FDA 510(k) Applications Received During May, 2002

FDA 510(k) Number Submission Date Device Name Applicant Contact
K021460 05/07/2002 OCO DENTAL IMPLANT "O" CO., INC. DAVID D DALISE
K021450 05/06/2002 CLINPRO PROPHY POWDER 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K021782 05/30/2002 BNF AAP IMPLANTATE AG DIPL-ING CHRISTIAN ABEL
K021445 05/06/2002 ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE AB BIODISK ANNE BOLMSTROM
K021637 05/17/2002 ACELL UBM LYOPHILIZED WOUND DRESSING ACELL, INC PATSY J TRISER
K021526 05/10/2002 ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K021614 05/16/2002 DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 ACTHERM, INC. RICHARD HSIEH
K021612 05/16/2002 DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038 ACTHERM, INC. RICHARD HSIEH
K021497 05/09/2002 CYPRESS ULTRASOUND SYSTEM ACUSON CORP. BOB LEIKER
K021669 05/21/2002 PHYSICIAN'S DESKTOP REVIEW ADAC LABORATORIES COLEEN COLEMAN
K021518 05/10/2002 PAINDOC ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K021528 05/10/2002 REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP ADVEN MEDICAL MARK W ALDANA
K021447 05/06/2002 TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K021417 05/03/2002 AART CHIN IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021419 05/03/2002 AART MALAR IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021418 05/03/2002 AART NASAL IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021542 05/10/2002 ADC DENTAL AGFA CORP. JEFF JEDLICKA
K021383 05/02/2002 ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL AGION TECHNOLOGIES, LLC. PAUL C FORD
K021566 05/13/2002 INFINITI ALCON LABORATORIES, INC. MICHAEL BUENGER
K021423 05/03/2002 INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K021386 05/02/2002 POLY STAT HCG DIPSTICK TEST ALIDEX, INC. HELEN LANDICHO
K021654 05/20/2002 REPROCESSED COMPRESSION SLEEVE ALLIANCE MEDICAL, INC. LORRI CHAVEZ
K021560 05/13/2002 MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS AMERIWATER BRAIN R BOWMAN
K021493 05/09/2002 ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S ANDERSEN PRODUCTS, INC. WENDY HEDRICK
K021389 05/02/2002 BIOLOGICAL SOUND MONITOR (BSM) SENSOR ANDROMED, INC. GENEVIEVE HAMEL
K021700 05/23/2002 ANIMUS EZSERTER INFUSION SET INSERTER ANIMAS CORP. RICHARD MICHELIN
K021439 05/06/2002 MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO ANIMAS CORP. MICHAEL J ANDREWS
K021672 05/21/2002 PANCREATIC DRAINAGE TUBE AOMORI OLYMPUS CO., LTD. LAURA STORMS-TYLER
K021754 05/29/2002 APEX MEDICAL DIGITAL EMS TS1311, TS1312 APEX MEDICAL CORP. ALAN CHANG
K021755 05/29/2002 APEX MEDICAL DIGITAL TENS TS1211, TS1212 APEX MEDICAL CORP. ALAN CHANG
K021412 05/03/2002 LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K021462 05/07/2002 ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 ARROW INTL., INC. WILLIAM PAQUIN
K021723 05/24/2002 SHEATH ADAPTER, MODEL SA-09847 ARROW INTL., INC. BRANDON EPTING
K021567 05/13/2002 STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 ARROW INTL., INC. WILLIAM G MCLAIN
K021434 05/06/2002 ARTHREX FIBERWIRE IN USP SIZES ARTHREX, INC. ANN WATERHOUSE
K021519 05/10/2002 ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
DEN020001 05/28/2002 BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL HOWARD M HOLSTEIN
K021767 05/29/2002 ASSUFIL ASSUT EUROPE S.P.A. LUCIO IMPROTA
K021473 05/08/2002 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K021699 05/22/2002 AUTOLENS CLEANING AND DISINFECTING UNIT AUTOLENS INC. RICHARD E LIPPMAN
K021516 05/10/2002 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K021488 05/08/2002 SURECAN SAFETY HUBER NEEDLE INFUSION SETS B. BRAUN MEDICAL, INC. SHERI L MASGNUNG
K021640 05/20/2002 HANSATOME EXCELLUS MICROKERATOME BAUSCH & LOMB, INC. DENNIS POZZO
K021615 05/16/2002 BAXTER ACCURA SYSTEM, MODEL 5M5660 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K021428 05/03/2002 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM BAYER CORP. KENNETH T EDDS
