FDA 510(k) Applications Received During February, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K043043 12/08/2004 HERMES BOND 2 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K040371 02/18/2004 A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K040229 02/10/2004 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 A & D ENGINEERING, INC. JERRY WANG
K043217 12/08/2004 A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K040465 02/23/2004 LATIT FLOW AB ARDENT CLYDE E INGERSOLL
K040327 02/10/2004 ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) ACCU-STAT DIAGNOSTICS, INC. JAMES G BARRONS
K040298 02/17/2004 ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS ACIST MEDICAL SYSTEMS, INC. CARL M BEAURLINE
K043581 12/28/2004 DUAL LUMEN CATHETER ACMI CORPORATION GRAHAM BAILLIE
K040274 02/05/2004 ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K043507 12/20/2004 ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K040445 02/20/2004 ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K040326 02/10/2004 AUTOQUANT PLUS ADAC LABORATORIES JOY M SACMAR
K043361 12/07/2004 ACCUHEART ELECTRODE BELT ADVANCED BIOELECTRIC CORPORATION MARC-ANDRE COTE
K043353 12/06/2004 OMEGA EXCEL/XP LASER SYSTEM ADVANCED MEDICAL TECHNOLOGIES, INC. M. JOYCE HEINRICH
K040463 02/23/2004 AESKULISA CARDIOLIPIN AGM AESKU, INC STANLEY AMMONS
K040344 02/12/2004 IMPAX OT3000 ORTHOPEDIC WORKSTATION AGFA CORP. PHIL CUSCUNA
K043487 12/17/2004 EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 AIZU OLYMPUS CO., LTD. LAURA STORMS-TYLER
K040293 02/09/2004 HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY AKERS LABORATORIES, INC. BARBARA A BAGBY
K040231 02/02/2004 INTELIPORT OCCLUDING DEVICE ALCON, INC. KIM B KRACKE
K043392 12/10/2004 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. MOIRA BARTON
K043393 12/10/2004 REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. JENN SELVEY
K043358 12/07/2004 REPROCESSED ULTRASONIC SCALPELS ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K040464 02/23/2004 AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST AMEDICA BIOTECH, INC. JEFF CHEN
K043543 12/20/2004 BLOOD GLUCOSE MONITORING SYSTEM AMERICAN HEALTHCARE INC. EDWARD LETKO
K043512 12/21/2004 EASYGLUCO IGM-0002 G2 AMERICAN HEALTHCARE INC. EDWARD LETKO
K040392 02/17/2004 TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K040399 02/17/2004 QONTRAST AMID COLLEEN DENSMORE
K043550 12/23/2004 AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 AMPLIFE CORPORATION SUSAN GOLDSTEIN-FALK
K040402 02/17/2004 ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K040446 02/24/2004 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K043508 12/20/2004 DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) ANSELL HEALTHCARE PRODUCTS LLC LON D MCILVAIN
K043350 12/06/2004 MISTAR, MODEL V3.2 APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD. QING YANG
K043519 12/20/2004 ARIOL HER-2/NEU FISH APPLIED IMAGING CORP. DIANE C DAY
K040295 02/09/2004 APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K040497 02/26/2004 DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. LOUISE M FOCHT
K040332 02/10/2004 POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER ARKRAY, INC. HELEN LANDICHO
K040260 02/04/2004 INTEGRAL HEMODIALYSIS CATHETER ARROW INT'L. BRANDON EPTING
K043337 12/03/2004 ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR ARTHREX, INC. SALLY FOUST
K040381 02/18/2004 HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 ARTHREX, INC. SALLY FOUST
K040338 02/11/2004 ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K040500 02/27/2004 ARTHROTEK LACTONAIL ARTHROTEK, INC. TRACY J BICKEL
K043422 12/13/2004 ASAHI PTCA GUIDE WIRE, J SHAPE SERIES ASAHI INTECC CO., LTD. YOSHI TERAI
K043241 12/01/2004 LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER ASTRA TECH, INC. BRUCE MANNING
