FDA 510(k) Decisions During July, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K031631 07/18/2003 STEREOTACTIC BODY FRAME, MODEL COD. 70-1A 3D LINE USA, INC. NADER SALEHI
K030899 07/02/2003 C-REACTIVE PROTEIN (CRP) ABBOTT LABORATORIES LINDA MORRIS
K030960 07/16/2003 ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE ACMI CORPORATION John DeLucia
K031784 07/14/2003 ACON STREP A RAPID TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K031905 07/07/2003 DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030 ACTHERM, INC. RICHARD HSIEH
K031438 07/17/2003 ACUMED SMALL BONE LOCKING ROD SYSTEM II ACUMED LLC ED BOEHMER
K030926 07/21/2003 FAST THROW STAINLESS STEEL SURGICAL SUTURE ADVANCED SURGICAL PRODUCTS, INC. JEFFERY S JONES
K031216 07/17/2003 MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE AESCULAP GEORG KELLER
K032059 07/25/2003 MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM AESCULAP, INC. GEORG KELLER
K032147 07/25/2003 SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES ALARIS MEDICAL SYSTEMS, INC. STACY L LEWIS
K031193 07/03/2003 SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION ALCON, INC. KIM B KRACKE
K032058 07/30/2003 MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K031394 07/25/2003 AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE AMERICAN SYRINGE COMPANY DAVID M GARVIN
K031273 07/15/2003 AMERITEK SURE-POINT HDR NEEDLE TEMPLATE AMERTEK MEDICAL, INC. GREG WIITA
K031978 07/21/2003 AMPLAID A756 SCREENING ADMITTANCE METER AMPLAID DANIEL KAMM
K030692 07/17/2003 POWER LASER 90 ANDI ELECTROMEDICAL APS JEFF WORRELL
K030754 07/11/2003 A/C ENZYMATIC HOMOCYSTEINE ASSAY ANTICANCER INC YUYING TAN
K023737 07/14/2003 INJECTOR ANTON MEYER & CO. LTD. THOMAS MEYER
K031913 07/09/2003 VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K031716 07/10/2003 SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE ASIA-MED GMBH AND CO KG Kevin Walls
K031319 07/17/2003 OSTEO-G BONE VOID FILLER SYSTEM ASPINE USA, INC. FLOYD G LARSON
K032082 07/30/2003 AURORA AURORA IMAGING TECHNOLOGY, INC. JAMES R VEALE
K030638 07/09/2003 DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML AVANTEC VASCULAR CORP. JAMES M SHY
K030830 07/15/2003 B. BRAUN NERVE BLOCK CATHETER B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K030135 07/15/2003 SAFETY INTRODUCER NEEDLE B. BRAUN MEDICAL, INC. AMY K SMITH
K031950 07/17/2003 BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD BAYLIS MEDICAL CO., INC. KRIS SHAH
K032013 07/24/2003 COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER BECKMAN COULTER, INC. LOURDES COBA
K031870 07/15/2003 SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT BECKMAN COULTER, INC. MARY BETH TANG
K031530 07/10/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML BECTON DICKINSON & CO. MONICA EVELYN GIGUERE
K031912 07/21/2003 BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML BECTON, DICKINSON & CO. MICHELLE B BANDY
K031699 07/30/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K031589 07/11/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K031679 07/16/2003 BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. BRADFORD SPRING
K031478 07/02/2003 MICROHEATER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K031352 07/16/2003 BIO-LOGIC INSERT EARPHONES BIO-LOGIC SYSTEMS CORP. ERIK C GUNDERSEN
K030076 07/07/2003 PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING SUSAN B FENTRESS
K031737 07/14/2003 BACT/ALERT MP CULTURE BOTTLES (PLASTIC) BIOMERIEUX, INC. JOCELYN JENNINGS
K031410 07/10/2003 VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. Nancy Weaver
K031734 07/01/2003 GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS BIOMET, INC. GARY BAKER
K031881 07/28/2003 AIRBRUSH LIPOSCULPTOR SYSTEM BIOSCULPTURE TECHNOLOGY, INC. ROBERT CUCIN
K031161 07/22/2003 VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER BIOSENSE WEBSTER, INC. WILLIAM WELCH
K024337 07/03/2003 GENERAL SEMEN ANALYSIS (GSA) KIT BIOSHAF LTD. TOM TSAKERIS
K031118 07/08/2003 INTRAOS 70 BLUE X IMAGING SRL AL SOSA
K030769 07/14/2003 ULTRAFLEX PRECISION COLONIC STENT BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K031844 07/15/2003 VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K032008 07/14/2003 VAXCEL WITH PASV PORT, MODEL 45-213 BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K030113 07/02/2003 MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 BRANAN MEDICAL CORP. RAPHAEL WONG
