FDA 510(k) Decisions During January, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K053438 01/18/2006 GLASS CERAMICS 3M ESPE AG DENTAL PRODUCTS SABINE KRISCHER
K062493 11/17/2006 LAVA SOFTWARE 3M ESPE AG DENTAL PRODUCTS SABINE KRISCHER
K062855 11/22/2006 CALCIUM ABBOTT LABORATORIES LINDA MORRIS
K052566 01/06/2006 NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY ABBOTT SPINE, INC. NOAH BARTSCH
K060020 01/20/2006 AUTOQUANT PLUS ADAC LABORATORIES COLEEN A COLEMAN
K063173 11/03/2006 MODIFICATION TO SILVER ALGINATE II WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED GRAHAME SOMERVILLE
K062135 11/07/2006 ART SHIELDED BREAST APPLICATOR ADVANCED RADIATION THERAPY, LLC RAYMOND J BRICAULT
K062510 11/17/2006 AESCULAP STERILCONTAINER SYSTEM AESCULAP MATTHEW M HULL
K062413 11/21/2006 AESCULAP PNEUMATIC KERRISON AESCULAP, INC. KATHY A RACOSKY
K062684 11/22/2006 EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD AESCULAP, INC. KATHY A RACOSKY
K053526 01/18/2006 MICROSPEED UNI MOTOR SYSTEM AESCULAP, INC. KATHY A RACOSKY
K053158 01/18/2006 OPTILENE MESH LP AESCULAP, INC. MATTHEW M HULL
K052825 01/20/2006 VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG AFFINITY BIOLOGICALS INC. DENISE FOULON
K051028 01/27/2006 BREEZE AFIKIM ELECTRIC VEHICLES AVNER FISHBEIN
K062434 11/13/2006 ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 AGAMATRIX CONNIE HERTEL
K052762 01/23/2006 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 AGAMATRIX INC CONNIE HERTEL
K063421 11/22/2006 DX-SI AGFA CORP. JEFFERY A JEDLICKA
K053634 01/17/2006 COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION AGFA CORPORATION JEFFERY A JEDLICKA
K052697 01/04/2006 HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL AKERS BIOSCIENCES, INC. BARBARA A BAGBY
K062930 11/08/2006 LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM ALCON RESEARCH, LTD. JANET G JOHNSON
K052918 01/27/2006 REPROCESSED EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K060059 01/13/2006 ALOKA SD-3500 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K051031 01/06/2006 AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS AMERIWATER BRIAN R BOWMAN
K052548 01/06/2006 UROK ROCKING WHEELCHAIR, MODEL 700-4XX AMG MEDICAL INC. KENNETH LEVESQUE
K062212 11/21/2006 SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S ANACAPA TECHNOLOGIES, INC. ILA DOSHI
K060096 01/24/2006 MODULAR TROCAR SYSTEM APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K060051 01/19/2006 SPECIMEN RETRIEVAL SYSTEM APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K051648 01/31/2006 SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS ARKRAY, INC. HELEN LANDICHO
K062466 11/29/2006 ARTHREX INTERFERENCE SCREW ARTHREX, INC. ANN WATERHOUSE
K053338 01/26/2006 ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS ARTHREX, INC. ANN WATERHOUSE
K053180 01/25/2006 PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K052830 01/19/2006 SPORTMESH ARTIMPLANT AB TERRY SHERIDAN POWELL
K061601 11/17/2006 ASAHI PRECIOUS GUIDE CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K062186 11/09/2006 ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J ASAHI INTECC CO., LTD. YOSHI TERAI
K052666 01/25/2006 NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN ASCEND EAGLE, INC. JARILYN LIM
K062467 11/22/2006 AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 AXIS-SHIELD DIAGNOSTICS, LTD. ERICA CONWAY
K061639 11/01/2006 ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON AXON SYSTEMS, INC. HOWARD BAILIN
