FDA 510(k) Decisions During April, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K011524 04/10/2002 IMMEDIATE STABILIZING DEVICE (ISD) "O" CO., INC. DAVID D DALISE
K020589 04/22/2002 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE 3M COMPANY JOANN L HUEHN
K020946 04/04/2002 ADPER PROMPT 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K020394 04/12/2002 APC PLUS ADHESIVE 3M UNITEK MARLYN SCHEFF
K020748 04/29/2002 ETEST ERTAPENEM AB BIODISK ANNE BOLMSTROM
K020294 04/22/2002 MOTION TRACKING ACCURAY, INC. DONALD E CADDES
K021015 04/26/2002 ACIST PLUS 4 ANGIOGRAPHIC CATHETER ACIST MEDICAL SYSTEMS CARL M BEAURLINE
K020951 04/16/2002 H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 ACKRAD LABORATORIES RICHARD HETTENBACH
K020954 04/24/2002 H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY ACKRAD LABORATORIES RICHARD HETTENBACH
K020376 04/09/2002 AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE ADVANCED HEALTHCARE LTD. PERRY KASHFIAN
K020728 04/05/2002 MIETHKE SHUNT SYSTEM AESCULAP, INC. JOYCE KILROY
K013569 04/04/2002 ORTHOPILOT 2 AESCULAP, INC. GEORG KELLER
K020592 04/03/2002 ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 ALBA-WALDENSIAN, INC. DAVID BOWMAN
K013637 04/16/2002 ACTICHROME HEPARIN (ANTI-FIIA) AMERICAN DIAGNOSTICA, INC. JOHN BERRYMAN
K020570 04/24/2002 SIMPLICITY APEX DENTAL MATERIALS, INC. CHRIS KULTON
K020435 04/15/2002 WOUND PROTECTOR/RETRACTOR APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K020838 04/23/2002 ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) AR ALLIANCE HEALTHCARE SDN. BHD. CHAU CHOON CHUAN
K020024 04/03/2002 CARIS MINITOME BIOPSY INSTRUMENT ARTEMIS MEDICAL, INC. ALLAN L ABATI
K020043 04/02/2002 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B ARTHREX, INC. ANN WATERHOUSE
K020832 04/09/2002 ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K020919 04/19/2002 ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 ATRICURE, INC. MARK L FRIEDMAN
K020333 04/25/2002 ATRION MEDICAL QL FLUID DISPENSING SYRINGE ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K020767 04/03/2002 ADVANTA SST BIFURCATED GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K013672 04/08/2002 BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM AZARY TECHNOLOGIES LLC. JOSEPH M AZARY
K020061 04/03/2002 IMAGEDESK BARCO NV FRANK FERGUSON
K020058 04/04/2002 MEDICAL LE BARCO NV FRANK FERGUSON
K020059 04/03/2002 MFCD 118I BARCO NV FRANK FERGUSON
K013762 04/03/2002 RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB INCORPORATED DEBRA L.B. KETCHUM
K020210 04/30/2002 GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED) BAYER GROUP DIAGNOSTICS GEORGE M TANCOS
K020208 04/29/2002 GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) BAYER GROUP DIAGNOSTICS GEORGE M TANCOS
K020350 04/30/2002 BCI 3180 PULSE OXIMETER BCI, INC. DONALD ALEXANDER
K013621 04/16/2002 BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K014123 04/19/2002 BACTEC MGIT 960 SIRE KITS BECTON, DICKINSON & CO. JODY J HOFFMANN
K020323 04/04/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. BRADFORD M SPRING
K003896 04/24/2002 LYMPHA VISION-EXPERT BEXLEY TRADING, INC. MICHAEL ZMUDA
K020878 04/15/2002 LYPHOCHEK HEMOSTASIS, MODELS 798, 799 BIO-RAD MARIA ZEBALLOS
K020610 04/22/2002 LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 BIO-RAD YVETTE LLOYD
K020817 04/12/2002 LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K020099 04/11/2002 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC. CAROL J MORELLO