K021535 05/10/2002 ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021532 05/10/2002 ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021475 05/08/2002 BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET BD PASQUALE AMATO
K021572 05/14/2002 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K021582 05/14/2002 BACTEC MGIT 960 PZA KIT BECTON, DICKINSON & CO. MICHELLE B BANDY
K021649 05/20/2002 BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK BINAX, INC. Anne Jepson
K021646 05/20/2002 BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK BINAX, INC. Anne Jepson
K021687 05/22/2002 BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK BINAX, INC. Anne Jepson
K021498 05/09/2002 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL BIO-RAD MARIA ZEBALLOS
K021415 05/03/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 BIO-RAD ELIZABETH PLATE
K021414 05/03/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 BIO-RAD ELIZABETH PLATE
K021411 05/03/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 BIO-RAD ELIZABETH PLATE
K021384 05/02/2002 LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 BIO-RAD ELIZABETH PLATT
K021551 05/13/2002 STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT BIOCOMPOSITES LTD. J. STEPHEN BRATT
K021588 05/14/2002 ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K021799 05/31/2002 CEMENTED FEMORAL HEAD RESURFING DEVICE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K021403 05/02/2002 HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K021661 05/20/2002 RINGLOC CONSTRAINED LINERS BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K021559 05/13/2002 ASCENT ALL-POLY PS TIBIAL BEARINGS BIOMET, INC. DALENE T BINKLEY
K021621 05/16/2002 FIXED BEARING UNI COMPONENT BIOMET, INC. DALENE T BINKLY
K021380 05/01/2002 OSS LES PROXIMAL FEMORAL COMPONENT BIOMET, INC. PATRICIA SANDBORN BERES
K021728 05/24/2002 RINGLOC CONSTRAINED LINERS II BIOMET, INC. DALENE T BINKLEY
K021786 05/30/2002 TITANIUM ANKLE ARTHRODESIS NAIL BIOMET, INC. LONNIE WITHAM
K021697 05/22/2002 GLUCOSE CONTROL SOLUTION FOR BD LATITUDE BIONOSTICS, INC. KATHLEEN STORRO
K021624 05/16/2002 RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 BIONOSTICS, INC. KATHLEEN STORRO
K021684 05/22/2002 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. CAROL E JONES
K021397 05/02/2002 EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION BIOSPHERE MEDICAL, INC. SHIELA HEMEON-HEYER
K021503 05/09/2002 UNINHIBITED BISCO, INC. STEPHEN (STEVE) SMITH
K021630 05/17/2002 BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORP. TODD KORNMANN
K021721 05/24/2002 EQUALIZER BALLOON CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K021735 05/28/2002 BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER BOSTON SCIENTIFIC SCIMED, INC. CANDICE BURNS
K021494 05/09/2002 GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K021583 05/14/2002 PATXFER BRAINLAB AG STEFAN VILSMEIER
K021481 05/08/2002 BRESAGEN CATHETER, MODEL CS-3000 BRESAGEN, INC. JOHN KUCHARCZYK
K021736 05/28/2002 BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 C.R. BARD, INC. BRAIN A KANERVIKO
K021617 05/16/2002 C.T.M. POWER CHAIR, MODEL HS-2800 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K021484 05/08/2002 HEMOGLOBIN A1C CONTROL CANTERBURY SCIENTIFIC LTD. MAURICE OWEN
K021574 05/14/2002 TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K021694 05/22/2002 CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 CARDIOVENTION, INC. TESSA YAMUT
K021787 05/30/2002 VISUCAM CARL ZEISS OPHTHALMIC SYSTEMS, INC. DIONNE N LABATORE
K021704 05/23/2002 VAXCEL PICC WITH PASV VALVE TECHNOLOGY CATHETER INNOVATIONS, INC. ROGER L RICHINS
K021594 05/15/2002 COPC BAND CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC JOSEPH TERPENNING
K021781 05/30/2002 EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS CHAY MEDICAL, LLC. STEPHEN C PEARSON