K052773 01/24/2006 B. BRAUN 0.2 MICRON FILTER B. BRAUN MEDICAL, INC. CHRISTINE FORD
K063280 11/17/2006 INJEKT SYRINGE B. BRAUN MEDICAL, INC. CHRISTINE FORD
K062715 11/03/2006 SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW BAODING GUANZHONG GLOVE CO., LTD. MARY A DOUCETTE
K062131 11/17/2006 NIO 5MP-M-21" (NIO 5MP MAMMO); MDNG-5121 BB BARCOVIEW LIEVEN DE WANDEL
K053501 01/13/2006 POWERPICC BARD ACCESS SYSTEMS, INC. LYNN M KIRCHOFF
K062441 11/14/2006 BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 BARRX MEDICAL, INCORPORATED JONATHAN S KAHAN
K062723 11/09/2006 HALO90 COAGULATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K053124 01/30/2006 BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES BAUSCH & LOMB INCORPORATED LISA GRANEY
K062347 11/22/2006 ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE, LLC MARC HENN
K062944 11/15/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K062945 11/21/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062044 11/21/2006 THE 5.0 X 6.0MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K062109 11/09/2006 BINAXNOW INFLUENZA A & B TEST BINAX, INC. ANGELA DRYSDALE
K060001 01/20/2006 D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K061567 11/22/2006 BIOHORIZONS CERAMIC ABUTMENT BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K060027 01/26/2006 ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) BIOKIT S.A. JOAN GUIXER
K060050 01/23/2006 MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM BIOLITEC, INC. JONATHAN S KAHAN
K051774 01/20/2006 MBCP BIOMATLANTE MYRIAM VINCENT
K061794 11/21/2006 FIDIS TM THYRO, MODEL MX002 BIOMEDICAL DIAGNOSTICS (BMD) SA CHRISTELLE COURIVAUD
K053004 01/13/2006 MSAS-VANTAGE BIOMERIDIAN, INT. GENE SWIFT
K053299 01/05/2006 REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT BIOMET MANUFACTURING, INC. PATRICIA S BERES
K053327 01/26/2006 OXICOM CONTROL BIONOSTICS, INC. KATHLEEN STORRO
K062980 11/22/2006 ACTIVASCREW BIORETEC LTD MARI RUOTSALAINEN
K052789 01/23/2006 TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 BIOSITE INCORPORATED RACHAEL S WILLIAMSON
K052742 11/07/2006 HEPASPHERE MICROSPHERES BIOSPHERE MEDICAL, INC. ROSINA ROBINSON
K063060 11/29/2006 BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP BLUESHINE SRL ALICE NOVELLI
K052964 01/06/2006 EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN BOSTON SCIENTIFIC CORP. KATIE GERBENSKY
K063312 11/30/2006 MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K051880 01/04/2006 RIO ASPIRATION CATHETER BOSTON SCIENTIFIC CORP. CATHERINE A PETERS
K060078 01/31/2006 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORPORATION CHRISTINE M CAMERON
K060006 01/31/2006 BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER BRAUN GMBH FRED SCHLADOR
K053065 01/03/2006 FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) BRYAN KEROPIAN DDS BRYAN KEROPIAN
K063178 11/21/2006 BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 C.R. BARD, INC. STEPHANIE BAKER
K063240 11/21/2006 SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR C.R. BARD, INC. LYNN M KIRCHOFF
K061705 11/21/2006 CADWELL EASYNET NASAL PRESSURE MODULE CADWELL LABORATORIES, INC. CHRIS BOLKAN
K053221 01/12/2006 CDMX-H CAMSIGHT CO., INC. JAY CHOI
K062886 11/06/2006 ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 CAO GROUP, INC. ROBERT K LARSEN
K062619 11/14/2006 DENLASER 800 PLUS CAO GROUP, INC. ROBERT K LARSEN
