FDA 510(k) Decisions During February, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K010142 02/01/2001 OCO DENTAL IMPLANT "O" CO., INC. DAVID D DALISE
K011255 12/20/2001 3D LINE STEROTACTIC HARDWARE ACCESSORIES 3D LINE USA, INC. KAREN H RIGAMONTI
K010056 02/01/2001 UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 A & A MEDICAL, INC. JIHAD MANSOUR
K003762 02/28/2001 ALI 3D TOOL MODULE FOR MEDICAL IMAGES A.L.I. TECHNOLOGIES, INC. ROBERT MACNEIL
K003512 02/08/2001 LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II A.R.C. LASER AG DANIEL HOEFER
K012014 12/05/2001 MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. EVE A CONNER
K013538 12/14/2001 ETHANOL ABBOTT LABORATORIES ALICIA SIMPSON
K013683 12/06/2001 MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE ABBOTT VASCULAR INC. PATTY HEVEY
K002075 02/02/2001 ACE SDS 3.75MM SCREW DENTAL IMPLANT ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K013972 12/17/2001 H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 ACKARD LABORATORIES RICHARD HETTENBACH
K013380 12/18/2001 ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K010238 02/06/2001 ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ ACTHERM, INC. RICHARD HSIEH
K013616 12/19/2001 POLARUS CAP SCREW ACUMED, INC. SHARI JEFFERS
K002237 02/02/2001 P3IMRT TM ADAC LABORATORIES JANICE E BROWN
K003612 02/20/2001 MICROSPEED EC MOTORSYSTEM GD650/GD653 AESCULAP, INC. JOYCE THOMAS
K003608 02/20/2001 SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY AESCULAP, INC. LISA M MILLINGTON
K003940 02/08/2001 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES GRETEL LUMLEY
K002758 02/22/2001 AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A AGILENT TECHNOLOGIES DEUTSCHLAND GMBH EGON PFEIL
K010048 02/01/2001 M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. MIKE HUDON
K010342 02/14/2001 M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K013302 12/17/2001 DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K010211 02/15/2001 STERILE NITRILE POWDER-FREE EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K003252 02/21/2001 COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. PAUL J NOWACKI
K003638 02/13/2001 MOJAVE CATARACT EXTRACTION SYSTEM ALLERGAN, INC. MARK O'DONNELL
K012631 12/06/2001 REPROCESSED SOFT TISSUE ABLATORS ALLIANCE MEDICAL CORP. DON SELVEY
K001585 02/13/2001 BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE AMERICAN BIOCURVE, INC. MARTIN DALSING
K002910 02/07/2001 HOLY DRAGON ACUPUNCTURE NEEDLES ANC IMPORT & EXPORT CO. LTD. WILLIAM ZHANG
K013813 12/14/2001 MODIFICATION TO:APEX MEDICAL IF-4100 APEX MEDICAL CORP. ALAN CHANGE
K012029 12/31/2001 REMEDY MODEL 2Z12 APOLLO CORP. ADRIAN SWEEN
K003443 02/01/2001 SUCTION IRRIGATOR APPLIED MEDICAL ANIL BHALANI
K012968 12/03/2001 APPLIED ACCESS SEAL APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K002054 02/16/2001 X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 APPRIVA MEDICAL, INC. MICHAEL KOLBER
K011212 12/20/2001 FILTERFLO H ARC MEDICAL, INC. HAL NORRIS
K013320 12/19/2001 BLUE LATEX EXAMINATION GLOVES, POWDER FREE ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K013334 12/13/2001 ENDOFLIP ARTHOCARE CORPORATION NICK WOODS
K003651 02/21/2001 AURORA AURORA IMAGING TECHNOLOGY, INC. JAMES J ROGERS
K013818 12/05/2001 AUTOGENESIS AUTOMATOR, MODEL M1000 AUTOGENESIS, INC. JAMES EDWARDS
K013231 12/03/2001 AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L AVID N.I.T., INC. SCOTT HENDERSON
K003041 02/07/2001 ULTRASOUND SCANNER TYPE 2101 B-K MEDICAL A/S VILLY BRAENDER
K003749 02/23/2001 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN BANTA HEALTHCARE YOLNDA SMITH
K012988 12/05/2001 HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K002210 02/14/2001 SYNTRA DIALYZER, MODEL SYNTRA 120, 160 BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K003796 02/05/2001 ADVIA 120 HEMATOLOGY BAYER CORP. FREDRICK CLERIE
K012337 12/06/2001 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM BAYER CORP. KENNETH T EDDS
K013568 12/21/2001 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER CORP. KENNETH T EDDS
K013606 12/21/2001 ACS 180 HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K010050 02/05/2001 ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY BAYER DIAGNOSTICS CORP. THOMAS F FLYNN
K013406 12/18/2001 ADVIA CENTAUR HOMOCYSTEINE ASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K012183 12/27/2001 BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY BAYER DIAGNOSTICS CORP. BARBARA PREISEL-SIMMONS
K990284 02/01/2001 BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE BAYLIS MEDICAL CO., INC. KRIS SHAH
K003461 02/01/2001 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC M. WENDY BOSSHARDT
K010064 02/07/2001 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 BECKMAN COULTER, INC. STAN SUGRUE
K010066 02/07/2001 5C-ES CELL CONTROL, MODELS 7547191, 7547192 BECKMAN COULTER, INC. STAN SUGRUE
K013842 12/13/2001 IMMUNO-TROL LOW CELLS BECKMAN COULTER, INC. LOURDES COBA
K014034 12/18/2001 MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) BECKMAN COULTER, INC. ANNETTE HELLIE
K013076 12/12/2001 SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K013800 12/21/2001 INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K002650 02/16/2001 VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 BENTEC MEDICAL, INC. DAVID TUCKER
K003641 02/08/2001 BIOLOK SCREW, BIOSTEON SCREW BIOCOMPOSITES LTD. J.STEPHEN BRATT
K013193 12/21/2001 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC. CAROL J MORELLO
K003795 02/14/2001 BIOLUCENT MAMMOGRAPHY CUSHION BIOLUCENT, INC. STEVE GEX
K003856 02/21/2001 EZ-HCG URINE(PREGNANCY TEST) BIOMERICA, INC. JAY SINGH
K012469 12/03/2001 RESORBABLE NO PROFILE SCREW AND WASHER BIOMET MANUFACTURING, INC. SARA B SHULTZ
K013657 12/03/2001 MODIFICATION TO: BIOMET HUMERAL CABLE PLATES BIOMET ORTHOPEDICS, INC. TRACY J BICKEL
K013534 12/17/2001 SELF-COUNTERSINKING BONE SCREW BIOMET ORTHOPEDICS, INC. SARA B SHULTZ
