K083435 |
11/20/2008 |
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID |
ARTHREX, INC. |
SALLY F OUST |
| K083306 |
11/10/2008 |
MODIFICATION TO ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K083240 |
11/03/2008 |
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K080156 |
01/23/2008 |
OSSEOSPEED TM PROFILE SYSTEM |
ASTRA TECH AB |
LINDA K SCHULZ |
| K083488 |
11/25/2008 |
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT |
AUDIFON-USA INC. |
JANE E PERRONE |
| K083313 |
11/10/2008 |
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER |
AVINGER, INC. |
HIMANSHU PATEL |
| K083222 |
11/03/2008 |
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
Claire Dora |
| K083460 |
11/21/2008 |
DIALOG WITH ADIMEA OPTION |
B. BRAUN AVITUM AG |
BONNIE KINCAID, RAC |
| K080166 |
01/23/2008 |
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 |
BECKMAN COULTER, INC. |
JEFFREY L KOLL |
| K083466 |
11/24/2008 |
MD2000A VITAL SIGN MONITOR, MODEL MD2000A |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K083303 |
11/10/2008 |
LANDLEX, MODEL: 402X |
BESTEAM TECHNOLOGY INC. |
JUNNATA CHANG |
| K080003 |
01/02/2008 |
BINAXNOW G6PD TEST |
BINAX, INC. |
Anne Jepson |
| K080012 |
01/03/2008 |
PLATELIA LYME IGG ASSAY |
BIO-RAD |
FRAN WHITE |
| K080008 |
01/02/2008 |
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET |
BIO-RAD LABORATORIES, INC. |
CYNTHIA SINCLAIR |
| K083274 |
11/06/2008 |
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER |
BIOCOMPATIBLES, INC. |
WAYNE RICHARDSON |
| K080210 |
01/28/2008 |
PRO QR ADVANCED FORMULA POWDER |
BIOLIFE, LLC |
Karen O'Toole |
| K083536 |
11/28/2008 |
DENSICHEK PLUS |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K080017 |
01/03/2008 |
VIDAS AFP ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K080194 |
01/25/2008 |
VIDAS CEA (S) ASSAY |
BIOMERIEUX, INC. |
NIKITA S MAPP |
| K080107 |
01/15/2008 |
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM |
BIOMERIEUX, INC. |
Nancy Weaver |
| K083383 |
11/17/2008 |
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K080201 |
01/28/2008 |
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K080088 |
01/14/2008 |
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS |
BIOMET MANUFACTURING, INC. |
ROBERT R FRIDDLE |
| K080204 |
01/28/2008 |
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS |
BIOMET, INC. |
GARY BAKER |
| K083490 |
11/25/2008 |
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 |
BIOPRO, INC. |
DAVID MRAK |
| K083384 |
11/17/2008 |
THERMODILUTION CATHETER |
BIOSENSORS INTL. PTE. LTD. |
MOSES THAM |
| K083355 |
11/13/2008 |
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 |
BLAIREX LABORATORIES, INC. |
CAREY BOTTOM |
| K083374 |
11/13/2008 |
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
Marybeth Gamber |
| K083420 |
11/19/2008 |
MEDONIC M SERIES |
BOULE MEDICAL AB |
MICHAEL ELLIOTT |
| K083372 |
11/14/2008 |
ARROWBONE-A, ARROWBONE-B |
BRAINBASE CORPORATION |
H. NEAL DUNNING |
| K083483 |
11/24/2008 |
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED |
BRAINLAB AG |
MICHAEL HOTTNER |
| K083310 |
11/10/2008 |
SPINE & TRAUMA ICT |
BRAINLAB AG |
RAINER BIRKENBACH |
| K083424 |
11/19/2008 |
BUSSE SURGICAL DRAPE |
BUSSE HOSIPITAL DISPOSABLES |
MUHAMAD ANSARI |
| K083417 |
11/18/2008 |
INTRATEMP SOLUTION WARMER |
C CHANGE SURGICAL LLC |
PATRICK KAMMER |
| K080170 |
01/24/2008 |
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) |
C.R. BARD, INC. |
SKIP RIMER |
| K080023 |
01/04/2008 |
MODIFICATION TO: SPIRIT |
CAIRE, INC. |
ZULFIQAR A CHOUDARY |
| K083273 |
11/06/2008 |
MICRODOT XTRA |
CAMBRIDGE SENSORS LIMITED |
WARREN REEVES |
| K080154 |
01/23/2008 |
ACUITY UNIVERSAL CUTTER |
CARDIAC PACEMAKERS, INC. |
KATHLEEN VITTUM |
| K080174 |
01/24/2008 |
PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C |
CARDIOMED SUPPLIES, INC. |
CHRISTIAN G DUBE |
| K083291 |
11/07/2008 |
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
| K080076 |
01/11/2008 |
RX DC X-RAY UNIT |
CEFLA S.C.R.L. |
CLAUDE BERTOIN |
| K080084 |
01/11/2008 |
CELL GEN LASER, MODEL CG-4000 |
CELL GEN THERAPEUTICS, LLC |
DICK RIVERA |
| K083433 |
11/20/2008 |
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 |
CHATTANOOGA GROUP |
MICHAEL TREAS |
| K080105 |
01/14/2008 |
ENDOTRACHEAL TUBE |
CHILECOM MEDICAL DEVICES CO., LTD. |
BRANDON CHOI |
| K080072 |
01/11/2008 |
MRI PATIENT POSITIONING DEVICES |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
ARTHUR WARD |
| K080196 |
01/25/2008 |
Z3D CONTRAST ACUITY |
CLARIO MEDICAL IMAGING, INC. |
CHRIS WOOD |
| K083499 |
11/25/2008 |
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS |
COLOPLAST A/S |
JANELL A COLLEY |
| K083304 |
11/10/2008 |
TEMPOSIL 2 |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
| K083351 |
11/13/2008 |
PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P |
COMDEK INDUSTRIAL CORP. |
Y.S. KUO |
| K083224 |
11/03/2008 |
CPI RAD VISION, MODEL VZW2944XX-YY |
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. |
NORM MORIKAWA |
| K083331 |
11/12/2008 |
CONFIDANT, MODEL 2.6 |
CONFIDANT INC. |
DANIEL R PLONSKI |
| K083448 |
11/21/2008 |
CABLE, TRANSDUCER, MODEL 2400GN |
CONMED CORPORATION |
