FDA 510(k) Applications Received During September, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K033022 09/25/2003 PROTEMP 3 GARANT 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K032756 09/05/2003 A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 A-DEC, INC. TOM LOUISELL
K032757 09/05/2003 A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE A-DEC, INC. TOM LOUISELL
K033356 09/20/2003 VERASOFT ES AALBA DENT, INC. VINCENT BENETTI
K032929 09/22/2003 MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 ABBOTT VASCULAR INC. JOANNA KUSKOWSKI
K032956 09/22/2003 ACCUSONIC A-SCAN MODEL, 24-4000 ACCUTOME, INC. JEFFREY L WRIGHT
K032903 09/17/2003 ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K033047 09/29/2003 ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K033041 09/29/2003 ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP ACON LABORATORIES, INC. EDWARD TUNG
K032970 09/23/2003 ACRA-CUT XPRESS 120 ACRA CUT, INC. KENNETH M NICOLL
K032847 09/12/2003 EXCISOR BIOPTOME, MODEL 01-0004 ACUEITY, INC. NANCY LINCE
K032724 09/03/2003 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM ADAC LABORATORIES RANDY VADER
K032879 09/15/2003 NAVIGATOR I ADAPTIVE HEALTHCARE TECHNOLOGIES, INC. JOAN JOHNSON
K032830 09/11/2003 PLLA CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS STEVE JANIN
K032742 09/04/2003 SILVER FOAM WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LTD. JOHN GREEN
K033148 09/30/2003 ART ANTERIOR SPINAL SYSTEM ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K033150 09/30/2003 ART POSTERIOR SPINAL SYSTEM ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K032751 09/05/2003 MODIFICATION TO RENEW LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K032959 09/23/2003 CIDEX OPA CONCENTRATE ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K032849 09/12/2003 AERONEB GO NEBULIZER, MODEL AG-AG2000 AEROGEN, INC. Nancy E Isaac
K032736 09/04/2003 HEART 2006 AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K033008 09/26/2003 AIR SAFETY HEPA AND NON-HEPA FILTERS AIR SAFETY LTD PAUL DRYDEN
K032922 09/22/2003 CLARISSA INFANT NCPAP CANNULA AIRWAYS LTD., INC. RICHARD J LARKIN
K032801 09/09/2003 MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K033013 09/26/2003 MDIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K032875 09/15/2003 ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM ALOKA CO. LTD USA RICHARD J CEHOVSKY
K033090 09/29/2003 ICON POLYAXIAL PEDICLE SCREW SYSTEM ALPHATEC MFG., INC. ELLEN A HICKS
K032744 09/04/2003 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD L SCHRAYER
K033053 09/29/2003 ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. Howard Schrayer
K033045 09/29/2003 DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST AMERICAN GREEN DENT. MFG, INC. ANDREW ROWE
K033044 09/29/2003 DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER AMERICAN GREEN DENT. MFG, INC. ANDREW ROWE
K032789 09/08/2003 REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K033076 09/29/2003 LIFESTYLES LIQUID PERSONAL LUBRICANT ANSELL HEALTHCARE, INC. LON D MCILVAIN
K032896 09/17/2003 ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02 ANSON MEDICAL LTD. IAN QUIRK
K032710 09/02/2003 CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT APOGEE MEDICAL, INC. DIANE N PEPER
K033099 09/29/2003 ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 APPLIED DIABETES RESEARCH, INCORPORATED JIM BARLEY
K032889 09/17/2003 OPTICAL SEPARATOR APPLIED MEDICAL RESOURCES CHERYL BLAKE
K033024 09/26/2003 MODIFICATION TO SUTURE CLINCH APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K032962 09/23/2003 AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE ARROW INTL., INC. ELIZABETH PRICE
K032822 09/10/2003 ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 ASAP ENDOSCOPIC PRODUCTS GMBH MARTINA GUENDEROTH
K032840 09/11/2003 ATRION MEDICAL QL INFLATION DEVICE ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K033015 09/26/2003 AXIOM BIOLASER LLLT SERIES-3 AXIOM USA. INC JIM GIBSON
K033028 09/26/2003 ANEFIN, MODEL 100 AXON MEDICAL JOSEPH ORR
K032741 09/04/2003 EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION AXON SYSTEMS, INC. HOWARD BAILIN