K003493 02/09/2001 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT BIOMET, INC. SARA A BAILEY
K993836 12/19/2001 GENERATION 4 BONE CEMENT BIOMET, INC. MARY VERSTYNEN
K011139 12/20/2001 LORENZ LACTOSORB PANELS AND FASTENERS BIOMET, INC. TRACY J BICKEL
K012569 12/21/2001 MODIFICATION TO: INJECTABLE MIMIX BIOMET, INC. SARA B SHULTZ
K010212 02/14/2001 OFFSET TIBIAL TRAY BIOMET, INC. CAROL LAUSTER
K011451 12/10/2001 REUNITE FUSION SCREW BIOMET, INC. SARA BAILEY SHULTZ
K012572 12/03/2001 SOFT TISSUE SCREW AND WASHER BIOMET, INC. SARA B SHULTZ
K003659 02/20/2001 PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 BIONX IMPLANTS, INC. TUIJA ANNALA
K003757 02/07/2001 THERMOFX MESH BIONX IMPLANTS, LTD. TUIJA ANNALA
K013055 12/07/2001 THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. CAROL E JONES
K013050 12/10/2001 THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. CAROL E JONES
K002642 02/05/2001 MINIQUANT D-DIMER, MODEL 1447 BIOPOOL INTL., INC. MICHAEL D BICK
K010057 02/02/2001 MODIFICATION TO ARTOSCAN M BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K013289 12/27/2001 BIOTEQUE VAGINAL PESSARIES BIOTEQUE AMERICA, INC. DENIS DORSEY
K013151 12/14/2001 ASMOTOM AUTOMATED TREPHINE SYSTEM BKG OPTHALMICS USA, INC. ART WARD
K013177 12/19/2001 MULTITAK SUTURE SNAP SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K013866 12/14/2001 CONVOY ADVANCED DELIVERY SHEATH KIT BOSTON SCIENTIFIC ANDREA L RUTH
K003782 02/14/2001 CONSTELLATION CATHETER, MODEL 8031 BOSTON SCIENTIFIC CORP. ANDREA BOUMIS
K011889 12/21/2001 ULTRA -THIN SDS BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K013789 12/06/2001 EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 BOSTON SCIENTIFIC, TARGET GEORGE J PRENDERGAST
K003268 02/22/2001 Z-TOUCH BRAINLAB, AG
K013928 12/03/2001 PAIN CARE 3200 BREG, INC. KATHLEEN BARBER
K010343 02/14/2001 BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 BUCK MEDICAL RESEARCH REBECCA ELLIS
K011589 12/26/2001 CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M BYPASS LTD. JONATHAN S KAHAN
K010444 02/28/2001 ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP C.R. BARD, INC. KERRY CHUNKO
K010169 02/13/2001 BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. BARD, INC. CAROL VIERLING
K012686 12/13/2001 CAIRD TECHNOLOGY HOLTER 2000 CAIRD TECHNOLOGY JAMES H BROWN
K013251 12/18/2001 SPIRIT 300 CAIRE, INC. ROGER BRIESE
K013907 12/18/2001 INVERNESS MEDICAL EARLY PREGNANCY TEST CAMBRIDGE DIAGNOSTICS IRELAND, LTD. AVRIL MURRAY
K013807 12/12/2001 MICROJET QUARK, MODEL U100 OR U40 CANE SRL DANIEL KAMM
K013753 12/10/2001 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR CANOPUS MEDICAL SUPPLY CO., LTD. ELIZABETH DENG
K013019 12/18/2001 DATACAPTOR CAPSULE TECHNOLOGIE DANIEL KAMM
K013901 12/20/2001 MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) CARDIOFOCUS, INC. JOSEPH CURTIS
K010261 02/28/2001 CARDIOMEDICS ECP SYSTEM CARDIOMEDICS, INC. JOHN HUTCHINS
K003885 02/22/2001 VISULAS YAG II CARL ZEISS, INC. SCOTT A MARGOLIN
K010349 02/28/2001 DUAL LUMEN MIDLINE CATHETER CATHETER INNOVATIONS, INC. ROGER L RICHINS
K013512 12/20/2001 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K012731 12/26/2001 SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K003586 02/08/2001 FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES CIBA-GEIGY CORP. STEVEN DOWDLEY
K011849 12/10/2001 MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS CIRCON VIDEO WAYNE B STERNER
K013721 12/28/2001 SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC. THERESA LEINEN
K011454 12/13/2001 SPINE SCOPE, MODEL 2180 CLARUS MEDICAL, LLC. TOM BARTHEL
K003833 02/13/2001 SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR CLEARLAB PTE LTD. JOHN M SZABOCSIK
K003958 02/06/2001 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE COALESCENT SURGICAL MICHAEL A DANIEL
K003549 02/15/2001 CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS Codman & Shurtleff, Inc. JAMES M FLAHERTY
K013877 12/19/2001 CODMAN SLIM-LOC SYSTEM Codman & Shurtleff, Inc. KATHRYN WUNDER
K013400 12/10/2001 SYNERGY FLOW COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K013804 12/10/2001 SOCRATES ROBOTIC TELEMONITORING SYSTEM COMPUTER MOTION, INC. DAVID U THOMAS
K013112 12/05/2001 FOCAL SIM COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K011893 12/06/2001 COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES CONTACT COLOR SRL Maria E Donawa
K002958 12/18/2001 SHAPEABLE DOPPLER FLOW PROBE COOK VASCULAR, INC. THOMAS J KARDOS
K013916 12/20/2001 MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. HEIDI MASTEN
K003666 02/08/2001 TAPER-FIT TOTAL HIP SYSTEM CORIN U.S.A. JOEL K BATTS
K010243 02/15/2001 TRI-FIT FEMORAL STEM CORIN U.S.A. JOEL K BATTS
K003567 02/12/2001 SERENOCEM, MODEL BC 010 CORINTHIAN MEDICAL LTD. DAGMAR MASER
K001631 02/22/2001 CORTEX METAMAX CORTEX BIOPHYSIK GMBH ART WARD
K981052 12/18/2001 CRESCO TI IMPLANT CONCEPT CRESCO TI SYSTEMS AB PER E NILSSON
K012327 12/20/2001 CSIST DICOM GATEWAY/IMAGE MANAGER CSIST CARL ALLETO
K010210 02/21/2001 CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 CURON MEDICAL, INC. THOMAS C WEHMAN
K013878 12/07/2001 CYBERMED, INC., V-WORKS CYBERMED, INC. GARY J ALLSEBROOK
K010208 02/20/2001 DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 DADE BEHRING, INC. RICHARD M VAUGHT
K003963 02/28/2001 DIMENSION PSA FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE M PLUMMER
K003419 02/14/2001 RCRP FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE H PIETRAK
K003870 02/20/2001 THROMBOREL S DADE BEHRING, INC. REBECCA S AYASH
K013423 12/12/2001 MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K013246 12/11/2001 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 DATEX-OHMEDA JOEL KENT
K001003 12/10/2001 Z-NET DEMITE LIMITED WILLIAM H.E. VON OEHSEN
K011958 12/04/2001 CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT DENKA SEIKEN'S SEIYA SATO