K043579 12/28/2004 ATRICURE BIPOLAR SYSTEM ATRICURE, INC. ELSA C ABRUZZO, RAC
K043554 12/31/2004 ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 B-K MEDICAL A/S VILLY BRAENDER
K043524 12/31/2004 ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 B-K MEDICAL A/S VILLY BRAENDER
K040365 02/13/2004 COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K040425 02/18/2004 ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS BAYER HEALTHCARE, LLC KENNETH T EDDS
K043311 12/01/2004 ASCENSIA ELITE DIABETES CARE SYSTEM BAYER HEALTHCARE, LLC GEORGE M TANCOS
K040339 02/11/2004 BRACHYTHERAPY STRAND DEVICE BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH SVEN LANGER
K043556 12/27/2004 SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K043397 12/10/2004 MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K043458 12/15/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K043389 12/09/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K040405 02/23/2004 CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K040103 02/03/2004 SOUNDSKIN PHOTOTHERAPY SYSTEM BHC INTERNATIONAL, LTD. MICHAEL BREEN
K043423 12/13/2004 MODEL SC-3008 SEQUENTIAL CIRCULATOR BIO COMPRESSION SYSTEMS, INC. RON MOTHERWELL
K040256 02/04/2004 PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 BIO-DETEK, INC. ROBERT MORSE
K040485 02/25/2004 MAXAIR SURGICAL HELMET SYSTEM BIO-MEDICAL DEVICES, INC. NICK HERBERT
K040275 02/05/2004 LYPHOCHEK HEMOSTASIS CONTROL BIO-RAD ELIZABETH PLATT
K043341 12/03/2004 BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC. CHRISTOPHER BENTSEN
K043584 12/28/2004 LIQUICHEK BNP CONTROL BIO-RAD LABORATORIES, INC. SUZANNE S PARSONS
K040277 02/05/2004 LIQUICHEK CARDIAC MARKER CONTROL LT BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K040273 02/05/2004 LYPHOCHEK ASSAYED CHEMISTRY CONTROL BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K043514 12/22/2004 ALLOGRAN-N-BONE VOID FILLER BIOCOMPOSITES LTD. STEPHEN BRATT
K040265 02/05/2004 LITTLE GRAFTER SCREW BIOCOMPOSITES LTD. J. STEPHEN BRATT
K043428 12/13/2004 RELIADENT DENTAL IMPLANT SYSTEM BIOINFERA, INC. CHAN Q WANG
K043304 12/02/2004 Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 BIOJECT MEDICAL TECHNOLOGIES INC. LAURENCE A POTTER
K040306 02/09/2004 HIGH VOLTAGE PULSED STIMULATOR, MODEL "BMLS02-7" BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K043371 12/13/2004 BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER BIOMERIX CORPORATION CHRISTINA L KICHULA
K043547 12/23/2004 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM BIOMET, INC. GARY BAKER
K043505 12/20/2004 DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM BIOMET, INC. GARY BAKER
K040475 02/24/2004 MICROMAX SUTURE ANCHOR BIOMET, INC. KACY ARNOLD
K043537 12/22/2004 TAPERLOC 12/14 TAPER FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K043598 12/29/2004 FC 1400 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K043597 12/29/2004 FC 700 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K043542 12/23/2004 BIOPRO TARA FEMORAL RESURFACING COMPONENT BIOPRO, INC. DAVID MRAK
K040352 02/12/2004 NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) BIORESOURCE TECHNOLOGY, INC. ALAN POSNER
K043521 12/20/2004 BIOSYAG 50 MED BIOS S.R.L. ALESSANDRO FRANCHI ONDE
K040459 02/23/2004 TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K040437 02/23/2004 TRIAGE PROFILER S.O.B. PANEL BIOSITE INCORPORATED JEFFREY R DAHLEN
K043548 12/23/2004 BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K043338 12/03/2004 BLAKSTONE LAMINOPLASTY FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K040219 02/02/2004 COBRA SURGICAL PROBE BOSTON SCIENTIFIC CORP. APRIL I MALMBORG
K040342 02/12/2004 INTERLOCKING DETACHABLE COIL SYSTEM (IDC) BOSTON SCIENTIFIC CORP. ARTHUR FRIEDMAN
