FDA 510(k) Applications Received During September, 2002

FDA 510(k) Number Submission Date Device Name Applicant Contact
K023033 09/12/2002 ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) INTL., INC. MICHAEL D CECCHI
K022973 09/06/2002 ADHESIVE 14 AB ARDENT CLYDE E INGERSOLL
K022975 09/06/2002 ETCHING 15 AB ARDENT CLYDE E INGERSOLL
K022972 09/06/2002 MICROFILL 13 AB ARDENT CLYDE E INGERSOLL
K022971 09/06/2002 MICROHYBRID 11 AB ARDENT CLYDE E INGERSOLL
K022974 09/06/2002 MICROHYBRID 12 AB ARDENT CLYDE E INGERSOLL
K022941 09/03/2002 MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING ABBOTT LABORATORIES JOSEPH MAGLIOZZI
K023256 09/30/2002 PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO ABBOTT LABORATORIES JANET CONNOLLY
K023062 09/16/2002 GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT ABBOTT LABORATORIES INC FRANK POKROP
K023060 09/13/2002 ACCULASER PRO4 ACCULASER, INC. PATSY J TRISLER
K022896 09/03/2002 CSV12 SOFTWARE VIEWER ACUSON CORP. BOB LEIKER
K023037 09/12/2002 MID STREAM PREGNANCY TEST ADVANCED DIAGNOSTICS, INC. D.M. CHOUHAN
K023010 09/09/2002 SNIFF POSITION PILLOWS/POPITZ PILLOWS AEOLUS INTERNATIONAL CORPORATION MICHAEL D POPITZ
K022942 09/05/2002 CRANIOCUT AESCULAP, INC. GEORG KELLER
K023212 09/26/2002 AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS AG GARMENTS ATHENA SHUDDE
K023020 09/11/2002 AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE AGFA CORP. PAMELA K GWYNN
K023264 09/30/2002 MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K023249 09/30/2002 ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM ALCON LABORATORIES, INC. CHRISTY STEVENS
K022915 09/03/2002 INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K023167 09/23/2002 BREATHABLE SURGICAL GOWN ALLEGIANCE HEALTHCARE CORP. SHARON NICHOLS
K023170 09/23/2002 NITRILE POWDER-FREE EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K023104 09/18/2002 AMEDICA DRUG SCREEN AMPHETAMINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K022954 09/05/2002 AMEDICA DRUG SCREEN COCAINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023101 09/18/2002 AMEDICA DRUG SCREEN METHAPHETAMINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023047 09/12/2002 AMEDICA DRUG SCREEN OPIATES TEST AMEDICA BIOTECH, INC. Jeff Chen
K023109 09/18/2002 AMEDICA DRUG SCREEN PHENCYCLIDINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K022955 09/05/2002 AMEDICA DRUG SCREEN THC TEST AMEDICA BIOTECH, INC. Jeff Chen
K023126 09/19/2002 AMEDITECH IMMUTEST HCG PREGANCY TEST AMEDITECH, INC. JOHN WU
K023229 09/27/2002 S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE AMERICAN MAMMOGRAPHICS, INC. ADRIAN PALMER
K022970 09/06/2002 AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 AMICAS, INC. PATRICE NEDELEC
K023079 09/16/2002 NEW OUTLINE ANAXDENT GMBH DVORAH RICHMAN
K023161 09/23/2002 SMARTSTEP SYSTEM ANDANTE MEDICAL DEVICE, LTD. ORLY MAOR
K023173 09/23/2002 ANDREWS INTRODUCER, MODEL ASI01 ANDREWS SURGICAL INNOVATIONS, LTD. EMMET ANDREWS
K023213 09/26/2002 RDH-2000 ANODIA SYSTEMS THAD OVERMYER
K023153 09/23/2002 MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K022987 09/09/2002 LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K023072 09/16/2002 POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K023119 09/19/2002 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B ARTHREX, INC. ANN WATERHOUSE
K023004 09/09/2002 LFRE INDIRECT LARYNGOSCOPE ASTRALITE CORP. DORIAN SWARTZ
K023108 09/18/2002 STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE ATLANTIC PRODUCTS, INC. MAHBUBUR RAHMAN
K023160 09/23/2002 DRX5000 AXIOM USA. INC JIM GIBSON
K023285 09/16/2002 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K023253 09/30/2002 PEDIATRIC CENTRAL VENOUS CATHETER KIT B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K023189 09/24/2002 VISTA BASIC WITH FM SYSTEM B. BRAUN MEDICAL, INC. LINDA MORGAN