K033005 09/25/2003 MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033004 09/25/2003 MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033103 09/29/2003 MGD 2621L MEDICAL GREYSCALE DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033104 09/29/2003 MGD 2621P MEDICAL GREYSCALE DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033007 09/26/2003 BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K033036 09/29/2003 BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 BECKMAN COULTER, INC. BRENT TABER
K033038 09/29/2003 GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 BECKMAN COULTER, INC. BRENT TABER
K032843 09/11/2003 NEXIVA CLOSED IV CATHETER SYSTEM BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K033126 09/30/2003 MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM BEHAVIORAL TECHNOLOGY, INC. SUSAN E OLSEN
K032778 09/08/2003 LARGE VOLUME FLUID RESERVOIR BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K033155 09/30/2003 BIOCENTREX CARDIAC PANEL BIOCENTREX THOMAS H GROVE
K032874 09/15/2003 HBA SPERM-HYALURONAN BINDING ASSAY BIOCOAT, INC. JAMES B JOHNSTON
K032864 09/12/2003 CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 BIOLITEC, INC. JONATHAN S KAHN
K032863 09/12/2003 CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 BIOLITEC, INC. JONATHAN S KAHAN
K032788 09/08/2003 VITEK 2 GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC. Nancy Weaver
K032861 09/12/2003 VITEK 2 GRAM NEGATIVE MOXIFLOXACIN BIOMERIEUX, INC. Nancy Weaver
K032766 09/05/2003 VITEK 2 GRAM POSITIVE LINEZOLID BIOMERIEUX, INC. Nancy Weaver
K032738 09/04/2003 VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN BIOMERIEUX, INC. Nancy Weaver
K032711 09/02/2003 VITEK GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC. Nancy Weaver
K032895 09/17/2003 BI-ANGULAR SHOULDER SYSTEM BIOMET, INC. PATRICIA S BERES
K032819 09/10/2003 GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM BIONOSTICS, INC. KATHLEEN STORRO
K032992 09/25/2003 UNIMARK HOME PREGNANCY TEST DEVICE BIOTECH ATLANTIC, INC. FRANCIS L DENG
K032747 09/04/2003 BIOTOP DJT-A SAFETY SYRINGE BIOTOP TECHNOLOGY CO., LTD. Ke-Min Jen
K032976 09/24/2003 BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 BIOVALVE TECHNOLOGIES, INC. SCOTT HUIE
K032700 09/02/2003 BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K032713 09/02/2003 BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K032707 09/02/2003 CONTOUR SE MICROSPHERES (SYRINGE) BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K032930 09/22/2003 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K032712 09/02/2003 VAXCEL PLUS CHRONIC DIALYSIS CATHETER BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K032884 09/16/2003 FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH BOSTON SCIENTIFIC EPI DEBBIE MCINTIRE
K033010 09/26/2003 BRM2 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. CHRIS MANDER
K032940 09/22/2003 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K032938 09/22/2003 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K032918 09/22/2003 C.T.M. MOBILITY SCOOTER, MODEL HS-235 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K032919 09/22/2003 C.T.M. MOBILITY SCOOTER, MODEL HS-250 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K033172 09/30/2003 CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS CANDELA CORP. LORRAINE CALZETTA-PATROVIC
K033085 09/29/2003 PORTACLAMP CARDIO LIFE RESEARCH, S.A. JAMES R VEALE
K033037 09/29/2003 MODIFICATION TO GLOBALCARDIO CARDIOCOMM SOLUTIONS, INC. JANET WAINMAN
K033123 09/30/2003 STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE CARL ZEISS MEDITEC INC R. MICHAEL CROMPTON
K033048 09/29/2003 CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K032835 09/11/2003 H/S CATHETER SET CATHETER RESEARCH, INC. JOHN A STEEN
K032838 09/11/2003 CELON ENT SYSTEM CELON AG MEDICAL INSTRUMENTS ANDRE ROGGAN
K032951 09/22/2003 CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A CHRONO-LOG CORP. NICHOLAS J VERIABO
K032978 09/24/2003 MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME CIBA VISION CORPORATION PENNY NORTHCUTT
K033147 09/30/2003 CLEARTOOTH DIGITAL X-RAY SYSTEM CLEARTOOTH ELECTRONICS, INC. GREG HOLLAND
K033162 09/30/2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K033020 09/26/2003 IMPAK ACRYLIC REPAIR RESIN LIQUID CMP INDUSTRIES LLC. WILLIAM REGAN