K063193 11/21/2006 MODIFICATION TO BIOMARC TISSUE MARKER CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K052556 01/09/2006 CG-7000DX-BT ECG RECORDER/TRANSMITTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K052570 01/17/2006 TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 CARDIAC ASSIST, INC. TIM KRAUSKOPF
K052316 01/03/2006 POWERHEART ECD CARDIAC SCIENCE, INC. KENNETH OLSON
K053062 01/06/2006 CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 CARDIARC LTD. JONATHAN KAHN
K053524 11/16/2006 C-PORT DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. DAVID CASAL
K053272 01/05/2006 CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES CARDINAL HEALTH AMY HOYD
K063288 11/28/2006 SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X CARDINAL HEALTH 303, INC. STACY L LEWIS
K053049 01/12/2006 ALARIS SAFETY MALE LUER CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K062340 11/30/2006 CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM CARDIO-OPTICS, INC. LARRY BLANKENSHIP
K063222 11/14/2006 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 CARDIONET, INC JACK GAIKWAD
K052295 01/13/2006 CARDIOSOFT PC ECG, USB VERSION CARDIOSOFT, L.P. S. MORADI
K062400 11/16/2006 IMPRESSIX, COLORCHANGE ALGINATE CAVEX HOLLAND B.V. RICHARD WOORTMAN
K062487 11/17/2006 APERFIX FEMORAL IMPLANT WITH INSERTER CAYENNE MEDICAL, INC. FLOYD LARSON
K063289 11/16/2006 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063266 11/09/2006 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC CHI LIN TECHNOLOGY CO., LTD. JUDY LIN
K063291 11/21/2006 INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 CHOICE SMART HEALTH CARE CO. LTD. JANICE MA
K053324 01/05/2006 CHROMOLITE SYSTEM CHROMOGENEX PLC CHRIS WILLIAMS
K062262 11/14/2006 CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS CIBA VISION CORPORATION ALICIA M PLESNARSKI
K063079 11/07/2006 I-STOP TRANS OBTURATOR MALE SLING CL MEDICAL VINCENT GORIA
K053379 01/25/2006 RELI-ON ONE STEP, ORTHODONTIC ADHESIVE CLASSONE ORTHODONTICS, INC. JUDY RIBORDY
K053156 01/31/2006 MINI-WRIGHT DIGITAL, MODEL 3120001 CLEMENT CLARKE INTL., LTD. PHILIP HALLYBONE
K051435 01/19/2006 ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 CLINICAL MICRO SENSORS WILLIAM A COTY
K053107 01/19/2006 CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD CODMAN & SHURTLEFF, INC. SUSAN KAGAN
K053350 01/19/2006 MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS CODMAN & SHURTLEFF, INC. BRIAN KANERVIKO
K052812 01/25/2006 OSSIMEND (TM) BONE GRAFT MATERIAL COLLAGEN MATRIX, INC. PEGGY C HANSEN
K052820 01/09/2006 PARAPOST PARACORE AUTOMIX 5ML COLTENE/WHALEDENT AG H. J. VOGELSTEIN
K062593 11/22/2006 CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET COMPASS BIOSCIENCE CARTER GRANDJEAN
K061814 11/30/2006 VASOPRESS DVT SYSTEM, MODEL VP500D COMPRESSION THERAPY CONCEPTS, INC. LEONARD NASS
K062548 11/01/2006 MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K063252 11/14/2006 ATB ADVANCED PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K061948 11/22/2006 PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS COOPERVISION, INC. LISA HAHN
K060987 11/02/2006 OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 CP MEDICAL BETSY CORTELLONI
K051145 01/18/2006 CRITIVIEW CRITISENSE LTD. PAUL E DRYDEN
K053436 01/13/2006 SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE CRYOCATH TECHNOLOGIES, INC. FRED MILDER
K061892 11/22/2006 PROPATCH SOFT TISSUE REPAIR MATRIX CRYOLIFE, INC. JOHN D FERROS