K013430 12/17/2001 ACE BIO WIN TIBIAL NAILING SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003800 02/09/2001 AML HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013563 12/27/2001 LONG TROCHANTERIC NAIL SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013352 12/17/2001 SUMMIT CEMENTED HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K010025 02/22/2001 ELECTRICATOR MODEL 26000 DERMATOLOGIC LAB & SUPPLY, INC. DEBORAH GRAFELMAN
K013880 12/07/2001 DAYLITE XENON LIGHT SOURCES DESIGNS FOR VISION, INC. AMY GRUMET-AVALLONE
K013178 12/18/2001 DC-UIBC-CO2-CAL, MODEL SE-153 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K004002 02/14/2001 IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K003597 02/05/2001 IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K003767 02/12/2001 ASSERACHROM HPIA TEST KIT DIAGNOSTICA STAGO, INC. ANDREW LOC B LE
K002756 02/23/2001 EASE-A-CULT DIAGNOSTICA, INC. YOLANDA SMITH
K013628 12/21/2001 DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K013850 12/21/2001 STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K013915 12/27/2001 D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER DIDECO S.P.A. SHAWN RIEDEL
K013449 12/19/2001 MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. ELAD MAGAL
K003977 02/15/2001 DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET DISETRONIC MEDICAL SYSTEMS AG DAVID E CHADWICK
K013786 12/17/2001 DRG ORTHOHEX SS BONE SCREW DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K013271 12/13/2001 DXS DIGITAL X-RAY SYSTEM DOUGLAS C. YOON, DDS DOUGLAS C YOON
K010793 12/20/2001 OXYLOG 1000, MODEL 2M86840 DRAGER MEDIZINTECHNIK GMBH JAMES J BRENNAN
K012390 12/18/2001 NO STEP ON SITE DEUG TEST CUP DRUG FREE ENTERPRISES PERRY RUCKER
K002877 02/05/2001 MICTEC ENDOSCOPES AND ACCESSORIES DUFNER INSTRUMENTE GMBH DAGMAR MASER
K010386 02/27/2001 DUO-DENT DENTAL IMPLANT DUO-DENT DENTAL IMPLANT SYSTEMS LLC. MICHAEL H VOVOLKA
K013686 12/07/2001 KODAK DIRECTVIEW TABLETOP CASSETTE EASTMAN KODAK COMPANY JUDITH A WALLACE
K010179 02/09/2001 EBI VUECATH SPINAL ENDOSCOPIC SYSTEM EBI, L.P. JON CAPAROTTA
K013739 12/13/2001 MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K003529 02/12/2001 SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS EDAP TECHNOMED, INC. Scott J Mindrebo
K010526 12/13/2001 MODIFICATION TO THE GRIP ELCARE INNOVATIONS, INC. ELROY T CANTRELL
K013861 12/06/2001 MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE ELEKTA INSTRUMENT AB CAROL PATTERSON
K003324 12/06/2001 PLASMA SPRAYED SHOULDER ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K003615 02/01/2001 STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. BRUCE G PIEKARSKI
K013493 12/13/2001 INDIGO OPTIMA LASER SYSTEM ETHICON ENDO-SURGERY, INC. LINDA HILL
K013413 12/03/2001 MICROMARK II TISSUE MARKER,MODEL C1535 ETHICON ENDO-SURGERY, INC. GEORGIA C ABERNATHY
K003648 02/23/2001 FREEDLAND TENSION SYSTEM ETZEM TECHNOLOGIES, INC. AHAVA SHEIN
K013226 12/20/2001 EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT EVENFLO COMPANY, INC. MATTHEW G MCCARTY
K010081 02/05/2001 ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS EXACTECH, INC. Lisa Simpson
K000943 02/08/2001 CEMEX SYSTEM GUN APPLICATION VERSION EXACTECH, INC. GARY J MILLER
K010120 02/09/2001 MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S EXACTECH, INC. GARY J MILLER
K013211 12/05/2001 MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS EXACTECH, INC. ROBERT PAXSON
K010150 02/09/2001 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 EXCEL TECH. LTD. SONJA MARKEZ
K010091 02/01/2001 EEG WITH VIDEO, MODEL EX-NW EXCEL TECH. LTD. SONJA MARKEZ
K003627 02/08/2001 EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET EXELINT INTERNATIONAL CO. ARMAND HAMID
K013037 12/07/2001 EXCEL A.V FISUTAL NEEDLE SET EXELINT INTL. CO. ARMAND HAMID
K003644 02/01/2001 EYETECT TREMOR MONITOR UNIT (TMU) EYETECT, L.L.C. REBECCA M CUETO
K003665 02/23/2001 FADASSI MEDICAL FM-1 NO BLENDER FADASIS MEDICAL, INC. RAYMOND RIDDLE
K013256 12/07/2001 BI-3M NEEDLE-FREE INJECTOR SYSTEM FELTON INTERNATIONAL, INC. ALAN FELTON
K003540 02/09/2001 (DISPOSABLE) VAGINAL SPECULUM FEMINICA, INC. DENIS H DUBOIS
K003776 02/23/2001 MICROTARGETING DRIVE SYSTEM FHC, INC. FREDERICK HAER
K014024 12/18/2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC. GREG HOLLAND
K013445 12/26/2001 OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES FLORIDA OPTICAL ENGINEERING, INC. RICHARD A GRIFFIN
K011939 12/27/2001 FOTONA DUALIS, FOTONA DUALIS PLUS FOTONA D.D. MOJCA VALJAVEC
K013438 12/20/2001 FRIALIT-2 ESTHETICBASE ABUTMENT FRIADENT GMBH CAROL PATTERSON
K013218 12/20/2001 FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II FUJIFILM MEDICAL SYSTEM U.S.A., INC. JOSEPH M AZARY
K013273 12/20/2001 FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE FUKUDA DENSHI USA, INC. LARRY WALKER
K003946 02/27/2001 SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL GE MEDICAL SYSTEMS LARRY A KROGER
K010336 02/16/2001 ADVANTAGE WINDOWS CT/PET FUSION GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K002596 02/15/2001 GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 GEBAUER CO. DENISE E SPELLMAN
K014058 12/21/2001 ENTEGRA PE PERSONAL DIGITAL ASSISTANT GENERAL ELECTRIC MEDICAL SYSTEMS D. DUERSTELER
K012660 12/20/2001 GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES GIMMI GMBH DAGMAR MASER
K003807 02/22/2001 CYSTOSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003806 02/22/2001 URETEROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K013446 12/20/2001 GLUSITE, MODEL GLU002 GLUSTITCH, INC. DON BLACKLOCK
K012258 12/03/2001 COMPANION MODEL 221, 321, 421 GOLDEN TECHNOLOGIES, INC. FRED KIWAK
K003495 02/07/2001 ANCURE LLIAC BALLOON CATHETER GUIDANT CARDIAC AND VASCULAR SURGERY JACQUELINE J JACKSON
K013092 12/13/2001 HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. JENNIFER P RIGGS
K013638 12/04/2001 MODIFICATION TO VIKING OPTIMA GUIDING CATHETER GUIDANT CORP. NANCY E RALSTON