K040447 02/20/2004 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K040203 02/02/2004 MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 BRANAN MEDICAL CORP. RAPHAEL WONG
K043502 12/20/2004 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC C.R. BARD, INC. LYNN M KIRCHOFF
K040243 02/03/2004 BARD ATLAS PTA BALLOON DILATATION CATHETER C.R. BARD, INC. AYMEE R BERRY
K040504 02/27/2004 BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS C.R. BARD, INC. JOHN C KNORPP
K040438 02/19/2004 POWERHEART AED G3A CARDIAC SCIENCE, INC. KENNETH OLSON
K043518 12/20/2004 RADIOPAQUE BONE CEMENT CARDINAL HEALTH SHARON NICHOLS
K043590 12/28/2004 SE INFUSION SYSTEM WITH MMS CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K043575 12/27/2004 DERMILLUME, MODEL PRO1000 CARE ELECTRONICS, INC. THOMAS MOODY
K040468 02/24/2004 CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K040285 02/17/2004 VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER CHATTANOOGA GROUP MICK DAVIS
K043580 12/28/2004 ALLIGATOR RETRIEVAL DEVICE (ARD) CHESTNUT MEDICAL TECHNOLOGIES, INC. ANNA LONGWELL
K040489 02/26/2004 AQUADEX SYSTEM 100, MODEL A1100 CHF SOLUTIONS, INC. AMY PETERSON
K043558 12/27/2004 XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. GEORGE SU
K040424 02/18/2004 LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 CLARUS MEDICAL, LLC. TOM BARTHEL
K040508 02/27/2004 VITALAB MAGNESIUM REAGENT CLINICAL DATA, INC. WYNN STOCKING
K040467 02/24/2004 VITALAB URIC ACID REAGENT CLINICAL DATA, INC. WYNN STOCKING
K040455 02/23/2004 LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K040403 02/20/2004 COLLAGEN WOUND DRESSING - ORAL COLLAGEN MATRIX, INC. PEGGY HANSEN
K043570 12/27/2004 UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD CONFORMIS, INC. LYNDALL ERB
K043418 12/13/2004 COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH COOK UROLOGICAL, INC. CINDY RUMPLE
K043509 12/21/2004 GUNTHER TULIP VENA CAVA FILTER SET COOK, INC. EARL E KNIGHT III
K043481 12/15/2004 MODIFICATION TO: ZILVER 635 BILIARY STENT COOK, INC. LELAND KEYT
K040505 02/27/2004 ZILVER 635 BILIARY STENT COOK, INC. LELAND KEYT
K040413 02/18/2004 CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018" DELIVERY SYSTEM CORDIS EUROPA N.V. KAREN WILK
K043605 12/30/2004 INSCOPE 3-STAGE BALLOON DILATOR CORDIS EUROPA, N.V. HARM HOVINGA
K043538 12/22/2004 HYPERTRANSIT INFUSION CATHETER CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K040216 02/03/2004 CERASORB M ORTHO CURASAN AG ERIC WIECHERT
K043522 12/21/2004 ISSYS PEDICLE SCREW SYSTEM CUSTOM SPINE, INC. DEBBIE IAMPIETRO
K043326 12/02/2004 BEWELL, MODEL SC 20 CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN LAN
K043332 12/02/2004 WHEELCHAIR, MODEL 8500-II CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER ZEN-JYE CHEN
K043429 12/13/2004 CYNERGY LASER CYNOSURE, INC. GEORGE CHO
K040289 02/06/2004 SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER CYNOSURE, INC. GEORGE CHO
K043546 12/23/2004 DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE DADE BEHRING, INC. STANLEY GORAK
K043476 12/16/2004 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT DADE BEHRING, INC. GEORGE M PLUMMER
K040491 02/27/2004 CHIN-UP STRIP DALE MILLER, INC. - THE CHIN-UP COMPANY DALE MILLER
K043572 12/27/2004 COMPATIBILITY ECG TRUNK CABLES DATEX-OHMEDA JOEL C KENT
K043551 12/23/2004 DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K040313 02/09/2004 HRV TOOLS DEL MAR REYNOLDS MEDICAL, LTD. GEORGE MYERS
K043539 12/22/2004 DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES DEMETECH CORP. ARTHUR WARD
K043330 12/06/2004 POLYPROPILENE SURGICAL SUTURES DEMETECH CORP. ARTHUR WARD
K043264 12/14/2004 LDL-EX SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K040421 02/18/2004 DUCERAGOLD PORCELAINS DENTSPLY INTL. P. JEFFERY LEHN
K040420 02/18/2004 DUCERAM PLUS CERAMIC SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K040375 02/17/2004 IDEAL 1 ORTHODONTIC BAND CEMENT DENTSPLY INTL. P. JEFFERY LEHN
