FDA 510(k) Decisions During June, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K031350 06/23/2003 3TP SOFTWARE OPTION 3TP LLC VINCENT J MCGILL
K031353 06/19/2003 SOLUTION FACE MASKS A PLUS INTERNATIONAL, INC SOLOMON CHEN
K031048 06/16/2003 CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST ACCESS BIO INCORPORATE YOUNG HO CHOI
K031052 06/13/2003 CARESTART HCG ONE-STEP PREGNANCY TEST ACCESS BIO INCORPORATE YOUNG HO CHOI
K030935 06/23/2003 BERKELEY V-10 VACUUM CURETTAGE SYSTEM ACMI CORPORATION FRANK FUCILE
K030684 06/03/2003 SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH ACMI CORPORATION FRANK FUCILE
K023726 06/17/2003 TENS PRO 900 ACUMED MEDICAL SUPPLIES, LTD. RICHARD KEEN
K031705 06/17/2003 SKYLIGHT IMAGING SYSTEM ADAC LABORATORIES COLEEN A COLEMAN
K031872 06/20/2003 ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] ADAC LABORATORIES CHARLENE BRUMBAUGH
K024298 06/30/2003 ANTIMICROBIAL ALGINATE DRESSING ADVANCED MEDICAL SOLUTIONS LTD. JOHN GREEN
K031303 06/04/2003 AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) AESCULAP, INC. MATTHEW M HULL
K031198 06/20/2003 SCANX 10 AIR TECHNIQUES, INC. JOSEPH CAREY
K024019 06/03/2003 ARTERIALFLOW SYSTEM, MODEL 32A AIRCAST, INC. STEPHEN L KENNEY
K024344 06/03/2003 PNEUTON VENTILATOR AIRON CORPORATION G. ERIC GJERDE
K024360 06/10/2003 INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K031271 06/17/2003 ONE-STEP PREGNANCY TEST AMERISOURCE PHARMACAL, INC. FRAN WHITE
K031233 06/18/2003 ANDIODYNAMICS, INC. ELVS PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K031626 06/19/2003 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K024000 06/26/2003 METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER ANGIOMETRX INC. CARL YOUNGMANN
K022394 06/05/2003 EZMANAGER PLUS ANIMAS CORP. MICHAEL J ANDREWS
K023815 06/19/2003 C-1805M ANODIA SYSTEMS THAD J OVERMYER
K023896 06/19/2003 C-1890 ANODIA SYSTEMS THAD OVERMYER
K031029 06/19/2003 ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K031141 06/30/2003 ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUNDEROTH
K024111 06/10/2003 ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED ASTRA TECH, INC. BRUCE R MANNING
K031177 06/19/2003 DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K031041 06/19/2003 FLUENCY TRACHEOBRONCHIAL STENT GRAFT BARD PERIPHERAL VASCULAR AYMEE R BERRY
K030099 06/17/2003 BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K031038 06/23/2003 ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY BAYER HEALTHCARE, LLC KENNETH T EDDS
K031393 06/24/2003 BAYER ADVIA CENTAUR CA 19-9 ASSAY BAYER HEALTHCARE, LLC KENNETH T EDDS
K031644 06/25/2003 BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL BAYER HEALTHCARE, LLC ANDRES HOLLE
K031682 06/25/2003 LIPOPROTEIN CALIBRATOR BAYER HEALTHCARE, LLC KENNETH T EDDS
K031429 06/06/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML BD DIAGNOSTIC SYSTEMS KATHRYN B POWERS
K031606 06/20/2003 ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY BECKMAN COULTER, INC. LYNN WEIST
K031506 06/02/2003 ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY BECKMAN COULTER, INC. LYNN WEIST
K031200 06/24/2003 MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO. CYNTHIA LACATENA
K031306 06/02/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K023955 06/24/2003 BD VIPER INSTRUMENT BECTON, DICKINSON & CO. COLLEN A KISTLER
K024057 06/18/2003 CURAD SCAR THERAPY BEIERSDORF, INC. FRANCES K WU