SARAH RIZK |
| K083330 |
11/12/2008 |
ECHOTIP ULTRA ULTRASOUND NEEDLE |
COOK ENDOSCOPY |
SCOTTIE FARIOLE |
| K083482 |
11/24/2008 |
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET |
COOK VASCULAR INC. |
JIM FERGUSON, JR. |
| K080037 |
01/07/2008 |
MODIFICATION TO ZILVER 635 BILIARY STENT |
COOK, INC. |
STEPHANIE ROBERTS |
| K083312 |
11/10/2008 |
MINIHIP STEM |
CORIN U.S.A. |
ASHLEA BOWEN |
| K083287 |
11/07/2008 |
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM |
CORVENTIS, INC. |
DAWN CHANG |
| K083325 |
11/12/2008 |
N-600X WITH SPD, OXIMAX N-600X |
COVIDIEN |
SCOTT D DICKERHOFF |
| K083350 |
11/13/2008 |
TENS/NMES/FES STIMULATING ELECTRODE |
COVIDIEN LP |
WEI ZHAO |
| K083519 |
11/26/2008 |
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
FRANK GIANELLI |
| K083321 |
11/11/2008 |
CARDIO-VIEW |
CURLVIEW IGT, LLC |
|
| K080006 |
01/02/2008 |
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE |
CYNOSURE, INC. |
GEORGE CHO |
| K083379 |
11/14/2008 |
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE |
CYNOSURE, INC. |
GEORGE CHO |
| K080121 |
01/17/2008 |
CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K080207 |
01/28/2008 |
DANYANG HUAYI K2 AND K7 WHEELCHAIRS |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
NORMAN F ESTRIN |
| K080114 |
01/16/2008 |
HUAYI H035 BASIC WHEELCHAIR |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
NORMAN F ESTRIN |
| K080175 |
01/24/2008 |
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 |
DATASCOPE CORP., PATIENT MONITORING DIVISION |
KATHLEEN KRAMER |
| K083398 |
11/17/2008 |
CERCOM CEMENT |
DENALI R&D CORPORATION |
JAN G STANNARD |
| K083473 |
11/24/2008 |
CLEAR BRAVO |
DENALI R&D CORPORATION |
JAN STANNARD |
| K083543 |
11/28/2008 |
DENOVISMED DENTAL IMPLANT SYSTEMS |
DENOVIS MEDICAL, LLC |
KEVIN A THOMAS |
| K083252 |
11/04/2008 |
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM |
DENTALEZ GROUP, STARDENTAL DIVISION |
DALE BRAAS |
| K083400 |
11/17/2008 |
CUSTOM COMFORT NIGHTGUARD |
DENTEK ORAL CARE, INC. |
HOWARD M HOLSTEIN |
| K083326 |
11/12/2008 |
FLUOROCORE 2 |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K080246 |
01/31/2008 |
COMPOSITE ALIGNER BUTTON |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K080203 |
01/28/2008 |
MTA ROOT CANAL SEALER |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K083364 |
11/13/2008 |
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K080191 |
01/25/2008 |
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
FRANK S JURCZAK |
| K083532 |
11/28/2008 |
ADX4000-L, DX3000-L |
DEXCOWIN CO., LTD |
CLAUDE YANG |
| K083391 |
11/17/2008 |
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
| K080005 |
01/02/2008 |
SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 |
DING HWA CO., LTD. |
HUI-CHEN KAI |
| K080126 |
01/17/2008 |
DIO PROTEM IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
HYUNGICK KIM |
| K080129 |
01/17/2008 |
SECURE IMPLANT SYSTEM (2.5/3.0MM) |
DIO DEPARTMENT DSI, INC. |
HYUNGICK KIM |
| K080128 |
01/17/2008 |
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
HYUNGICK KIM |
| K080195 |
01/25/2008 |
NACERA Z AND NACERA Z MEDIUM |
DOCERAM MEDICAL CERAMICS GMBH |
HOLGER WAMPERS |
| K083258 |
11/04/2008 |
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE |
DORNIER MEDTECH AMERICA, INC. |
THERON GOBER |
| K083500 |
11/25/2008 |
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE |
DORNIER MEDTECH AMERICA, INC. |
THERON GOBER |
| K080064 |
01/10/2008 |
FLAATZ 750 |
DRTECH CORP. |
BEOM-JIN MOON |
| K083320 |
11/12/2008 |
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE |
DUKAL CORP. |
JIM VILARDI |
| K080036 |
01/07/2008 |
PORTABLE ECSCOPE 12I |
DYANSYS, INC. |
SRINI NAGESHWAR |
| K080087 |
01/11/2008 |
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K083470 |
11/24/2008 |
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 |
EDWARDS LIFESCIENCES, LLC. |
ERICA WALTERS |
| K080250 |
01/31/2008 |
LEKSELL SURGIPLAN, MODEL 1006947 |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K083478 |
11/24/2008 |
SMOOTHLIPO |
ELEME MEDICAL, INC. |
MICHAIL PANKRATOV, MD |
| K080075 |
01/11/2008 |
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
ELITE SURGICAL SUPPLIES (PTY) LTD. |
CHARISE DE BARROS |
| K083292 |
11/10/2008 |
HABIB ENDOHPB |
EMCISION, LTD. |
NAGY HABIB |
| K080258 |
01/31/2008 |
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM |
ENDIUS, INC. |
REGINA WAGNER |
| K083461 |
11/21/2008 |
IMAGINE TC SKIN THERAPY SYSTEM |
ENDYMION MEDICAL LTD |
YORAM LEVY |
| K080032 |
01/07/2008 |
ENVOYCEM, MODEL 1640 |
ENVOY MEDICAL CORPORATION |
BERNARD (BUD) HORWATH |
| K083452 |
11/21/2008 |
ERBE MODEL VIO 300 D WITH ACCESSORIES |
ERBE USA, INC. |
JULIE STEPHENS |
| K080146 |
01/22/2008 |
ZIRKONDENT |
ERGOMETA |
MIKE ARTEMOV |
| K080102 |
01/14/2008 |
TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM |
ESCADA INTERNATIONAL, INC. |
Kevin Walls |
| K080049 |
01/08/2008 |
VASCUVIEW ULTRASOUND SYSTEM |
ESCALON MEDICAL CORP. |
MARK WALLACE |
| K080119 |
01/17/2008 |
CLEARSCAN |
ESI, INC. |
GEORGE MYERS |
| K083381 |
11/14/2008 |
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
| K083342 |
11/12/2008 |