K020813 04/17/2002 BACT/ALERT FA CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020815 04/18/2002 BACT/ALERT FN CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020923 04/18/2002 BACT/ALERT PF CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020931 04/18/2002 BACT/ALERT SA CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K021123 04/26/2002 BACT/ALERT SN CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020221 04/02/2002 IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET BIOMET ORTHOPEDICS, INC. LOMNIE WITHAM
K020905 04/15/2002 NBX - NON-BRIDGING EXTERNAL FIXATOR BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K020963 04/16/2002 TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K020819 04/22/2002 DISTAL RADIUS PLATING SYSTEM BIOMET, INC. MARY VERSTYNEN
K020970 04/04/2002 MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) BIOMET, INC. TRACY J BICKEL
K020761 04/03/2002 POWER TEK II BIOMET, INC. PATRICIA S BERES
K012221 04/03/2002 SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K014168 04/25/2002 AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) BIOSOUND ESAOTE, INC. COLLEEN H DENSMORE
K021029 04/12/2002 ABP-2000 G-3 BIOTRAC, INC. JAIME GUTTMAN
K010281 04/09/2002 MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP BIOTRONIK, INC. JON BRUMBAUGH
K020746 04/22/2002 BIRD TBIRD VELA VENTILATOR BIRD PRODUCTS CORP. TOM GUTIERREZ
K020674 04/03/2002 BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K020079 04/19/2002 BLADEWORKS MICROKERATOME BLADE, MODEL 7061 BLADE WORKS, INC. MARK MOYER
K020110 04/03/2002 MODIFICATION TO TRELEX MESH SURGICAL MESH BOSTON SCIENTIFIC DONNA M GARDNER
K021046 04/16/2002 COBRA COOLED SURGICAL PROBE, MODEL 1596X BOSTON SCIENTIFIC CORP. SUSAN POOL
K020765 04/05/2002 MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K021213 04/19/2002 MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K020824 04/12/2002 SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K020988 04/04/2002 PAIN CARE 4200 BREG, INC. KATHLEEN BARBER
K021055 04/29/2002 BUSSE UMBILICAL CORD CLAMP CUTTER BUSSE HOSPITAL DISPOSABLES, INC. JOSEPH M AZARY
K020682 04/02/2002 BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. CAROL VIERLING
K013776 04/26/2002 MICROJET MODEL # CD4 AND CD4/20 CANE S.R.I. DANIEL KAMM
K013234 04/26/2002 MICROJET CRONO CANE SRL DANIEL KAMM
K020825 04/05/2002 KING OF HEARTS EXPRESS + AF MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALDEN KAY
K020366 04/30/2002 GLOBAL ECG MANAGEMENT SYSTEM (GEMS) CARDIOCOMM SOLUTIONS, INC. ANGELA HALWAS
K012325 04/09/2002 CARDIOVENTION CORX SYSTEM, MODEL FG 0001 CARDIOVENTION, INC. TESSA YAMUT
K020488 04/15/2002 CARESIDE TRGLYCERIDE CARESIDE, INC. KENNETH B ASARCH
K020292 04/17/2002 UTERINE INJECTOR CATHETER RESEARCH, INC. JOHN A STEEN
K020242 04/17/2002 EMULATE FAST SET AND EMULATE REGULAR SET CAVEX HOLLAND B.V. RICHARD WOORTMAN
K020695 04/19/2002 QAB2A IGG ELISA KIT CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K020694 04/19/2002 QAB2A IGM ELISA KIT CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K020268 04/25/2002 ISAAC 1.5 T MR SYSTEM CHI, INC. T. WHIT ATHEY
K013204 04/03/2002 AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION STEVEN DOWDLEY
K020139 04/09/2002 FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN CIBA VISION CORPORATION ALICIA M PLESNARSKI
K012214 04/26/2002 CRYOPEN AND ACCESSORIES CIMEX BIOTECH, LLC. MICHAEL HAAS
K012758 04/09/2002 URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, CIRCON VIDEO WAYNE STERNER
K011880 04/17/2002 COMPEX SPORT COMPEX S.A. ANSIS M HELMANIS
K020135 04/12/2002 CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 CONMED CORP. CHARLES M HART
K020186 04/12/2002 CONMED SYSTEM 5000 ESU CONMED CORP. CHARLES M (MIKE) HART
K020654 04/09/2002 STRATASIS SLING KIT COOK BIOTECH, INC. MARK BLEYER
