FDA 510(k) Decisions During October, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K023336 10/09/2002 OCO DENTAL IMPLANT (5.0MM DIAMETER) "O" CO., INC. DAVID D DALISE
K021125 10/25/2002 SENSUA! AAC CONSULTING GROUP, INC. EDUARDO MARCH
K022941 10/28/2002 MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING ABBOTT LABORATORIES JOSEPH MAGLIOZZI
K022589 10/28/2002 ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K022896 10/03/2002 CSV12 SOFTWARE VIEWER ACUSON CORP. BOB LEIKER
K022441 10/08/2002 STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K023010 10/01/2002 SNIFF POSITION PILLOWS/POPITZ PILLOWS AEOLUS INTERNATIONAL CORPORATION MICHAEL D POPITZ
K022942 10/21/2002 CRANIOCUT AESCULAP, INC. GEORG KELLER
K022306 10/10/2002 AART SILICONE TUBING AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K023287 10/22/2002 DRYSTAR 5500 AGFA CORP. JEFF JEDLICKA
K023249 10/18/2002 ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM ALCON LABORATORIES, INC. CHRISTY STEVENS
K023167 10/02/2002 BREATHABLE SURGICAL GOWN ALLEGIANCE HEALTHCARE CORP. SHARON NICHOLS
K022765 10/11/2002 NITRILE POWDER-FREE EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K023170 10/09/2002 NITRILE POWDER-FREE EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K014071 10/01/2002 PMX DISPOSABLE BAG MASK RESUSCITATOR ALLIED HEALTHCARE PRODUCTS, INC. VERNON TRIMBLE
K022226 10/08/2002 ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS ALTUS MEDICAL, INC. KATHY MAYNOR
K023079 10/30/2002 NEW OUTLINE ANAXDENT GMBH DVORAH RICHMAN
K021389 10/01/2002 BIOLOGICAL SOUND MONITOR (BSM) SENSOR ANDROMED, INC. GENEVIEVE HAMEL
K022298 10/01/2002 I-STETHOS LINK ANDROMED, INC. GENEVIEVE HAMEL
K022342 10/09/2002 EZ-SCOPE AN, EZ-SCOPE LIGHT ANZAI MEDICAL CO, LTD. T. WHIT ATHEY
K023368 10/28/2002 TRUCATH.IP AORTECH CRITICAL CARE LTD. PAUL BURNS
K022666 10/09/2002 PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. CHARLES F ANDREWS
K022987 10/21/2002 LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K021210 10/28/2002 ARTERIA OCCLUSION BALLOON ARTERIA MEDICAL SCIENCE, INC. ALAN HINTON
K022234 10/03/2002 ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B ARTHREX, INC. ANN WATERHOUSE
K022475 10/03/2002 MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K022217 10/24/2002 AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM ASEPTICO, INC. GRANT RAMALEY
K023285 10/09/2002 DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K022785 10/09/2002 EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION AXON SYSTEMS, INC. HOWARD BAILIN
K022207 10/04/2002 AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM AXYA MEDICAL, INC. HOWARD L SCHRAYER
K022398 10/11/2002 REUSABLE BRONCHIAL BIOPSY FORCEPS BALLARD MEDICAL PRODUCTS CINDY ELLIS
K022668 10/15/2002 ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K020807 10/01/2002 AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K023049 10/04/2002 SYNCHRON LX I 725 CLINICAL SYSTEM BECKMAN COULTER, INC. MARY BETH TANG
K022580 10/09/2002 BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM BECTON DICKINSON & CO. PETER ZURLO
K023092 10/18/2002 BD K-4000 MICROKERATOME SYSTEM BECTON DICKINSON & CO. EILEEN T SCHWEIGHARDT
K022637 10/16/2002 BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME BECTON DICKINSON & CO. EILEEN T SCHWEIGHARDT
K022581 10/09/2002 BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM BECTON DICKINSON & CO. JOHN SCHALAGO
K023273 10/31/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K023136 10/16/2002 OLEEVA FABRIC BIO MED SCIENCES, INC. MARK E DILLON