K003922 02/15/2001 NITRILE EXAMINATION GLOVES (POWERED) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K003985 02/09/2001 POWDERFREE NITRILE PATIENT EXMINATION GLOVE GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K013069 12/12/2001 BIOSPEED H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013070 12/12/2001 JAMSHIDI BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K013071 12/12/2001 SECURCUT ASPIRATION BIOPSY NEEDLE H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K002827 02/28/2001 MAC ACUPUNCTURE NEEDLE HAENGLIM SEOWON CORP. YUN CHOL CHO
K013424 12/20/2001 INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND HAND INNOVATIONS, INC. AL WEISENBORN
K003649 02/23/2001 TRITON HIP SYSTEM HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K003507 02/21/2001 MEDRELIEF HEALTHONICS, INC. T. WHIT ATHEY
K013466 12/21/2001 SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 HELENA LABORATORIES PATRICIA FRANKS
K012583 12/11/2001 ACUGLIDE BRAND ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. YI FEN CHANG
K003915 02/15/2001 ACCUFUSER; ACCUFUSER PLUS HELPTECHNOLOGIES ROBERT J BARD
K003930 02/01/2001 FLEXTIME MAGNUM 360 HERAEUS KULZER, INC. CHERYL ZIMMERMAN
K004008 12/13/2001 STRESS GUARD, MODEL HERDEV1 HERBO MEDEX INTERNATIONAL, INC. RICHARD KEEN
K001988 02/05/2001 MODULAR HEYER AMERICA, INC. ART WARD
K013141 12/19/2001 MICROGYN PLUS STIMULATION DEVICE HOLLISTER, INC. JOSEPH S TOKARZ
K010189 02/12/2001 VORTEX ACCESS SYSTEM HORIZON MEDICAL PRODUCTS, INC. PENNY M NORTHCUTT
K010075 02/14/2001 TEKNIQUE HOVEROUND CORP. TONY DIGIOVANNI
K013772 12/03/2001 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K001147 02/15/2001 ENHANCED POLYETHYLENE KNEE PROSTHESES HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K013688 12/05/2001 MODIFICATION TO XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K013676 12/05/2001 TRIDENT HEMISPHERICAL ACETABULAR SHELLS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K013475 12/20/2001 TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K013823 12/19/2001 XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012199 12/19/2001 DIGICAP HUMANA USA, INC. H.N. DUNNING
K012501 12/11/2001 H.M.T. ACUPUNCTURE NEEDLE HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C. GEOFFREY HSU
K003840 02/01/2001 CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES I.C. MEDICAL, INC. CRAIG HARSHMAN
K013060 12/10/2001 ICS MEDICAL MODEL VG-30 VIDEO GOGGLES ICS MEDICAL ROBERT M SIMENSON
K010166 12/03/2001 IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM IMAGYN MEDICAL TECHNOLOGIES, INC. JULIE POWELL
K013570 12/17/2001 OSSEOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K004047 12/18/2001 HOME-AWAY SYSTEM IN-X CORP. CHARLIE HENRY
K003854 02/05/2001 INTRAVASCULAR ADMINISTRATION SET INFUSION DEVICES, INC. PAUL E DRYDEN
K013333 12/07/2001 LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM INNOVATIVE GLOVES CO; LTD RAJEEV K SOOD
K013798 12/19/2001 PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG LINDA JALBERT
K003338 02/07/2001 BIO-EYE II ORBITAL IMPLANT INTEGRATED ORBITAL IMPLANTS, INC. FLOYD G LARSON
K010219 02/21/2001 CHALLENGER DIRECT COMPOSITE INTERNATIONAL DENTAL RESEARCH PAMELA PAPINEAU
K003892 02/20/2001 TOTAL BILIRUBIN REAGENT INTERSECT SYSTEMS, INC. JOAN CATHEY
K013516 12/13/2001 INVACARE ELEVATING SEAT OPTION ESS6 INVACARE CORP. RAE A FARROW
K010135 02/16/2001 MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4 INVACARE CORP. RAE A FARROW
K003646 02/22/2001 SUTUREGROOVE WEIGHT SIZING SET IOP, INC. JASON MALECKA
K010304 02/12/2001 MXR-2000 MOBILE X-RAY UNIT IROM IMAGING, INC. ROMAN KRYSTYNIAK
K003882 02/21/2001 NUCAMMA BI90 IS2 RESEARCH, INC. VICTOR WOODBURN
K001852 02/21/2001 PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE ITAMAR MEDICAL (C.M.) 1997 LTD. AHAVA STEIN
K003293 02/06/2001 EXCITE DSC IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K010250 02/28/2001 TETRIC CERAM HB IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K013017 12/06/2001 MEDIGROUP KEY TUBE JANIN GROUP, INC. JOHN A NAVIS
K013698 12/21/2001 AST (SGOT) JAS Diagnostics, Inc. David Johnston
K003912 02/21/2001 PHOSPHORUS REAGENT JAS Diagnostics, Inc. David Johnston
K003829 02/12/2001 TOTAL BILIRUBIN JAS Diagnostics, Inc. David Johnston
K010044 02/09/2001 COSMIC JENERIC/PENTRON, INC. ANNMARIE TENERO
K010231 02/09/2001 JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE JK GLOVES SDN. BHD. TAI SAI LEONG
K993229 02/02/2001 ANALGESIC PULSER, MODEL AP-439 JOHARI ELECTRO-TECH CO. NISHA JOHARI
K013939 12/14/2001 JOSTRA FLOWPROBE FP-32E JOSTRA AG KATHLEEN JOHNSON
K013401 12/14/2001 K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 K-SYSTEMS, KIVEX BIOTEC LTD. JACOB MOLLENBACH
K004037 02/02/2001 X-RAY SYSTEM XR-MX KARL STORZ ENDOSCOPY JENNIFER S PORTUGAL
K010340 02/13/2001 MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI KARL STORZ LITHOTRIPSY-AMERICA, INC. MARIKA ANDERSON
K011691 12/27/2001 KIMSTIM AURICULAR ELECTRODE KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C. DONALD F GRABARZ
K003347 02/23/2001 ORTHOPILOT KINAMED, INC. JOEL SLOMOFF
K013537 12/07/2001 ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) KOON SENG SDN.BHD LIM WENG HENG
K010246 02/14/2001 KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A KYPHON, INC. KAREN TALMADGE
K011960 12/21/2001 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4) LARES RESEARCH, INC. THOMAS H LOUISELL
K003760 02/06/2001 TAI-CHI ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K001447 02/16/2001 DULBECCO'S MODIFIED EAGLE MEDIUM ("DMEM") LIFE TECHNOLOGIES, INC. JONATHAN S KAHAN, ESQ.
DEN000008 02/16/2001 DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. JONATHAN S KAHAN, ESQ.
K001329 02/14/2001 INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET LIFEMED OF CALIFORNIA PATRICIA BRINKER
K013553 12/19/2001 PRE-LOADED ULTRAFIX RC LINVATEC CORP. LAURA D SENEFF
K011197 12/14/2001 DERMACLEAR UV-B PHOTOTHERAPY SYSTEM LUMENIS C. ROBERT PAYNE JR.