ORBITAL RECONSTRUCTIVE IMPLANT II |
EVERA MEDICAL, INC. |
RANDY KESTEN |
| K083302 |
11/10/2008 |
LIFECARE ELECTRODES |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K083392 |
11/17/2008 |
NOVATION 12/14 CEMENTED FEMORAL STEMS |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K083508 |
11/26/2008 |
SWABCAP |
EXCELSIOR MEDICAL CORP. |
ROSHANA AHMED |
| K083428 |
11/19/2008 |
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY |
FIAB SPA |
SILVIA CALABRO |
| K083418 |
11/18/2008 |
CPR MASK |
FIRSTAR HEALTHCARE CO., LTD. |
YOVETTE MUMFORD |
| K080209 |
01/28/2008 |
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
TINA MASON |
| K083347 |
11/13/2008 |
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS |
FLUKE BIOMEDICAL |
COLLEEN BOSWELL |
| K083542 |
11/28/2008 |
FRESENIUS STERILE STAY SAFE CAP |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET KAY |
| K080039 |
01/07/2008 |
PASSIVE WASTE GAS SCAVENGER, MODEL 14600 |
G. DUNDAS CO.,INC. |
MARIO SORCI |
| K083504 |
11/26/2008 |
GE DISCOVERY NM/CT 570C |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| K080124 |
01/17/2008 |
VENTRI 1.1 |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| K080251 |
01/31/2008 |
APEXPRO TELEMETRY SYSTEMS |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
BERNARD SANDLER |
| K080157 |
01/23/2008 |
DASH 2500 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
SHARON UNTZ |
| K083421 |
11/19/2008 |
MR-TOUCH OPTION |
GE MEDICAL SYSTEMS, LLC |
Daniel Biank |
| K083471 |
11/24/2008 |
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 |
GENERIC MEDICAL DEVICE, INC. |
MONICA MONTANEZ |
| K080117 |
01/17/2008 |
PATIENT ISOLATION UNIT, MODEL G019-1000 |
GENTEX CORPORATION |
BARRY SHOPE |
| K083509 |
11/26/2008 |
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA |
GENX INTL., INC. |
MICHAEL D CECCHI |
| K083272 |
11/06/2008 |
SKINCLEAR Q-SWITCHED ND:YAG LASER |
GLOBAL USA DISTRIBUTION, LLC. |
MATT MAKOUSKY |
| K083389 |
11/17/2008 |
COALITION SPACER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K083232 |
11/03/2008 |
MODIFICATION TO:MICROFUSE BONE VOID FILLER |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K083442 |
11/20/2008 |
CORRIDOR FIXATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K083416 |
11/18/2008 |
REVOLVE STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K083399 |
11/17/2008 |
ICS CHARTR EP 200 |
GN OTOMETRICS A/S |
DAN SANSONETTI |
| K080070 |
01/10/2008 |
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
JEFF COBB |
| K083479 |
11/24/2008 |
BIOCRYL X |
GREAT LAKES ORTHODONTICS, LTD. |
MARK LAUREN |
| K080235 |
01/30/2008 |
SAFETY INFUSION SET |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
JUDITH SMITH |
| K080169 |
01/24/2008 |
HEARTSTRING III PROXIMAL SEAL SYSTEM |
GUIDANT CORPORATION, CARDIAC SURGERY |
ELIZABETH TRUJILLO |
| K080025 |
01/04/2008 |
LED.L, LED.M, LED.G, LED.B |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
CHARLIE MACK |
| K080066 |
01/10/2008 |
VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K080093 |
01/14/2008 |
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK |
GYRUS ACMI, INC. |
TERRENCE E SULLIVAN |
| K080181 |
01/24/2008 |
MODIFICATION TO GALILEO GOLD |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K080019 |
01/03/2008 |
HARDYDISK AST DORIPENEM 10 UG |
HARDY DIAGNOSTICS |
WENDY PHILLIPS |
| K083457 |
11/21/2008 |
TACTIPEN |
HASELMEIER GMBH |
STEPHEN J GOLDNER, JD, RAC |
| K080091 |
01/14/2008 |
MODIFICATION TO:HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
ROBIN BUSH SAWAMURA |
| K080242 |
01/31/2008 |
HEARTWAY POWER MOBILITY SCOOTER, PF7 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
| K080221 |
01/29/2008 |
EA STIMULATOR |
HELIO MEDICAL SUPPLIES, INC. |
YUKUO HSO |
| K080226 |
01/29/2008 |
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 |
HILL-ROM MANUFACTURING, INC. |
DAWN M REILLY |
| K083533 |
11/28/2008 |
ECHELON C MRI SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEHWAITE |
| K080062 |
01/09/2008 |
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
| K083534 |
11/28/2008 |
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
NANCY GERTLAR |
| K083437 |
11/20/2008 |
MODIFICATION TO T2 RECON NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
AVITAL MERL-MARGULIES |
| K083468 |
11/24/2008 |
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) |
i-SENS, Inc. |
HYUN JOON OH |
| K080184 |
01/25/2008 |
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINOCOTT |
| K080077 |
01/11/2008 |
CLAVE STOPCOCK |
ICU MEDICAL, INC |
TRACY BEST |
| K080007 |
01/02/2008 |
GRADUATED ADAPTER WITH CLAVE |
ICU MEDICAL, INC |
TRACY BEST |
| K080223 |
01/29/2008 |
ZURA TEE SYSTEM |
IMACOR LLC |
STEVEN B DATLOF M.D., J.D. |
| K083480 |
11/24/2008 |
INCLUSIVE ZIRCONIA ABUTMENT BLANKS |
INCLUSIVE DENTAL SOLUTIONS |
KEITH D ALLRED |
| K083511 |
11/26/2008 |
ENVIRO SHARP SOLUTIONS 3 |
INDUSTRIAL WATER SOLUTIONS, INC |
THOMAS P STEWART |
| K083378 |
11/14/2008 |
SYNERGY |
INNERSPACE, INC. |
DON BOBO |
| K083288 |
11/07/2008 |
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER |
INNOVA VISION INC. |
JENNIFER REICH |
| K083518 |
11/26/2008 |
