| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K083250 |
11/04/2008 |
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS |
AA NEUROMED CORP. |
HERMANN DOLKER |
| 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 |
| K083377 |
11/14/2008 |
ACCUPEN |
ACCUTOME ULTRASOUND, INC. |
BRIAN T.S. BARRETT |
| K083419 |
11/19/2008 |
ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 |
ACTHERM, INC. |
RICHARD HSIEH |
| 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 |
| K083507 |
11/26/2008 |
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| K083385 |
11/17/2008 |
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K083274 |
11/06/2008 |
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER |
BIOCOMPATIBLES, INC. |
WAYNE RICHARDSON |
| K083536 |
11/28/2008 |
DENSICHEK PLUS |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K083383 |
11/17/2008 |
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| 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 |
| K083273 |
11/06/2008 |
MICRODOT XTRA |
CAMBRIDGE SENSORS LIMITED |
WARREN REEVES |
| 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 |
| K083433 |
11/20/2008 |
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 |
CHATTANOOGA GROUP |
MICHAEL TREAS |
| 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. |
| 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 |
|
| K083379 |
11/14/2008 |
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE |
CYNOSURE, INC. |
GEORGE CHO |
| 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 |
| 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 |
| 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 |
| 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 |
| K083320 |
11/12/2008 |
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE |
DUKAL CORP. |
JIM VILARDI |
| K083470 |
11/24/2008 |
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 |
EDWARDS LIFESCIENCES, LLC. |
ERICA WALTERS |
| K083478 |
11/24/2008 |
SMOOTHLIPO |
ELEME MEDICAL, INC. |
MICHAIL PANKRATOV, MD |
| K083292 |
11/10/2008 |
HABIB ENDOHPB |
EMCISION, LTD. |
NAGY HABIB |
| K083461 |
11/21/2008 |
IMAGINE TC SKIN THERAPY SYSTEM |
ENDYMION MEDICAL LTD |
YORAM LEVY |
| K083452 |
11/21/2008 |
ERBE MODEL VIO 300 D WITH ACCESSORIES |
ERBE USA, INC. |
JULIE STEPHENS |
| 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 |
| 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 |
| K083504 |
11/26/2008 |
GE DISCOVERY NM/CT 570C |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| 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 |
| 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 |
| K083479 |
11/24/2008 |
BIOCRYL X |
GREAT LAKES ORTHODONTICS, LTD. |
MARK LAUREN |
| K083457 |
11/21/2008 |
TACTIPEN |
HASELMEIER GMBH |
STEPHEN J GOLDNER, JD, RAC |
| K083533 |
11/28/2008 |
ECHELON C MRI SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEHWAITE |
| 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 |
| 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 |
| K083256 |
11/04/2008 |
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| 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 |
| 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 |
| K083387 |
11/17/2008 |
MODIFICATION TO KOWA NONMYD ALPHA-DIII |
KOWA CO. LTD. |
AKIHIRO FUJITA |
| K083510 |
11/26/2008 |
KUBTEC XPERT 20 |
KUB TECHNOLOGIES, INC |
JOSEPH M AZARY |
| K083229 |
11/03/2008 |
E.S TECK ( ELECTRO SENSOR TECK) |
L.D. TECHNOLOGY, LLC |
RICHARD CLEMENT |
| K083253 |
11/04/2008 |
LOTUS II PULSED ER: YAG LASER SYSTEM |
LASEROPTEK CO. LTD. |
PHILLIP CHEON |
| 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 |
| 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 |
| K083472 |
11/24/2008 |
MEDEGEN PRESSURE RATED EXTENSION SETS |
MEDEGEN INC. |
TIM L TRUITT |
| K083455 |
11/21/2008 |
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 |
MEDI-KHAN USA, INC |
JULIE SANTIAGO |
| K083308 |
11/10/2008 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K083423 |
11/19/2008 |
COLONCAD API 3.1 |