K040268 02/05/2004 DEPUY PRESERVATION UNICONDYLAR TIBIA DEPUY ORTHOPAEDICS, INC. ABRAHAM WRIGHT
K040281 02/06/2004 LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN
K040383 02/17/2004 TRIFLANGE II ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN
K043308 12/08/2004 MODIFICATION TO: HEALOS BONE GRAFT MATERIAL DEPUY SPINE, INC. SHARON STAROWICZ
K043406 12/10/2004 VERTEBROPLASTIC RADIOPAQUE BONE CEMENT DEPUY SPINE,INC SHARON STAROWICZ
K043530 12/21/2004 DVI CURING LIGHT DESIGNS FOR VISION, INC. MARY MCNAMARA-CULLINANE
K043344 12/06/2004 DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM DIALYSIS SERVICES, INC. MIKE STERLING
K040362 02/18/2004 DIAPHARMA FACTOR X KIT DIAPHARMA GROUP, INC. JENNIFER J KIBLINGER
K040290 02/06/2004 DIASORIN LIAISON CMV IGM/IGG DIASORIN S.P.A. DAVID M IKEDA
K043323 12/02/2004 D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR DIDECO S.R.L. BARRY SALL
K043491 12/22/2004 ENFANTTM DIOPSYS INC. JOSEPH FONTANETTA
K043409 12/10/2004 ACCUCHANGER DIREX SYSTEMS CORP. LARISA GERSTEIN
K040474 02/24/2004 ACCUSOFT DIREX SYSTEMS CORP. LARISA GERSTEIN
K040470 02/24/2004 TRIPTER X-1 COMPACT DIREX SYSTEMS CORP. LARISA GERSHTEIN
K043328 12/02/2004 MICROFLO-SAFE SCALP VEIN SET DKS LOVERSAN INDUSTRIA BIOMEDICA SPA ARTHUR WARD
K040380 02/17/2004 DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 DOLPHIN MEDICAL INC. JON WERNER
K040443 02/20/2004 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I DOME IMAGING SYSTEMS, INC. SUSAN HAMANN
K043461 12/15/2004 CUSTODIOL DR. FRANZ KOHLER CHEMIE GMBH T. WHIT ATHEY
K043549 12/23/2004 INFINITY GATEWAY SUITE, VF4 DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K043439 12/14/2004 INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K043378 12/08/2004 DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT DREW SCIENTIFIC LTD. DIANE HILL
K040457 02/23/2004 NOMAD FROM DYNAMIS MOBILITY LTD. DYNAMIS MOBILITY LTD. RUTH LYTLE
K040253 02/04/2004 EASY MED TN-28 C EASYMED INSTRUMENT CO., LTD. WU TINGJIE
K040482 02/25/2004 EBI ESL SPINE SPACER SYSTEM EBI, L.P. FREDERIC TESTA
K040480 02/25/2004 SONOTRAX ULTRASONIC POCKET DOPPLER EDAN INSTRUMENTS, INC. WILLIAM STERN
K040287 02/06/2004 VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR EDWARDS LIFESCIENCES, LLC. PAULA A TORRIANNI
K043309 12/01/2004 GEODESIC PHOTOGRAMMETRY SYSTEM ELECTRICAL GEODESICS, INCORPORATED LINDA J BOVARD
K040367 02/13/2004 MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ ELECTROMED, INC. CHET SIEVERT
K043238 12/06/2004 COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K043446 12/14/2004 EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER EMMEBI SRL MARJORIE BUSH
K040314 02/09/2004 HEALICOLL ENCOLL CORP. SUBRAMANIAN GUNASEKARAN
K040354 02/13/2004 METAL/METAL HIP SYSTEM ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K040397 02/17/2004 MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K043489 12/22/2004 ENPATH DEFLECTABLE CATHETER ENPATH MEDICAL INCORPORATED KARYL D HASKELL
K043463 12/15/2004 ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS ENVITEC-WISMAR GMBH STEPHEN GORSKI
K043467 12/16/2004 FLEXIBLE SPINAL NEEDLE EPIMED INTERNATIONAL, INC. CHRISTOPHER LAKE
K040286 02/06/2004 ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS ETHOX CORP. EON VERRALL
K040283 02/06/2004 BIOPAD EURORESEARCH S.R.L. E. SMITH
K040345 02/12/2004 MODIFICATION TO NITREX NITINOL GUIDEWIRE EV3 INC CAROLYN ANDERSON
K040220 02/05/2004 MEDICAL AIR COMPRESSOR EVENT MEDICAL LTD ROBBIE WALSH
K043403 12/10/2004 CEMEX SYSTEM GENTA FAST BONE CEMENT EXACTECH, INC. LISA SIMPSON
K040360 02/13/2004 EMU128S, MODEL EX-NW-128S EXCEL TECH. LTD. CAMERON MAHON
K040358 02/13/2004 XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 EXCEL TECH. LTD. CAMERON MAHON
