FDA 510(k) Decisions During June, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K021445 06/06/2002 ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE AB BIODISK ANNE BOLMSTROM
K020866 06/11/2002 FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. DONNA K TEMPLEMAN
K012701 06/12/2002 ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) ACCUMETRICS, INC. RHONDA MOE
K021669 06/05/2002 PHYSICIAN'S DESKTOP REVIEW ADAC LABORATORIES COLEEN COLEMAN
K021518 06/06/2002 PAINDOC ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K021008 06/20/2002 ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K021423 06/17/2002 INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K012645 06/24/2002 REPROCESSED EBI EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. DON SELVEY
K012623 06/24/2002 REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL CORP. DON SELVEY
K012648 06/24/2002 REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. DON SELVEY
K012634 06/24/2002 REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL, INC. DON SELVEY
K014040 06/03/2002 FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS ALTUS MEDICAL, INC. KATHY MAYNOR
K021072 06/06/2002 FILMSAVER, NT VERSION 5.03 AMERICAN MEDICAL RESOURCES, LTD. (AMR) ELIZABETH N FAULSTICH
K011592 06/19/2002 OXYGEN TREATMENT HOOD AMRON INTERNATIONAL DIVING SUPPLY, INC. NORMA F OCKWIG
K021700 06/04/2002 ANIMUS EZSERTER INFUSION SET INSERTER ANIMAS CORP. RICHARD MICHELIN
K021754 06/28/2002 APEX MEDICAL DIGITAL EMS TS1311, TS1312 APEX MEDICAL CORP. ALAN CHANG
K021755 06/12/2002 APEX MEDICAL DIGITAL TENS TS1211, TS1212 APEX MEDICAL CORP. ALAN CHANG
K020296 06/25/2002 ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 APOTHECARY PRODUCTS, INC. GREG LARSON
K021412 06/07/2002 LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K021462 06/06/2002 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
K021567 06/19/2002 STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 ARROW INTL., INC. WILLIAM G MCLAIN
K021519 06/06/2002 ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K021640 06/19/2002 HANSATOME EXCELLUS MICROKERATOME BAUSCH & LOMB, INC. DENNIS POZZO
K020666 06/24/2002 DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML BAXTER HEALTHCARE CORP. ARLENE VIDOR
K014088 06/07/2002 DUPLOREACH BAXTER HEALTHCARE CORP. ARLENE VIDOR
K021535 06/27/2002 ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021532 06/27/2002 ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K020739 06/03/2002 BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR BCI, INC. DONALD J ALEXANDER
K021150 06/11/2002 COULTER CELLPREP BECKMAN COULTER, INC. LOURDES COBA
K021229 06/28/2002 MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 BECKMAN COULTER, INC. BRUCE BACKLUND
K020834 06/12/2002 BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LASLIE WOOD
K021801 06/27/2002 BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K020835 06/12/2002 CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 BIOLITEC, INC. JONATHAN S KAHAN
K013790 06/11/2002 CALCIGEN-S BONE VOID FILER BIOMET ORTHOPEDICS, INC. PATRICIA S BERES
K021799 06/26/2002 CEMENTED FEMORAL HEAD RESURFING DEVICE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K021832 06/26/2002 ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER BIOMET, INC. SARA B SHULTZ
K021559 06/05/2002 ASCENT ALL-POLY PS TIBIAL BEARINGS BIOMET, INC. DALENE T BINKLEY