K032133 07/21/2003 BRODA MODEL 587 MANUAL WHEELCHAIR BRODA ENT., INC. PHILLIP MCTAGGART
K030442 07/21/2003 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. RAMON RICART
K030268 07/30/2003 NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS C.R. BARD, INC. GLENN NORTON
K031328 07/25/2003 RECOVERY FILTER SYSTEM, MODEL RF-048F C.R. BARD, INC. Mary J Edwards
K032044 07/10/2003 X-PROT DUO PORT C.R. BARD, INC. JOHN C KNORPP
K031987 07/30/2003 POWERHEART AED G3, MODEL 9300 CARDIAC SCIENCE KENNETH OLSON
K031207 07/15/2003 SAFETY RELEASE ARCH BAR KIT CASEY SURGICAL, LLC JAMES E STANLEY
K030403 07/17/2003 CEFAR REHAB 2 AND REHAB 2 PRO CEFAR MEDICAL AB CONSTANCE G BUNDY
K031183 07/14/2003 TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE CENTERPULSE ORTHOPEDICS, INC. ROBERT M WOLFARTH
K031416 07/15/2003 CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF CLEAR MEDICAL, INC. LANE ABENROTH
K031044 07/15/2003 ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR CLINICAL DATA, INC. WYNN STOCKING
K031536 07/18/2003 BRAIN COIL, MODEL 9900GE-64 CLINICAL MR SOLUTIONS, LLC RALPH S HASHOIAN
K031575 07/23/2003 LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS CLINIQA CORPORATION CAROL RUGGIERO
K031623 07/03/2003 MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K031720 07/11/2003 MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. KEITH LOWREY
K031956 07/17/2003 MODIFICATION TO HERMES O.R. CONTROL CENTER COMPUTER MOTION, INC. KEITH LOWREY
K031979 07/25/2003 CONMED INTEGRATED SYSTEMS NURSES ASSISTANT CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K031704 07/31/2003 FILMLESS CLINIC CONNECT IMAGING, INC. PHILIP J MANLY
K030841 07/11/2003 COOK GASTRIC SIZING BALLOON CATHETER COOK, INC. CAROL ZWISSLER
K031821 07/18/2003 MODIFICATION TO COOK ZILVER BILIARY STENT COOK, INC. CAROL ZWISSLER
K031802 07/21/2003 CORIX 70 PLUS-USV CORAMEX, S.A. AL SOSA
K031777 07/07/2003 MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K031208 07/07/2003 REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 CORGENIX, INC. NANCI DEXTER
K031482 07/10/2003 CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE CRYOMEDICAL INSTRUEMTS LTD. GARETH COPPING
K031258 07/08/2003 CYNOSURE PHOTOLIGHT PL CYNOSURE, INC. GEORGE CHO
K031690 07/08/2003 CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) CYNOSURE, INC. GEORGE CHO
K031512 07/23/2003 EMIT II PLUS COCAINE METABOLITE ASSAY DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K031602 07/31/2003 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K031910 07/25/2003 STAINLESS STEEL AQUATIC WHEELCHAIR DB PERKS & ASSOCIATES LTD. ED OLIVER
K031615 07/21/2003 SLED CURING LIGHT SYSTEM DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K031145 07/15/2003 ESTYLUS ELECTRIC MOTOR SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K031203 07/14/2003 BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN
K031803 07/01/2003 DEPUY CERAMIC FEMORAL HEADS DEPUY ORTHOPAEDICS, INC. KARLA A HAM
K031969 07/28/2003 DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT DEPUY ORTHOPAEDICS, INC. KATHY K TRIER
K030477 07/18/2003 DIADEXUS PLAC TEST DIADEXUS, INC. ROBERT L WOLFERT
K032040 07/09/2003 IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR DIDECO S.P.A. BARRY SALL
K031400 07/15/2003 FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K032135 07/21/2003 SITE-RITE IV ULTRASOUND SYSTEM DYMAX CORP. CHARLES MORREALE
K030058 07/30/2003 EARLYDETECT MENOPAUSE TEST FOR FSH EARLY DETECT, INC. PETER GEORGE
K031355 07/22/2003 EBI SPINELINK - II SPINAL FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K031424 07/22/2003 EBI SPINELINK SPINAL FIXATION SYSTEM EBI, L.P. BARRY SANDS
K031093 07/10/2003 EBI XFIX OPTIROM KNEE FIXATOR EBI, L.P. JON CAPAROTTA
K031045 07/10/2003 AEROLET TOILET LIFT, MODEL AER-01 ECONOMIC HOLLAND B.V. STEPHANIE WOLFKAMP
K024303 07/03/2003 EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM EDWARDS LIFESCIENCES, LLC. KAVIN DRISKO
K030637 07/22/2003 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K031638 07/21/2003 CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION ELECTROMED IMAGING INC. WARREN BAKER