K022912 09/03/2002 POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM BASIC DENTAL IMPLANT SYSTEMS, INC. DAN BLACKLOCK
K022968 09/06/2002 ADVIA TESTPOINT CSF CONTROL BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K023184 09/24/2002 ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K023075 09/16/2002 BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS JING ZHANG
K023093 09/18/2002 ACCESS HYPERSENSITIVE HTSH ASSAY BECKMAN COULTER, INC. DENISE THOMPSON
K023048 09/13/2002 MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K023049 09/12/2002 SYNCHRON LX I 725 CLINICAL SYSTEM BECKMAN COULTER, INC. MARY BETH TANG
K023092 09/18/2002 BD K-4000 MICROKERATOME SYSTEM BECTON DICKINSON & CO. EILEEN T SCHWEIGHARDT
K023219 09/26/2002 BECTON DICKINSON DIABETES SOFTWARE BECTON DICKINSON & CO. JOHN SCHALAGO
K023136 09/20/2002 OLEEVA FABRIC BIO MED SCIENCES, INC. MARK E DILLON
K022991 09/09/2002 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 BIO-RAD MARIA ZEBALLOS
K022995 09/09/2002 COLLATEK HYDROGEL BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K023089 09/17/2002 GELSPHERES EMBOLIC AGENT BIOCURE, INC. JOHN GREENBAUM
K023203 09/25/2002 OSSTAPLE BIOMEDICAL ENT., INC. W. CASEY FOX
K022925 09/04/2002 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K023063 09/16/2002 COMPREHENSIVE HUMERAL FRACTURE SYSTEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K023188 09/24/2002 PRESS-FIT HEAD RESURFACING DEVICE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K023085 09/17/2002 RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K022952 09/05/2002 MODULAR HEAD BONE SCREW BIOMET, INC. KACY ARNOLD
K023082 09/17/2002 BABYCARE BIONET COMPANY LTD JAY MANSOUR
K023034 09/12/2002 CARDIOTOUCH-3000 BIONET COMPANY LTD JAY MANSOUR
K023022 09/11/2002 NUGEN FX SCREW BIONX IMPLANTS, INC. GERARD S CARLOZZI
K022986 09/09/2002 THE BIOPLATE BATTERY POWERED DRILL BIOPLATE, INC. BRUCE F MACKLER
K023032 09/11/2002 LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL BIORESOURCE TECHNOLOGY, INC. ALAN POSNER
K023255 09/30/2002 TECHNOS MP, MODEL AU6 BIOSOUND ESAOTE, INC. COLLEEN HITTLE DENSMORE
K023099 09/18/2002 AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP BIOTRONIK, INC. Jon Brumbaugh
K023205 09/25/2002 ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP BIOTRONIK, INC. Jon Brumbaugh
K022965 09/06/2002 BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K023147 09/20/2002 ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 BORTEC BIOMEDICAL, LTD. CARL YOUNGMAN
K022983 09/09/2002 BARDPORT X-PORT ISP PORT C.R. BARD, INC. JOHN C KNORPP
K022923 09/04/2002 CANDELA GENTLE YAG LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K023193 09/25/2002 CANDELA GENTLE YAG LASER SYSTEM CANDELA CORP. William McGrail
K022951 09/05/2002 CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG CANDELA CORP. LORRAINE NELSON
K023124 09/19/2002 CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT CANON, INC. SHIELA DRISCOLL
K022929 09/04/2002 PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 CARDIAC SCIENCE, INC. JOHN CARLINE
K023036 09/12/2002 CARE ETS CARE REHAB AND ORTHOPAEDIC CHRISTIAN E HUNT
K022978 09/06/2002 STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS CASE MEDICAL, INC. MARCIA A FRIEZE
K023106 09/18/2002 PROMOTOR CERES FERTILITY, INC. GRACE HOLLAND
K023224 09/27/2002 INFUSION CATHETER EXTENSION SET CHF SOLUTIONS, INC. AMY PETERSON
K022936 09/04/2002 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE CLINIQA CORPORATION CAROL RUGGIERO
K023250 09/30/2002 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE CLINIQA CORPORATION CAROL RUGGIERO
K023125 09/19/2002 COALESCENT U-CLIP- AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K023254 09/30/2002 SPEEDICATH COLOPLAST CORP. ELIZABETH BOOTS
K023095 09/18/2002 HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. CATHY STUPAK
K022897 09/03/2002 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. CATHY STUPAK