K021621 06/05/2002 FIXED BEARING UNI COMPONENT BIOMET, INC. DALENE T BINKLY
K021260 06/05/2002 REDUCED SIZE ONCOLOGY SALVAGE SYSTEM BIOMET, INC. SARA B SHULTZ
K021930 06/25/2002 MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL BIONOSTICS, INC. KATHY STORRO
K021924 06/24/2002 MEDICA EASYQC HEMATOCRIT CONTROL BIONOSTICS, INC. KATHY STORRO
K020056 06/26/2002 DUET SUTURE ANCHOR BIONX IMPLANTS, LTD. TUIJA ANNALA
K021684 06/26/2002 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. CAROL E JONES
K014247 06/03/2002 TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 BIOSITE INCORPORATED JEFFREY R DAHLEN
K020821 06/03/2002 SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 BIOTRONIK, INC. Jon Brumbaugh
K021833 06/10/2002 MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM BLUE SKY BIO ALBERT ZICKMANN
K021721 06/20/2002 EQUALIZER BALLOON CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K021494 06/06/2002 GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K020860 06/06/2002 M3 (MICRO-MULTILEAF COLLIMATOR) BRAINLAB AG STEFAN VILSMEIER
K013032 06/04/2002 PHYSIOLOG, SERIES 95000 CAMTRONICS, LTD. SCOTT J PEASE
K020958 06/21/2002 CANDELA CBEAM PULSED DYE LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K021484 06/14/2002 HEMOGLOBIN A1C CONTROL CANTERBURY SCIENTIFIC LTD. MAURICE OWEN
K021160 06/12/2002 DERMMATRIX SURGICAL MESH CARBON MEDICAL TECHNOLOGIES, INC. KAREN E PETERSON
K013593 06/24/2002 CARDEON AEGIS CATHETER CARDEON CORP. JANE BEGGS
K020487 06/04/2002 CARESIDE ALT CARESIDE, INC. KENNETH B ASARCH
K021787 06/21/2002 VISUCAM CARL ZEISS OPHTHALMIC SYSTEMS, INC. DIONNE N LABATORE
K021704 06/06/2002 VAXCEL PICC WITH PASV VALVE TECHNOLOGY CATHETER INNOVATIONS, INC. ROGER L RICHINS
K020803 06/10/2002 CEFAR MEDICAL AB CEFAR PRIMO CEFAR MEDICAL AB CONSTANCE G BUNDY
K021129 06/03/2002 CHARE CARIOVASCULAR PATCH CHASE MEDICAL, INC. DAVE HERNON
K013733 06/03/2002 SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET CHF SOLUTIONS, INC. DIANNA THOMSEN
K021480 06/27/2002 EXTENSION SET LIGHT-SAFE, MODEL BC565 CODAN US CORP. MARILYN R POURAZAR
K020211 06/28/2002 BODY FORCE, MODEL BT 6000 COMPOSITES SOLUTIONS, INC. RANDY SISK
K021299 06/26/2002 CONMED HEATWAVE HAND-CONTROLLED ELETRODE CONMED CORP. IRA D DUESLER
K013814 06/21/2002 ABSORBENT ANTIMICROBIAL WOUND DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS DEMETRIOS KYDONIEUS
K010952 06/10/2002 SURGISIS GUIDED TISSUE REGENERATION MATRIX COOK BIOTECH, INC. MARK BLEYER
K021743 06/10/2002 (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW COPIOUMED INTL., INC. JANNA P TUCKER
K021345 06/28/2002 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM CORDIS CORP. KAREN WILK
K021593 06/13/2002 MODIFICATION TO ENVOY AND VISTA BRITE TIP CORDIS CORP. STEPHEN M ENOS
K020776 06/03/2002 MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS CORONET GROUP NORTH AMERICA, LLC. THOMAS E FERARI
K020980 06/21/2002 DIMENSION TPSA CALIBRATOR, MODEL #RC459 DADE BEHRING, INC. GEORGE M PLUMMER
K020410 06/11/2002 MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K021381 06/10/2002 MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 DADE BEHRING, INC. DONNA A WOLF
K020979 06/27/2002 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 DADE BEHRING, INC. REBECCA S AYASH
