FDA 510(k) Decisions During July, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K021817 07/11/2002 AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K021874 07/12/2002 ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 ABBOTT LABORATORIES FRANK POKROP
K022200 07/29/2002 PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 ABX DIAGNOSTICS TIM LAWTON
K020657 07/29/2002 ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE ACCULASER, INC. PATSY J TRISLER
K012018 07/16/2002 BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 ACMI CORPORATION FRANK J FUCILE
K021526 07/17/2002 ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K021321 07/17/2002 WRIST FUSION PLATE ACUMED, INC. CARRIE MCMICHAEL
K021497 07/09/2002 CYPRESS ULTRASOUND SYSTEM ACUSON CORP. BOB LEIKER
K021966 07/02/2002 Q LAB SOFTWARE ADVANCED TECHNOLOGY LABORATORIES, INC. SARAH BAXTER
K022073 07/24/2002 HEARTLINE RECEIVING STATION AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K021327 07/25/2002 ORTHOPILOT HTO MODULE AESCULAP, INC. GEORGE KELLER
K021313 07/22/2002 SEARCH EVOLUTION TOTAL KNEE SYSTEM AESCULAP, INC. JOYCE KILROY
K021417 07/02/2002 AART CHIN IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021839 07/16/2002 AART GLUTEAL IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021419 07/02/2002 AART MALAR IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021418 07/02/2002 AART NASAL IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021337 07/03/2002 AART PECTORALIS IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021820 07/16/2002 AART SILICONE CARVING BLOCK AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021383 07/17/2002 ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL AGION TECHNOLOGIES, LLC. PAUL C FORD
K002741 07/03/2002 BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK ALBERT BROWNE LTD. CYNTHIA J.M.NOLTE
K013713 07/15/2002 ARM AUTOMATIC REPROCESSING MACHINE ALCAVIS INTERNATIONAL INCORPORATED LUDOVICO GIAVOTTO
K021566 07/02/2002 INFINITI ALCON LABORATORIES, INC. MICHAEL BUENGER
K020818 07/05/2002 POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K020668 07/10/2002 ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 ALOKA CO., LTD. KELVIN BURROUGHS
K020356 07/23/2002 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM ALPHATEC MFG., INC. ELLEN A HICKS
K021114 07/23/2002 'RAPIDTEC' 5A MULTIPLE DIP TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K020527 07/09/2002 HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 AMERICAN OPTISURGICAL, INC. NANETTE CANEPA
K010065 07/02/2002 CRANIAL STEREOTACTIC EQUIPMENT ARPLAY MEDICAL S.A. RICHARD BORGI
K013418 07/09/2002 AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY ASAHI MEDICAL CO., LTD DAVID L WEST
K021809 07/18/2002 V-2100G ADVANCED INFANT INCUBATOR ATOM MEDICAL CORP. SHEILA HEMEON-HEYER
K022125 07/30/2002 PROVOX FREEHANDS HME, MODEL 7710 ATOS MEDICAL AB EDDY ABERG
K021473 07/09/2002 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K014246 07/16/2002 AVID-NIT NERVE STIMULATION NEEDLES AVID N.I.T., INC. SCOTT HENDERSON
K013420 07/19/2002 CHEMWELL, ALSO KNOWN AS PROJECT 2900 AWARENESS TECHNOLOGY, INC. GLEN VAN SLOOTEN
K021516 07/23/2002 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K021094 07/03/2002 INTROCAN SAFETY IV CATHETER B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K021488 07/08/2002 SURECAN SAFETY HUBER NEEDLE INFUSION SETS B. BRAUN MEDICAL, INC. SHERI L MASGNUNG
K021958 07/03/2002 TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH, 20CM, (100CM CATHETER LENGTH, 10CM INFUSION H BACCHUS VASCULAR, INC. GREG MATHINSON
K013892 07/11/2002 LUTZ NEEDLE BALLARD MEDICAL PRODUCTS SYDNEE F MCMILLAN
K020073 07/12/2002 MEDICAL ADMINISTRATOR BARCO NV FRANK FERGUSON
K020828 07/24/2002 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER CORP. KENNETH T EDDS