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K083414 |
11/18/2008 |
RADIONICS XKNIFE HDRT SYSTEM |
INTEGRA RADIONICS, INC. |
KEVIN O'CONNELL |
| K083520 |
11/26/2008 |
INTELEPACS, MODEL VERSION 3.X.X |
INTELERAD MEDICAL SYSTEMS INCORPORATED |
ANIBAL JODORCOVSKY |
| K080155 |
01/23/2008 |
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
MICHAEL H YRAMATEGUI |
| K080067 |
01/10/2008 |
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER |
ISCIENCE INTERVENTIONAL |
GRACE BARTOO |
| K080220 |
01/29/2008 |
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE |
ITALIA MEDICA S.R.L. |
BERTHOIN CLAUDE |
| K080259 |
01/31/2008 |
JMEA CANNULATED BONE SCREW SYSTEM |
JMEA CORPORATION |
SAM SON |
| K080040 |
01/07/2008 |
ORTHO ALL-FLEX DIAPHRAGM |
JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA. |
WILLIAM GREENROSE |
| K083256 |
11/04/2008 |
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K080024 |
01/04/2008 |
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 |
K2M, INC. |
RICHARD W WOODS |
| K083544 |
11/28/2008 |
KAT IMPLANT SYSTEM |
KAT IMPLANTS, LLC |
VITALI BONDAR |
| K083357 |
11/13/2008 |
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 |
KCI USA, INC. |
CHRISTY H OVIATT |
| K080229 |
01/30/2008 |
5.5 MM SUTURE LOCK BONE SCREW ANCHOR |
KFX MEDICAL |
GAYLE HIROTA |
| K080253 |
01/31/2008 |
KIMBERLY-CLARK INTRODUCER KITS |
KIMBERLY-CLARK CORP. |
SHERRY SAURINI |
| K083234 |
11/03/2008 |
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 |
KIMBERLY-CLARK CORP. |
LISA PEACOCK |
| K083432 |
11/20/2008 |
DRILL FREE MMF SCREW |
KLS MARTIN L.P. |
TOM FAUCET |
| K080178 |
01/24/2008 |
VALVULOTOME BY KOVEN |
KOVEN TECHNOLOGY, INC. |
J. HARVEY KNAUSS |
| K083387 |
11/17/2008 |
MODIFICATION TO KOWA NONMYD ALPHA-DIII |
KOWA CO. LTD. |
AKIHIRO FUJITA |
| K080159 |
01/23/2008 |
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K083510 |
11/26/2008 |
KUBTEC XPERT 20 |
KUB TECHNOLOGIES, INC |
JOSEPH M AZARY |
| K080010 |
01/03/2008 |
NOCC HYDROPHILIC WOUND DRESSING |
KYTOGENICS, INC |
MARINA ZAZANIS |
| K083229 |
11/03/2008 |
E.S TECK ( ELECTRO SENSOR TECK) |
L.D. TECHNOLOGY, LLC |
RICHARD CLEMENT |
| K080144 |
01/22/2008 |
MANDREL GUIDEWIRES OR M-WIRES |
LAKE REGION MFG., INC. |
DEEP PAL |
| K080173 |
01/24/2008 |
STAR 55 |
LARSEN & TOUBRO LIMITED |
S.B. BHOSALE |
| K083253 |
11/04/2008 |
LOTUS II PULSED ER: YAG LASER SYSTEM |
LASEROPTEK CO. LTD. |
PHILLIP CHEON |
| K080140 |
01/22/2008 |
LAURIMED SPINAL INJECTION SYSTEM |
LAURIMED LLC |
NANCY LINCE |
| K080158 |
01/23/2008 |
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM |
LB MEDICAL L.L.C. |
TERRY SHERIDAN POWELL |
| K080106 |
01/15/2008 |
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K083340 |
11/12/2008 |
LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE |
LEVITRONIX LLC. |
SUSAN HAMANN |
| K083281 |
11/07/2008 |
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- |
LINVATEC CORP. |
LISA ANDERSON |
| K080248 |
01/31/2008 |
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K080162 |
01/23/2008 |
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K080029 |
01/04/2008 |
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K080238 |
01/31/2008 |
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER |
MASIMO CORPORATION |
MARQUERITE THOMLINSON |
| K083275 |
11/06/2008 |
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 |
MAX ENDOSCOPY INC. |
MICHAEL WOLF |
| K080112 |
01/16/2008 |
PATIENT CABLE |
MED-DYNE |
E.W. JOHNSON |
| K083472 |
11/24/2008 |
MEDEGEN PRESSURE RATED EXTENSION SETS |
MEDEGEN INC. |
TIM L TRUITT |
| K080212 |
01/29/2008 |
MEDELA THOPAZ, MODEL 200 0288 |
MEDELA AG |
BRUNO GRETLER |
| K083455 |
11/21/2008 |
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 |
MEDI-KHAN USA, INC |
JULIE SANTIAGO |
| K080113 |
01/16/2008 |
APEX DAL ELECTRONIC APEX LOCATOR |
MEDICNRG LTD. |
GEORGE J HATTUB |
| K083308 |
11/10/2008 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K080099 |
01/14/2008 |
PASS SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K083423 |
11/19/2008 |
COLONCAD API 3.1 |
MEDICSIGHT PLC |
AMARJIT GILL |
| K080172 |
01/24/2008 |
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 |
MEDICULT A/S |
RONALD G LEONARDI |
| K080095 |
01/14/2008 |
CORAMATE/SPIROTOME SYSTEM |
MEDINVENTS |
JAAK JANSSENS |
| K083531 |
11/28/2008 |
LIQUIBAND ULTIMA, MODEL LB0004 |
MEDLOGIC GLOBAL LTD. |
TIERNEY NORSTED |
| K080097 |
01/14/2008 |
MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K080083 |
01/11/2008 |
INTREPID SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K083422 |
11/19/2008 |
6F TAIGA GUIDING CATHETER |
MEDTRONIC VASCULAR |
VIC ZHANG |
| K080257 |
01/31/2008 |
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS |
MEDTRONIC XOMED, INC. |
JAYME WILSON |
| K083537 |
11/28/2008 |
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM |
MEDWAVES INCORPORATED |
TED ORMSBY |
| K083447 |
11/21/2008 |
MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K083464 |
11/24/2008 |
PREMIER CAMPY, MODEL 618096 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN D ROLIH |
| K083523 |
11/26/2008 |
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
SUSAN D SCOTT |