MEDICSIGHT PLC |
AMARJIT GILL |
| K083531 |
11/28/2008 |
LIQUIBAND ULTIMA, MODEL LB0004 |
MEDLOGIC GLOBAL LTD. |
TIERNEY NORSTED |
| K083422 |
11/19/2008 |
6F TAIGA GUIDING CATHETER |
MEDTRONIC VASCULAR |
VIC ZHANG |
| 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 |
| 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 |
| 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 |
| 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 |
| K083476 |
11/24/2008 |
NOVEON MODEL LS1100-03 |
NOMIR MEDICAL TECHNOLOGIES, INC. |
RICHARD F BURTT |
| K083458 |
11/21/2008 |
INTRAMEDULLARY FIXATION ROD (IFS) |
NOVALIGN ORTHOPAEDICS, INC |
JEFFREY G ROBERTS |
| 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 |
| K083491 |
11/25/2008 |
NEUROSCAPE |
OLEA MEDICAL |
NEAL KOLBER |
| K083335 |
11/12/2008 |
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
| K083516 |
11/26/2008 |
PERIOGENIX |
OROSCIENCE, INC. |
MARY MCNAMARA |
| K083286 |
11/05/2008 |
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K083494 |
11/25/2008 |
ULTIMA FIVE |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K083231 |
11/03/2008 |
PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT |
PANTHERA PRODUCTION AB |
STUART R GOLDMAN |
| K083489 |
11/25/2008 |
JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| 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 |
| 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 |
| 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 |
| K083502 |
11/25/2008 |
PANTHER REALART, MODEL 4.7 |
PROWESS, INC. |
RACHEL SCARANO |
| K083233 |
11/03/2008 |
THE PFT FILTER |
PULMONARY FILTRATION TECHNOLOGIES LLC |
PAUL DRYDEN |
| 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 |
| 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 |
| K083444 |
11/21/2008 |
C-REACTIVE PROTEIN (LATEX) |
ROCHE DIAGNOSTICS CORP. |
KATHIE J GOODWIN |
| 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 |
| 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 |
| 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 |
| K083522 |
11/26/2008 |
SONY UP-DF750 DIGITAL FILM IMAGER |
SONY ELECTRONICS, INC. |
CYNTHIA SINCLAIR |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K083307 |
11/10/2008 |
SYNTHASOME X-REPAIR |
SYNTHASOME, INC. |
ANTHONY RATCLIFFE |
| 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 |
| 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 |
| K083337 |
11/12/2008 |
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES |
TERANG NUSA SDN BHD |
ROBERT HILL |
| 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 |
| 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 |
| 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 |
| K083503 |
11/26/2008 |
DRAD30003/RADREX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K083282 |
11/07/2008 |
MODEL TSX-301B AQUILION CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K083434 |
11/20/2008 |
TT1 GENERAL PURPOSE COIL |
TURSIOP TECHNOLOGIES LLC |
|
| K083454 |
11/21/2008 |
NUOVOCATH |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINE SMITH |
| K083535 |
11/28/2008 |
HEARTRAK SMART ECAT |
UNIVERSAL MEDICAL, INC. |
JOYCE W DEAN |
| 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 |
| 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 |
| K083429 |
11/19/2008 |
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT |
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. |
Diana Hong |
| K083512 |
11/26/2008 |
FLUID-FILLED TEETHER |
WILTEC INDUSTRIES LTD. |
Kevin Walls |
| 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 |
| K083309 |
11/10/2008 |
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 |
ZARGIS MEDICAL CORP. |
JOHN KALLASSY |
| K083324 |
11/12/2008 |
LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM |
ZEST ANCHORS, INC. |
RICHARD A OVERTON |
| K083545 |
11/28/2008 |
ZIEHM VISION RFD |
ZIEHM IMAGING, INC. |
RICHARD WESTRICH |
| K083474 |
11/24/2008 |
ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| 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 |