K013597 04/17/2002 TAMPONADE UTERINE BALLOON CATHETER SET COOK OB/GYN CINDY RUMPLE
K010128 04/25/2002 COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE COOK VASCULAR, INC. THOMAS J KARDOS
K013865 04/22/2002 TIP DEFLRCTING ENDOBRONCHIAL BLOCKER COOK, INC. LISA HOPKINS
K020392 04/26/2002 FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR COOPERVISION, INC. BONNIE TSYMBAL
K020809 04/12/2002 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT CORDIS CORP. DONNA MARSHALL
K013169 04/02/2002 IMMUNE CELL FUNCTION ASSAY CYLEX, INC. JUDI SMITH
K020319 04/17/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020397 04/22/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020691 04/30/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020686 04/30/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020626 04/26/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020556 04/26/2002 MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020506 04/17/2002 MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) DADE MICROSCAN, INC. MAUREEN MENDE
K013210 04/04/2002 TRUWAVE DAN MED, INC. THOMAS SANDGAARD
K020257 04/24/2002 DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S DATASCOPE CORP. JOANN WOLF
K020206 04/11/2002 INTRAORAL CAMERA ME-15 DENT CORP. RESEARCH & DEVELOPMENT DAVID ABELDA
K020697 04/12/2002 DEPILASE TWIN YAG LASER SYSTEM DEPILASE GROUP LTD. MARIO RUSSO
K020230 04/23/2002 DIASOL-BICARB DIASOL, INC. MONICA ABELES
K020997 04/04/2002 APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.P.A. BARRY SALL
K020468 04/16/2002 CHIN ELECTRODE DYMEDIX, INC. GARY SYRING
K013471 04/29/2002 "DELTA 2000" SERIES EXTRACORPOREAL LITHOTRIPTER E.S.W.L. PRODUCTS, INC. DANIEL KAMM
K020448 04/12/2002 STATIC CRANIOPLASTY ORTHOSIS EASTERN CRANIAL AFFILIATES JOSEPH TERPENNING
K020681 04/03/2002 EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. PATRICIA FLOOD
K013088 04/04/2002 ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS ECHOTECH 3D IMAGING SYSTEMS, INC. KEVIN MORNINGSTAR
K020918 04/19/2002 ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. SHIRANTHA SAMARAPPULI
K002578 04/11/2002 AXILLARY ACCESS ARTERIAL CANNULA EDWARDS LIFESCIENCES, LLC. KAREN JONES
K020864 04/17/2002 EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 EDWARDS LIFESCIENCES, LLC. SUSAN REYNOLDS
K020995 04/12/2002 EFILM WORKSTATION WITH MODULES EFILM MEDICAL, INC. JOSEPH A THOMAS
K020575 04/12/2002 ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS ELAN DIAGNOSTICS WYNN STOCKING
K013122 04/19/2002 EMS ELECTROSTATIC FLITER AND HME COMBINATION ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K013349 04/09/2002 ASTRONOMER PLUS SYSTEM EP TECHNOLOGIES, INC. ANDREA L RUTH
K020276 04/12/2002 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 ETHICON ENDO-SURGERY, INC. GEORGE C ABERNATHY
K020530 04/29/2002 EVANS SUB-Q, MODEL MC4206 EVANS MEDICAL, INC. DANIEL KAMM
K013067 04/09/2002 FRIALOC DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K020933 04/04/2002 GARAVENTA SUPER-TRAC TRE-52 GARAVENTA ACCESSIBILITY NORM COOPER
K020578 04/26/2002 GC FUJI ORTHO BAND PASTE PAK GC AMERICA, INC. TERRY L JORITZ
K020929 04/03/2002 SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 GE MEDICAL SYSTEMS
K021049 04/17/2002 OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM GE OEC MEDICAL SYSTEMS BILL GISLASON
K020789 04/04/2002 GE VIVID 3 EXPERT; GE VIVID 3 PRO GENERAL ELECTRIC CO. ALLEN SCHUH
K020106 04/10/2002 VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER GISH BIOMEDICAL, INC. JAMES H KNAUSS
K021052 04/09/2002 MODEL GT010706 ELECTRONIC THERMOMETER GLOBAL TREASURE INDUSTRIES LTD.