K023116 09/19/2002 CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B CORDIS CORP. KAREN WILK
K023217 09/26/2002 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K022992 09/09/2002 REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 CORGENIX, INC. NANCI DEXTER
K022990 09/09/2002 REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 CORGENIX, INC. NANCI DEXTER
K022906 09/03/2002 RESQPOD CIRCULATORY ENHANCER CPRX LLC JOHN F STAPLETON
K023065 09/16/2002 CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE PIESTRAK
K023141 09/20/2002 MODIFICATION TO STANDARD HUMAN PLASMA DADE BEHRING, INC. DONNA A WOLF
K022976 09/06/2002 STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D DADE BEHRING, INC. RICHARD M VAUGHT
K022977 09/06/2002 STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C DADE BEHRING, INC. RICHARD M VAUGHT
K023202 09/25/2002 MICROSCAN SYNERGIES PLUS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K023028 09/11/2002 DEMETECH NYLON NONABSORBABLE SUTURE DEMETECH CORP. LUIS ARGUELLO
K023030 09/11/2002 DEMETECH POLYESTER NONABSORBABLE SUTURE DEMETECH CORP. LUIS ARGUELLO
K023029 09/11/2002 DEMETECH SILK NONABSORBABLE SUTURE DEMETECH CORP. LUIS ARGUELLO
K023115 09/19/2002 ACE VERSANAIL DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN, J.D.
K023103 09/18/2002 DEPUY 1 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K023012 09/10/2002 SMARTSET HV BONE CEMENT DEPUY ORTHOPAEDICS, INC. JANET JOHNSON
K023152 09/23/2002 IMMULITE 2000 ALLERGEN-SPECIFIC IGE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K023110 09/19/2002 CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 DIGIRAD CORP. COREY STEWART
K023233 09/27/2002 EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM EBI, L.P. JON CAPAROTTA
K023204 09/25/2002 MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K023133 09/20/2002 MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. FREDERIC TESTA
K023105 09/18/2002 ATAC CALCIUM REAGENT AND ATAC CALIBRATOR ELAN DIAGNOSTICS WYNN STOCKING
K023148 09/20/2002 EPW POWERED WHEELCHAIR, GP-201 EMG TECHNOLOGY CO., LTD. Ke-Min Jen
K022894 09/03/2002 EPICOR MEDICAL ABLATION SYSTEM EPICOR MEDICAL, INC. KATHI GUERRANT
K023140 09/20/2002 VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K023120 09/19/2002 OXYCON MOBILE ERICH JAEGER GMBH EARL DRAPER
K023182 09/24/2002 INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS ETHICON ENDO-SURGERY, INC. CAROL SPRINKLE
K022933 09/04/2002 EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT EVENFLO COMPANY, INC. MATTHEW G MCCARTY
K023186 09/24/2002 OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY EXACTECH, INC. MARTIN SPRUNCH
K023209 09/26/2002 INSIGHT MILLENNIUM III FASSTECH LEE BRODY
K023017 09/10/2002 TUCKER EMBRYO CATHETER FERTILITY TECHNOLOGY RESOURCES, INC. THOMAS J ZINNANTI
K023314 09/03/2002 MICROFIX FIXANO SA FRANK FERGUSON
K023241 09/30/2002 TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRIE M. FRANK LEWIS
K023162 09/23/2002 FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS FRESENIUS MEDICAL CARE NICHOLE RIEK
K023080 09/17/2002 GALIX PACESTAR GALIX BIOMEDICAL INSTRUMENTATION, INC. JORDAN GAVRIELIDES
K022919 09/04/2002 SMART BREATH RESPIRATORY COMPENSATION OPTION GE MEDICAL SYSTEMS LARRY A KROGER
K022960 09/06/2002 GE QUASAR NUCLEAR MEDICINE SYSTEM GE MEDICAL SYSTEMS F.I. HAIFA HEMY NEUMAN
K023178 09/23/2002 INNOVA 4100 GE MEDICAL SYSTEMS, INC. LARRY A KROGER, PH.D
K023100 09/18/2002 ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LISA LEE MICHELS
K022989 09/09/2002 RADLITE TISSUE RETRACTOR SYSTEM GENZYME BIOSURGERY KAREN K SYLVIA
K022980 09/09/2002 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA (SHOS) FRIEDMAN
K023246 09/30/2002 AMALGA PACS GLOBAL CARE SOLUTIONS, S.A. CARL ALLETTO
K022934 09/04/2002 SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS ECKHARDT ALBERS
K023025 09/11/2002 SELF SEAL STERILIZATION POUCH GRANTON MEDICAL LTD. E. J. SMITH