K021428 07/05/2002 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM BAYER CORP. KENNETH T EDDS
K020792 07/11/2002 ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021151 07/13/2002 AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K020616 07/17/2002 BAYER RAPIDPOINT 405 SYSTEM BAYER DIAGNOSTICS CORP. THOMAS F FLYNN
K020794 07/11/2002 SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021475 07/19/2002 BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET BD PASQUALE AMATO
K022161 07/29/2002 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 BECKMAN COULTER, INC. STAN SUGRUE
K021572 07/19/2002 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K022130 07/29/2002 BD VACUTAINER PLUS PST II TUBE BECTON DICKINSON & CO. JING ZHANG
K021582 07/13/2002 BACTEC MGIT 960 PZA KIT BECTON, DICKINSON & CO. MICHELLE B BANDY
K022129 07/25/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K020921 07/11/2002 NO-POKES NEEDLE SAFETY DEVICE BEMIS MFG. CO. JOHN B HOWELL
K021304 07/23/2002 PROLITE PULSED LIGHT SYSTEM BIG SKY LASER TECHNOLOGIES, INC. PATRICK MAINE
K021895 07/01/2002 BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K014019 07/11/2002 NEUROTECH MEDISTIM PLUS, TYPE 291 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K014020 07/11/2002 NT MEDITENS PLUS, TYPE 290 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K022041 07/16/2002 LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K021326 07/18/2002 VIDAS TESTOSTERONE (TES), MODEL 30 418 BIOMERIEUX, INC. KELLY ROWLAND
K021254 07/17/2002 LACTOSORB MINI INTERFERENCE SCREW BIOMET ORTHOPEDICS, INC. SARA B SHULTZ
K022094 07/25/2002 PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING BIOMET, INC. TRACY J BICKEL
K021071 07/01/2002 PCCS GRAFT DELIVERY SYSTEM BIOMET, INC. LONNIE WITHAM
K021927 07/12/2002 PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM BIOMET, INC. LONNIE WITHAM
K021828 07/01/2002 SMALL HAMMER TOE PIN BIOMET, INC. SARA B SHULTZ
K021697 07/12/2002 GLUCOSE CONTROL SOLUTION FOR BD LATITUDE BIONOSTICS, INC. KATHLEEN STORRO
K021624 07/12/2002 RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 BIONOSTICS, INC. KATHLEEN STORRO
K022033 07/19/2002 STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM BIOPLATE, INC. BRUCE F MACKLER
K021317 07/01/2002 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED JEFFERY R DAHLEN
K013634 07/09/2002 BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK BIOTEQUE CORP. JENNIFER REICH
K013873 07/11/2002 COBRA CARDIAC ELECTROSURGICAL SYSTEM BOSTON SCIENTIFIC CORP. ANDREA L RUTH
K014297 07/09/2002 ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K021901 07/09/2002 WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM BOSTON SCIENTIFIC SCIMED, INC. SHERRY L SPARROW
K014256 07/19/2002 KOLIBRI IGS SYSTEMS BRAINLAB AG STEFAN VILSMEIER
K022355 07/30/2002 QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 BRANAN MEDICAL CORP. RAPHAEL WONG
K021165 07/01/2002 NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES BROMAC ASSISTIVE TECHNOLOGY DAVID K BROWN
K021736 07/16/2002 BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 C.R. BARD, INC. BRAIN A KANERVIKO
K022149 07/16/2002 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 CAMBRIDGE HEART, INC. JOHN GREENBAUM
K022152 07/16/2002 HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS CAMBRIDGE HEART, INC. JOHN GREENBAUM
K020222 07/29/2002 WISORB MALLEOLAR SCREW CAMBRIDGE SCIENTIFIC, INC. DEBRA J TRANTOLO
K021236 07/17/2002 SURGERY AND ACCESSORIES CAMTRONICS, LTD. SCOTT PEASE
K021180 07/02/2002 CANDELA VBEAM PULSED DYE LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K022174 07/29/2002 MODIFICATION TO CARDEON AEGIS CATHETER CARDEON CORP. JANE BEGGS
K020486 07/01/2002 CARESIDE GGT CARESIDE, INC. KENNETH B ASARCH
K020484 07/03/2002 CARESIDE LDH CARESIDE, INC. KENNETH B ASARCH