K043527 12/21/2004 RELIEVA SINUS BALLOON DILATION CATHETER EXPLORAMED NC1, INC. WILLIAM M FACTEAU
K042308 12/13/2004 SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 FACILE MEDICAL, INC. ALBERT REGO
K040506 02/27/2004 FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K040366 02/13/2004 PRESSURE MANIFOLD, MODEL BC 110 FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K043363 12/07/2004 FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K043407 12/10/2004 INF 4160, MODEL D-FJ27F FUJI DYNAMICS LIMITED ANTHONY AH YIN SHUM
K040246 02/03/2004 FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC. LARRY D WALKER
K043525 12/21/2004 CATHETER INTRODUCER GALT MEDICAL CORP. DAVID CATLIN
K040301 02/09/2004 GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K043342 12/06/2004 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR GAMBRO RENAL PRODUCTS KAE MILLER
K040255 02/04/2004 POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE GAMBRO RENAL PRODUCTS, INC. JEAN WILLEY
K043471 12/24/2004 FUSION FAST GC AMERICA, INC. TERRY L JORITZ
K043493 12/24/2004 FUSION PUTTY TYPE GC AMERICA, INC. TERRY JORITZ
K043301 12/06/2004 GC TION GINGIVAL PROTECTOR GC AMERICA, INC. TERRY JORITZ
K040251 02/03/2004 GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC ALLEN SCHUH
K043381 12/09/2004 INFINIA LIGHTSPEED GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
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K040350 02/12/2004 RANDOX AMPHETAMINE CLASS ASSAY RANDOX LABORATORIES, LTD. P. ARMSTRONG
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K040351 02/12/2004 RANDOX LIQUID CRP CONTROLS RANDOX LABORATORIES, LTD. P. ARMSTRONG
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K040266 02/09/2004 CORE NEEDLE BIOPSY REMINGTON MEDICAL, INC. MARIA P GRANITO
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K043607 12/30/2004 BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX RESPIRONICS, INC. ZITA A YURKO
K040417 02/18/2004 PILLAR PALATAL IMPLANT SYSTEM RESTORE MEDICAL INC. EDWARD W NUMAINVILLE
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K040252 02/04/2004 CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT REX MEDICAL SUSAN D GOLDSTEIN-FALK
K043529 12/21/2004 ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K043474 12/16/2004 ACCU-CHEK AVIVA SYSTEM ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K040245 02/03/2004 CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) ROCHE DIAGNOSTICS CORP. THERESA M AMBROSE
K040264 02/04/2004 CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K043320 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043318 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043327 12/02/2004 ONLINE DAT BENZODIAZEPINES PLUS ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K040280 02/06/2004 PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K040435 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K040434 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K040431 02/19/2004 ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
DEN040011 12/20/2004 AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. JAMES F KELLY
K043576 12/27/2004 ROCHE AMPLICHIP CYP450 TEST ROCHE MOLECULAR SYSTEMS, INC. JAMES F KELLY
K040396 02/17/2004 ULTRASONIC SCALER ELEGANCE MS-10 (25K) ROLENCE ENTEPRISE, INC. STERLING CHENG
K043325 12/02/2004 ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES ROLENCE ENTEPRISE, INC. STERLING CHENG
K040448 02/20/2004 GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM ROSNER-MAUTBY MEDITRADE(THAILAND) LTD. HO WENG FATT
K043369 12/08/2004 CERVEX-BRUSH COMBI ROVERS MEDICAL DEVICES B.V. IR. M.D. ZWART
K040454 02/24/2004 BIOFILL BONE VOID FILLER SCIENT'X J.D. WEBB
K040376 02/19/2004 SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE SECTRA-IMTEC AB CARL ALLETTO
K040498 02/27/2004 MYSHELL SEDAT S.A. PETER C WOOD