K063102 11/09/2006 MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) DADE BEHRING, INC. SHANNON POPSON
K063099 11/01/2006 MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) DADE BEHRING, INC. MAY MORISHIMA
K063101 11/01/2006 MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML DADE BEHRING, INC. MAUREEN MENDE
K063299 11/27/2006 MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN DADE BEHRING, INC. MAY MORISHIMA
K062938 11/20/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML DADE BEHRING, INC. ROBERT EUSEBIO
K052534 01/27/2006 TACAHE DALTON MEDICAL CORP. WILL RIDGWAY
K062754 11/02/2006 GAS MODULE SE, MODEL 0998-00-0481-02 DATASCOPE CORP. KATHLEEN KRAMER
K062469 11/03/2006 VOYAGER 12 DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K063188 11/30/2006 DEL-IMS DEL MEDICAL IMAGING CORP. WILLIAM J ENGEL
K062733 11/09/2006 TOMAS PIN SD 6, 8, AND 10 MM DENTAURUM CHARLES R BELL
K062828 11/27/2006 MOUTHGUARD AND ALIGNER MATERIALS DENTSPLY INTL., INC. HELEN LEWIS
K063273 11/22/2006 PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR DEPUY MILTEK, A JOHNSON & JOHNSON CO. KRISTINE CHRISTO
K062748 11/30/2006 MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD DEPUY ORTHOPAEDICS, INC. ANNE M SCHULER
K060031 01/31/2006 DEPUY MODULAR M HEADS DEPUY ORTHOPAEDICS, INC. KELI K HANKEE
K053445 01/06/2006 SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K062174 11/02/2006 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. MARY GRAY
K063156 11/22/2006 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K061101 11/20/2006 D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K063067 11/03/2006 CONFIDENCE FENESTRATED INTRODUCER NEEDLE DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K063146 11/27/2006 ACCU-CHEK LINKASSIST DISETRONIC MEDICAL SYSTEMS AG SCOTT THIEL
K052649 01/27/2006 DRG SLV TESTOSTERONE ELISA TEST DRG INTL., INC. GARY LEHNUS
K053176 01/30/2006 DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 DUCKWORTH & KENT, LTD. MARTIN LOCK
K053285 01/05/2006 MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM DURTECH SYSTEM CORP. ADA LIN
K063029 11/02/2006 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 E-Z-EM, INC. TRACEY CAMPBELL
K053347 01/04/2006 KODAK CARESTREAM PACS EASTMAN KODAK COMPANY CAROLYN L WAGNER
K053606 01/24/2006 BE PLUS / AURA-LTM64 AMPLIFIER EB NEURO, S.P.A. CARRI GRAHAM
K061696 11/13/2006 IQQA-LIVER SOFTWARE EDDA TECHNOLOGY, INC. XIAOLAN ZENG
K063120 11/09/2006 COLOR LCD MONITOR, RADIFORCE, MODEL RX210 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K053437 01/06/2006 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K062507 11/22/2006 MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K063448 11/30/2006 EMG AC/DC SUCTION UNIT EMG TECHNOLOGY CO., LTD. SALLY CHUANG
K052438 01/31/2006 EMG HANDLE NEBULIZER NB02 SERIES EMG TECHNOLOGY CO., LTD. GENE R KULON
K053455 01/25/2006 ENCOMPASS.NET EMPIRIC SYSTEMS, LLC CARL ALLETTO
K063257 11/22/2006 FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT ENCORE MEDICAL, L.P. TEFFANY HUTTO
K053267 01/13/2006 ENDIUS ATAVI SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K053326 01/06/2006 ESTECH COBRA ELECTROSURGICAL UNIT & CABLE ENDOSCOPIC TECHNOLOGIES, INC. CRAIG COOMBS
K052479 01/26/2006 MBATH 1000 (60") ENNEKING MEDICAL INC. STEPHEN WHITTENBURG
K063277 11/30/2006 MAPMATE EP MEDSYSTEMS, INC. LARRY PICCIANO
K063207 11/09/2006 S-SCAN MRI SYSTEM ESAOTE, S.P.A. CARRI GRAHAM
K053557 01/20/2006 ESKA-LIBUR HIP STEM ESKA IMPLANTS GMBH & CO. J. D WEBB