K021390 05/02/2002 PMX COMPACT RESUCITATOR CHEEN HOUNG ENT. CO. LTD. JAY WANG
K021387 05/02/2002 POLAR WAND CHEK-MED SYSTEMS ROB WHALEN
K021611 05/16/2002 QAB2A IGG ELISA KIT HRP CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K021610 05/16/2002 QAB2A IGM ELISA KIT HRP CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K021395 05/02/2002 MODIFICATION TO 30 EXTENSION SET CHURCHILL MEDICAL SYSTEMS, INC. KEVIN PALUCH
K021635 05/17/2002 KARATS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K021407 05/03/2002 COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K021480 05/08/2002 EXTENSION SET LIGHT-SAFE, MODEL BC565 CODAN US CORP. MARILYN R POURAZAR
K021653 05/20/2002 CODMAN BACTISEAL EVD CATHETER SET Codman & Shurtleff, Inc. KATHY WUNDER
K021737 05/28/2002 REPHRESH VAGINAL GEL COLUMBIA LABORATORIES, INC. SUSAN A WITHAM
K021616 05/16/2002 DELIGHT DENTAL ER: YAG LASER SYSTEM CONTINUUM ELECTRO-OPTICS, INC. TOM HANEY
K021557 05/13/2002 SPECTRUM SILICONE CATHETER COOK, INC. APRIL LAVENDER
K021743 05/28/2002 (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW COPIOUMED INTL., INC. JANNA P TUCKER
K021593 05/15/2002 MODIFICATION TO ENVOY AND VISTA BRITE TIP CORDIS CORP. STEPHEN M ENOS
K021591 05/15/2002 PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K021539 05/10/2002 DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS CREATIVE CONTRACT (M) SDN BHD MARK REIBER
K021546 05/10/2002 DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR CREATIVE CONTRACT (M) SDN BHD MARK REIBER
K021533 05/10/2002 DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE) CREATIVE CONTRACT (M) SDN BHD MARK REIBER
K021633 05/17/2002 ECAT VISION PET SCANNER, MODELS 3000 & 5000 CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K021444 05/06/2002 CYNOSURE PHOTOGENICA SV CYNOSURE, INC. GEORGE CHO
K021676 05/21/2002 CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL CYPRESS MEDICAL PRODUCTS, LTD. ANTONIO L GIACCIO
K021381 05/01/2002 MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 DADE BEHRING, INC. DONNA A WOLF
K021376 05/01/2002 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE DATEX-OHMEDA JOEL C KENT
K021378 05/01/2002 PORTABLE HDX INTRAORAL X-RAY DENTALEZ GROUP DEON BECK
K021416 05/03/2002 AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFERY LEHN
K021413 05/03/2002 AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFERY LEHN
K021410 05/03/2002 AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFERY LEHN
K021499 05/09/2002 CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K021478 05/08/2002 DELTA SHOULDER DEPUY, INC. JANET G JOHNSON
K021394 05/02/2002 DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K021732 05/24/2002 DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT DIDECO S.P.A. BARRY SALL
K021725 05/24/2002 DISETRONIC D-TRON INSULIN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS AG SANDRA SONIEC
K021740 05/28/2002 TOTAL KNEE CEMENTED, SEMI-CONSTRAINED DJ ORTHOPEDICS, LLC NORA C.R. YORK
K021724 05/24/2002 DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS DORNIER MEDTECH AMERICA, INC. Tim Thomas
K021601 05/15/2002 MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER DUTECK INDUSTRIAL CO., LTD. YI-LANG LIN
K021753 05/29/2002 E-CARE INFARED EAR THERMOMETER, MODEL LCT-200 E-CARE TECHNOLOGY CORPORATION SUSAN D GOLDSTEIN-FALK
K021695 05/22/2002 EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM EBI, L.P. PATRICIA M FLOOD
K021749 05/28/2002 EBI DYNAFIX VS OSTEOTOMY SYSTEM EBI, L.P. JON CAPARETTA
K021598 05/15/2002 ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. SHIRANTHA SAMARAPPULI
K021385 05/02/2002 ATAC PAK BUN REAGENT ELAN DIAGNOSTICS WYNN STOCKING
K021550 05/13/2002 LUMENIS SELECTA DUET Ellex Medical Pty. Ltd. BILL SWAIM
K021520 05/10/2002 EMT-CPAP EMERGENCY MEDICAL TECHOLOGY GREG HOLLAND
K021748 05/28/2002 ENDIUS ATAVI SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K021765 05/29/2002 CEMENT RESTRICTOR, SMALL AND LARGE EXACTECH, INC. GARY MILLER