K020478 07/17/2003 ELECTROMEDICARIN 900 ELECTROMEDICARIN, S.A. JAY MANSOUR
K031999 07/25/2003 ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT ELEKTA INSTRUMENT AB PETER LOWENDAHL
K031980 07/25/2003 MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM ELEKTA INSTRUMENT AB PETER LOWENDAHL
K031846 07/21/2003 CARDIOVATIONS OPTICAL BIPOLAR DEVICE ETHICON, INC. PETER CECCHINI
K031847 07/21/2003 CARDIOVATIONS RETRACTOR ETHICON, INC. PETER CECCHINI
K031227 07/17/2003 LORDEX POWER TRACTION EQUIPMENT EVER PROSPEROUS INSTRUMENT INC JOHN BOREN
K031500 07/25/2003 EXCEL PRIMARY SOLUTION SET EXELINT INTL. CO. ARMAND HAMID
K031067 07/14/2003 FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB
K020332 07/07/2003 RESPIRATORY HUMIDIFIER, MODEL MR850 FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K031828 07/17/2003 NATURALASE LP ND:YAG LASER FOCUS MEDICAL, LLC. JOHN LEE, JR
K024204 07/07/2003 FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM FOTONA D.D. MOJCA VALJAVEC
K031916 07/17/2003 GALT MEDICAL GUIDEWIRE GALT MEDICAL CORP. DAVID CATLIN
K030962 07/25/2003 DPX SERIES BRAVO DUO BONE DENSITOMETER GE LUNAR CORP. JAMES P RASKOB
K032045 07/30/2003 8 CHANNEL CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS LARRY KROGER
K031927 07/02/2003 GE DELTA SOFTWARE OPTION FOR MRI GE MEDICAL SYSTEMS LARRY KREGER
K031376 07/16/2003 DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K031036 07/10/2003 GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 GEBAUER CO. AMY J PAUKOVITS
K030788 07/12/2003 KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS GEISTER MEDIZINTECHNIK GMBH DAGMAR MASER
K032182 07/25/2003 GE LOGIQ 7, MODEL 2354858 GENERAL ELECTRIC CO. ALLEN SCHUH
K031554 07/25/2003 S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM GENZYME BIOSURGERY DENISE LIMA
K031647 07/29/2003 BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR GETINGE USA, INC KARLA BYRNE
K031033 07/01/2003 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K031581 07/24/2003 NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG GREEN PROSPECT SDN BHD JANNA P TUCKER
K031580 07/25/2003 NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE GREEN PROSPECT SDN BHD JANNA P TUCKER
K030547 07/11/2003 MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE GUARDIAN ANGEL PRODUCTS, INC. ERNEST H PESCATORE
K031459 07/23/2003 RAPIDO CUT-AWAY CUTTER GUIDANT CORP. SHAH HILALI
K031688 07/02/2003 RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE GUIDANT CORPORATION STEPHANIE ISGRIGG ROBINSON
K031085 07/21/2003 GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) GYRUS MEDICAL, INC. MERCEDES BAYANI
K031695 07/01/2003 HL168R HEALTH & LIFE CO., LTD. SUSAN CHEN
K031835 07/01/2003 HL888RA HEALTH & LIFE CO., LTD. SUSAN CHEN
K022967 07/08/2003 SUILE WOUND DRESSING HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. ERIC LUO
K014074 07/23/2003 HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION HOFFRICHTER GMBH STEPHEN H GORSKI
K030703 07/11/2003 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K031718 07/02/2003 LIFEVALVE CENTRAL VENOUS CATHTER HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K031480 07/31/2003 GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K031941 07/24/2003 HOFFMANN II COMPACT BALTIMORE COUPLING HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K031959 07/25/2003 STRYKER PLATING SYSTEM PERIARTICULAR PLATES HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K031893 07/17/2003 XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K031383 07/07/2003 MODEL 780 HUDSON RESPIRATORY CARE, INC. CHARLES MIERKIEWICZ
K031986 07/24/2003 ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS ICS MEDICAL DELMAR F BLOEM
K031991 07/30/2003 DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS IMAGE ANALYSIS, INC. BEN ARNOLD
K031490 07/16/2003 RUBELLACOL IMMUNOSTICS, INC. JEFFREY FLEISHMAN
K031475 07/28/2003 OSSEOTITE NT CERTAIN IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K031823 07/11/2003 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 IMPLEX CORP. MARCI HALEVI
K031829 07/31/2003 HEMOSIL FACTOR IX DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K030600 07/11/2003 AUTION JET AJ-4270 URINE ANALYZER INTERNATIONAL REMOTE IMAGING SYSTEMS CYNTHIA J.M. NOLTE