K021351 10/17/2002 BIOSTEON CROSS PIN BIOCOMPOSITES LTD. J. STEPHEN BRATT
K023203 10/17/2002 OSSTAPLE BIOMEDICAL ENT., INC. W. CASEY FOX
K023488 10/31/2002 OSSTAPLE, CRANIOFACIAL BIOMEDICAL ENTERPRISES, INC W. CASEY FOX
K023486 10/31/2002 OSSTAPLE, MAXILLOFACIAL BIOMEDICAL ENTERPRISES, INC W. CASEY FOX
K020810 10/03/2002 VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 BIOMERIEUX, INC. SANDRA PERREAND
K021661 10/25/2002 RINGLOC CONSTRAINED LINERS BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K023085 10/17/2002 RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K021728 10/25/2002 RINGLOC CONSTRAINED LINERS II BIOMET, INC. DALENE T BINKLEY
K023022 10/04/2002 NUGEN FX SCREW BIONX IMPLANTS, INC. GERARD S CARLOZZI
K023032 10/08/2002 LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL BIORESOURCE TECHNOLOGY, INC. ALAN POSNER
K023099 10/18/2002 AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP BIOTRONIK, INC. JON BRUMBAUGH
K011208 10/02/2002 BIOVER BIOVER AG HEINZ E WICK
K022493 10/11/2002 EMS 400 BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K021630 10/25/2002 BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORP. TODD KORNMANN
K023291 10/17/2002 COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X BOSTON SCIENTIFIC CORP. ANDREA L RUTH
K022357 10/16/2002 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 BOSTON SCIENTIFIC, TARGET GEORGE J PRENDERGAST
K021306 10/25/2002 VECTORVISION CT-FREE KNEE BRAINLAB AG RAINER BIRKENBACH
K021835 10/17/2002 BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX BRENNEN MEDICAL, INC. PHILLIP B LAWIN
K014128 10/04/2002 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K023124 10/04/2002 CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT CANON, INC. SHIELA DRISCOLL
K022373 10/07/2002 CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS CANTOR & NISSEL LTD. MARTIN DALSING
K022210 10/04/2002 MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 CARDIAC SCIENCE, INC. JOHN CARLINE
K022670 10/17/2002 CARRAKLENZ AND ULTRAKLENZ CARRINGTON LABORATORIES, INC. MARY MC-NAMARA-CULINANE
K022881 10/22/2002 CEDARA I-SOFTVIEW CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K022615 10/29/2002 CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR CENTERPULSE SPINE-TECH, INC. ANGELA BYLAND
K021390 10/04/2002 PMX COMPACT RESUCITATOR CHEEN HOUNG ENT. CO. LTD. JAY WANG
K023224 10/25/2002 INFUSION CATHETER EXTENSION SET CHF SOLUTIONS, INC. AMY PETERSON
K021635 10/28/2002 KARATS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K022936 10/02/2002 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE CLINIQA CORPORATION CAROL RUGGIERO
K023250 10/17/2002 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE CLINIQA CORPORATION CAROL RUGGIERO
K022867 10/02/2002 LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE CLINIQA CORPORATION CAROL RUGGIERO
K022885 10/02/2002 LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE CLINIQA CORPORATION CAROL RUGGIERO
K020285 10/23/2002 CMA CEREBRAL TISSUE MONITORING SYSTEM CMA MICRODIALYSIS AB SHEILA HEMEON-HEYER
K013525 10/04/2002 CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) COLOPLAST CORP. HARVEY M ARBIT
K021910 10/11/2002 COMFORT DREAMRIDER SCOOTER, LY-EW402 COMFORT ORTHOPEDIC CO. LTD. JEN KE-MIN
K022369 10/11/2002 COMFORT WINDJOY SCOOTER, MODEL LY-EW302 COMFORT ORTHOPEDIC CO. LTD. JEN KE-MIN
K022897 10/11/2002 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. CATHY STUPAK
K020027 10/08/2002 FOCUS RADIATION TREATMENT PLANNING SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K021186 10/25/2002 CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG, CONDOMI ERFERT PRODOKTIONSGESELLSCHAFT MBH CAROLANN KOTULA
K022351 10/16/2002 DIODENT DENTAL LASER SYSTEM CONTINUUM ELECTRO-OPTICS, INC. THOMAS J HANEY
K022484 10/25/2002 COOK INJECTION NEEDLE COOK UROLOGICAL, INC. DEBBIE SCHMITT
K023116 10/18/2002 CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B CORDIS CORP. KAREN WILK
K023217 10/25/2002 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K022194 10/29/2002 TRAXX ELECTRIC WHEELCHAIR CROSSROADS DISTRIBUTION COMPANY, L.L.C. KEVIN WALLS
K021854 10/25/2002 DFV CPG COLPOSCOPE D.F. VASCONCELLOS S.A. JEAN M BUCHWALD
K023065 10/16/2002 CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE PIESTRAK
K023202 10/23/2002 MICROSCAN SYNERGIES PLUS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K022485 10/03/2002 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE DATEX-OHMEDA JOEL KENT
K021955 10/08/2002 TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES DATEX-OHMEDA, INC. MICHAEL A CHILBERT
K022300 10/03/2002 ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V DENTAL VIPI LTDA KEVIN WALLS
K020231 10/21/2002 DIASOL-ADDITIVES DIASOL, INC. MONICA ABELES
K022450 10/22/2002 INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY DIDECO S.P.A. BARRY SALL
K023471 10/29/2002 DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS AG DAVID E CHADWICK
K020339 10/25/2002 DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM DORNIER MEDTECH AMERICA, INC. TIM THOMAS
K012816 10/17/2002 DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 DYNAREX CORP. JOHN GAGLIARDI
K023399 10/25/2002 EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K023204 10/18/2002 MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K023133 10/18/2002 MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. FREDERIC TESTA
K023324 10/18/2002 MODIFICATION TO EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K022583 10/31/2002 FLASH 1 EMED, INC. KENNETH KARASIUK
K022199 10/02/2002 ENDIUS ATAVI SYSTEM ENDIUS, INC. CHRISTINE KUNTZ NASSIF
K022613 10/25/2002 HELIX HYDRO-JET ERBE USA, INC. JOHN TARTAL
K021087 10/11/2002 HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE ERECORDS LIMITED ED GOSS
K023182 10/24/2002 INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS ETHICON ENDO-SURGERY, INC. CAROL SPRINKLE
K020750 10/31/2002 DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K020749 10/31/2002 DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K023186 10/17/2002 OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY EXACTECH, INC. MARTIN SPRUNCH
K022276 10/04/2002 KOKOMATE FERRARIS RESPIRATORY, INC. JIM LEWIS
K023314 10/18/2002 MICROFIX FIXANO SA FRANK FERGUSON
K021142 10/01/2002 ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 FORTUNE MEDICAL INSTRUMENT CORP. TYLER WANG
K022536 10/30/2002 RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR FRESENIUS MEDICAL CARE ART EILINSFELD
K021238 10/09/2002 FRYE ADJUSTING INSTRUMENT FRYE HEALTH SYSTEMS DEBORAH F KONENMAN
K023323 10/29/2002 1CC FUTURA SAFETY SYRINGE FUTURA MEDICAL TECHNOLOGY DAVID OLMSTEAD
K021742 10/25/2002 GALEMED NEB-EASY NEBULIZER GALEMED CORP. TOM SHANKS
K022430 10/18/2002 ISO FUNCTIONAL GC AMERICA, INC. TERRY L JORITZ
K022794 10/11/2002 E-SPEED EBT SCANNER SYSTEM GE IMATRON KERRY A SPEAR
K023332 10/23/2002 LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW GE MEDICAL SYSTEMS LARRY A KROGER
K022322 10/08/2002 INNOVA AND INNOVA 2000 S GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K023100 10/11/2002 ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LISA LEE MICHELS
K021454 10/01/2002 UNITY NETWORK ID GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN JOELLE NEIDER
K022495 10/08/2002 GETTIG DISPOSABLE SYRINGES GETTIG PHARMACEUTICAL INSTRUMENT CO. JAMES A BENZ
K023300 10/28/2002 HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J GUIDANT CORP. JANELL A COLLEY
K021595 10/24/2002 GYRUS ENT NERVE STIMULATOR GYRUS ENT L.L.C. GREG SREDIN
K021250 10/24/2002 MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) HANDPIECE UNLIMITED MARTINA GUNDEROTH
K023005 10/18/2002 AQUILLA MODULAR WHEELCHAIR HAYWOOD VOCATIONAL OPPORTUNITIES RICHARD O WOOD
K022667 10/22/2002 HCMI X-RAY HEALTH CARE MFG., INC. DANIEL KAMM
K022737 10/22/2002 HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC HEALTH CARE MFG., INC. DANIEL KAMM
K022757 10/11/2002 SPIFE CK KIT, MODEL 3332, 3333 HELENA LABORATORIES PATRICIA FRANKS
K022455 10/01/2002 SPIFE LD-12 KIT, MODEL 3338 HELENA LABORATORIES PATRICIA FRANKS
K021923 10/24/2002 INRATIO SELF-TEST HEMOSENSE, INC. JUDITH BLUNT
K022612 10/28/2002 IBOND GLUMA INSIDE HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K022390 10/11/2002 HITACHI ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K022665 10/09/2002 POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE HOHENSTEIN ENTERPRISES, INC. L. FRANKLIN BOST
K022243 10/25/2002 HORIZONS REUSABLE HOT BIOPSY FORCEPS HORIZONS INTL. CORP. RAFIC SALEH
K022268 10/25/2002 HORIZONS REUSABLE POLYPECTOMY SNARES HORIZONS INTL. CORP. RAFIC SALEH
K023102 10/09/2002 ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM HOWMEDICA OSTEONICS CORP. DEBRA BING
K023294 10/09/2002 BOSWORTH CORACO-CLAVICULAR SCREW HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K021451 10/18/2002 DURACON CS TIBIAL INSERT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K022403 10/17/2002 GMRS PRESS FIT STEMS WITH PUREFIX HA HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K022651 10/17/2002 HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K022545 10/11/2002 GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 HYPOGUARD USA, INC. BRUCE A MACFARLANE
K023318 10/18/2002 I-FLOW ELASTOMERIC PUMP WITH BOLUS I-FLOW CORP. SHANE NOEHRE
K021608 10/22/2002 SMITHWICK CAROTID SHUNT IMPLANTABLE DEVICES WILLIAM E MCPHERSON
K022966 10/02/2002 PROXILOCK HIP PROSTHESIS; SIZE 12/36 IMPLEX CORP. MARCI HALEVI
K012271 10/04/2002 ACUTEVENTILATOR IMPOEX INTERNATIONAL, LTD. SIVERT CLAESSON
K022781 10/08/2002 MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE INDUSTRIAL CLOTHINGS, LTD. S.N. HARI
K022630 10/09/2002 MODIFICATION TO FOCUS INSTRUMENTARIUM CORP. MARK MASON
K022940 10/11/2002 IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0 INTELLIGENT IMAGES SRL MAURIZIO PIAGGIO
K022728 10/11/2002 AUDIOTRAVELLER, MODEL AA222 INTERACOUSTICS A/S, ASSENS DANIEL EGGAN
K022774 10/21/2002 IQ 200 SYSTEM INTL. REMOTE IMAGING SYSTEMS HARVEY L KASDAN
K022228 10/08/2002 FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES IRIDEX CORP. JOHN D'ANGELO
K022384 10/18/2002 XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP ISOLUX AMERICA NIKOLAOS ANDREOULAKIS
K022969 10/18/2002 UNIVERSAL CERAMIC SOLDER IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K022811 10/09/2002 W-5 IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K020334 10/03/2002 INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC JAC-CELL MEDIC CORPORATION JOHN GAGLIARDI
K023360 10/25/2002 LEFORTE SYSTEM BONE PLATE JEIL MEDICAL CORPORATION DANIEL KAMM
K022862 10/18/2002 TRANSCURE, MODEL 2910 KINETIC INSTRUMENTS, INC. WILLIAM J BECKER
K023061 10/11/2002 KONICA DIRECT DIGITIZER REGIUS, MODEL 170 KONICA MINOLTA MEDICAL & GRAPHIC, INC. KOJI KUBO
K013805 10/11/2002 KOWA AUTOMATED TONOMETER KT-500 KOWA OPTIMED, INC. FRANCES K WU
K023002 10/25/2002 CLEARFIL AP-X PLT KURARAY MEDICAL INC. MASAYA SASAKI
K022999 10/24/2002 CLEARFIL AP-X PLT INTRO KIT KURARAY MEDICAL INC. MASAYA SASAKI
K022346 10/18/2002 CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES LATEXX MANUFACTURING SDN.BHD. TEOH CHOH SHEE
K023194 10/24/2002 SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM LIFESCAN, INC. JOJN E HUGHES
K021752 10/11/2002 FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL LUCID KOREA CO., LTD DONG KUN LEE
K023223 10/24/2002 MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER LUMEND, INC. MICHAEL A DANIEL
K022060 10/30/2002 LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES LUMENIS, INC. ANNE WORDEN
K022327 10/16/2002 NOVUS SPECTRA LUMENIS, INC. KELLY MOHROR
K022181 10/01/2002 NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES LUMENIS, INC. KAREN L BAKER
K020839 10/11/2002 QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL LUMENIS, INC. ALAN L VOSS
K022716 10/11/2002 MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB MED-LOGICS, INC. MARK MOYER
K022219 10/07/2002 EXOMIO, MODEL 1.1 MEDCOM GMBH IOANNIS NOMIKOS
K020936 10/11/2002 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL MEDCOMP FLORENCE A CAIKOSKI
K022570 10/31/2002 MEDCOMP REPAIR KIT, MODEL ASPCRPK MEDCOMP FLORENCE A CAIKOSKI
K022513 10/25/2002 MEDCOMP VASCU-SHEATH INTRODUCER SET MEDCOMP FLORENCE A CAIKOSKI
K022043 10/18/2002 SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 MEDENNIUM, INC. JULIAN ABADIA
K023307 10/31/2002 MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K022378 10/18/2002 PLASMALITE PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K022895 10/18/2002 ELCAM STOPCOCKS AND MANIFOLDS MEDICAL DEVICE CONSULTANTS, INC. DANIEL J DILLON
K022743 10/09/2002 REPROCESSED DISPOSABLE TROCARS MEDICAL DEVICE SERVICES MARK ALDANA
K022748 10/09/2002 REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS MEDICAL DEVICE SERVICES MARK ALDANA
K023420 10/25/2002 PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB MEDICAL ELECTRONIC DEVICES, INC. THOMAS WENZEL
K022585 10/11/2002 KIMAX QMA MEDICAL METRICS, INC. MARK LAMP
K023069 10/18/2002 TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETER MEDPORT, INC. FRAN WHITE
K023303 10/29/2002 EXPORT ASPIRATION CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K022238 10/09/2002 MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 MEDTRONIC VASCULAR MARY ELLEN BEST
K022370 10/18/2002 FRAMELOCK; FRAMELOCK ACCESSORIES MEDTRONIC XOMED, INC. B.L. MCDERMOTT
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K021976 10/25/2002 FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON VITAL SCIENTIFIC N.V. ISRAEL M STEIN
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K023221 10/11/2002 CONTACT LASER & DIAGNOSTIC LENSES VOLK OPTICAL, INC. RICHARD E LIPPMAN
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K022257 10/04/2002 VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX VOMED VOLZER MEDIZINTECHNIK GMBH & CO. DAGMAR MASER
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K020641 10/29/2002 SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 WORLDWIDE MEDICAL TECHNOLOGIES, LLC JONATHAN LEE
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