K021715 05/23/2002 CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL EXACTECH, INC. GARY J MILLER
K021599 05/15/2002 96 CHANNEL EEG HEADBOX MODEL EMU96 EXCEL TECH. LTD. JOHN MUNFORD
K021429 05/03/2002 HERPESELECT 1 ELISA IGG, MODEL EL0910G FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K021486 05/03/2002 HERPESELECT 2 ELISA IGG, MODEL ELO920G FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K021602 05/15/2002 FOSSA URETERAL STONE SWEEPER FOSSA INDUSTRIES, INC. PAMELA PAPINEAU
K021548 05/13/2002 FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM FOTONA D.D. MOJCA VALJAVEC
K021742 05/28/2002 GALEMED NEB-EASY NEBULIZER GALEMED CORP. TOM SHANKS
K021435 05/06/2002 DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K021491 05/09/2002 HISPEED DUAL GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K021726 05/24/2002 GEBAUER'S INSTANT ICE GEBAUER CO. SUZANNE B WOJCIK
K021780 05/30/2002 ADVANTAGE SIM 6.0 GENERAL ELECTRIC MEDICAL SYSTEMS LARRY A KROGER
K021470 05/08/2002 SEER LIGHT COMPACT DIGITAL HOLTER RECORDER GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LISA LEE MICHELS
K021454 05/06/2002 UNITY NETWORK ID GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN JOELLE NEIDER
K021730 05/24/2002 GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) GLOVCO (M) SDN. BHD. TAN PENG HOCK
K021757 05/29/2002 CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET GOOD BIOTECH CORP. VICTOR CHIOU
K021455 05/06/2002 RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, GUIDANT CORP. KAREN S ALSOP
K021777 05/30/2002 GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) GYRUS ENT L.L.C. JEFFREY W COBB
K021595 05/15/2002 GYRUS ENT NERVE STIMULATOR GYRUS ENT L.L.C. GREG SREDIN
K021525 05/10/2002 TOPCUT H.S. HOSPITAL SERVICE S.R.L. LUCIO IMPROTA
K021466 05/07/2002 CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K021605 05/16/2002 MEDGEM HEALTHETECH, INC. GLENN M THIBAULT
K021775 05/29/2002 LTFS230 HEALTHTRONICS, INC. PETER WEIMAN
K021479 05/08/2002 CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR MASER
K021622 05/16/2002 HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 HILL-ROM AIR-SHIELDS MONICA FERRANTE
K021751 05/28/2002 ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K021472 05/08/2002 HMS-DHR-3 NEUROMUSCULAR STIMULATOR HOME MEDICAL SERVICES C.A. TEKLINSKI
K021496 05/09/2002 HMS-DHR-3 NEUROMUSCULAR STIMULATOR HOME MEDICAL SERVICES C.A. TEKLINSKI
K021706 05/23/2002 HORIZONS HOT BIOPSY FORCEPS HORIZONS INTL. CORP. RAFIC SALEH
K021451 05/06/2002 DURACON CS TIBIAL INSERT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K021744 05/28/2002 T2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K021509 05/09/2002 HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K021623 05/16/2002 UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS IAME, INC. DAVID W SCHLERF
K021692 05/22/2002 CLC2000 CATHETER PATENCY DEVICE ICU MEDICAL, INC. ALISON D BURCAR
K021698 05/22/2002 MY ALLERGY TEST IMMUNETECH CORPORATION VIVIANNE NOETZEL
K021608 05/16/2002 SMITHWICK CAROTID SHUNT IMPLANTABLE DEVICES WILLIAM E MCPHERSON
K021586 05/14/2002 SECURE RELINE/PICKUP MATERIAL IMTEC CORP. BRAD VANCE
K021437 05/06/2002 SECURE SOFT IMTEC CORP. BRAD VANCE
K021465 05/07/2002 MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE INDUSTRIAL CLOTHINGS, LTD. UMAIR AHMED
K021668 05/21/2002 NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR) INNOVATIVE GLOVES CO; LTD RAJEEV KUMAR SOOD
K021648 05/20/2002 QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K021482 05/08/2002 QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K021792 05/31/2002 BILAYER MATRIX WOUND DRESSING INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K021789 05/31/2002 QUICKLAB RSV INTEGRATED BIOTECHNOLOGY CORP. SALLY A BOOTH
K021636 05/17/2002 ALBUMIN REAGENT INTERSECT SYSTEMS, INC. JOAN CATHEY