K021028 04/08/2002 MODEL GT980201 ELECTRONIC THERMOMETER GLOBAL TREASURE LTD. BEN MA
K020363 04/10/2002 GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) GREAT GLOVE SDN BHD NOOR AKILAH
K020067 04/04/2002 GYRUS ENT SOMNOPLASTY GENERATOR GYRUS ENT L.L.C. JEFFREY W COBB
K013108 04/04/2002 BIOSUC HAKKO MEDICAL CO., LTD. MSHIRO KITAGAWA
K020307 04/26/2002 LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112 HAKKO SHOJI CO., LTD. ELIZABETH MILLER
K020252 04/05/2002 SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 HARVEST TECHNOLOGIES, CORP. JOHN D BONASERA
K020153 04/15/2002 CONSENSUS ACETABLAR SHELL, TI COATED HAYES MEDICAL, INC. WILLIAM J GRIFFIN
K020766 04/05/2002 HL168F HEALTH & LIFE CO., LTD. SUSAN CHEN
K013253 04/05/2002 HISONIC-TRD TINNITUS RELIEF DEVICE HEARING INNOVATIONS, INC. GERARD J PRUD'HOMME
K020935 04/03/2002 HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 HEMOCUE, INC. R.J. SLOMOFF
K020184 04/22/2002 HOMMED CENTRAL STATION HOMMED LLC. TOMMIE J MORGAN
K014025 04/09/2002 HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER HOMMED LLC. TOMMIE J MORGAN
K021197 04/26/2002 SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16" HOSUK CO., LTD. CAROLE STAMP
K021136 04/19/2002 TEKNIQUE-HOVEROUND POWER WHEEL CHAIR HOVEROUND CORP. TONY DIGIOVANNI
K013106 04/03/2002 2 PIECE MODULAR HIP STEM HOWMEDICA OSTEONICS CORP. WILLIAMR J CYMBALUK
K020841 04/11/2002 AVON PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K020773 04/04/2002 LONG LENGTH GAMMA NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K021026 04/25/2002 S2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K021027 04/25/2002 S2 TIBIAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K020989 04/26/2002 SUPER EON PLUS FEMORAL STEMS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K020390 04/19/2002 MODIFICATION TO FETAL ASSIST HUNTLEIGH DIAGNOSTICS LTD. AUDREY WITKO
K020688 04/03/2002 HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR HYDROCISION, INC. DEBBIE IAMPIETRO
K012417 04/08/2002 HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012654 04/12/2002 HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012651 04/12/2002 HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012956 04/11/2002 HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012657 04/12/2002 HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K012650 04/12/2002 HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K020387 04/17/2002 MYALLERGYTEST SYSTEM IMMUNETECH CORPORATION VIVIANNE NOETZEL
K020396 04/10/2002 BIOCELLECT -PERIO IMTEC CORP. M.K. PATTERSON
K020414 04/29/2002 QUANTA LITE CCP ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K011986 04/03/2002 SAFE-STEER GUIDE WIRE SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA L MISAJON
K020253 04/17/2002 4 ALL (DW286A) IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K020454 04/08/2002 CHEMISTRY CALIBRATOR JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K020499 04/22/2002 BOND-3 ADHESIVE JENERIC/PENTRON, INC. ANNMARIE TENERO
K020854 04/11/2002 MODIFICATION TO FOX PTA CATHETER JOMED AG CHRISTINA KICHULA
K020515 04/24/2002 JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA JOSTRA AG KATHLEEN JOHNSON
K011793 04/17/2002 KSEA FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K020303 04/19/2002 XR PRIMER 2 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K020325 04/15/2002 L.A.M. IPM WOUND GEL L.A.M. PHARMACEUTICAL, CORP. CLAWSON BOWMAN
