FDA 510(k) Applications Received During November, 2008

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
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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
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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
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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
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K083446 11/21/2008 CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING ZIOSOFT, INC. RICHARD BALL


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