K002688 02/01/2001 PERSONAL GLUCOSE CONTROL CHARTING SYSTEM LXN CORP. SANDRA F SELVAGGI
K012025 12/03/2001 MACROPORE SURGIWRAP (TS) MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K000581 02/23/2001 MAEDA NEW NEEDLE DISPOSABLE MAEDA TOYOKICHI SHOTEN E.J. Smith
K003075 12/11/2001 KNIGHTSTAR 330 VENTILATOR MALLINCKRODT, INC. ANTHONY MULLIN
K013792 12/11/2001 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K012186 12/07/2001 MASTER & FRANK SURGICAL GOWNS (STERILE) MASTER & FRANK ENT. CO., LTD. JENNIFER REICH
K010069 02/15/2001 DURABOND NON-PRECIOUS CERAMIC ALLOY MATECH, INC. PAUL L SAXTON
K011845 12/04/2001 MILLCOMP MATH RESOLUTIONS, LLC. WENDEL DEAN RENNER
K010297 02/16/2001 SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) MAXXIM MEDICAL WUNAN HUANG
K013244 12/07/2001 COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE MED GEN, INC. THEDORE BARASH
K002515 02/22/2001 MEDLOGICS ML 4000, MODEL 4000 MED-LOGICS, INC. GARY MOCNIK
K013225 12/26/2001 INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE MEDAFOR, INC. PHILIP B JARVI
K003672 02/22/2001 MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE MEDGE PLATFORMS, INC. GUSTAVO EDUARDO ABELLA
K002666 02/27/2001 DIAMOND ALOE VERA, STERILE MEDI-TECH INTL. CORP. HERBERT A PERRY
K002407 02/02/2001 EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER MEDICA CORP. Photios Makris
K010111 02/28/2001 CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK MEDICAL ANALYSIS SYSTEMS, INC. DARWIN RICHARDSON
K013734 12/07/2001 MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K013995 12/21/2001 MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K010021 02/23/2001 MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S MEDICAL COMPONENTS, INC. FLORENCE A CAIKOSKI
K002699 02/15/2001 PARIETEX COMPOSITE (PCO) MESH MEDICAL DEVICE CONSULTANTS, INC. MARY MCNAMARA-CULLINANE
K002280 02/05/2001 PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 MEDICAL DEVICES, INC. WARREN R WALTERS
K003489 02/02/2001 NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 MEDICAL ILLUMINATION INTERNATIONAL, INC. DAVID GLOVER
K013098 12/07/2001 KIMAX REMOTE VIEWING STATION MEDICAL METRICS, INC. ANN TUNSTALL
K010187 02/14/2001 KIMAX, MODEL 1024 MEDICAL METRICS, INC. ANN TUNSTALL
K011202 12/31/2001 MSI BIPOLAR SHEATH MEDICAL SCIENTIFIC, INC. PAUL NARDELLA
K002079 02/22/2001 MULTI-FUNCTION DEFIBRILLATION ELECTRODE MEDICOTEST A/S EMALEE G MURPHY
K003332 02/21/2001 MEDITHERM MED2000 MEDITHERM, INC. PETER LEANDO
K003699 02/27/2001 MEDIVISION IGS SYSTEM MEDIVISION (U.S.A.), INC. SANDRA WILLIAMSON
K003755 02/16/2001 MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K013761 12/06/2001 MEDLINE EXCEL RECLINCER WHEELCHAIR MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K013815 12/13/2001 MEDRAD QWIK-FIT SYRINGE MEDRAD, INC. FRANK W PELC III
K010138 02/14/2001 PROFILE II ER MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K013013 12/04/2001 MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. MEDTRONIC CARDIAC SURGICAL PRODUCTS ROGER W BRINK
K000776 02/07/2001 MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP MEDTRONIC CARDIAC SURGICAL PRODUCTS JAMES BALUN
K010130 02/07/2001 POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TOVE KJAER
K013063 12/11/2001 GRIP LOCK ANCHOR, MODEL 411374 MEDTRONIC NEUROLOGICAL MONAYA LEE
K013000 12/05/2001 MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 MEDTRONIC NEUROSURGERY JANET MCAULEY
K011144 12/03/2001 LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR MEDTRONIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K003914 02/22/2001 MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES MEDTRONIC PS MEDICAL JANET MCAULEY
K010249 02/23/2001 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K013663 12/05/2001 CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K013829 12/19/2001 MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICK W TREHARNE
K014076 12/27/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K011406 12/27/2001 SPINAL MESH SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K003718 02/14/2001 TITANIUM CEMENT RESTRICTOR (TCR) MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K003667 02/14/2001 REVEAL PLUS INSERTABLE LOOP RECORDER MEDTRONIC VASCULAR STACEY P WESSMAN
K003535 02/08/2001 STYLET KIT, MODELS 6254,6282,6293 MEDTRONIC VASCULAR KAREN CLEMENT
K011500 12/03/2001 MENTOR CONTOUR PROFILE TISSUE EXPANDER MENTOR CORP. DONNA CRAWFORD
K013788 12/11/2001 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 MERITS HEALTH PRODUCTS CO., LTD. WINSTON ANDERSON
K013505 12/19/2001 AUROFLUID PLUS METALOR TECHNOLOGIES USA BRUCE BARTON
K010102 02/09/2001 SONIC MODEL SO-300 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K003260 02/22/2001 VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K010004 02/13/2001 FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 MICRO THERAPEUTICS, INC. EBEN GORDEN
K003695 02/14/2001 MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES MICRO-MEDICAL DEVICES, INC. GEORGE COLEMAN
K002113 12/04/2001 CTXA HIP; CTXA; QCT PRO CTXA HIP MINDWAYS SOFTWARE, INC. CHRISTOPHER CANN
K013040 12/07/2001 LIGHT SABER INTRODUCER NEEDLE MINRAD, INC. HOWARD M HOLSTEIN
K002406 02/15/2001 MITEK 2GII MENISCAL REPAIR SYSTEM MITEK PRODUCTS CAROL CHAOUI
K013047 12/06/2001 FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM MOJCA VALIJAVEC MOJCA VALJAVEC
K010140 02/22/2001 HRH-127 HEAD ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K003655 02/02/2001 PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K012088 12/18/2001 NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT NASTECH PHARMACEUTICAL COMPANY, INC. PETER C APRILE
K013024 12/04/2001 SELECTIVA GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K001781 02/05/2001 CURRY MULTIMODAL NEUROIMAGING SOFTWARE NEUROSOFT, INC. DAVID B JONES
K002042 02/01/2001 TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 NEW ENGLAND MEDICAL CORP. STEVEN FODOR
K013992 12/13/2001 NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS ROBERT SCHMIDT
K013419 12/20/2001 NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM NICOLET BIOMEDICAL DAVID W WAGNER
K002068 02/08/2001 ORG-9200A NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K013293 12/14/2001 NIPRO HYPODERMIC NEEDLE NIPRO MEDICAL CORP. KAELYN B HADLEY
K013287 12/03/2001 NIPRO SAFELET CATH NIPRO MEDICAL CORP. KAELYN B HADLEY
K993600 02/05/2001 MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 NISHA COMMUNICATION INDUSTRIES NISHA JOHARI
K013036 12/07/2001 NOMOS MOTORIZED CRANE II NOMOS CORP. FRANCIS X DOBSCHA
K013436 12/21/2001 NORMATEC PCD NORMATEC, INC. JONATHAN S KAHAN
K001965 02/02/2001 SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS NORTH AMERICAN MEDICAL PRODUCTS, INC. ARTHUR GIANAKOS
K001916 02/16/2001 COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX NOVARTIS NUTRITION CORP. SHARON MARTIN
K002429 02/02/2001 SELECT SEED I-125 NUCLETRON CORP. ROBERT APPLEBAUM
K004000 02/21/2001 OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K003996 02/21/2001 OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K013377 12/20/2001 BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC. RICHARD LIPPMAN
K010850 12/17/2001 POLESTAR N-10 ODIN MEDICAL TECHNOLOGIES LTD. ADI ICKOWICZ
K010388 12/11/2001 SONDREX P.A.L. SYSTEM OHMEDA MEDICAL ALBERTO F PROFUMO
K013066 12/11/2001 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K001744 02/27/2001 OLYMPUS ENDOSCOPIC LIGATION DEVICE OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K013591 12/26/2001 XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K003522 02/13/2001 SALUTE ONUX MEDICAL, INC. GREGORY E SANCOFF