K043441 12/14/2004 MIRAGE, RELEASE 5.5 SEGAMI CORPORATION PHILIPPE BRIANDET
K043425 12/13/2004 SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) SHEATHING TECHNOLOGIES, INC. LARRY POLAYES
K043563 12/27/2004 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K043348 12/06/2004 MODIFICATION TO PM-8000 PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K040311 02/09/2004 SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331 SHIAN JIA MEEI ENTERPRISE CO., LTD. JENNIFER REICH
K043159 12/01/2004 POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. EMMY TJOENG
K043499 12/17/2004 POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. EMMY TJOENG
K043478 12/16/2004 POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. EMMY TJOENG
K043475 12/16/2004 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) SHIJIAZHUANG WINFUL PLASTIC CO., LTD. CHEN YUHONG
K043477 12/16/2004 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) SHIJIAZHUANG WINFUL PLASTIC CO., LTD. CHEN YUHONG
K043379 12/30/2004 SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 SHIMADZU CORP. RANDAL WALKER
K040406 02/17/2004 POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. JANNA P TUCKER
K040408 02/17/2004 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE) SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD. JANNA P TUCKER
K043469 12/16/2004 SYNGO INSPACE 4D SIEMENS AG, MEDICAL SOLUTIONS RUEDIGER KOERNER
K040502 02/27/2004 SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICK J LYNCH
K040347 02/12/2004 SIREMOBIL ISO-C 3D SIEMENS MEDICAL SYSTEMS, INC. NEALIE HARTMAN
K043316 12/02/2004 RABEA SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH TRACY L GRAY
K040320 02/09/2004 SINON POWER WHEELCHAIR, SN-P401 SINON CORPORATION JEN KE-MIN
K040319 02/09/2004 SINON POWER WHEELCHAIR, SN-W401 SINON CORPORATION JEN KE-MIN
K043355 12/06/2004 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X SINTEA BIOTECH, INC. GUIDO ZORZOLI
K043306 12/01/2004 SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR SKYLARK DEVICE & SYSTEMS CO., LTD BETTY CHIEN
K043395 12/10/2004 SMITH & NEPHEW VIDEOARTHROSCOPE SMITH & NEPHEW, INC. KATHLEEN BURNS
K043440 12/14/2004 SMITH & NEPHEW, INC. REVISION KNEE SYSTEM SMITH & NEPHEW, INC. GINO ROUSS
K040331 02/12/2004 SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS SMITH & NEPHEW, INC. DENISE LIMA
K043495 12/17/2004 BABYPAC SMITHS MEDICAL INTERNATIONAL LTD., LUTON DONALD ALEXANDER
K043483 12/17/2004 RADIN, MODEL V 3.0 SOHARD AG RALPH LOOS
K043578 12/28/2004 THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM SOLCO BIOMEDICAL CO., LTD. SAEYOUNG AHN
K043511 12/20/2004 SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 SOLEUS CHAMP INTERNATIONAL CO., LTD. KE-MIN JEN
K043559 12/27/2004 SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) SONOSITE,INC. DAINA L GRAHAM
K043452 12/15/2004 TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM SONOSITE,INC. DAINA L GRAHAM
K040382 02/18/2004 CRANEX BASEX D OR CRANEX EXCEL D SOREDEX PALODEX GROUP OY KAI LANER
K043307 12/01/2004 CRANEX D SOREDEX PALODEX GROUP OY KAI LANER
K040393 02/17/2004 RIVA LUTING SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K040330 02/25/2004 QUIESCENCE SPECTRAL VISUALIZATION & DEVELOPMENT, INC. DENNIS WOO
K043465 12/15/2004 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 SPECTRANETICS CORP. ADRIAN E ELFE
K043401 12/10/2004 SPECTRANETICS LLD CS, MODEL 518-039 SPECTRANETICS CORP. MICHAEL J RYAN
K040509 02/27/2004 ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 SPIRE BIOMEDICAL INC DONALD FICKETT
K040353 02/12/2004 FLIGHT SOCK SSL AMERICAS, INC. KATHLEEN J HARRIS
K040240 02/05/2004 STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) STELLARTECH RESEARCH CORP. JAMES R SANTOS
K043457 12/15/2004 MODIFICATION TO ENDOVASCULAR GUIDE WIRE STEREOTAXIS, INC. GARY RAUVOLA