K020735 07/12/2002 SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES CATHAY INTERNATIONAL, LTD. ANNE JEN
K021146 07/02/2002 D/SENSE 1-STEP CENTRIX, INC. JOHN DISCKO
K020475 07/05/2002 CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 CHAD THERAPEUTICS, INC. KEVIN MCCULLOH
K021387 07/31/2002 POLAR WAND CHEK-MED SYSTEMS ROB WHALEN
K021611 07/12/2002 QAB2A IGG ELISA KIT HRP CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K021610 07/12/2002 QAB2A IGM ELISA KIT HRP CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K012600 07/03/2002 CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L CLEAR MEDICAL, INC. RICHARD RADFORD
K012609 07/03/2002 CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 CLEAR MEDICAL, INC. RICHARD RADFORD
K012622 07/03/2002 CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 CLEAR MEDICAL, INC. RICHARD RADFORD
K021407 07/03/2002 COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K021830 07/02/2002 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC. SHAWN RIEDEL
K021653 07/29/2002 CODMAN BACTISEAL EVD CATHETER SET Codman & Shurtleff, Inc. KATHY WUNDER
K013434 07/09/2002 VP-2000/1000 COLIN CORP. KENICHI SAKURADO
K020004 07/24/2002 CLINDATALINK VERSION 1.0 FOR SPIROMETRY COMPLEWARE CORP. KAY WEILER
K021899 07/10/2002 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 CONCENTRIC MEDICAL, INC. KEVIN MACDONALD
K021079 07/01/2002 ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX CONMED CORP. CHARLES M HART
K021616 07/11/2002 DELIGHT DENTAL ER: YAG LASER SYSTEM CONTINUUM ELECTRO-OPTICS, INC. TOM HANEY
K013182 07/01/2002 TRIPLE LUMEN CENTRAL VENOUS CATHETER COOK, INC. LISA HOPKINS
K021961 07/02/2002 POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE COPIOUMED INTL., INC. JANNA P TUCKER
K021191 07/12/2002 AUTOALIGN CORTECHS LABS, INC. JEFFREY M ANDERSON
K021311 07/13/2002 SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL CP MEDICAL MARY ANN GREENAWALT
K021676 07/12/2002 CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL CYPRESS MEDICAL PRODUCTS, LTD. ANTONIO L GIACCIO
K020413 07/17/2002 MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K021199 07/12/2002 PRIMECHAIR DALTON MEDICAL CORP. WILL RIDGWAY
K021279 07/19/2002 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE DATEX-OHMEDA JOEL C KENT
K021376 07/24/2002 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE DATEX-OHMEDA JOEL C KENT
K022190 07/24/2002 MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM DEPUY ACROMED KAREN F JURCZAK
K021335 07/11/2002 MONARCH SPINE SYSTEM DEPUY ACROMED LISA GILMAN
K021499 07/24/2002 CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K022118 07/22/2002 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K021394 07/09/2002 DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K021869 07/01/2002 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP DIROS TECHNOLOGY, INC. LESLIE W ORGAN
K021356 07/16/2002 THE DIVACUP MENSTRUAL SOLUTION DIVA INTERNATIONAL INC FRANCINE CHAMBERS
K021959 07/11/2002 DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 DOLPHIN MEDICAL INC. JON WERNER
K021601 07/10/2002 MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER DUTECK INDUSTRIAL CO., LTD. YI-LANG LIN
K011329 07/26/2002 ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER E. BENSON HOOD LAB, INC. LEWIS MARTEN
K021903 07/10/2002 KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE EASTMAN KODAK COMPANY PATRICIA B LANZONI
K021829 07/02/2002 MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM EASTMAN KODAK COMPANY CAROL RYERSON
K022109 07/12/2002 EIZO, MODEL FC-2091 EIZO NANAO CORPORATION YUUICHI SEKI
K021385 07/12/2002 ATAC PAK BUN REAGENT ELAN DIAGNOSTICS WYNN STOCKING
K022119 07/25/2002 EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE ELECTRO MEDICAL SYSTEMS SA MARY MCNAMARA-CULLINANE