| K083469 |
11/24/2008 |
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 |
METASURG |
MARK MYERS |
| K083343 |
11/13/2008 |
HEADWAY 17 MICROCATHETER |
MICROVENTION, INC. |
|
| K083467 |
11/24/2008 |
REBOUND HRDV |
MINNESOTA MEDICAL DEVELOPMENT, INC. |
STEVE NUSS |
| K083412 |
11/18/2008 |
PATHFAST HSCRP |
MITSUBISHI KAGAKU IATRON |
HELEN LANDICHO |
| K080217 |
01/29/2008 |
COMPONENT NEUROMONITORING SYSTEM |
MOBERG RESEARCH, INC. |
Damon Lees |
| K080035 |
01/07/2008 |
LED CURING LIGHT |
MONITEX INDUSTRIAL CO., LTD. |
SHU-LUNG WANG |
| K083441 |
11/20/2008 |
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION |
MOTION MEDICAL PRODUCTS LLC |
GARY BUSSETT |
| K083493 |
11/25/2008 |
MYOSCIENCE CRYO-TOUCH |
MYOSCIENCE INC |
TRACEY HENRY |
| K083430 |
11/19/2008 |
REAL-TIME PCR INTERNAL CONTROL 2B SET |
NANOGEN, INC. |
E. JOSEPH MCMULLEN |
| K083294 |
11/10/2008 |
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST |
NANOSPHERE, INC |
GREGORT W SHIPP |
| K083371 |
11/14/2008 |
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) |
NATUS MEDICAL, INC. |
NICOHL R WILDING |
| K083332 |
11/12/2008 |
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K080219 |
01/29/2008 |
MODIFICATION TO:NESS L300 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
EVAN ROSENFELD |
| K080168 |
01/23/2008 |
SHUNTCHECK - CSF SHUNT FLOW DETECTOR |
NEURO DIAGNOSTIC DEVICES |
FREDERICK J FRITZ |
| K083322 |
11/12/2008 |
NEUROMETRIX BIOAMPLIFIER |
NEUROMETRIX, INC. |
RAINER MAAS |
| K083538 |
11/28/2008 |
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 |
NEURONETICS |
JUDY P WAYS |
| K080163 |
01/23/2008 |
COOLTOUCH MODELS LC215 AND COOLLIPO |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K083352 |
11/13/2008 |
VEINWAVE, TC3000 |
NEWLANDS CLINICAL TRIALS LTD |
WILLIAM GREENROSE |
| K083271 |
11/06/2008 |
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K083456 |
11/21/2008 |
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K080177 |
01/24/2008 |
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KOBO |
| K083476 |
11/24/2008 |
NOVEON MODEL LS1100-03 |
NOMIR MEDICAL TECHNOLOGIES, INC. |
RICHARD F BURTT |
| K080255 |
01/31/2008 |
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K080141 |
01/22/2008 |
PC ECG 1200W SYSTEM |
NORAV MEDICAL LTD. |
BENNY ARAZY |
| K080009 |
01/03/2008 |
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
| K083458 |
11/21/2008 |
INTRAMEDULLARY FIXATION ROD (IFS) |
NOVALIGN ORTHOPAEDICS, INC |
JEFFREY G ROBERTS |
| K080228 |
01/30/2008 |
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH |
NOVAMIN TECHNOLOGY, INC. |
ROBERT G ROTHFRITZ |
| K080057 |
01/09/2008 |
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL |
NOVX SYSTEMS INC. |
THOMAS TSAKERIS |
| K083341 |
11/12/2008 |
NUVASIVE HELIX-T ACP SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K083323 |
11/12/2008 |
NUVO VERDE LED LIGHTING SYSTEM |
NUVO, INC. |
CURT V SCHAAFF |
| K080115 |
01/16/2008 |
I-MINI DENTAL IMPLANT |
OCO BIOMEDICAL |
Kevin Walls |
| K083491 |
11/25/2008 |
NEUROSCAPE |
OLEA MEDICAL |
NEAL KOLBER |
| K080187 |
01/25/2008 |
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS |
OLSEN MEDICAL |
JOHN P WATERS |
| K080094 |
01/14/2008 |
OLYMPUS TOTAL BHCG TEST SYSTEN |
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
STEPHANIE DONNELLY |
| K080065 |
01/10/2008 |
OSFERION |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
LAURA STORMS-TYLER |
| K083335 |
11/12/2008 |
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
| K080202 |
01/28/2008 |
ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT |
ONCOBIONICS, INC. |
PAUL MIKUS |
| K080048 |
01/08/2008 |
MSK EXTREME MR SCANNER, MODEL AA5000 |
ONI MEDICAL SYSTEMS, INC. |
MARK PUOPOLO |
| K080180 |
01/24/2008 |
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) |
OPTICAL IMAGING LTD. |
JONATHAN S KAHAN |
| K083516 |
11/26/2008 |
PERIOGENIX |
OROSCIENCE, INC. |
MARY MCNAMARA |
| K083286 |
11/05/2008 |
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K080108 |
01/15/2008 |
CORTOSS BONE AUGMENTATION MATERIAL |
ORTHOVITA, INC. |
GINA M NAGVAJARA |
| K080082 |
01/11/2008 |
OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS |
OXLIFE LLC |
MARGARET K POTEAT |
| K080149 |
01/22/2008 |
HEATER BASE, MODEL PMH7000 |
PACIFIC MEDICO CO., LTD. |
YOSHIMO TOYAMA |
| K083494 |
11/25/2008 |
ULTIMA FIVE |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K080244 |
01/31/2008 |
PALOMAR LUX 1540 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K083231 |
11/03/2008 |
PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT |
PANTHERA PRODUCTION AB |
STUART R GOLDMAN |
| K080241 |
01/31/2008 |
DDS STABILIZATION SYSTEM |
PARADIGM SPINE, LLC |
JUSTIN EGGLETON |
| K080098 |
01/14/2008 |
MRJ EXTENDED |
PARAMED SRL |
MICHAEL A DOUGLAS |
| K083489 |
11/25/2008 |
JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K080161 |
01/23/2008 |
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR |
PATTON SURGICAL CORP. |
MICHAEL PATTON |
| K083415 |
11/18/2008 |
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K083413 |
11/18/2008 |
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM |
PHILIPS MEDICAL SYSTEMS |