K043592 12/29/2004 REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC. BRUCE R LESTER
K043453 12/15/2004 STERILEMED REPROCESSED IVUS IMAGING CATHETER STERILMED, INC. BRUCE LESTER
K043513 12/20/2004 STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER STERILMED, INC. BRUCE R LESTER
K043482 12/17/2004 THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 STERIS CORPORATION MARGARET MARSH
K040390 02/17/2004 STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM STRYKER ENDOSCOPY CHRISTOPHER L COOK
K043334 12/03/2004 BONE SOURCE HAC RAPID SETTING CEMENT STRYKER INSTRUMENTS WADE T RUTKOSKIE
K043466 12/15/2004 PAINPUMP2 STRYKER INSTRUMENTS JENNIFER MARS
K040300 02/11/2004 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) STRYKER INSTRUMENTS JEAN W SHEPPARD
K040369 02/13/2004 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM STRYKER INSTRUMENTS JEAN W SHEPPARD
K043442 12/14/2004 STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE STRYKER INSTRUMENTS JEAN SHEPPARD
K040432 02/19/2004 SOLAR 2 ANATOMIC SHOULDER STRYKER ORTHOPAEDICS GINNY STAMBERGER
K040412 02/18/2004 TRIDENT "T" ACETABULAR SHELLS STRYKER ORTHOPAEDICS GINNY STAMBERGER
K043473 12/16/2004 MODIFICATION TO XIA SPINAL SYSTEM STRYKER SPINE SIMONA VOIC
K040261 02/04/2004 REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM STRYKER SPINE SIMONA VOIC
K043054 12/08/2004 GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL SULTAN CHEMISTS, INC. CLARK SMITH
K043435 12/13/2004 QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR SUNRISE MEDICAL JOSEPH E OLSAVSKY
K043533 12/22/2004 SURGICAL DESIGN CIRCUMCISION CLAMP SURGICAL DESIGN, INC. MOHAMMAD BASHIR
K040477 02/24/2004 MONODERM SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
K040223 02/02/2004 POLYVAC INSTRUMENT DELIVERY SYSTEM SYMMETRY MEDICAL USA INC. DAVID FURR
K040415 02/18/2004 PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT SYNOVIS SURGICAL INNOVATIONS ANGELA MALLERY
K040272 02/05/2004 SYNTHES (USA) CRANIOFACIAL PLATES SYNTHES (USA) LISA M BOYLE
K043310 12/01/2004 SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SYNTHES (USA) LISA M BOYLE
K040336 02/11/2004 SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES (USA) SHERI MUSGNUNG
K043555 12/27/2004 SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR SYNTHES (USA) KATHY ANDERSON
K040258 02/04/2004 SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE SYNTHES (USA) ANGELA SILVESTRI
K040507 02/27/2004 TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H TAGA MEDICAL TECHNOLOGIES, INC. GARY AUSTIN
K043593 12/29/2004 SPINE-FIX BIOMIMETIC BONE CEMENT TEKNIMED SA J. D. WEBB
K040472 02/24/2004 FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE TELEFLEX MEDICAL ANGELA TRAN
K040466 02/24/2004 BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS THE BINDING SITE JAY H GELLER
K040363 02/18/2004 CERAMIC TIPPED SKULL PIN THE JEROME GROUP, INC. RONALD KOWALSKI
K040244 02/03/2004 MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 THE MICROOPTICAL CORPORATION DANIEL J DILLON
K040469 02/24/2004 THE STRAUMANN ORTHO IMPLANT SYSTEM THE STRAUMANN CO. CAROLYN BITETTI
K043596 12/29/2004 THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 THERAGENICS CORP. BETSY CORTELLONI
K040291 02/06/2004 EL-ANA PROFILES: ANTI-CHROMATIN THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K040134 02/09/2004 THERILINK BONE VOID FILLER THERICS, INC. JOHNATHAN S KAHAN
K043402 12/10/2004 THERMAGE THERMACOOL SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K043438 12/14/2004 LARGE BORE SPLITTABLE INTRODUCER KIT THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K043382 12/09/2004 TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K043366 12/08/2004 PERMACOL SURGICAL IMPLANT TISSUE SCIENCE LABORATORIES, PLC VICTORIA TAYLOR
K043486 12/17/2004 PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 TOPCON MEDICAL LASER SYSTEMS, INC JOHN JOSSY