K020769 04/03/2002 SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. CHIU CHIN CHANG
K013369 04/04/2002 RESECTION ABLATOR LINVATEC CORP. LAURA D SENEFF
K020289 04/24/2002 MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS MACHNET BV DANIEL KAMM
K021155 04/29/2002 MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K020911 04/29/2002 MID LABS AUTONOMOUS VIT ENHANCER (AVE) MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. LINDA M UPTON
K020147 04/03/2002 MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP MEDTRONIC PERFUSION SYSTEMS LUCY TAN
K013517 04/25/2002 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 MEDTRONIC VASCULAR KRISTY K MOLLNER
K021077 04/17/2002 MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K020176 04/08/2002 HDR MIAMI APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K021139 04/17/2002 TRULINE REINFORCED VALVED INFUSION CATHETER MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K013988 04/04/2002 MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R MILLIPORE CORP. THOMAS BORROWS
K020546 04/26/2002 FUSION 7D MIRADA SOLUTIONS LTD. ROGER W BARNES
K020894 04/29/2002 CALIBRATING MATERIAL, CAL-PAK, BUFFERS MISSION DIAGNOSTICS LINDA STUNDTNER
K020548 04/05/2002 FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 MONOBIND JAY SINGH
K020327 04/08/2002 SURGIC IV IMPLANT CONTROL UNIT NAKANISHI, INC. HIROJI SEKIGUCHI
K020604 04/23/2002 WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 NELLCOR PURITAN BENNETT, INC. GINA TO
K020913 04/03/2002 CT-C3000 SPIRAL CT SCANNER SYSTEM NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD. WANG ZHIQIANG
K013281 04/18/2002 VERSALAB APM NICOLET BIOMEDICAL DAVID W WAGNER
K020955 04/17/2002 NICOLET ELECTROCAUTERY DETECTOR NICOLET BIOMEDICAL, INC. GARY SYRING
K020218 04/22/2002 SNAP EEG MONITOR NICOLET BIOMEDICAL, INC. GARY SYRING
K014274 04/17/2002 NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 NIDEK, INC. CAROL PATTERSON
K020858 04/17/2002 NXSTAGE THERAPY SYSTEM NXSTAGE MEDICAL, INC. NORMA LEMAY
K020690 04/26/2002 OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K020601 04/24/2002 FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL ODIN MEDICAL TECHNOLOGIES LTD. ADI ICKOWICZ
K013428 04/04/2002 MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM OHIO MEDICAL INSTRUMENT CO., INC. DONALD A LINCOLN
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K011710 04/02/2002 OXOID PBP2 1 LATEX AGGLUTINATION TEST OXOID, LTD. A. HOLLINGSWORTH
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K013310 04/25/2002 PVS BASIC 2; EPIC 2 PARAGON VISION SCIENCES WILLIAM E MEYERS
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K020555 04/22/2002 SONATA MICRO HYBRID COMPOSITE PENTRON LABORATORY TECHNOLOGIES ANNMARIE TENERO
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K020447 04/12/2002 MITYVAC MERLIN, MODEL 10027 PRISM ENTERPRISES, INC. HOWARD M HOLSTEIN
K013905 04/22/2002 MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS PRO-TECH SERVICES, INC. NEIL SHELLER
K020287 04/12/2002 DENTITION INTEGRATING MATERIAL PULPDENT CORPORATION KENNETH J BERK
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K020481 04/17/2002 PULPDENT POST CEMENT PULPDENT CORPORATION KENNETH J BERK
K013715 04/01/2002 RE-USABLE STERILIZATION POUCH / BAG QUALITY PRODUCTS OF MONTANA LARRY LARSON
K020072 04/09/2002 ATHOS LASER QUANTEL MEDICAL ROGER W BARNES
K020071 04/05/2002 VIRIDIS DERMA LASER QUANTEL MEDICAL ROGER W BARNES
K020219 04/12/2002 RPI SKIN OR AIR TEMPERATURE PROBE REPLACEMENT PARTS INDUSTRIES, INC. IRA LAPIDES