K030708 06/25/2003 SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K031231 06/18/2003 LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS BIO-RAD ELIZABETH PLATT
K030682 06/27/2003 CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 BIOFORM, INC. WILLIAM G HUBBARD
K030700 06/04/2003 CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT BIOLITEC, INC. JONATHAN S KAHAN
K024323 06/30/2003 CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 BIOMEDICAL SYSTEMS CORP. K. MICHAEL KROEHNKE
K030950 06/16/2003 VIDAS TROPONIN I (TNI), MODEL 30 445 BIOMERIEUX, INC. Nancy Weaver
K030710 06/04/2003 BIO-MODULAR SHOULDER SYSTEM BIOMET, INC. PATRICIA SANDBORN BERES
K030861 06/12/2003 HA PMI FLANGED ACETABULAR COMPONENT BIOMET, INC. PATRICIA SANDBORN BERES
K030332 06/06/2003 MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 BIONICARE MEDICAL TECHNOLOGIES, INC. KENT HOFFMAN
K030951 06/06/2003 TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P BISCO, INC. STEPHEN (STEVE) SMITH
K030197 06/12/2003 BLACKSTONE POSTERIOR CERVICAL SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030581 06/26/2003 BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030744 06/27/2003 BLACKSTONE SURGICAL TITANIUM MESH BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K031527 06/05/2003 MODIFICATION TO CAVERMAP SURGICAL AID BLUE TORCH MEDICAL TECHNOLOGIES FREDERICK TOBIA
K031538 06/27/2003 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K023691 06/04/2003 BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC BOSTON SCIENTIFIC EPI TIMOTHY J JOHNSON
K024192 06/11/2003 VECTORVISION FLUORO3D BRAINLAB, AG RAINER BIRKENBACH
K031466 06/11/2003 IQMARK DIGITAL HOLTER BRENTWOOD MEDICAL TECHNOLOGY CORP. RUOMEI ZHANG
K031773 06/24/2003 ENDO GATOR SYSTEM BYRNE MEDICAL, INC. J. HARVEY KNAUSS
K030020 06/16/2003 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER C.R. BARD, INC. GLENN NORTON
K031000 06/03/2003 LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 C.R. BARD, INC. DEBORAH L HERRINGTON
K031633 06/11/2003 CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C CANON U.S.A., INC. SHEILA DRISCOLL
K031629 06/06/2003 CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI CANON U.S.A., INC. SHEILA DRISCOLL
K031468 06/20/2003 TEMPORARY TITANIUM ANEURYSM CLIP Cardinal Health LANCE MACRCONI
K023036 06/19/2003 CARE ETS CARE REHAB AND ORTHOPAEDIC CHRISTIAN E HUNT
K031521 06/27/2003 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K031522 06/27/2003 SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K030528 06/17/2003 ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) CLINICAL DATA WYNN STOCKING
K030636 06/05/2003 C-PORT CLINISURG VASCULAR PRODUCTS, LLC DONALD F HULTS
K023817 06/25/2003 SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 CLIO DESIGNS, INC. BERNARD FABRICANT
K030578 06/24/2003 BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM COMPUTER MOTION, INC. CATHY STUPAK
K031382 06/30/2003 MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. KEITH LOWREY
K030718 06/05/2003 SCB COMPUTER MOTION INTERFACE CONTROLLER COMPUTER MOTION, INC. KEITH LOWREY
K030807 06/09/2003 CARIES INDICATOR CONFI-DENTAL PRODUCTS CO. STEPHEN RUDOLPH
K031766 06/26/2003 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K031058 06/13/2003 CORD STICK MULTIPLE DRAW SYSTEM CORD STICK CORP. MICHAEL MOEN
K031197 06/16/2003 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K030963 06/20/2003 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CORDIS NEUROVASCULAR, INC. ALINA CARABALLO
K024372 06/19/2003 CP MEDICAL BONE WAX CP MEDICAL SUE RIDGE