K021520 07/15/2002 EMT-CPAP EMERGENCY MEDICAL TECHOLOGY GREG HOLLAND
K020114 07/12/2002 3D KNEE ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K021881 07/29/2002 ENDIUS TITLE SPINAL FIXATION SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K013728 07/30/2002 TRACH VOX ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K020926 07/12/2002 EXTENSION SET, MODELS 1911-512 EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K022029 07/30/2002 QUINCKE SPINAL NEEDLE EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K022148 07/23/2002 INJEX 30 NEEDLE FREE INJECTION SYSTEM EQUIDYNE SYSTEMS, INC. JIM BARLEY
K020431 07/03/2002 FIBIOCORE EST. ANTHOGYR CLAUDE ANTHOINE
K021075 07/12/2002 MECHANICAL DAILY USE WHEELCHAIR FIRST WORLD SERVICES, INC. LEONARD FRIER
K021429 07/29/2002 HERPESELECT 1 ELISA IGG, MODEL EL0910G FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K021602 07/26/2002 FOSSA URETERAL STONE SWEEPER FOSSA INDUSTRIES, INC. PAMELA PAPINEAU
K013263 07/29/2002 FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST FRED HUTCHINSON CANCER RESEARCH CENTER SHELBY J HALL
K021318 07/02/2002 XIVE DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K021261 07/03/2002 SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 GALIL MEDICAL LTD. JONATHAN S KAHAN
K021990 07/18/2002 GALT MEDICAL GUIDEWIRE GALT MEDICAL CORP. DAVID CATLIN
K014255 07/02/2002 DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES THOMAS ENGLISH
K021780 07/29/2002 ADVANTAGE SIM 6.0 GENERAL ELECTRIC MEDICAL SYSTEMS LARRY A KROGER
K021366 07/03/2002 MAC-LAB/CARDIOLAB EP/COMBOLAB GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LISA LEE MICHELS
K021316 07/25/2002 ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR GENZYME CORP. BARABRA PIZZA
K021730 07/05/2002 GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) GLOVCO (M) SDN. BHD. TAN PENG HOCK
K021757 07/29/2002 CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET GOOD BIOTECH CORP. VICTOR CHIOU
K021882 07/11/2002 CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 GOOD BIOTECH CORP. VICTOR CHIOU
K021824 07/02/2002 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 GUIDANT CORP. MARTHA MURARI
K020585 07/13/2002 ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT GYRUS MEDICAL, INC. FREDERICK G MADES
K021525 07/12/2002 TOPCUT H.S. HOSPITAL SERVICE S.R.L. LUCIO IMPROTA
K021466 07/24/2002 CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K022049 07/19/2002 MODIFICATION TO RAICHEM CALCIUM REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K021194 07/29/2002 RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K011741 07/23/2002 CRIT-LINE MONITOR III TQA (CLM TQA) HEMAMETRICS MATTHEW L HAYNIE
K021314 07/02/2002 SCEPTRE-VS HITACHI MEDICAL SYSTEMS AMERICA, INC. ROBERT H MCCARTHY
K021998 07/12/2002 HORIZONS CYTOLOGY BRUSH HORIZONS INTL. CORP. RAFIC SALEH
K022077 07/25/2002 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K021911 07/02/2002 TRIDENT CROSSFIRE POLYUETHYLENE LINERS HOWMEDICA OSTEONICS CORP. DEBRA BING
K020042 07/30/2002 HYCARE LATEX EXAMINATION GLOVE, POWDER FREE HYCARE INTL. CO., LTD. JANNA P TUCKER
K020433 07/11/2002 FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER IDT TECHNOLOGY LIMITED JAMES J ROGERS
K021967 07/17/2002 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 IMPLEX CORP. ROBERT A POGGIE
K021970 07/12/2002 THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) IMPLEX CORP. ROBERT A POGGIE
K021437 07/19/2002 SECURE SOFT IMTEC CORP. BRAD VANCE
K021984 07/02/2002 PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT INCEPTIO MEDICAL TECHNOLOGIES, LC ROSINA ROBINSON
K021280 07/17/2002 INION HEXALON BIODEGRADABLE ACL/PCL SCREW INION LTD. HANNA MARTTILA
K021482 07/30/2002 QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K020399 07/02/2002 RESPERATE; MODEL RR-150 INTERCURE LTD. JONATHAN S KAHAN