K011068 04/11/2002 RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L RHIGENE, INC. DAVID KOLESAR
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K020740 04/16/2002 ROCHE ONLINE THEOPHYLLINE ROCHE DIAGNOSTICS CORP. MIKE FLIS
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K003916 04/15/2002 DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM SCANDIA MANUFACTURING LTD. RONALD E BERGLUND
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K020868 04/22/2002 CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) SEAL POLYMER INDUSTRIES BHD. CHUN CHOOI FONG
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K014089 04/25/2002 VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES SUN BIOMEDICAL LABORATORIES, INC. MING SUN
K020495 04/23/2002 INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL SURGI-VISION, INC. NANCY E TAYLOR
K020940 04/17/2002 SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X SUTURA, INC. JAMES BONDS
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K020517 04/15/2002 SYNTHES DUAL-OPENING USS SYNTHES (USA) VIKKI M HOFFMAN
K020505 04/23/2002 SYNTHES TRANSLATING MAXILLARY DISTRACTOR SYNTHES (USA) MATTHEW H HULL
K020152 04/16/2002 SYNTHES VERTEBRAL SPACER TI SYNTHES (USA) JONATHAN GILBERT
K020244 04/22/2002 SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) SYNTHES SPINE VIKKI M HOFFMAN
K020496 04/12/2002 HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY SYSMEX CORPORATION OF AMERICA NINA GAMPERLING
K020705 04/26/2002 SIIS#1 TISSUE SUSPENSION SYSTEM TAG MEDICAL PRODUCTS DAN MOOR
K013300 04/16/2002 MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM TECHNOLOGY DELIVERY SYSTEMS, INC. DAVID W SCHLERF
K020455 04/03/2002 TISSUEMEND SOFT TISSUE REPAIR MATRIX TEI BIOSCIENCES INC. KENNETH JAMES
K020998 04/04/2002 SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY COURTNEY
K020089 04/10/2002 MAHURKAR TRIPLE LUMEN CATHETER, 12 FR THE KENDALL COMPANY REGINA YEH
K012803 04/08/2002 AL-2000 COMBINED BIOMETER AND PACHYMETER TOMEY CORP. MAUREEN O'CONNELL
K020151 04/10/2002 UD-1000 ULTRASONIC A/B SCANNER TOMEY CORP. USA MAUREEN O'CONNELL
K013363 04/02/2002 CROSSPOINT TRANSACCESS CATHETER TRANS VASCULAR INCORPORATED STEVE JWANOUSKOS
K013848 04/08/2002 U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 U-SYSTEMS, INC. SHEILA W PICKERING
K020134 04/15/2002 SPIRAL RADIUS 90-D RODDING SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER SCHUCK
K020568 04/30/2002 AKUPORT M-2 VIBRANT HEALTH STEPHEN EMOND
K020565 04/30/2002 EAV COMBI-2 VIBRANT HEALTH STEPHEN EMOND
K020564 04/30/2002 EAV KINDLING 2000S GSR DEVICE VIRBRANT HEALTH STEPHEN EMOND
K011903 04/12/2002 LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE VIVOMETRICS, INC. KEITH GILROY
K021359 04/30/2002 DIGI-PRO TENS MODEL WL-2203 AND WL-2205 WELL-LIFE HEALTHCARE, INC. TONY C.S. CHANG
K020314 04/30/2002 DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 WELL-LIFE HEALTHCARE, INC. TONY C.S. CHANG
K020347 04/24/2002 AGC SPEZIALLEGIERUNG WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K011510 04/02/2002 MULTI HI-FLO PNEU, WISAP #7080 WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH HORST SEMM
K021048 04/22/2002 THERMOMETER MODELS ST8631 Z7 INTERNATIONAL PHIL ZULUETA
K021103 04/24/2002 MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K011541 04/11/2002 ZOLL PAD WITH CPR AID ZOLL MEDICAL CORP. PAUL DIAS


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