K023111 09/19/2002 GYRUS PLASMA SKIN RESURFACING SYSTEM GYRUS MEDICAL, INC. MARK JENSEN
K023007 09/09/2002 DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. RICHARD D BLISS
K023005 09/09/2002 AQUILLA MODULAR WHEELCHAIR HAYWOOD VOCATIONAL OPPORTUNITIES RICHARD O WOOD
K022967 09/06/2002 SUILE WOUND DRESSING HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. ERIC LUO
K023259 09/30/2002 INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 HELIX MEDICAL, INC. CYNTHIA M ANDERSON
K022998 09/09/2002 HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 HOME CARE TECHNOLOGY CO., LTD. SHU-CHEN CHENG
K023001 09/09/2002 HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L HOME CARE TECHNOLOGY CO., LTD. SHU-CHEN CHENG
K023000 09/09/2002 HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES HOME CARE TECHNOLOGY CO., LTD. SHU-CHEN CHENG
K022917 09/03/2002 HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES HOME CARE TECHNOLOGY CO., LTD. JEN KE-MIN
K022905 09/03/2002 LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K022993 09/09/2002 HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS HOVEROUND CORP. TONY DIGIOVANNI
K023102 09/18/2002 ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM HOWMEDICA OSTEONICS CORP. DEBRA BING
K023087 09/17/2002 GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K023267 09/30/2002 T2 SUPRACONDYLAR NAIL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K022928 09/04/2002 HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS HUDSON DIAGNOSTIC IMAGING LLC MARTIN E WENDELKEN
K022945 09/05/2002 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA HYCOR BIOMEDICAL, INC. RANDY WILSON
K022944 09/05/2002 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA HYCOR BIOMEDICAL, INC. RANDY WILSON
K023138 09/20/2002 HYDROFERA BACTERIOSTATIC WOUND DRESSING HYDROFERA, LLC. HEATHER S BOND
K023252 09/30/2002 RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 ICN BIOMEDICALS, INC. CHARLES C.F. YU
K023242 09/30/2002 I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE IMPLANT SCIENCES CORP. JEFFREY GIBBS
K023073 09/16/2002 SEED LINK IMPLANT SCIENCES CORP. JOHN J MUNRO
K022966 09/06/2002 PROXILOCK HIP PROSTHESIS; SIZE 12/36 IMPLEX CORP. MARCI HALEVI
K023067 09/16/2002 IMTEC SENDAX MDI ORTHO6 AND ORTHO8 IMTEC CORP. BRAD VANCE
K023159 09/23/2002 MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE INDUSTRIAL CLOTHINGS, LTD. UMAIR AHMED
K022981 09/09/2002 INION CPS 2.5/2.8 SCREW INION LTD. HANNA MARTTILA
K022979 09/09/2002 LAPARETTE, MODEL LAP J L S H N INSTRUMENTS MEDICAUX G.B., INC. MARTIN PAQUETTE
K022911 09/03/2002 MODEL AMI1200 C-ARM INTEGRITY PRACTICE MANAGEMENT, INC. KEVIN J MEURET
K022940 09/04/2002 IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0 INTELLIGENT IMAGES SRL MAURIZIO PIAGGIO
K023222 09/27/2002 ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 INVITROCARE, INC. ROBERT E LOVINS
K022931 09/04/2002 HYALURONIDASE SOLUTION IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K023035 09/12/2002 SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K022969 09/06/2002 UNIVERSAL CERAMIC SOLDER IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K022900 09/03/2002 BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES JOHN O. BUTLER CO. KEVIN G YOST
K023132 09/20/2002 JOSTRA MECC SYSTEM JOSTRA AG KATHLEEN JOHNSON
K022916 09/03/2002 BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211 K-JUMP HEALTH CO., LTD. JONATHAN S KAHAN
K023187 09/24/2002 KSEA SPINOSCOPE KARL STORZ ENDOSCOPY JAMES A LEE
K023061 09/16/2002 KONICA DIRECT DIGITIZER REGIUS, MODEL 170 KONICA MINOLTA MEDICAL & GRAPHIC, INC. KOJI KUBO
K023143 09/20/2002 ECHO SOUNDER, ES-102EX KOVEN TECHNOLOGY, INC. J. HARVEY KNAUSS
K023064 09/16/2002 HEMOCLEAN KRD CO., LTD JEFFERY R SHIDEMAN
K023002 09/09/2002 CLEARFIL AP-X PLT KURARAY MEDICAL INC. MASAYA SASAKI
K022999 09/09/2002 CLEARFIL AP-X PLT INTRO KIT KURARAY MEDICAL INC. MASAYA SASAKI