TERESA SCHMIDT |
| K080120 |
01/17/2008 |
HFO SHOULDER COIL |
PHILIPS MEDICAL SYSTEMS MR FINLAND |
CATHERINE CONNELL |
| K083498 |
11/25/2008 |
PHILIPS MODEL MX 16 SLICE CT SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL CHILBERT |
| K083228 |
11/03/2008 |
PHILIPS INTELLIVUE MP5 PATIENT MONITOR |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
JENS-PETER SEHER |
| K083517 |
11/26/2008 |
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K083284 |
11/07/2008 |
PIEZOSURGERY MEDICAL |
PIEZOSURGERY SRL |
ROGER GRAY |
| K083449 |
11/21/2008 |
E-MATRIX GRAFT BONE EXTENDER |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K080026 |
01/04/2008 |
QUANTUM-MIS CANNULATED SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K080197 |
01/25/2008 |
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM |
PLASMA SURGICAL, LTD. |
PETER GIBSON |
| K080165 |
01/23/2008 |
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) |
PLATINUM GLOVE INDUSTRIES SDN.BHD. |
SO SOON CHEAW |
| K083527 |
11/28/2008 |
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K083453 |
11/21/2008 |
COSTORSOL |
PRESERVATION SOLUTIONS, INC. |
NEIL BURRIS |
| K080145 |
01/22/2008 |
PRIMAEVA MEDICAL SYSTEM |
PRIMAEVA MEDICAL, INC. |
BRIAN GRIGSBY |
| K080240 |
01/31/2008 |
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE |
PROMIDENT LLC |
GARY KRIS |
| K083502 |
11/25/2008 |
PANTHER REALART, MODEL 4.7 |
PROWESS, INC. |
RACHEL SCARANO |
| K080256 |
01/31/2008 |
PULMODYNE CHF FLOW GENERATOR SYSTEM |
PULMODYNE |
PAUL DRYDEN |
| K083233 |
11/03/2008 |
THE PFT FILTER |
PULMONARY FILTRATION TECHNOLOGIES LLC |
PAUL DRYDEN |
| K080206 |
01/28/2008 |
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM |
RADI MEDICAL SYSTEMS AB |
HELENE EKSTRAND |
| K083255 |
11/04/2008 |
16CH AI BREAST COILS 1.5 T AND 3 T |
RAPID BIOMEDICAL GMBH |
ARMIN PUREA |
| K083264 |
11/05/2008 |
RAYAUTOPLAN 1.0 |
RAYSEARCH LABORATORIES AB |
ANDERS MURMAN |
| K080079 |
01/11/2008 |
S8 ESCAPE II |
RESMED LTD. |
DAVID D'CRUZ |
| K080131 |
01/18/2008 |
VPAP ST |
RESMED LTD. |
DAVID D'CRUZ |
| K083526 |
11/28/2008 |
TRILOGY 100 VENTILATOR |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K083260 |
11/05/2008 |
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN |
Roche Diagnostics |
JACK ROGERS |
| K080227 |
01/30/2008 |
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K083444 |
11/21/2008 |
C-REACTIVE PROTEIN (LATEX) |
ROCHE DIAGNOSTICS CORP. |
KATHIE J GOODWIN |
| K080183 |
01/25/2008 |
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
| K080092 |
01/14/2008 |
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB |
ROCHE DIAGNOSTICS CORP. |
STEPHANIE GREEMAN |
| K080147 |
01/22/2008 |
ELECSYS PROBNP II CALCHECK |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K080216 |
01/29/2008 |
SUPRAMESH EXTRA |
S. JACKSON, INC. |
NORMAN R ESTRIN |
| K080243 |
01/31/2008 |
PORTABLE OXYGEN UNIT SCA900 |
SAN CHEONG CO. LTD. |
JUNG BAE BANG |
| K080171 |
01/24/2008 |
SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 |
SANARUS MEDICAL, INC. |
LISA HENRY |
| K083382 |
11/14/2008 |
CHROMA, MODEL: RZ153C |
SCOTTCARE CORPORATION |
TIMOTHY J LEYVA |
| K083338 |
11/12/2008 |
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM |
SEASPINE, INC. |
ETHEL BERNAL |
| K083295 |
11/10/2008 |
SERIM DISINTEK GTA 2.1%, MODEL: 5164 |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
| K083349 |
11/13/2008 |
BLOOD TRANSFUSION SET |
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
Diana Hong |
| K083505 |
11/26/2008 |
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
TAN CHAUNBIN |
| K080192 |
01/25/2008 |
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
| K080047 |
01/08/2008 |
CARDIOSEN'C |
SHL TELEMEDICINE INTERNATIONAL LTD. |
YORAM LEVY |
| K080068 |
01/10/2008 |
BEAUTIFIL OPAQUER |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K080004 |
01/02/2008 |
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM |
SICEL TECHNOLOGIES, INC. |
TAMMY B CARREA |
| K080167 |
01/23/2008 |
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS |
SIEMENS HEALTHCARE DIAGNOSTICS |
PHILIP LIU |
| K083386 |
11/17/2008 |
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
CAROL BIANCA |
| K083463 |
11/24/2008 |
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA M KATHLEEN ENNIS |
| K083465 |
11/24/2008 |
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K083462 |
11/24/2008 |
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 |
SIEMENS HEALTHCARE DIAGNOSTICS |
HELEN M LEE |
| K083487 |
11/25/2008 |
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS |
YUK-TING LEWIS |
| K083314 |
11/10/2008 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K083262 |
11/05/2008 |
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) |
SIEMENS HEALTHCARE DIAGNOSTICS |
LIBBY WARRINER |
| K083445 |
11/21/2008 |
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC |
SIEMENS HEALTHCARE DIAGNOSTICS |
HELEN M LEE |
| K083339 |
11/12/2008 |
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) |
Siemens Healthcare Diagnostics Inc. |
Lubomyr Shchur |
| K083373 |
11/14/2008 |
IMMULITE 2000 FREE T4 |
Siemens Healthcare Diagnostics Inc. |
PHILIP LIU |