K021638 05/20/2002 ILT ADVANCING MECHANISM, MODEL A115AMI INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K021680 05/22/2002 INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 INVACARE CORP. RAE ANN FARROW
K021685 05/22/2002 VENTURE HOMEFILL II WITH OXYGEN CONSERVER INVACARE CORP. EDWARD A KROLL
K021671 05/21/2002 JAS HDL CHOLESTEROL (AUTOMATED) REAGENT JAS Diagnostics, Inc. David Johnston
K021750 05/28/2002 LID CHAIN EYELID WEIGHTS JEDMED INSTRUMENT CO. CRAIG R PARKS
K021547 05/10/2002 FLOWLINE BIOPORE EPTFE VASCULAR GRAFT JOTEC GMBH JOE SHARBER
K021660 05/20/2002 K-ASSAY LP(A) ASSAY KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K021776 05/29/2002 KSEA QUADRO SWITCH KARL STORZ ENDOSCOPY JAMES A LEE
K021467 05/07/2002 AUTOCON II 400 ELECTROSURGICAL GENERATOR KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K021501 05/09/2002 V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT KINETIC CONCEPTS, INC. WILLIAM H QUIRK
K021500 05/09/2002 VACUUM ASSISTED CLOSURE KINETIC CONCEPTS, INC. WILLIAM H QUIRK
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K021573 05/14/2002 PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION PURITAN-BENNETT GINA TO
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K021527 05/10/2002 SECTRA OSTEOPOROSIS PACKAGE SECTRA-IMTEC AB CARL ALLETTO
K021707 05/23/2002 SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS SENORX, INC. AMY BOUCLY
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K021719 05/23/2002 FORTITUDE CEMENT RESTRICTOR SPINAL CONCEPTS, INC. DAVID M HOOPER
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K021549 05/13/2002 CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM STD MFG., INC. STEVE EK
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K021440 05/06/2002 BONESOURCE HAC STRYKER INSTRUMENTS WADE T RUTKOSKIE
K021563 05/13/2002 INTRACOIL SELF-EXPANDING PERIPHERAL STENT SULZER INTRATHERAPEUTICS, INC. MARIA E BRITTLE
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K021642 05/20/2002 SYNTHES CRANIOFACIAL PLATES SYNTHES (USA) MATTHEW M HULL
K021458 05/07/2002 SYNTHES IN-SITU BENDER/CUTTER SYNTHES (USA) MATTHEW M HULL
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K021421 05/03/2002 PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE TZ MEDICAL, INC. MADALYN DUNCAN
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K021657 05/20/2002 UKNEE TOTAL KNEE SYSTEM UNITED ORTHOPEDIC CORP. PHILIP LEUNG
K021632 05/17/2002 GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C URESIL, L.P. CHARLES P GILL
K021537 05/10/2002 MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 VERMONT MEDICAL, INC. MARC FILLION
K021745 05/28/2002 VASCLIP VMBC, LLC DAVID ELLIOT, JR.
K021477 05/08/2002 PRECLUDE MVP DURA SUBSTITUTE W. L. GORE & ASSOCIATES, INC. TIMOTHY J RYNN
K021686 05/22/2002 LASER FIBER GF500 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K021522 05/10/2002 LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW WALTER LORENZ SURGICAL, INC. SHERYL MALMBERG
K021681 05/22/2002 MICROPAQ, MODELS 402, 404 WELCH ALLYN PROTOCOL, INC. DON M ABBEY
K021756 05/29/2002 WELCH ALLYN ABPM 6100 WELCH ALLYN, INC. DAVID KLEMENTOWSKI
K021733 05/28/2002 AUTOPAL 50 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K021717 05/23/2002 ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 WORLD OF MEDICINE LEMKE GMBH SUSANNE RAAB
K021456 05/06/2002 ER150/M2 WORLD OF MEDICINE LEMKE GMBH SUSANNE RAAB
K021489 05/08/2002 REPIPHYSIS LIMB SALVAGE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
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K021536 05/10/2002 DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR WRP SPECIALTY PRODUCTS SDN. BHD. V. NADARAJAN
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K021396 05/02/2002 DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE WRP SPECIALTY PRODUCTS SDN. BHD. V. NADARAJAN
K021641 05/20/2002 XTD THROMBECTOMY CATHETER, XX CM XTRAK MEDICAL INC. DEBBIE IAMPIETRO


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