K013110 12/19/2001 ANISEIKONIA INSPECTOR OPTICAL DIAGNOSTICS, INC. JOYCE DE WIT
K003704 02/05/2001 OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) OPTOVENT AB CLAES RYMOND
K003482 02/01/2001 PROCLUDE-SENSITIVE ORTEK THERAPEUTICS, INC. JULES T MITCHEL
K013900 12/21/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS MARLENE A SHULMAN
K011887 12/27/2001 AVALON CUP SYSTEM ORTHOPEDIC SOURCE INC. STEVEN L MANDELL
K013094 12/14/2001 ORTHOSONIX ENERGEX ORTHOSONIX, INC. RUSSELL PAGANO
K012762 12/11/2001 MJS POSTERIOR STABILIZED KNEE SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K013371 12/21/2001 UBIT-IR300 INFRARED SPECTROMETRY SYSTEM OTSUKA PHARMACEUTICAL CO., LTD. CYNTHIA A SINCLAIR
K012588 12/10/2001 OXOID PYLORI TEST KIT, MODEL DR0130M OXOID, LTD. ANDY HOLLINGSWORTH
K013028 12/06/2001 PALOMAR SLP 1000 PALOMAR MEDICAL PRODUCTS, INC. Marcy Moore
K010001 02/05/2001 LIVESURE THC SCREEN TEST PAN PROBE BIOTECH, INC. ALICE H YU
K010109 02/28/2001 FLUOROPERM 151-OK, PARAGON HDS 100-OK PARAGON VISION SCIENCES WILLIAM E MEYERS
K003102 02/27/2001 PARE ENDOSCOPIC SUTURING SYSTEM PARE SURGICAL, INC. RICHARD P FLEENOR
K003737 02/01/2001 POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHANG
K003858 02/12/2001 MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 PHAMATECH CARL A MONGIOVI
K013410 12/06/2001 AT HOME DRUG TEST, MODEL 9064 PHAMATECH INC. CARL MONGIOVI
K013412 12/06/2001 AT HOME DRUG TEST, MODEL 9069 PHAMATECH INC. CARL MONGIOVI
K013409 12/06/2001 AT HOME DRUG TEST, MODEL 9074 PHAMATECH INC. CARL MONGIOVI
K013408 12/06/2001 AT HOME DRUG TEST, MODEL 9079 PHAMATECH INC. CARL MONGIOVI
K013407 12/06/2001 AT HOME DRUG TEST, MODEL 9084 PHAMATECH INC. CARL MONGIOVI
K013344 12/11/2001 INTERA I/T PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PETER ALTMAN
K003853 02/13/2001 INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DUANE PRASCHAN
K003437 02/02/2001 ODYSSEY LX, MODEL 211320 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. RONALD J MARTONE
K013624 12/03/2001 MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH DENISE HALEY
K013451 12/18/2001 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K003496 02/08/2001 CANNULATED SCREW SYSTEM PIONEER SURGICAL TECHNOLOGY AMY H MOMMAERTS
K013340 12/20/2001 RT-PLUS KNEE ADDITIONAL COMPONENTS PLUS ORTHOPEDICS HARTMUT LOCH
K003932 02/16/2001 BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY POLYMER TECHNOLOGY NANCY ABRAHAM
K003933 02/16/2001 BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY POLYMER TECHNOLOGY NANCY ABRAHAM
K014099 12/21/2001 BIOSCANNER PLUS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K012108 12/19/2001 MEDPOR COATED TEAR DRAIN POREX SURGICAL, INC. HOWARD MERCER
K013172 12/20/2001 PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL PORGES S.A. BERNARD ISMAEL
K013708 12/10/2001 REFERENCE CHECK, CATALOG NUMBER-RCN-10 PRECISION BIOLOGIC STEPHEN L DUFF
K003843 02/08/2001 ENVIVE MINIFORMS PROCTER & GAMBLE CO. KATHLEEN C BLIEZNER
K013411 12/12/2001 PULPDENT CAVITY PREPARATION IV PULPDENT CORP. KENNETH J BERK
K013358 12/13/2001 DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM PULSE METRIC, INC. ROBERT DUFFY
K010077 02/28/2001 HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES PWA INDUSTRIES SDN. BHD. K. KARUNAKARAN
K013943 12/18/2001 RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 RADI MEDICAL SYSTEMS AB MATS GRANLUND
K013660 12/05/2001 GENETRA RADIOMED CORPORATION GORDON ROBERTS
K013661 12/03/2001 XPLAN 2.2 WITH THE BODY SYSTEM RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP KEVIN J O'CONNELL
K011393 12/04/2001 RANDOX PHENYTOIN RANDOX LABORATORIES, LTD. P. ARMSTRONG
K002585 02/05/2001 RANDOX TRANSFERRIN RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K010194 02/15/2001 COMFOR-CLINER RECLINER CARE, INC. MARK D BROWN
K013328 12/03/2001 REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 REMINGTON PRODUCTS COMPANY, L.L.C. PAMELA J FURMAN
K013200 12/14/2001 RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 RENNELS MEDICAL CORP. DAVID LEE
K013027 12/06/2001 MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 RESPIRONICS HEALTHSCAN, INC. SUSAN D GOLDSTEIN-FALK
K012323 12/20/2001 BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K003499 02/09/2001 REMVIEW SLEEP RECORDER, MODEL 320 RESPIRONICS, INC. DAVID J VANELLA
K012040 12/18/2001 RAMP MYOGLOBIN ASSAY RESPONSE BIOMEDICAL CORP. WILLIAM J RADVAK
K013367 12/13/2001 CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH REYNOLDS MEDICAL LTD. GEORGE MYERS
K993535 12/07/2001 METAPAK MULTI-PURPOSE INSTRUMENT TRAY RILEY MEDICAL, INC. MARY MCNAMARA-CULLINANE
K013482 12/21/2001 ABUSCREEN ONLINE OPIATES 300 / 2000 ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K012324 12/05/2001 ACCU-CHEK ACTIVE TEST SYSTEM ROCHE DIAGNOSTICS CORP. MIKE FLIS
K003865 02/28/2001 COBAS INTEGRA AMPHETAMINES ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K010237 02/14/2001 ELECSYS HCG+B CALCHECK ROCHE DIAGNOSTICS CORP. HELEN T TORNEY
K010190 02/08/2001 WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 ROSSMAX INTERNATIONL LTD. MICHAEL YEH
K010068 02/08/2001 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM RUSCH INTL. KARENANN J BROZOWSKI
K010012 02/14/2001 LC PROVIFILL S & C POLYMER GMBH JURGEN ENGELBRECHT
K002712 02/08/2001 THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F S.A.A.T., LTD. SHOSHANA FRIEDMAN
K013379 12/12/2001 SAS STREPALERT SA SCIENTIFIC, INC. RICARDO R MARTINEZ
K010502 02/27/2001 MODEL THERMO TEK QUICKCARE SAAT LTD. E. J SMITH
K013801 12/13/2001 ULTRASAFE DENTAL INJECTION SYSTEM SAFETY SYRINGES, INC. THOMAS L HALL
K011323 12/17/2001 HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 SALIMETRICS LLC. EVE SCHWARTZ
K013703 12/14/2001 SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M SANYO NORTH AMERICA CORP. SACHI KATAOKA
K013649 12/26/2001 SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS SAUFLON PHARMACEUTICALS, LTD. LIGIA DELACRUZ
K010559 12/20/2001 SAUFLON MULTI LENS CARE SYSTEM SAUFLON PHARMACEUTICALS, LTD. LIGIA DELACRUZ
K013288 12/03/2001 NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E SGMP CO., LTD. JANNA TUCKER
K010095 02/09/2001 NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR SGMP CO., LTD. JANNA P TUCKER
K010247 02/06/2001 SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES SHANGHAI CHINASTAR CORP. LEE HUNG TE CHIH
K013327 12/14/2001 CTS-415 SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS BOB LEIKER
K003515 02/12/2001 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 SHIMADZU MEDICAL SYSTEMS MASAAKI SHIBATA
K003514 02/12/2001 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 SHIMADZU MEDICAL SYSTEMS MASAAKI SHIBATA
K003130 02/16/2001 REGUTHERM 952 THERMOGRAPHIC SYSTEM SIE-MED, INC. CHARLES H KYPER
K010925 12/18/2001 SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E SIEMENS ELEMA AB DIANE WURZBURGER
K003945 02/02/2001 OPDIMA SIEMENS MEDICAL SOLUTIONS USA, INC. PRAVEEN NADKARNI
K010137 02/13/2001 ORBITER II CCI/SPECT ORBITER II CCI/SPECT SIEMENS MEDICAL SOLUTIONS USA, INC. RONALD NOLTE
K013586 12/28/2001 MAGNETOM TRIO SYSTEM SIEMENS MEDICAL SYSTEMS, INC. JAMIE YIEH
K013549 12/26/2001 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K011907 12/18/2001 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM SIMS LEVEL 1, INC. GABRIEL J MURACA, JR.
K002201 02/05/2001 ELECTROSTATIC HYDROPHOBIC BREATHING FILTER SIMS PORTEX, INC. TIMOTHY J TALCOTT
K013056 12/21/2001 GELCLAIR CONCENTRATED ORAL GEL SINCLAIR PHARMACEUTICALS, LTD. PRISCILLA COX
K013659 12/06/2001 MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM SIRONA DENTAL SYSTEMS GMBH SHEILA HEMEON-HEYER
K013650 12/06/2001 ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD SIRONA DENTAL SYSTEMS GMBH SHEILA M HEMEON-HEYER
K013727 12/07/2001 STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G SMART GLOVE CORP. SDN BHD NG YEW SOON
K012378 12/13/2001 3D HUMERAL HEADS SMITH & NEPHEW, INC. DAVID HENLEY
K003566 02/14/2001 COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS SMITH & NEPHEW, INC. DAVID HENLEY
K003572 02/15/2001 DYONICS CONTROL RF SYSTEM SMITH & NEPHEW, INC. MARK KIERAS
K003710 02/02/2001 DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 SMITH & NEPHEW, INC. JANICE HASELTON
K013658 12/05/2001 MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS SMITH & NEPHEW, INC. DAVID HENLEY
K003599 02/15/2001 SMITH & NEPHEW SUTURE ANCHOR SMITH & NEPHEW, INC. WILLIAM MCCALLUM
K013989 12/19/2001 ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER SMITH & NEPHEW, INC. JANET JOHNSON GREEN
K013817 12/21/2001 GLO-SPEC SOL WEISS MD INC SOL WEISS
K014116 12/20/2001 HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL HOFFMAN
K010374 02/21/2001 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. MICHAEL A HOFFMAN
K013090 12/13/2001 SOPRO 67D OPERATING ROOM CAMERA SOPRO PIERRE MONTILLOT
K003789 02/21/2001 SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT SPECIALTY ULTRAVISION, INC. DEBBIE MCINTIRE
K003526 02/12/2001 SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) SPECIALTY ULTRAVISION, INC. GAROLD L EDWARDS
K003423 02/22/2001 ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. FRANCIS HONG
K012268 12/03/2001 TRIMAX STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K010282 02/09/2001 LATERAL OFFSET PROTRACT PRESS FIT HIP STEM STELKAST COMPANY DONALD A STEVENS
K010241 02/08/2001 PROTRACT PRESS FIT HIP STEM-HA COATED STELKAST COMPANY DONALD A STEVENS
K013139 12/18/2001 STELLARTECH COAGULATION SYSTEM STELLARTECH RESEARCH CORP. JAMES R SANTOS
K013630 12/05/2001 ISITE RADIOLOGY STENTOR, INC. GARY J ALLSEBROOK
K002912 02/21/2001 VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 STERINC TODD ABRAHAM
K013242 12/13/2001 AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS Corporation ROBERT H MCCALL
K003533 02/07/2001 CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L STERITEC PRODUCTS, INC. LINDA NELSON
K013502 12/03/2001 SIMPLICITY CLASSIC WING QD INFUSION SET STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K013767 12/12/2001 SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K003792 02/21/2001 STRYKER HEATED INSUFFLATOR TUBE SET STRYKER CORP. MICHAEL BAYCURA
K014091 12/31/2001 STRYKER PAINPUMP STRYKER CORP. NICOLE PETTY
K012380 12/03/2001 MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY STRYKER LEIBINGER ROBIN L ROWE
K013935 12/13/2001 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K003801 02/28/2001 ANATOMICAL PRESS-FIT HUMERAL STEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K013031 12/07/2001 MOST OPTIONS SYSTEM SULZER ORTHOPEDICS, INC. FRANCES E HARRISON
K010198 02/23/2001 STERILE POWDERED LATEX SURGEON GLOVES SUPERMAX GLOVE MANUFACTURING SDN BHD STANLEY THAI
K003436 02/02/2001 SURGI-VISION GUIDEWIRE COIL SURGI-VISION, INC. NANCY E TALOR
K013132 12/20/2001 SIGN IM NAIL SURGICAL IMPLANT GENERATION NETWORK (SIGN) DOUG DONNELLY
K013337 12/13/2001 PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI SURGIN INC DON HAAR
K010214 02/22/2001 FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 SURVIVALINK CORP. Sew-Wah Tay
K003640 02/22/2001 MINIENDO III SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSELL
K003650 02/15/2001 PERMLASTIC 3 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K012415 12/18/2001 AURIS AEP SYNAPSYS, INC. JULIEN CHAUSSY
K010030 02/14/2001 LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV. JAMES F GODFREY
K013527 12/21/2001 MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM SYNTHES (USA) BONNIE J SMITH
K011897 12/20/2001 NORIAN SRS BONE VOID FILLER SYNTHES (USA) ANGELA J SILVESTRI
K003786 02/27/2001 SMF RESORBABLE MESHES AND SHEETS SYNTHES (USA) THOMAS M MAGUIRE
K010121 02/09/2001 STERILE BUTTON PLATE SYNTHES (USA) THOMAS M MAGUIRE
K012945 12/03/2001 SYNTHES 2.4 MM CANNULATED SCREW SYNTHES (USA) MATTHEW M HULL
K013044 12/03/2001 SYNTHES 3.9 MM PELVIC SCREWS SYNTHES (USA) MATTHEW M HULL
K003700 02/20/2001 SYNTHES HAMSTRING LOOP SYNTHES (USA) THOMAS M MAGUIRE
K013248 12/19/2001 SYNTHES LCP DISTAL TIBIA PLATES SYNTHES (USA) MATTHEW M HULL
K003743 02/09/2001 SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K010094 02/15/2001 A & I WHEELCHAIRS TAIWAN AN I CO.,LTD. ANI HWONG
K010007 02/22/2001 ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP TAUT, INC. RONALD KENSETH
K003703 02/22/2001 TAUT-INSUFFLATION NEEDLE TAUT, INC. RONALD KENSETH
K013323 12/05/2001 TCI-31 LIFELONG OVULATION TESTER TCI NEW YORK Erika B Ammirati
K991259 02/21/2001 TE ME NA EPIDURAL CATHETER TE ME NA S.A.R.L. JOE HARMS
K013317 12/17/2001 TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TEKMEDIC (M) SDN BHD KOK-KEE HON
K003591 02/14/2001 TENSCARE, MODEL TENS XL-2 TENS CARE LTD. BERNARD J TREMAINE
K003629 02/22/2001 MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 TERRAY CORP. STEVE WANG
K003604 02/07/2001 ADAPTERS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K010443 12/11/2001 CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K003425 02/01/2001 CLIRANS E-SERIES HOLLOW FIBER DIALYZERS TERUMO MEDICAL CORP. YUK-TING LEWIS
K003571 02/12/2001 SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE TERUMO MEDICAL CORP. BARBARA SMITH
K013849 12/03/2001 TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS TETRAD CORP. CHARLES F HOTTINGER