| K083524 |
11/28/2008 |
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORRINE MCLEOD |
| K083327 |
11/12/2008 |
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GUNHILD PAULSEN |
| K080199 |
01/25/2008 |
SYMMETRIC TOTAL KNEE SYSTEM |
SIGNAL MEDICAL CORPORATION |
BRIAN KATERBERG |
| K083344 |
11/13/2008 |
HELIODENT PLUS |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K083226 |
11/03/2008 |
SMITH & NEPHEW PEEK INTERFERENCE SCREW |
SMITH & NEPHEW ENDOSCOPY, INC. |
KATHY REDDIG |
| K083375 |
11/14/2008 |
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY |
SMITH & NEPHEW, INC. |
LAURA KREJCI |
| K083528 |
11/28/2008 |
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K083336 |
11/12/2008 |
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL |
SMITHS MEDICAL ASD, INC. |
CHRISTINE LLOYD |
| K083451 |
11/21/2008 |
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS |
SMITHS MEDICAL ASD, INC. |
CYNTHIA ENGELHARDT |
| K080224 |
01/29/2008 |
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK |
SOADCO, S.L. |
MARIA MITJANETA |
| K083522 |
11/26/2008 |
SONY UP-DF750 DIGITAL FILM IMAGER |
SONY ELECTRONICS, INC. |
CYNTHIA SINCLAIR |
| K080122 |
01/17/2008 |
SOPRO 670 ARTHROSCOPIC PUMP |
SOPRO |
STEVE SALESKY |
| K083334 |
11/12/2008 |
ELASTO-GEL MANUKA HONEY WOUND DRESSING |
SOUTHWEST TECHNOLOGIES, INC. |
EDWARD STOUT |
| K083475 |
11/24/2008 |
LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K083230 |
11/03/2008 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K080058 |
01/09/2008 |
TURBO PRIME IBD SYSTEM |
SPINE SELECT, LLC |
RICHARD JANSEN |
| K083353 |
11/13/2008 |
CAPSURE(R) PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| DEN080011 |
11/03/2008 |
SNAP WOUND CARE DEVICE |
SPIRACUR, INC. |
JANICE M HOGAN |
| K080050 |
01/08/2008 |
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE |
SPIRUS MEDICAL, INC. |
PAMELA PAPINEAU |
| K080042 |
01/08/2008 |
SPIRUS MEDICAL SURGICAL INSTRUMENT |
SPIRUS MEDICAL, INC. |
PAMELA PAPINEAU |
| K083402 |
11/18/2008 |
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 |
ST. JUDE MEDICAL |
MAC MCKEEN |
| K083328 |
11/12/2008 |
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 |
ST. JUDE MEDICAL |
KAREN MCKELVEY |
| K080179 |
01/24/2008 |
REFLEXION HD HIGH-DENSITY MAPPING CATHETER |
ST. JUDE MEDICAL |
ANDREA HUDACK |
| K080136 |
01/22/2008 |
INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K080239 |
01/31/2008 |
P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS |
STRAUMANN MANUFACTURING, INC. |
ELAINE ALAN |
| K080016 |
01/03/2008 |
NRBC-CHEX FOR ADVIA |
Streck |
ERIN JOHNSON |
| K080052 |
01/08/2008 |
STRYKER ESSX WITH NAVIGATION MOUNT |
STRYKER CORP. |
VALERIE FRANCK |
| K080143 |
01/22/2008 |
MODIFICATION TO STRYKER SPINE OASYS SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K083393 |
11/17/2008 |
XIA 3 SPINAL SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K083249 |
11/04/2008 |
QUICKIE RHYTHM |
SUNRISE MEDICAL HHG, INC. |
JAMES W LEWIS |
| K080089 |
01/14/2008 |
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K083297 |
11/10/2008 |
PITT-EASY DENTAL IMPLANT SYSTEM |
SYBRON IMPLANT SOLUTIONS GMBH |
Wendy Garman |
| K083263 |
11/05/2008 |
SYMCARE DIABETES MANAGEMENT PROGRAM |
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC |
RAE ANN DELAY |
| K080193 |
01/25/2008 |
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR |
Synergeyes, Inc. |
RICHARD E LIPPMAN |
| K083307 |
11/10/2008 |
SYNTHASOME X-REPAIR |
SYNTHASOME, INC. |
ANTHONY RATCLIFFE |
| K080153 |
01/23/2008 |
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM |
SYNTHES (USA) |
ANDREA M TASKER |
| K080109 |
01/15/2008 |
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM |
SYNTHES (USA) |
JILL R SHERMAN |
| K083439 |
11/20/2008 |
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K083388 |
11/17/2008 |
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM |
SYNTHES (USA) |
ANDREA M TASKER |
| K080020 |
01/03/2008 |
ARCOFIX |
SYNTHES SPINE CO.LP |
KIRSTEN STOWELL |
| K080014 |
01/03/2008 |
CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K083299 |
11/10/2008 |
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER |
TaiDoc Technology Corporation |
JEFF WANG |
| K083259 |
11/04/2008 |
PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE |
TANGSHAN ZHONGYING PLASTIC PRODUCTS CO., LTD. |
JOHN ZHAO |
| K083440 |
11/20/2008 |
PRIMATRIX DERMAL REPAIR SCAFFOLD |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K080230 |
01/30/2008 |
NEB-U-MASK SYSTEM, MODELS 1895, 1896 |
Teleflex Medical, Inc. |
PAUL DRYDEN |
| K083337 |
11/12/2008 |
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K080234 |
01/30/2008 |
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO |
TERATECH CORP. |
|
| K080034 |
01/07/2008 |
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
ANDREA WALLEN |
| K083301 |
11/10/2008 |
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
JUNKO KUROSAWA |
| K083514 |
11/26/2008 |
TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K080132 |
01/18/2008 |
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE |
THD SPA |
GUIDO BONAPACE |
| K083289 |
11/07/2008 |