K021018 06/11/2002 MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021181 06/17/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021111 06/06/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021110 06/06/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021188 06/06/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021184 06/20/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021078 06/06/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020938 06/03/2002 MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K021169 06/06/2002 MICROSTREP PLUS PANEL, AZITHROMYCIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K013896 06/19/2002 SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA DEFIBTECH, LLC GINTARAS VAISNYS
K021378 06/07/2002 PORTABLE HDX INTRAORAL X-RAY DENTALEZ GROUP DEON BECK
K021879 06/26/2002 CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) DEPUY ACROMED LISA GILMAN
K021880 06/26/2002 CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) DEPUY ACROMED LISA GILMAN
K020753 06/13/2002 DEROYAL SURGICAL, UMBILICUP DEROYAL AUDREY DANIELS
K021257 06/03/2002 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K021695 06/20/2002 EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM EBI, L.P. PATRICIA M FLOOD
K021598 06/10/2002 ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. SHIRANTHA SAMARAPPULI
K021100 06/18/2002 300 PV COMPLETE ELECTROTHERAPY SYSTEM EMPI SHEILA HEMEON-HEYER
K020741 06/04/2002 UNICONDYLAR KNEE ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K021748 06/26/2002 ENDIUS ATAVI SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K021010 06/06/2002 MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE ENDOCARE, INC. EBEN GORDON
K020974 06/26/2002 BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER ENVIRONMENTAL TECTONICS CORP. MICHAEL W ALLEN
K020588 06/13/2002 X-IMAGE DIGITAL X-RAY SYSTEM ESCAPE TECHNOLOGY, INC. JAY CHOI
K020779 06/05/2002 PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS ETHICON ENDO-SURGERY, INC. DOUG KENTZ
K021715 06/12/2002 CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL EXACTECH, INC. GARY J MILLER
K021113 06/13/2002 MAMMOPATH FISCHER IMAGING CORP. SAMIR B PALIWAL
K013977 06/14/2002 ECHO-SCREEN T, TA, TD, TDA, TC FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. MICHAEL SOERENSEN
K020279 06/20/2002 FOREX CORPORATION, OPTIMA, SPINAL SYSTEM FOREX CORP. ROBERT MALONE
K021140 06/28/2002 FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT FOSSA INDUSTRIES, INC. GLORIA KOLB
K021109 06/12/2002 ESOP CO-CR FEMORAL HEADS FOURNITURES HOSPITALIERES ANDRE WEITH
K021030 06/25/2002 TITANIUM CANNULATED INTERFERENCE SCREW FUTURE MEDICAL SYSTEMS, INC. PATRICK JANIN
K021016 06/17/2002 AMX-4 PLUS MOBILE X-RAY SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K020560 06/19/2002 WORKBENCH BY GENX INTL., INC. MICHAEL D CECCHI
K021019 06/18/2002 COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE GENZYME CORP. MARY GRAY
K020205 06/24/2002 CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT GETINGE/CASTLE, INC. MARK N SMITH
K021353 06/06/2002 POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE GLORMED INTL., INC. JANNA P TUCKER
K020603 06/13/2002 CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 GOOD BIOTECH CORP. VICTOR CHIOU
K021043 06/21/2002 GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC GRAMSMED LLC ANTHONY J DIMERCURIO
K020891 06/17/2002 NAKAO SNARE II AND NAKAO SNARE III GRANIT MEDICAL INNOVATIONS NAOMI L NAKAO