K021636 07/17/2002 ALBUMIN REAGENT INTERSECT SYSTEMS, INC. JOAN CATHEY
K021322 07/24/2002 ENDOSSOUS IMPLANTS INTRA-LOCK INTERNATIONAL JEFFERY SAKOFF
K021638 07/26/2002 ILT ADVANCING MECHANISM, MODEL A115AMI INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K021243 07/11/2002 ILT TORQUER, MODEL 114TR1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K020386 07/02/2002 INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 INVACARE CORP. EDWARD A KNOLL
K021685 07/23/2002 VENTURE HOMEFILL II WITH OXYGEN CONSERVER INVACARE CORP. EDWARD A KROLL
K021358 07/05/2002 EMBRYO BIOPSY MEDIUM IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K021941 07/02/2002 SAMPLOK LUER KIT ITL CORPORATION, PTY LTD. WILIAM L MOBBS
K021892 07/25/2002 BRIGHT GOLD IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K022085 07/25/2002 J&S MEDICAL SENTRY URINE DIPSTICK CONTROL J & S MEDICAL ASSOC., INC. PAUL MACDONNELL
K021671 07/19/2002 JAS HDL CHOLESTEROL (AUTOMATED) REAGENT JAS Diagnostics, Inc. David Johnston
K021851 07/17/2002 DIGITAL CLINICAL THERMOMETER, MODEL KD-193 K-JUMP HEALTH CO., LTD. JONATHAN S KAHAN
K021660 07/25/2002 K-ASSAY LP(A) ASSAY KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K021438 07/16/2002 INSEMINATION CATHETER, MODEL 320301 LABOTECT LABOR-TECHNIK GOTTINGEN ANGELIKA ALBRECHT
K021831 07/01/2002 OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB LACRIMEDICS, INC. JERRY HENDERSON
K020021 07/02/2002 LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) LASERSCOPE PAUL HARDIMAN
K021164 07/01/2002 MACROPORE OS TRAUMA MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K020474 07/23/2002 MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 MAKRITE INDUSTRIES, INC. JOSEPH Z ZDROK
K022116 07/26/2002 ELPH INJECTION SYSTEM MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ELLIS ROGERS
K021231 07/30/2002 NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT MATRITECH, INC. MELODIE R DOMURAD
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K022083 07/16/2002 HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER THE BINDING SITE, LTD. JAY H GELLER
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K021844 07/19/2002 ADMIRA PROTECT VOCO GMBH GERALD W SHIPPS
K021842 07/29/2002 ADMIRA SEAL VOCO GMBH GERALD W SHIPPS
K021041 07/30/2002 WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES W.A. RUBBERMATE CO., LTD. LARA N SIMMONS
K021224 07/12/2002 ENDOCERVICAL BLOCK NEEDLE WALLACH SURGICAL DEVICES, INC. MICHAEL MALIS
K021681 07/23/2002 MICROPAQ, MODELS 402, 404 WELCH ALLYN PROTOCOL, INC. DON M ABBEY
K021124 07/02/2002 ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER WFR/AQUAPLAST CORP. J DAMON KIRK
K021926 07/25/2002 AUROPAL 60 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
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K011591 07/19/2002 ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE WILSON-COOK MEDICAL, INC. PAULA JOYCE
K020337 07/29/2002 READI-STRAND; MODEL PSSTRAND WORLDWIDE MEDICAL TECHNOLOGIES, LLC GARY LAMOUREUX
K021349 07/01/2002 METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K021346 07/02/2002 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX WRIGHT MEDICAL TECHNOLOGY, INC. ROGER D BROWN
K021119 07/05/2002 POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM WRP ASIA PACIFIC SDN. BHD. KK LEONG
K021159 07/03/2002 POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM WRP ASIA PACIFIC SDN. BHD. K. K LEONG
K021784 07/24/2002 PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K014119 07/25/2002 WU'S 3-WHEELED NEO SCOOTER, WT-M3 WU'S TECH CO., LTD. Ke-Min Jen
K013763 07/30/2002 WU'S 4-WHEELED NEO SCOOTER, WT-L4 WU'S TECH CO., LTD. JEN KE-MIN
K013926 07/18/2002 QIZHOU ACUPUNCTURE NEEDLE WUJIANG CITY SHENLI MEDICAL AND HEALTH MATERIAL CO GONG BO
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