K053021 01/26/2006 ESTECH CLEARVIEW MV ATRIAL DEPRESSOR ESTECH, INC. CRAIG COOMBS
K053631 01/30/2006 CONTOUR TRANSTAR CURVED CUTTER STAPLER SET ETHICON ENDO-SURGERY, INC. WENDY TURNER
K053056 01/19/2006 HARMONIC SCALPEL BLADES AND SHEARS ETHICON ENDO-SURGERY, INC. ELIZABETH MILLER
K063204 11/14/2006 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC DAVID WORRELL
K052453 01/13/2006 TRACTION SYSTEM, DIGIT-TRAC 930 EVER PROSPEROUS INSTRUMENT, INC. KE-MEN JEN
K053427 01/13/2006 FRESH, DENTAL IMPRESSION MATERIAL EXACTA DENTAL PRODUCTS, INC. RICHARD KEEN
K063279 11/29/2006 NOVATION SPLINED RDD FEMORAL STEMS EXACTECH, INC. MARITZA ELIAS
K052642 01/17/2006 SUTURING WASHER FIRST CALL, INC. DINA L WEISSMAN
K053460 01/13/2006 MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, FOX HOLLOW TECHNOLOGIES MELISSA MURPHY
K052813 01/25/2006 FD TENS 2030, MODEL DFJ24T FUJI DYNAMICS LIMITED ANTHONY AH YIN SHUN
K051163 01/31/2006 GALIX ECG PROFESSIONAL STATION GALIX BIOMEDICAL INSTRUMENTATION, INC. GREG VELEZ
K051400 01/20/2006 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS GE HEALTHCARE JOEL C KENT
K052976 01/13/2006 DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES GE HEALTHCARE JOEL KENT
K052975 01/20/2006 DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE GE HEALTHCARE JOEL KENT
K062440 11/07/2006 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 GEN-PROBE, INC. E JOSEPH MCMULLEN
K063006 11/02/2006 GE LOGIQ WORKS GENERAL ELECTRIC CO. ALLEN SCHUH
K053559 01/20/2006 PF4 ENHANCED SOLID PHASE ELISA GENETIC TESTING INSTITUTE LEIGH ANN TIDEY
K063162 11/02/2006 GOLDEN LITEWAY GOLDEN TECHNOLOGIES, INC. GENE R KULON
K052955 01/19/2006 NITRILE BLUE POWDERED EXAMINATION GLOVES GREAT GLOVE SDN BHD LIM WEE-CHAI
K062721 11/21/2006 GREENTON ECOLITE IPL SYSTEM GREENTON (LONDON) LTD. ROBERT T HANDREN
K061933 11/16/2006 HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER HAGER WORLDWIDE, INC. JAMES DELANEY
K052863 01/06/2006 RAPHAEL COLOR HAMILTON MEDICAL AG CURDIN DANUSER
K063046 11/17/2006 NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) HARTALEGA SDN BHD NURUL A KONG
K052925 01/04/2006 SMARTPREP2 CENTRIFUGE SYSTEM HARVEST TECHNOLOGIES, CORP. JOHN D BONASERA
K052935 01/13/2006 HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) HEIDELBERG ENGINEERING GERHARD ZINSER
K052723 01/13/2006 SEVEN STAR NEEDLE HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K062515 11/22/2006 RETENTION FLOW OPAQUE HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K061993 11/03/2006 EQUIVITAL, MODEL EQ-01 HIDALGO LIMITED JUSTIN PISANI
K051677 01/23/2006 OPTIGEN ALLERGEN SPECIFIC IGE ASSAY HITACHI CHEMICAL DIAGNOSTICS, INC. EMI ZYCHLINSKY
K061608 11/22/2006 MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP. DOUG THISTLETHWAITE
K053309 01/24/2006 ALTAIRE INTERVENTIONAL MR PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K053486 01/04/2006 TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET HOFFRICHTER GMBH STEPHEN H GORSKI
K062999 11/03/2006 OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN HOSPIRA, INC. DIANE RENNPFERD
K053472 01/11/2006 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K053198 01/26/2006 SIMPLEX P SPEEDSET BONE CEMENT HOWMEDICA OSTEONICS CORP TIFFANI D ROGERS
K062419 11/15/2006 TRIDENT LARGE DIAMETER ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
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K063138 11/22/2006 MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA W PICKERING PH.D.