K020987 06/25/2002 BMN I TYPE MARROW ASPIRATION NEEDLE H.S. HOSPITAL SERVICE S.R.L. LUCIO IMPROTA
K021605 06/14/2002 MEDGEM HEALTHETECH, INC. GLENN M THIBAULT
K021706 06/21/2002 HORIZONS HOT BIOPSY FORCEPS HORIZONS INTL. CORP. RAFIC SALEH
K020772 06/05/2002 OMEGA II SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K020830 06/06/2002 SCORPIO INSET PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K021744 06/26/2002 T2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K011866 06/06/2002 OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES HYPERBARIC TECHNOLOGIES, INC. DAVE HEANEY
K013213 06/04/2002 HYPERION VISIQUANT ANA TEST KIT HYPERION, INC. RADHA GOOLABSINGH
K020729 06/04/2002 NLITE SYSTEM,MODEL A00-1051 ICN PHOTONICS LTD. IAN MORTIMER
K021252 06/17/2002 BLOOD-PRESSURE METER IDT TECHNOLOGY LIMITED LILY LI
K020855 06/04/2002 IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT IGEL VISION CARE PTE LTD. DEBBIE MCINTIRE
K014018 06/24/2002 CHOLESTEROL 1, 2, 3 IMI THOMAS M TSAKERIS
K021586 06/14/2002 SECURE RELINE/PICKUP MATERIAL IMTEC CORP. BRAD VANCE
K021036 06/26/2002 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 INTUITIVE SURGICAL, INC. DAVID CASAL
K021680 06/18/2002 INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 INVACARE CORP. RAE ANN FARROW
K010156 06/19/2002 SLEEP PAT 200 DEVICE ITAMAR MEDICAL (C.M.) 1997 LTD. GEORGE H MYERS
K021017 06/19/2002 LEESPEC DISPOSABLE VAGINAL SPECULUM ITL CORPORATION, PTY LTD. WILLIAM L MOBBS
K014183 06/12/2002 AFB (ABSORBABLE FOAM BUTTRESS) J&J CORPORATE BIOMATERIALS CENTER DAVID A DALESSANDRO
K021372 06/07/2002 VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY J. MORITA USA, INC. KEITH A BARRITT
K021050 06/26/2002 KSEA NEUROENDOSCOPES AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K012308 06/26/2002 KAVO QUATTROCARE KAVO AMERICA JOHN WESTERMEIER
K020764 06/03/2002 NAVIPRO KINAMED, INC. VINEET K SARIN
K021427 06/07/2002 CLEARFIL SA PRIMER KURARAY MEDICAL INC. MASAYA SASAKI
K021943 06/28/2002 ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. JOHN E HUGHES
K003720 06/27/2002 ANGEL OF WATER COLON HYDROTHERAPY SYSTEM LIFESTREAM PURFICATION SYSTEMS, LLC. RICHARD A HAMER
K020395 06/04/2002 AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) Lin-Zhi International, Inc. CHIU CHIN CHANG
K021449 06/18/2002 CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. CHIN CHIN CHANG
K020368 06/04/2002 OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) Lin-Zhi International, Inc. CHIU CHIN CHANG
K013131 06/11/2002 BIOSCREW XTRALOK LINVATEC CORP. LAURA D SENEFF
K020880 06/10/2002 MARKNEW PRODUCTS ACUPUNCTURE NEEDLES MARKNEW PRODUCTS GREG HOLLAND
K020971 06/06/2002 DCM 2.0 MDS NORDION AB E. S MARTELL
K021004 06/06/2002 VALVED PEELABLE INTRODUCER MEDAMICUS, INC. KARYL HASKELL
K020996 06/24/2002 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL MEDEFIL, INC. PRADEEP AGGARWAL
K020999 06/20/2002 MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL MEDEFIL, INC. PRADEEP AGGARWAL
K021433 06/13/2002 MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL MEDICAL ADVANCES, INC. JERRY FROHLICH
K021168 06/26/2002 JUMP START, MODEL 970300 MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K020382 06/28/2002 BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA MEDICOTEST A/S EMALEE G MURPHY
K020907 06/14/2002 NEUROLINE, SUBDERMAL NEEDLE ELECTRODES MEDICOTEST A/S EMALEE G MURPHY