HUMAN BETA-2 MICROGLOBULIN KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K083242 |
11/03/2008 |
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR |
THE MAGSTIM COMPANY LTD. |
ANWEN EVANS |
| K080085 |
01/11/2008 |
MAS TOX CONTROL |
Thermo Fisher Scientific |
JACK ROGERS |
| K083269 |
11/05/2008 |
CROSSOVER |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K083348 |
11/13/2008 |
IMAGE-ARENA APPLICATIONS |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K083316 |
11/10/2008 |
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM |
TOPCON MEDICAL SYSTEMS, INC. |
BARBARA S FANT |
| K083268 |
11/05/2008 |
TORNIER, INC., INSITE SUTURE ANCHORS |
TORNIER, INC. |
HOWARD L SCHRAYER |
| K080160 |
01/23/2008 |
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K083503 |
11/26/2008 |
DRAD30003/RADREX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K080211 |
01/29/2008 |
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K083282 |
11/07/2008 |
MODEL TSX-301B AQUILION CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K080038 |
01/07/2008 |
VANTAGE TITAN, MODEL MRT-1504/S3 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K080116 |
01/16/2008 |
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
| K080189 |
01/25/2008 |
TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX |
TRIMLINE MEDICAL PRODUCTS CORP. |
NANCY SKOCYPEC |
| K080198 |
01/25/2008 |
TSO3 OZONE STERILIZATION WRAP |
TSO3 INC. |
CHARLES O HANCOCK |
| K083434 |
11/20/2008 |
TT1 GENERAL PURPOSE COIL |
TURSIOP TECHNOLOGIES LLC |
|
| K083454 |
11/21/2008 |
NUOVOCATH |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINE SMITH |
| K080249 |
01/31/2008 |
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K083535 |
11/28/2008 |
HEARTRAK SMART ECAT |
UNIVERSAL MEDICAL, INC. |
JOYCE W DEAN |
| K080022 |
01/03/2008 |
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP |
VASCULAR SOLUTIONS, INC. |
DEBORAH NEYMARK |
| K080104 |
01/14/2008 |
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 |
VASCULAR SOLUTIONS, INC. |
JAMES CHAPMAN |
| K083293 |
11/10/2008 |
VIATRONIX V3D-CARDIAC, REVISION 1.0 |
VIATRONIX, INC. |
DONGQING CHEN |
| K083227 |
11/03/2008 |
VIDA PULMONARY WORKSTATION 2 (PW2) |
VIDA DIAGNOSTICS, INC. |
JACK SLOVICK |
| K080051 |
01/08/2008 |
VIRTUAL PORTS ENDOCLEAR SYSTEM |
VIRTUAL PORTS LTD |
YORAM LEVY |
| K080060 |
01/09/2008 |
VIVOSONIC NEUROSCREEN |
VIVOSONIC, INC. |
AMJAD RANA |
| K083438 |
11/20/2008 |
BIFIX SE |
VOCO GMBH |
TH. PLAUMANN |
| K083266 |
11/05/2008 |
GORE BIO-A FISTULA PLUG |
W.L. GORE & ASSOCIATES,INC |
BARBARA L SMITH |
| K083300 |
11/10/2008 |
GORE FLOW REVERSAL SYSTEM |
W.L. GORE & ASSOCIATES,INC |
MICHELLE A WELLS |
| K080123 |
01/17/2008 |
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 |
WAKO CHEMICALS USA, INC. |
PETER PANFILI |
| K080125 |
01/17/2008 |
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 |
WAKO CHEMICALS USA, INC. |
PETER PANFILI |
| K083429 |
11/19/2008 |
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT |
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. |
Diana Hong |
| K080182 |
01/25/2008 |
ZENO PMMA DISC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K083512 |
11/26/2008 |
FLUID-FILLED TEETHER |
WILTEC INDUSTRIES LTD. |
Kevin Walls |
| K080134 |
01/18/2008 |
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000) |
WONJIN MULSAN CO., LTD. |
BRANDON CHOI |
| K080071 |
01/11/2008 |
SIDEKICK RAIL FIXATOR |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PEGGY S RIVERS |
| K083270 |
11/06/2008 |
WMT COMPOSITE DBM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN M BELANEY |
| K083409 |
11/18/2008 |
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083410 |
11/18/2008 |
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083305 |
11/10/2008 |
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K083408 |
11/18/2008 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
WRP ASIA PACIFIC SDN. BHD. |
KIRK PENNER |
| K080247 |
01/31/2008 |
QUIKCLOT NOSEBLEED |
Z-MEDICA CORPORATION |
RONALD E PETERSON |
| K083309 |
11/10/2008 |
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 |
ZARGIS MEDICAL CORP. |
JOHN KALLASSY |
| K080118 |
01/17/2008 |
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE |
ZELTIQ AESTHETICS |
DONALD V JOHNSON |
| K083324 |
11/12/2008 |
LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM |
ZEST ANCHORS, INC. |
RICHARD A OVERTON |
| K080130 |
01/18/2008 |
OCCLUFAST CAD |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K083545 |
11/28/2008 |
ZIEHM VISION RFD |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K080043 |
01/08/2008 |
VIZILITE EYEWEAR |
ZILA, INC. |
MARK BRIDE |
| K083474 |
11/24/2008 |
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K080164 |
01/23/2008 |
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT |
ZIMMER DENTAL INC. |
ERIN MCVEY |
| K083497 |
11/25/2008 |
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS |
ZIMMER, INC. |
CAROL VIERLING |
| K083446 |
11/21/2008 |
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING |
ZIOSOFT, INC. |
RICHARD BALL |
| K080232 |
01/30/2008 |
ZOLL E SERIES 12SL, ANALYSIS OPTION |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |