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K062454 11/03/2006 MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES SIEMENS MEDICAL SOLUTIONS, INC. JUDITH CAMPBELL
K052423 01/13/2006 MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION SIEMENS MEDICAL SOLUTIONS, INC. JUDITH CAMPBELL
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K062898 11/13/2006 SBI LATERAL RHEAD IMPLANT SMALL BONE INNOVATIONS INC. ROBERT HOEHN
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K062592 11/29/2006 CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE SMITHS MEDICAL MD, INC. MELANIE HESS
K062323 11/01/2006 DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 SMITHS MEDICAL MD, INC. DAVID H SHORT
K052654 01/30/2006 KLOCKNER DENTAL IMPLANT, MODEL S3M SOADCO, S.L. MARIA MITJANETA
K062064 11/09/2006 RIVA BOND LC SOUTHERN DENTAL INDUSTRIES, INC. RAY CAHILL
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K063010 11/28/2006 REGEN BIOCEMENT STEINER LABORATORIES GREGORY GENE STEINER
K063267 11/09/2006 ISITE PACS, V 4. X STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO. DEANA WISEMAN
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K052272 01/03/2006 STRAUMANN COMPUTER AIDED RESTORATION SERVICE STRAUMANN USA ELAINE ALAN
K053362 01/13/2006 CELL-CHEX AUTO STRECK KERRIE OETTER
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K051933 01/03/2006 EXPASYL POWER APPLICATOR SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
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K053135 01/04/2006 SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER SYSMEX AMERICA, INC. NINA GAMPERLING
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K062183 11/21/2006 FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT THE BINDING SITE, LTD. JAY H GELLER
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K052822 01/20/2006 DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 THUNDER TIGER CORP. KE MIN JEN
K062812 11/28/2006 DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N THUNDER TIGER CORP. JEN KE-MIN
K061617 11/22/2006 FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST TIANJIN NEW BAY BIORESEARCH CO., LTD. RODRIGO BERTIE
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K060544 11/13/2006 SALTO TALARIS TOTAL ANKLE PROSTHESIS TORNIER MIREILLE EMERY
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K063184 11/03/2006 MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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K063130 11/02/2006 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
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K063197 11/30/2006 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
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K061796 11/02/2006 HEPATOSTAT SET, MODEL 760X VYGON CORP. STEPHEN GOLDNER
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K063435 11/28/2006 GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL W. L. GORE & ASSOCIATES, INC. MICHAEL IVEY
K062161 11/09/2006 GORE PROPATEN VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC MICHAEL IVEY
K053169 01/17/2006 RM3 RENAL PRESERVATION SYSTEM WATERS INSTRUMENTS, INC. DAVE SCHOLLMAN
K062917 11/02/2006 STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 WEAR SAFE MALAYSIA SDN. BHD. TK LOH
K061653 11/09/2006 SOYALA FULL FACE MASK WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG ECKHARDT ABERS
K053136 01/05/2006 5TH METATARSAL FRACTURE SCREW WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K053642 01/26/2006 OSTEOSET DBM PELLETS WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
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K052915 01/27/2006 PROFEMUR XTR HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K062757 11/07/2006 XERON PACS XERON HEALTHCARE CORP. MELISSA MAHALL
K053433 01/19/2006 CAUTERY TIP CLEANER, MODEL 30500 XODUS MEDICAL, INC. BRENDA NIEL
K053321 01/19/2006 LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER XODUS MEDICAL, INC. CRAIG KAFOREY
K052176 01/12/2006 FLOWHANDY ZAN100 USB ZAN MESSGERATE GMBH JIM LEWIS
K052997 01/23/2006 ZIMMER DENTAL ONE-PIECE IMPLANT ZIMMER DENTAL INC. ERIN MCVEY
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K063303 11/22/2006 UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS ZIMMER, INC. ANTHONY FRANCALANCIA
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