K022922 09/04/2002 HARMONY INR MONITORING SYSTEM LIFESCAN, INC. JOHN E HUGHES
K023194 09/25/2002 SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM LIFESCAN, INC. JOJN E HUGHES
K023114 09/19/2002 LUMEND FRONTRUNNER CTO CATHETER LUMEND, INC. MICHAEL A DANIEL
K023223 09/27/2002 MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER LUMEND, INC. MICHAEL A DANIEL
K023054 09/13/2002 JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE MANDALA HEALTH CARE, LLC DASHIMA DOVCHIN
K023068 09/16/2002 PAPILLON MASK SET MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH ROGER KOTTER
K022961 09/06/2002 RTDOSEPLAN MATH RESOLUTIONS, LLC. WENDEL DEAN RENNER
K023236 09/27/2002 SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES MAXXIM MEDICAL ROY E MOSER
K023098 09/18/2002 ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT MCKINLEY INFUSER JOHN CHAPPELL
K022959 09/06/2002 SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 MDC RESEARCH LTD. CAROL PATTERSON
K022982 09/09/2002 MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB MED-LOGICS, INC. MARK MOYER
K022948 09/05/2002 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L MEDICAL ACTION INDUSTRIES, INC. SHARON SUESS GRAHAM
K023084 09/17/2002 MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL MEDICAL ADVANCES, INC. ANTHONY DIETZLER
K023081 09/17/2002 PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K022895 09/03/2002 ELCAM STOPCOCKS AND MANIFOLDS MEDICAL DEVICE CONSULTANTS, INC. DANIEL J DILLON
K023231 09/27/2002 ELFCARE DEVICE, MODELS 314A THROUGH 314G MEDISEB LTD. AHAVA STEIN
K023163 09/23/2002 LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020 MEDLOGIC GLOBAL LIMITED HOWARD BEAUMONT
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K023121 09/19/2002 LIFESTENT BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES JIM CLOSSICK
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K023137 09/20/2002 PHILIPS EASYVISION WORKSTATION RELEASE 6 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
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K022950 09/05/2002 MINIPHYSIONIZER 2.0 AND ELECTRODES PHYSION, INC. ERIC J NEMETH
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K023008 09/09/2002 UNIVERSAL SYSTEM, MODEL QV-800 QUANTUM MEDICAL IMAGING, LLC. MARK CAMIRAND
K023003 09/09/2002 IMAGECHECKER-CT WORKSTATION R2 TECHNOLOGY, INC. Kathy O'Shaughnessy
K023158 09/23/2002 RANDOX APOLIPOPROTEIN CALIBRATOR RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K023050 09/13/2002 RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI RELIANT TECHNOLOGIES, INC. ANNE WORDEN
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K023135 09/20/2002 IMAGE3 SE DISPOSABLE FULL FACE MASK RESPIRONICS, INC. ZITA A YURKO
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K022953 09/05/2002 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM SCHICK TECHNOLOGIES, INC. DANIEL MICHAELI
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K023128 09/19/2002 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM SECURE SCIENTIFIC SDN BHD CHONG NGIT-HENG
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K023235 09/27/2002 MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE SHANDONG JIAZHAN PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K023145 09/20/2002 VINYL EXAMINATION GLOVES, PRE-POWDERED SHANDONG JIAZHAN PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
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K023021 09/11/2002 MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T SMITH & NEPHEW, INC. WILLIAM MCCALLUM
K022902 09/03/2002 SMITH & NEPHEW HIP SYSTEM SMITH & NEPHEW, INC. DAVID HENLEY
K022958 09/06/2002 TOTAL HIP FEMORAL HEADS AND LINERS SMITH & NEPHEW, INC. KIM KELLY
K023066 09/16/2002 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) SODEM SYSTEMS CAROLE BURNIER
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K023210 09/26/2002 SEEDLINKS, MODELS 70301, 70302, 70303 SOURCETECH MEDICAL, L.L.C. DAVID T SIERACKI
K022997 09/09/2002 SPECTRUM CERVICAL SPINAL SYSTEM SPINAL INNOVATIONS, LLC. JOSEPH S CLIFT
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K023192 09/25/2002 STRYKER BIOZIP SUTURE ANCHOR Stryker Endoscopy ALISA MILLER
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K022949 09/05/2002 SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS SYNTHES (USA) VIKKI M HOFFMAN
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K022918 09/04/2002 ADAPTERS WITH X-COATING Terumo Cardiovascular Systems Corporation KAZUHITO INOUE
K022907 09/03/2002 ANSPACH POWERED KERRISON SYSTEM (PKS) THE ANSPACH EFFORT, INC. WILLIAM G CONETY
K023009 09/09/2002 FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER THE BINDING SITE, LTD. JAY H GELLER
K023131 09/09/2002 FREELITE HUMAN LAMBDA FREE KIT THE BINDING SITE, LTD. JAY H GELLER
K023207 09/25/2002 OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) TOSHIBA AMERICA MEDICAL SYSTEMS, INC. MICHAELA MAHL
K023239 09/27/2002 AIA-PACK CA 19-9 TOSOH CORP. JUDITH E LOEBEL
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K023091 09/17/2002 ST AIA-PACK TESTOSTERONE ASSAY TOSOH MEDICS, INC. LOIS NAKAYAMA
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K023227 09/27/2002 USG 2000SA ULTRAGUIDE LTD. GEORGE MYERS
K023176 09/23/2002 UNDUS MALE LATEX CONDOM (WITH FLAVORING) UNIDUS CORP. ELI J CARTER
K023059 09/13/2002 UNIDUS MALE LATEX CONDOM UNIDUS CORP. ELI J CARTER
K023175 09/23/2002 UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) UNIDUS CORP. ELI J CARTER
K023129 09/19/2002 UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) UNIDUS CORP. ELI J CARTER
K023247 09/30/2002 CHAMPION 5000 PERIPHERAL VASCULAR COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
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K023023 09/11/2002 LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA VASCA, INC. NAMA DODDI
K023024 09/11/2002 TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 VASCULAR CONTROL SYSTEMS, INC AL MEMMOLO
K023154 09/23/2002 VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 VASCULAR CONTROL SYSTEMS, INC AL MEMMOLO
K022996 09/09/2002 VITA IN-CERAM YZ CUBES FOR CEREC VIDENT BARBARA LEWANDOWSKI
K023221 09/27/2002 CONTACT LASER & DIAGNOSTIC LENSES VOLK OPTICAL, INC. RICHARD E LIPPMAN
K022938 09/04/2002 VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 VOLUME INTERACTIONS PTE LTD JOHN BABY
K023019 09/11/2002 VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 VOMED VOLZER MEDIZINTECHNIK GMBH & CO. DAGMAR MASER
K023055 09/13/2002 BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200 VSM MEDTECH LTD. DARYL WISDAHL
K023078 09/16/2002 BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR VSM MEDTECH LTD. DARYL WISDAHL
K023041 09/12/2002 W.O.M. LASER U100 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K023230 09/27/2002 ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 WESTERN CLINICAL TECHNOLOGY SYSTEMS, INC. W.T. WORKMAN
K022962 09/06/2002 WIENER LAB. BILIRRUBINA TOTAL AA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K023179 09/24/2002 READI-STRAND, MODEL PSSTRAND WORLDWIDE MEDICAL TECHNOLOGIES, LLC GARY LAMOUREUX
K023088 09/17/2002 BONE GRAFT SYRINGE, MODEL 8600-00X0 WRIGHT MEDICAL TECHNOLOGY, INC. ROGER D BROWN
K022904 09/03/2002 DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K023040 09/12/2002 WU'S 3-WHEELED NEO SCOOTER, WT-L3 WU'S TECH CO., LTD. JEN KE-MIN
K023166 09/23/2002 WU'S 3-WHEELED NEO SCOOTER, WT-M4 WU'S TECH CO., LTD. JEN KE-MIN
K023168 09/23/2002 WU'S 3-WHEELED NEO SCOOTER, WT-T3B WU'S TECH CO., LTD. JEN KE-MIN
K023237 09/27/2002 XYLOS SURGICAL MESH XYLOS CORPORATION Patsy Trisler
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K023211 09/26/2002 NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS ZIMMER, INC. STEPHEN H MCKELVEY


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