K022906 06/11/2003 RESQPOD CIRCULATORY ENHANCER CPRX LLC JOHN F STAPLETON
K031488 06/04/2003 CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER CYNOSURE, INC. GEORGE CHO
K031135 06/02/2003 GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) DADE BEHRING, INC. LORRAINE PIESTRAK
K031004 06/06/2003 SYVA EMIT II PLUS AMPHETAMINES ASSAY DADE BEHRING, INC. RADAMES RIESGO
K031825 06/20/2003 C.CAM DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS SORENSEN
K031569 06/10/2003 DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX DATASCOPE CORP. JOANN TAYLOR
K031653 06/20/2003 DATEX-OHMEDA HMEF 750 DATEX-OHMEDA JOEL C KENT
K030990 06/25/2003 DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR DATEX-OHMEDA JOEL KENT
K031781 06/25/2003 DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K031479 06/06/2003 AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 DATEX-OHMEDA, INC. AL VAN HOUDT
K031027 06/26/2003 DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) DATEX-OHMEDA, INC. WILLIAM E EXNER
K023028 06/18/2003 DEMETECH NYLON NONABSORBABLE SUTURE DEMETECH CORP. LUIS ARGUELLO
K023030 06/18/2003 DEMETECH POLYESTER NONABSORBABLE SUTURE DEMETECH CORP. LUIS ARGUELLO
K030546 06/02/2003 CRP (II) CALIBRATORS DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K030545 06/02/2003 CRP-LATEX (II)X2 SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K030641 06/10/2003 CONTEC LIGHT DENTAURUM JAN W A. DOORSCHODT
K031635 06/23/2003 DEPUY ACROMED VBR SYSTEM DEPUY ACROMED LISA GILMAN
K031495 06/11/2003 PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS DEPUY ORTHOPAEDICS, INC. KARLA A HAM
K023591 06/18/2003 ULTRA HIGH PRESSURE INJECTOR LINES DEROYAL INDUSTRIES, INC. GRACIE GREENWAY
K030035 06/25/2003 IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE DIAMETRICS MEDICAL, INC. NANCY RING
K031159 06/25/2003 CALIBRATING MATERIAL, CALIBRATING STANDARDS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K031311 06/20/2003 INTEGRADWEB BY DYNAMIC IMAGING, INC. DYNAMIC IMAGING INC. CARL ALLETTO
K031571 06/19/2003 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 E-Z-EM, INC. STEVEN HARTMAN
K031423 06/27/2003 EBI P148 SPINAL FIXATION SYSTEM EBI, L.P. JON CAPARETTA
K031645 06/25/2003 EBI XFIX DFS SYSTEM EBI, L.P. ART KAUFMAN
K030944 06/20/2003 EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL EDWARDS LIFESCIENCES, LLC. JASON SMITH
K030800 06/11/2003 ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES ELETROMED, INC. LYDIA BAYNES
K031113 06/10/2003 DISPOSABLE POWDER FREE VINYL EXAM GLOVES ELITE INTERNATIONAL, INC. BOBBY LING
K031026 06/27/2003 ETI BIPOLAR HEMOSTATIC PROBE ENDO-THERAPEUTICS, INC. TODD ADKISSON
K031864 06/24/2003 NITREX NITINOL GUIDEWIRE EV3 CORPORATION CAROLYN ANDERSON
K023559 06/12/2003 FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK FISHER & PAYKEL HEALTHCARE, LTD. KEVIN SHERLOCK
K023670 06/12/2003 SINGLE USE ORAL MASK, MODEL HC455A FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K024243 06/20/2003 REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 FOX HOLLOW TECHNOLOGIES SUZON LOMMEL
K023080 06/11/2003 GALIX PACESTAR GALIX BIOMEDICAL INSTRUMENTATION, INC. JORDAN GAVRIELIDES
K023355 06/24/2003 ASYRA GALLOWAY TECHNOLOGIES, LLC JOE GALLOWAY
K031871 06/20/2003 AUTOBONE GE MEDICAL SYSTEMS EUROPE LARRY KROGER
K031663 06/09/2003 GE VIVID 7, MODEL FC0003XX GENERAL ELECTRIC CO. ALLEN SCHUH
K030174 06/19/2003 GENICON LAPAROSCOPES GENICON, LC GARY HABERLAND
K022926 06/06/2003 GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100 GENTEEL TECHNOLOGY CO., LTD. JENNIFER REICH
K031150 06/23/2003 HEMOBAG, MODEL HBBSD2000 GLOBAL BLOOD RESOURCES, LLC KEITH SAMOLYK
K031151 06/26/2003 TS3 TUBING SET GLOBAL BLOOD RESOURCES, LLC KEITH SAMOLYK
K031302 06/27/2003 SUSTAIN SPACER GLOBUS MEDICAL INC. DANIEL S PAUL
K031104 06/10/2003 POWDERED VINYL EXAM GLOVES, WHITE GLORMED INTL., INC. JANNA P TUCKER
K031505 06/25/2003 RAPIDO CUT-AWAY GUIDING CATHETER GUIDANT CORPORATION SHAH M HILALI
K023898 06/18/2003 GYNE IDEAS MINITAPE RP DEVICE GYNE IDEAS LTD. LOUIS MAZZARESE
K014013 06/25/2003 H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM H & W TECHNOLOGY, LLC CHARLES O HANCOCK
K030824 06/04/2003 LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112 HAKKO MEDICAL CO., LTD. ELIZABETH MILLER
K030519 06/10/2003 WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS HAND BIOMECHANICS LAB, INC. TIMOTHY R STALLINGS
K030822 06/03/2003 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS HANS RUDOLPH, INC. KEVIN RUDOLPH
K030727 06/05/2003 POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT HEALEX PRODUCTS, INC. MILTON HODOSH
K031101 06/16/2003 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 HEMAGEN DIAGNOSTICS, INC. JOSE MONTANEZ
K030946 06/19/2003 HEMCON BANDAGE OTC; HEMCON CATH/AID HEMCON, INC. JAMES F HENSEL
K030765 06/09/2003 HOBBS MISTIFIER SPRAY CATHETER HOBBS MEDICAL, INC. ROB WHALEN
K030948 06/17/2003 VMATE MODEL VMM1000 HOWARD INSTRUMENTS, INC. JACK HOWARD
K030211 06/13/2003 RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 ICN BIOMEDICALS, INC. CHARKES C.F. YU
K024189 06/20/2003 NLITE SYSTEM, MODEL#: A00-1025/A00-1033 ICN PHOTONICS LTD. MIKE KIERMAN
K030900 06/19/2003 INION OTPS BIODEGRADABLE FIXATON SYSTEM INION LTD. HANNA MARTTILA
K030887 06/13/2003 LEKTROGEL, MODEL LK3001 INMED LTDA. JAY MANSOUR
K031450 06/25/2003 QUANTA PLEX ENA PROFILE 6 INOVA DIAGNOSTICS, INC. BRYS C MYERS
K030964 06/06/2003 CALIBRATION PLASMA LMW HEPARIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K030965 06/06/2003 CONTROL PLASMA LMW HEPARIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K031583 06/16/2003 MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 INTEGRATED VASCULAR SYSTEMS, INC. SUSAN TURNER
K031096 06/24/2003 MODIFICATION TO TRANSPORT INCUBATOR 185 INTERNATIONAL BIOMEDICS, INC. GERALD MANNING
K024270 06/24/2003 CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 INTERSURGICAL, INC. THOMAS R GUNERMAN
K030761 06/09/2003 KAISHOU VAGINAL SPECULUM JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD GONG BO
K031346 06/23/2003 JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 JOMED, INC. LORRY W HUFFMAN
K030687 06/27/2003 K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K030848 06/02/2003 PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX KARL STORZ ENDOSCOPY PAUL S LEE
K031540 06/30/2003 APEX ELECTRIC HANDPIECE SYSTEM LARES RESEARCH, INC. JOHN DAHLGREN
K031098 06/04/2003 3-CCD DIGITAL CAMERA SYSTEM LINVATEC CORP. LAURA D SENEFF
K030720 06/03/2003 ULTRABLATOR ELECTRODE LINVATEC CORP. LAURA D SENEFF
K031443 06/18/2003 LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS LSI SOLUTIONS CHRISTOPHER A KLACZYK
K031005 06/18/2003 LUMEND FRONTRUNNER GW CTO CATHETER LUMEND, INC. MICHAEL A DANIEL
K024093 06/19/2003 MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS LUMENIS, LTD. ANNE WORDEN
K031594 06/06/2003 BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY M.K. MEDITECH CO. LTD. ROSINA ROBINSON
K021360 06/10/2003 SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 MED-TEC,INC. DONALD F RIIBE
K031614 06/06/2003 MEDELA PUMP IN STYLE ADVANCED BREAST PUMP MEDELA, INC. CHRISTOPHER L PETERSON
K030218 06/23/2003 PER, MODEL MEMO MEDICAL MONITORS PTY., LTD. HARRY L PLATT
K031486 06/27/2003 BLASTFREEZE AND BLASTTHAW MEDICULT A/S RONALD G LEONARDI
K031228 06/24/2003 SYNVITRO HYADASE MEDICULT A/S RONALD G LEONARDI
K031886 06/30/2003 SONOVIEW PRO BY MEDISON CO., LTD. MEDISON CO., LTD. CARL ALLETTO
K031888 06/27/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K030816 06/06/2003 MSD CABLE REDUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031655 06/27/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD W TREHARNE, PHD
K030875 06/24/2003 MODIFICATION TO COLORADO 2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K031533 06/13/2003 VANTAGE ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K031510 06/18/2003 NIM-SPINE MEDTRONIC XOMED MARTIN SARGENT
K030104 06/11/2003 PRIME ECG SYSTEM MERIDIAN MEDICAL TECHNOLOGIES, INC. JAMIL LAHAM
K030330 06/20/2003 CTXA HIP EXTENDED REFERENCE DATA MINDWAYS SOFTWARE, INC. CHRISTOPHER CANN
K030531 06/17/2003 MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER MINIMED, INC. GERDA P RESCH
K031248 06/20/2003 CONSULTIVA REPORT STATION, MODEL RS-1 MIRAMEDICA, INC WIDO MENHARDT
K031519 06/06/2003 CUFFLOK ANCHOR MITEK WORLDWIDE RUTH C FORSTADT
K030995 06/26/2003 MINILOK QUICKANCHOR PLUS MITEK WORLDWIDE RUTH C FORSTADT
K031131 06/10/2003 KLINIDRAPE SURGICAL DRAPES MOLNLYCKE HEALTH CARE LINDA A HENDRICKS
K030913 06/03/2003 NANMA VACUUM PUMP NANMA MFG CO., LTD. YOLANDA SMITH
K031627 06/11/2003 NANO-TICROWN NANO-WRITE CORP. KENNETH E KNAPP
K023367 06/25/2003 DETECTAR, MODEL N123-MI NEKS TECHNOLOGIES CHARLES H KYPER
K024259 06/20/2003 PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 NEW STAR LASERS, INC. DONALD V JOHNSON
K021328 06/26/2003 SMART BAG MO O-TWO SYSTEMS INTERNATIONAL INC. KEVIN BOWDEN
K030401 06/19/2003 DISPOSABLE M2-PE MICROKERATOME BLADES OASIS MEDICAL, INC. YVONNE FERNANDEZ
K031391 06/20/2003 HF MODULE WITH TRANSDUCERS OPHTHALMIC TECHNOLOGIES, INC. GEORGE MYERS
K031083 06/12/2003 OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 OPUS MEDICAL, INC. JAMES W HART
K023378 06/27/2003 ORIA CLARIS ORTHOTEC, L.L.C. PATRICK BERTRANOU
K031452 06/18/2003 ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 ORTHOTEC, L.L.C. PATRICK BERTRANOU
K031164 06/19/2003 PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV Oscor Inc. MILA DOCKOCIL
K023011 06/26/2003 OSMONICS SOLUTION DELIVERY SYSTEM OSMONICS MEDICAL SYSTEMS KRISTINE KALISZEWSKI
K030608 06/12/2003 OTI BONE CEMENT PLUG OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K024179 06/04/2003 PALOMAR LIGHTCUBE PALOMAR MEDICAL PRODUCTS, INC. Marcy Moore
K030863 06/27/2003 EBV VCA-P18 IGG ELISA PANBIO LIMITED HELEN JENNINGS
K031205 06/13/2003 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K031103 06/12/2003 PASCO MIC AND MIC/ID PANELS (ERTAPENEM) PASCO LABORATORIES, INC. LINDA K DILLON
K030987 06/12/2003 CONTACT LENS STORAGE CASE PELICAN PRODUCTS CAROL NOBEL
K031023 06/27/2003 PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 PEREGRINE SURGICAL LTD. TODD RICHMOND
K031021 06/13/2003 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD JAMES F LOGAN
K031414 06/26/2003 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE PERUSAHAAN GETAH ASAS SDN BHD JAMES F LOGAN
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