K043430 12/16/2004 20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K040426 02/19/2004 TRANS1 AXIAL FIXATION SYSTEM TRANS1, INC. CHERYL L JOHNS
K043351 12/06/2004 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N TRIAGE MEDICAL INC GAYLE HIROTA
K040250 02/02/2004 BONE-LOK HP WASHER TRIAGE MEDICAL INC GAYLE HIROTA
K040511 02/27/2004 SCD EXPRESS PORTABLE COMPRESSION SYSTEM TYCO HEALTHCARE/KENDALL BRIDGET GARDNER
K043377 12/08/2004 ZENO TYRELL, INC. DARLA J ELKIN
K040370 02/17/2004 WBR-FHR, WBR-FWB ULTRASPECT LTD. DAN LAOR
K040341 02/12/2004 CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST UNIPATH LTD. LOUISE ROBERTS
K040329 02/11/2004 MODIFICATION TO E.P.T. PREGNANCY TEST UNIPATH LTD. LOUISE ROBERTS
K040494 02/26/2004 CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 UNITED STATES ENDOSCOPY GROUP, INC. GRETCHEN Y COHEN
K040333 02/11/2004 VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS VALUMAX INTL., INC. JANET JIA
K043594 12/29/2004 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K043315 12/01/2004 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K043387 12/09/2004 VASCON POLARIS GUIDING CATHETER VASCON LLC STEPHEN F VADAS
K040510 02/27/2004 VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD VASCULAR SOLUTIONS, INC. GREGORY M SACHS
K043552 12/27/2004 VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES VASCUTEK LTD. STEVEN ARICK
K043562 12/27/2004 BC PLUS VERICOM CO., LTD. MYUNG-HWAN OH
K043515 12/21/2004 GRAFTSAVER VESCARE, INC. DAVID WALSH
K043490 12/17/2004 PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE VIDACARE CORPORATION GREG HOLLAND
K043340 12/03/2004 EZ SMART VIP DIAGNOSTICS LLC DAVID L ROSEN
K043368 12/08/2004 VITELCARE TURTLE, MODEL 400 VISUAL TELECOMMUNICATIONS NETWORK, INC. ALLEN IZADPANAH
K043503 12/20/2004 VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 VISX, INCORPORATED ALAN F RUSSELL
K040305 02/09/2004 VITREA2 VERSION 3.5 VITAL IMAGES, INC. TIMOTHY J KAPPERS
K043333 12/03/2004 VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM VITAL IMAGES, INC. TIMOTHY J KAPPERS
K040279 02/05/2004 VIVARING MICROWAVE ABLATION PROBE VIVANT MEDICAL, INC. STEVEN KIM
K043604 12/29/2004 LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE VIVOMETRICS, INC. HOWARD M HOLSTEIN
K043396 12/10/2004 INTEGRITY, MODEL V500 VIVOSONIC, INC. EDWARD GOSS
K040226 02/09/2004 WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET WAKO CHEMICALS, USA, INC. LORI CREASY
K040384 02/17/2004 MYDON C WAVELIGHT LASER TECHNOLOGIE AG MAUREEN O'CONNELL
K040433 02/19/2004 SINON WAVELIGHT LASER TECHNOLOGIE AG MAUREEN O'CONNELL
K040512 02/27/2004 LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 WELL-LIFE HEALTHCARE, INC. MIKE PRICE
K043540 12/22/2004 HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES WESTCON CONTACT LENS CO., INC. CAROL NOBLE
K040436 02/19/2004 SIMIDUR SUPERIOR WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K040324 02/10/2004 WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH WILSON-COOK MEDICAL, INC. MARGE WALLS-WALKER
K043583 12/28/2004 CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K040503 02/27/2004 ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR WRP ASIA PACIFIC SDN. BHD. TERENCE LIM
K043339 12/03/2004 REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG XTREMI-T, LLC SHAWN T HUXEL
K040111 02/13/2004 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K043356 12/06/2004 WAGNER SL REVISION STEM LATERAL ZIMMER AUSTIN, INC. AUDREY SWEARINGTON
K043565 12/27/2004 MODIFICATION TO DYNESYS SPINAL SYSTEM ZIMMER SPINE, INC TIM CRABTREE
K040389 02/17/2004 COONRAD/MORREY ELBOW CEMENT RESTRICTOR ZIMMER, INC. NOAH J BARTSCH
K043560 12/27/2004 PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 ZIMMER, INC. LAURA D WILLIAMS


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