K012969 06/12/2002 DOUBLE SPRINGERS NONOXNOL 9 CONDOM MEDTECH PRODUCTS LTD. A. V. K. REDDY
K013962 06/20/2002 EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K021066 06/18/2002 MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K021305 06/28/2002 MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K013297 06/14/2002 AIRCAST, MODEL #3011 MILLENIUM REPROCESSING SERVICES, INC. GARY J SFEIR
K020791 06/06/2002 HBS HEADLESS BONE SCREW MILLENNIUM MEDICAL TECHNOLOGIES, INC. DAVID W SCHLERF
K021373 06/27/2002 H12+HOLTER RECORDER MORTARA INSTRUMENT, INC. HARLAN L VAN MATRE
K020850 06/06/2002 GPF-29 GENERAL PURPOSE COIL SET MRI DEVICES CORP. DAVID A MOLYNEAUX
K021570 06/12/2002 HNC-127-TRIO NEUROVASCULAR ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K021575 06/12/2002 OBC-127 BREAST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K021811 06/19/2002 UNIDRIVE II PLUS DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GMBH JAMES A LEE
K014282 06/26/2002 BACSTOP FILTER,BACSTOP FILTER/HME MUNKTELL FILTER AB PAUL DRYDEN
K014281 06/26/2002 GARD FILTER, COMBIGARD FILTE / HME MUNKTELL FILTER AB PAUL DRYDEN
K021089 06/19/2002 OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR NELLCOR PURITAN BENNETT, INC. GINA TO
K021144 06/24/2002 SUBDURAL STRIP ELECTRODE NICOLET BIOMEDICAL, INC. Gary Syring
K013309 06/24/2002 GLUCOPRO EVO INFUSION PUMP NIPRO DIABETES SYSTEMS, INC. KAELYN B HADLEY
K014114 06/26/2002 GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX NIPRO DIABETES SYSTEMS, INC. KAELYN B HADLEY
K021584 06/05/2002 REPLACE SCALLOPED MARGIN IMPLANT SYSTEM NOBEL BIOCARE UAS INC RICHARD T ROSS
K020297 06/10/2002 STAT PROFILE CRITICAL CARE XPRESS ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K021823 06/17/2002 CARDIOSPECT D90/CARDIO CAM NUCLEAR CARDIOLOGY SYSTEMS, INC. CHARLIE H ROSE
K021656 06/13/2002 HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 NUCLEAR DIAGNOSTICS JAN BERTLING
K020853 06/13/2002 NUVASIVE MESH NUVASIVE, INC. LAETITIA BERNARD
K021288 06/27/2002 ORS-1000LD O.R. SOLUTIONS, INC. STEVE HANNES
K021289 06/26/2002 WARMER 2000LD O.R. SOLUTIONS, INC. STEVE HANNES
K013613 06/27/2002 SOFT PLUG ABSORBABLE PLUG-SA OASIS MEDICAL, INC. JAMES CHRISTENSEN
K020389 06/04/2002 BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS OCULAR SCIENCES RICHARD E LIPPMAN
K020335 06/18/2002 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 OLYMPIC MEDICAL CORP. EDWARD B (TED) WEILER
K021886 06/19/2002 OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K014166 06/25/2002 UHI-3 HIGH FLOW INSUFFLATION UNIT OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K020800 06/10/2002 OPTAX SYSTEM OPTAX SYSTEMS, INC. DEBBIE IAMPIETRO
K021502 06/06/2002 OSCAR, MODEL OE3000 ORTHOSONICS, LTD. T. WHIT ATHEY
K020896 06/14/2002 OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE OSYPKA MEDICAL, INC. MARKUS J OSYPKA
K013041 06/11/2002 PLEXOLONG SETS PAJUNK GMBH BURK A BRANDT
K020941 06/19/2002 PALOMAR LUXG HANDPIECE PALOMAR Marcy Moore
K020717 06/13/2002 EBV V VCA IGM ELISA KIT MODEL# EBM-200 PAN BIO PTY. LTD. HELEN JERNNINGS
K020707 06/13/2002 EBV-EBNA IGG ELISA KIT, MODEL EBG-100 PAN BIO PTY. LTD. HELEN JENNINGS
K020706 06/13/2002 EBV-VCA IGG ELISA TEST, MODEL EBG-100 PAN BIO PTY. LTD. HELEN JENNINGS
K021420 06/04/2002 PARACON II/FECAL CONCENTRATOR II PARA SCIENTIFIC CO. ERIC CARLSON
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