K031417 07/11/2003 ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K031783 07/01/2003 SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005 INTRAVASCULAR INCORPORATED STEVE APERAVICH
K031115 07/10/2003 RH-900 IOMED, INC. CURTIS JENSEN
K031059 07/10/2003 IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 IVD RESEARCH, INC. DAVE LAMBILLOTTE
K031342 07/10/2003 JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II JASON MARINE ENTERPRISES, INC. BRIAN GAGNON
K023668 07/01/2003 JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR JMS NORTH AMERICA CORP. SWEE CHEAU CHONG
K024377 07/21/2003 TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 KALACO SCIENTIFIC, INC. GRACE BARTOO
K032081 07/24/2003 KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 KAVO AMERICA DANIEL KAMM
K031868 07/09/2003 PROPHYPEARLS KAVO AMERICA DANIEL KAMM
K031484 07/03/2003 STAND OUT KERR CORP. COLLEEN BOSWELL
K031444 07/02/2003 OPTIBOND FL KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K031504 07/18/2003 ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX KOVEN TECHNOLOGY, INC. J. HARVEY KNAUSS
K031309 07/31/2003 KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 KUANN DAH INDUSTRY CO., LTD. Ke-Min Jen
K031250 07/15/2003 DBC PRESS ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K031060 07/11/2003 NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K031981 07/25/2003 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 LINVATEC BIOMATERIALS, LTD. LAURA KREJCI
K030033 07/21/2003 LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES LUMENIS, LTD. ANNE WORDEN
K030342 07/17/2003 LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS LUMENIS, LTD. ANDREA L RUTH
K024169 07/01/2003 MACROPORE OS RECONSTRUCTION MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K031445 07/01/2003 MAINLINE MAXIE HCG URINE PREGNANCY TEST MAINLINE TECHNOLOGY, INC. MARTHA MAZUREK
K031339 07/11/2003 OPTIBOLUS MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ELLIS ROGERS
K031372 07/02/2003 PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION MAXXVISION, LLC JAMES K WALKER
K031119 07/15/2003 MAYO CLINIC BC-10 1.5T MAYO MEDICAL VENTURES JADE SADOSTY
K031890 07/16/2003 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031392 07/01/2003 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031441 07/01/2003 URICHEMTRAK LIQUID ASSAYED URINE CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K022558 07/08/2003 NGT MEDICAL INNOVATIVE PRODUCTS DEBBIE IAMPIETRO
K031861 07/29/2003 MIX2VIAL TRANSFER DEVICE MEDIMOP MEDICAL PROJECTS, LTD. BENNY ARAZY
K030919 07/03/2003 SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES MEDISISS MRRY ANN BARKER
K031843 07/03/2003 MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K031808 07/11/2003 MEDRAD SWABBABLE VALVE TRANSFER SET MEDRAD, INC. ANDREW P ZELTWANGER
K031032 07/14/2003 VERDICT II, PROFILE II MEDTOX DIAGNOSTICS, INC. ALAN MORRIS
K031776 07/25/2003 MC2X MULTI-STAGE VENOUS CANNULA MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K031827 07/02/2003 ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX MEDTRONIC PERFUSION SYSTEMS PREETI JAIN
K031780 07/30/2003 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K031211 07/17/2003 ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH MEDTRONIC VASCULAR LYNN JENSEN
K031247 07/17/2003 CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM MEDTRONIC VASCULAR SCOTT CUNDY
K030671 07/31/2003 MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB MEDTRONIC VASCULAR FRED L BOUCHER
K030239 07/24/2003 MEGATECH SCIENTIFIC FACE MASK MEGATECH SCIENTIFIC PTE LTD CHIAM KIA CHEE
K031767 07/17/2003 MENTOR OBTAPE TRANS-OBTURATOR TAPE MENTOR CORP. DONNA CRAWFORD
K031411 07/30/2003 MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 MERCURY MEDICAL WAYNE GLOVER
K030392 07/21/2003 SAPPHIRE DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K031050 07/14/2003 PCW PERCUTANEOUS COMPRESSION WIRE MILLENNIUM MEDICAL TECHNOLOGIES, INC. DAVID W SCHLERF
K031390 07/23/2003 MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 MINIMED, INC. MIRIELLE MENGOTTO
K030852 07/10/2003 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX MOGUL ENTERPRISES JAMIL MOGUL
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