K032698 09/02/2003 COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K032770 09/08/2003 ENDOTINE FOREHEAD DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K032920 09/22/2003 THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 COEUR MEDICAL DEBRA F MANNING
K032857 09/12/2003 PRESS-MATE BX-10 VITAL SIGN MONITOR COLIN MEDICAL INSTRUMENTS CORP. MARK RISON
K033052 09/29/2003 CONDUCTIVE EEG ELECTROLYTE COMPUMEDICS USA, LTD. ELVIRA GARCIA
K032762 09/05/2003 XIO RADIATION TREATMENT PLANNING SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K032831 09/11/2003 PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 CONMED CORPORATION IRA DUESLER
K033093 09/29/2003 ECHOCONNEX COMMUNICATOR CONNEXMD CURTIS LEBLEU
K032734 09/04/2003 CONVATEC FECAL MANAGEMENT SYSTEM CONVATEC, A BRISTOL-MYERS SQUIBB CO. NANCY REGULSKI
K032869 09/15/2003 COOK CODA BALLOON CATHETER COOK, INC. Theodore Heise
K032931 09/22/2003 PTA BALLOON CATHETER COOK, INC. KAREN BRADBURN
K032873 09/15/2003 PROCLEAR COMPATIBLES MULTIFOCAL COOPER VISION, INC. LISA HAHN
K032737 09/04/2003 CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA CORDIS EUROPA N.V. KAREN WILK
K032868 09/15/2003 REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 CORGENIX, INC. NANCI DEXTER
K033156 09/30/2003 OB1 OBSTETRICAL DOPPLER D. E. HOKANSON, INC. D. EUGENE HOKANSON
K032798 09/09/2003 DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A DADE BEHRING, INC. ANDREA M TASKER
K032697 09/02/2003 DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) DADE BEHRING, INC. LORRAINE H PIESTRAK
K032706 09/02/2003 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML DADE BEHRING, INC. CYNTHIA VAN DUKER
K032692 09/02/2003 DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 DAKO A/S GITTE BRINKMANN
K032955 09/22/2003 AUTOMOVE, MODEL AM800 DANMETER A/S HANNE NIELSEN
K032988 09/24/2003 ELPHA 4 CONTI DANMETER A/S HANNE NIELSEN
K032954 09/22/2003 ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 DANMETER A/S HANNE NIELSEN
K033078 09/29/2003 DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE DATEX-OHMEDA JOEL KENT
K032803 09/09/2003 DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA DAN KOSEDNAR
K033144 09/30/2003 DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES DEFIBTECH, LLC JOHN L ROGERS
K032851 09/12/2003 ULTRACROWN 75 ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K032904 09/17/2003 ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 DENTSPLY INTL. JOHN R MILLER
K032892 09/17/2003 MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K033057 09/29/2003 DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE DEROYAL SHARON COOK
K032881 09/15/2003 IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K033056 09/29/2003 BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K033060 09/29/2003 CALIBRATING MATERIAL, CALIBRATING STANDARDS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K033061 09/29/2003 CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K033058 09/29/2003 CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K033055 09/29/2003 GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS DIAMOND DIAGNOSTICS, INC. LINDA STUNDTNER
K033063 09/29/2003 MISSION CONTROLS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K032844 09/11/2003 LIAISON 25 OH VITAMIN D DIASORIN, INC. DAVID IKEDA
K032730 09/03/2003 FIXION HIP SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. HILA WACHSLER-AVRAHAMI
K032947 09/22/2003 NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 DOLPHIN MEDICAL INC. BILL CURNAN
K032794 09/08/2003 CUSTODIOL DR. FRANZ KOHLER CHEMIE GMBH T. WHIT ATHEY
K033164 09/30/2003 ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM DR. LEN'S MEDICAL PRODUCTS LLC JAY MANSOUR
K032900 09/17/2003 LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS EDWARDS LIFESCIENCES, LLC. Daun Putnam
K032935 09/22/2003 EPI-SCAN, MODEL P 100 EDX EPI-SCAN, INC. GREG HOLLAND
K032996 09/25/2003 ELEKTA SYNERGY SYSTEM ELEKTA ONCOLOGY SYSTEMS, LTD. PETER STEGAGNO
K032905 09/17/2003 3DKNEE POROUS COATED FEMORAL COMPONENT ENCORE ORTHOPEDICS, INC. KIMBERLY L PRUITT
K033000 09/25/2003 NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM ESSEX CRYOGENICS OF MISSOURI, INC. ELIZABETH HUNNICUTT
K033138 09/30/2003 CAP3 BONE SUBSTITUTE MATERIAL ETEX CORP. PAMELA W ADAMS
K033134 09/30/2003 MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K033140 09/30/2003 NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOR
K032964 09/23/2003 EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS EXACTECH, INC. GARY J MILLER
K032769 09/08/2003 EYESOPEN TONOMETER EYE-DEAS, LLC STEVEN E FELDON
K033153 09/30/2003 DICOM THEATER FERGUSON MEDICAL FRANK FERGUSON
K033087 09/29/2003 ORACLE ORAL MASK, MODEL HC451A FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K032750 09/05/2003 MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE FRIANDENT GMBH CAROL PATTERSON
K032915 09/22/2003 ADVANTAGE 4D OPTION GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K032795 09/08/2003 GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K032720 09/02/2003 GEM-STIM TENS, MODELS GM3XY AND GM3AXY GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K032994 09/25/2003 GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K032719 09/02/2003 GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K033168 09/30/2003 GE 0.2T SIGNA PROFILE/I MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER
K032974 09/24/2003 GE LOGIQ 5 PRO OR EXPERT GENERAL ELECTRIC CO. ALLEN SCHUH
K033139 09/30/2003 GE MARLIN ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K032723 09/03/2003 BIOSIGN STEAM-24 BIOLOGICAL INDICATOR GETINGE USA, INC KARLA BYRNE
K033089 09/29/2003 HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM GYRUS ENT L.L.C. GREGORY SREDIN
K033161 09/30/2003 VISU-LOCK 5MM CLIP APPLIER GYRX, LLC CORY EDWARDS
K033112 09/30/2003 WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS HAND BIOMECHANICS LAB, INC. TIMOTHY R STALLINGS
K032705 09/02/2003 DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. AL WEISENBORN
K033125 09/30/2003 HANDIVIPP HANDINOR USA, INC. BARBARA CHIPONIS
K033116 09/30/2003 OPTI-RIDER DELUXE HANSUNG ECONET CO., LTD. CYNTHIA J.M. NOLTE
K033054 09/29/2003 HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP HARVARD CLINICAL TECHNOLOGY ERIC J FLACHBART
K032913 09/02/2003 HL888 AF HEALTH & LIFE CO., LTD. PAUL HUNG
K032839 09/11/2003 HL888BA HEALTH & LIFE CO., LTD. PAUL HUNG
K032695 09/02/2003 HL888BF HEALTH & LIFE CO., LTD. PAUL HUNG
K032837 09/11/2003 HL888BM HEALTH & LIFE CO., LTD. PAUL HUNG
K033043 09/29/2003 MODIFICATION TO HL168 HEALTH & LIFE CO., LTD. PAUL HUNG
K033133 09/30/2003 TELECARE D.R. SERVER SOFTWARE SYSTEM HEALTHCARE VISION, INC. CRAIG WALKER
K032969 09/23/2003 HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE HELICA INSTRUMENTS, LTD JOHN B WEBB
K032772 09/08/2003 MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM HILL-ROM MANUFACTURING, INC. CINDY L CROSBY
K032802 09/09/2003 HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III HK SURGICAL, INC. SALLY M BOWDON
K032985 09/24/2003 GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM HMD BIOMEDICAL, INC. JEFFREY FLEISHMAN
K032754 09/05/2003 VORTEX MP HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K032855 09/12/2003 STRYKER SPINE MAPS SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K033145 09/30/2003 HOFFMANN II PELVIC CLAMP HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K032829 09/11/2003 SCORPIO LOW PROFILE TIBIAL TRAY HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K032898 09/17/2003 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K032797 09/08/2003 DELIGHT DENTAL ER: YAG LASER SYSTEM HOYA PHOTONICS, INC. THOMAS HANEY
K032821 09/05/2003 HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF HYGIA HEALTH SERVICES, INC. TRACY W COMAS
K032796 09/08/2003 IBL C3D-CIC EIA TEST IBL GMBH Gary Lehnus
K032860 09/12/2003 IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K032850 09/12/2003 IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K033098 09/29/2003 OSTEOGEN SBRG IMPLADENT, LTD. MAURICE VALEN
K033072 09/29/2003 LUCENTLITE, MODEL IMD 010 INDUSTRIAL & MEDICAL DESIGN, INC. YEVGENIY KUKLIN
K033074 09/29/2003 INION GTR BIODEGRADABLE MEMBRANE SYSTEM INION LTD. HANNA MARTTILA
K033136 09/30/2003 I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 INNOVA VISION INC. JENNIFER REICH
K032704 09/02/2003 INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 INNOVATECH SURGICAL INC. MICHAEL J MCGOWAN
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