K004019 02/15/2001 ANA EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K010148 02/23/2001 ENA SCREEN EIA KIT THE BINDING SITE, LTD. JAY H GELLER
K003669 02/01/2001 KAPPA IMMAGE FREELITE KIT THE BINDING SITE, LTD. JAY H GELLER
K003671 02/01/2001 LAMBDA IMMAGE FREELITE KIT THE BINDING SITE, LTD. JAY H GELLER
K002896 02/21/2001 ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING THE WESTAIM CORP. STEVEN CHARTIER
K004048 02/06/2001 SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) TILLOTSON HEALTHCARE CORP. F.W. PERRELLA
K010267 02/27/2001 PALFIQUE ESTELITE LV CLEAR TOKUYAMA AMERICA, INC. DANIEL J MANELLI
K003936 02/14/2001 PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING TOMTEC IMAGING SYSTEMS, GMBH FLORIAN EISENBERGER
K012820 12/14/2001 AIA-PACK CTNI 2ND-GEN ASSAY TOSOH MEDICS, INC. LOIS NAKAYAMA
K002045 02/16/2001 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS TOTAL WATER TREATMENT SYSTEMS, INC. KENNETH J CLARK
K013580 12/12/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013925 12/21/2001 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K003834 02/23/2001 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K003868 02/27/2001 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K013903 12/17/2001 HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 TRIAD MEDICAL, INC. RITA GIEBEL
K013086 12/13/2001 WET LIGHT PERSONAL MOISTURIZER TRIGG LABORATORIES, INC. W. PATRICK NOONAN
K012514 12/21/2001 DIGIPAN / DPI TROPHY RADIOLOGIE MARIE-PIERRE LABAT-CAMY
K003470 02/20/2001 EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 TUTTNAUER CO. LTD. MARK YACURA
K993856 02/09/2001 TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP TUTTNAUER USA CO. LTD. MARK M YACURA
K013556 12/31/2001 MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE TYCO HEALTHCARE DAVID A OLSON
K003383 02/06/2001 PALMLIGHT ULTRADENT PRODUCTS, INC. MARKUS R GEE
K012071 12/03/2001 ENT LASERVISION UNION MEDICAL USA ANNIE VELEZ
K013860 12/19/2001 AUTO SUTURE SURGICAL STAPLES UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHESTER MCCOY
K013890 12/11/2001 SURGICAL DYNAMICS MENISCAL STAPLE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER SCHUCK
K010098 02/01/2001 MODIFICATION TO CAVERMAP SURGICAL AID UROMED CORP. FREDERICK TOBIA
K013528 12/13/2001 CRYSTAL 5000 PHASES ARRAY TMJ COIL USA INSTRUMENTS, INC. RONY THOMAS
K011683 12/10/2001 NURVO 9000 ENDOCAVITARY COILS USA INSTRUMENTS, INC. RONY THOMAS
K013541 12/14/2001 SHOULDER COIL USA INSTRUMENTS, INC. RONY THOMAS
K011832 12/21/2001 VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K003636 02/02/2001 PORTALVISION VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K003719 02/28/2001 VASCULAR ARCHITECTS PERISCOPE DEVICE VASCULAR ARCHITECTS, INC. JEAN M CAILLOUETTE
K012256 12/20/2001 GELBISH VASCULAR DILATOR VASCUMETRIX, LLC MIKE HAMMONS
K013308 12/20/2001 VENTLAB HYPERINFLATION BAG SYSTEM VENTLAB CORP. MARGE WALLS-WALKER
K011702 12/21/2001 VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX VERTIS NEUROSCIENCE, INC. LORI GLASTETTER
K013146 12/07/2001 VIATRONIC V3D CALCIUM SCORING VIATRONIX, INC. SUSAN D GOLDSTEIN-FALK
K013702 12/27/2001 VICTORCH HCG TEST STRIP VICTORCH MEDITEK, INC. PIERCE LIU
K013678 12/27/2001 VICTORCH MEDITEK'S HCG TEST CARD VICTORCH MEDITEK, INC. PIERCE LIU
K012587 12/11/2001 RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE VIDAMED, INC. YI CHEN
K002583 02/13/2001 TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM VIDAMED, INC. TOM MCGAFFIGAN
K003510 02/12/2001 INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 VISUALIZATION TECHNOLOGY, INC. NORMA LEMAY
K003607 02/15/2001 ONYX-RAD TELEMEDICINE PACS VIZTEK, INC. JOSIP CERMIN
K003684 02/23/2001 PERCUSSIVENEB, MODEL PN-2001 VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K002469 02/07/2001 IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) W & H DENTALWERK BUERMOOS GMBH HERBERT TRASCHWANDTNER
K013282 12/14/2001 GORE INTRODUCER SHEATH W. L. GORE & ASSOCIATES, INC. R. LARRY PRATT
K013346 12/19/2001 GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE W.L. GORE & ASSOCIATES,INC JACQUELINE KALBACH
K010228 02/21/2001 GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W.L. GORE & ASSOCIATES,INC R. LARRY PRATT
K003668 02/12/2001 AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 WALLAC OY GUNNEL LAAKSONEN
K003664 02/14/2001 DELFIA NEONATAL IRT KIT, MODEL A005-110 WALLAC OY GUNNEL LAAKSONEN
K002083 02/12/2001 LORENZ RESORBABLE DISTRACTOR SYSTEM WALTER LORENZ SURGICAL, INC. STEVE HERRINGTON
K002219 02/02/2001 WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE WANDY RUBBER INDUSTRIAL CO., LTD JANIS YANG
K002227 02/02/2001 WANDY SILICONE CONDUCTIVE RUBBER PAD WANDY RUBBER INDUSTRIAL CO., LTD JANIS YANG
K003773 02/02/2001 CLEAN SCRAPE WEBB RESEARCH II, INC. STEVEN KRUPNICK
K002466 02/16/2001 ACTICOAT COMPOSITE DRESSING WESTAIM BIOMEDICAL, INC. Steve Chartier
K010059 02/27/2001 ENGPLUS WESTERN SYSTEMS RESEARCH, INC. LINDA DAVIS-O'LEARY
K012839 12/31/2001 AUROPAL, ORDER-NO.: 2101 WIELAND EDELMETALLE GMBH & CO. GERHARD P0LZER
K013652 12/21/2001 WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K011953 12/21/2001 WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013035 12/07/2001 GUARDIAN LIMB SALVAGE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K004032 02/15/2001 PERFECTA AND EXTEND WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K013942 12/31/2001 POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) WRP SPECIALTY PRODUCTS SDN. BHD. MOHD H HUSSEIN
K010099 02/01/2001 ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER ZCV ,INC. JING ZHANG
K011244 12/10/2001 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K013991 12/27/2001 PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS ZIMMER, INC. STEPHEN H MCKELVEY
K003478 02/05/2001 TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 ZIMMER, INC. KAREN CAIN
K010257 02/28/2001 ZOLL M SERIES ZOLL MEDICAL CORP. PAUL DIAS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact