FDA 510(k) Applications Received During June, 2002

FDA 510(k) Number Submission Date Device Name Applicant Contact
K021913 06/11/2002 CALSCOR SOFTWARE 3D MED CO., LTD. MARY MCNAMARA-CULLINANE
K021817 06/03/2002 AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K021874 06/07/2002 ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 ABBOTT LABORATORIES FRANK POKROP
K021960 06/14/2002 PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY ABBOTT LABORATORIES JANET S CONNOLLY
K021964 06/14/2002 ALPHA INFUSION PUMP AND CATHETERS ADVANCED INFUSION, INC. JAMES CHRISTENSEN
K021966 06/17/2002 Q LAB SOFTWARE ADVANCED TECHNOLOGY LABORATORIES, INC. SARAH BAXTER
K022073 06/26/2002 HEARTLINE RECEIVING STATION AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K021839 06/04/2002 AART GLUTEAL IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021820 06/04/2002 AART SILICONE CARVING BLOCK AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K021934 06/12/2002 MODIFICATION TO MEDSTATION AISOFTW@RE MEDICAL, S.P.A. DIANA UPTON
K021975 06/17/2002 LASERSYSTEM BEAUTYSTAR 532 ASCLEPION-MEDITEC AG WILLIAM KELLY
K021809 06/03/2002 V-2100G ADVANCED INFANT INCUBATOR ATOM MEDICAL CORP. SHEILA HEMEON-HEYER
DEN020003 06/21/2002 RETROX AURIC HEARING SYSTEMS, INC. DAVID J NAVAROLI
K021859 06/06/2002 WRIST IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K021929 06/12/2002 AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM AXYA MEDICAL, INC. HOWARD L SCHRAYER
K022019 06/20/2002 PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. AMY S KRALL
K021958 06/14/2002 TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH, 20CM, (100CM CATHETER LENGTH, 10CM INFUSION H BACCHUS VASCULAR, INC. GREG MATHINSON
K022096 06/27/2002 URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021814 06/03/2002 ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 BECKMAN COULTER, INC. BRENT TABER
K021954 06/14/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K022024 06/20/2002 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) BEST MANUFACTURING COMPANY DAVID C YOUNG
K021843 06/05/2002 EYEFEEL OPHTHALMIC WARMER BIO-LIPID, INC. DAVID J BLOCH
K021801 06/03/2002 BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K021895 06/10/2002 BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K022041 06/24/2002 LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K021877 06/07/2002 MDA D-DIMER BIOMERIEUX, INC. RON SANYAL
K022045 06/24/2002 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID BIOMERIEUX, INC. Nancy Weaver
K021832 06/04/2002 ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER BIOMET, INC. SARA B SHULTZ
K021992 06/18/2002 DHS DISPOSABLE HOOD SYSTEM BIOMET, INC. KACY ARNOLD
K022094 06/27/2002 PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING BIOMET, INC. TRACY J BICKEL
K021927 06/12/2002 PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM BIOMET, INC. LONNIE WITHAM
K022079 06/26/2002 SHORT AND LONG SOFT TISSUE ATTACHMENT BIOMET, INC. KACY ARNOLD
K021828 06/04/2002 SMALL HAMMER TOE PIN BIOMET, INC. SARA B SHULTZ
K021930 06/12/2002 MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL BIONOSTICS, INC. KATHY STORRO
K021924 06/11/2002 MEDICA EASYQC HEMATOCRIT CONTROL BIONOSTICS, INC. KATHY STORRO
K022033 06/21/2002 STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM BIOPLATE, INC. BRUCE F MACKLER
K021847 06/05/2002 BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES BIOPSY SCIENCES, LLC SHARON ROCKWELL
K022004 06/19/2002 CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 BIOSENSORS INTERNATIONAL-USA JORGE HAIDER
K021833 06/04/2002 MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM BLUE SKY BIO ALBERT ZICKMANN
K021846 06/05/2002 804SIII; 804W; LIBRA TENS; 410; S-TENS II BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K022076 06/26/2002 FIRST CHOICE & FIRST CHOICE PLUS BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K021996 06/18/2002 BOLTON PTA CATHETER Bolton Medical, Inc. VIVIAN KELLY
K022067 06/25/2002 CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC ANDREA L RUTH
K022059 06/25/2002 MICROVASIVE PULMONARY GUIDEWIRE BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K021901 06/10/2002 WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM BOSTON SCIENTIFIC SCIMED, INC. SHERRY L SPARROW
K021835 06/04/2002 BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX BRENNEN MEDICAL, INC. PHILLIP B LAWIN
K021994 06/18/2002 BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. AYMEE BERRY
K022054 06/24/2002 F 900 C.S.O. S.R.L. R. BRENT MINER
K022042 06/24/2002 MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) CARDEON CORP. JANE BEGGS
K022008 06/19/2002 CARDIMA ABLATION SYSTEM CARDIMA, INC. ROBERT A CHIN
K022107 06/28/2002 CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 CARDIOMEDICS, INC. GARY CLARK
K021905 06/10/2002 CLASSIC NMS CARE REHAB, INC. CHRISTIAN E HUNT
K021946 06/13/2002 CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM CELL ROBOTICS, INC. GLEN GOFF
K022093 06/27/2002 CHASE CARDIOVASCULAR PATCH KIT CHASE MEDICAL, INC. DAVE HERNON
K021848 06/05/2002 CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 CLARUS MEDICAL, LLC. TOM BARTHEL
K022023 06/20/2002 COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 CLINICAL INNOVATIONS, INC. WILLIAM DEAN WALLACE
K021830 06/04/2002 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC. SHAWN RIEDEL
K021910 06/10/2002 COMFORT DREAMRIDER SCOOTER, LY-EW402 COMFORT ORTHOPEDIC CO. LTD. JEN KE-MIN
K021899 06/10/2002 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 CONCENTRIC MEDICAL, INC. KEVIN MACDONALD
K021977 06/17/2002 HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR CONTAMAC LTD. Kevin Walls
K022044 06/24/2002 SURGISIS STAPLE LINE REINFORCEMENT COOK BIOTECH, INC. MARK BLEYER
K022002 06/19/2002 SYDNEY IVF CULTURE OIL COOK UROLOGICAL, INC. BRENDA DAVIS
K021920 06/11/2002 7.0 FR. ENDOBRONCHIAL BLOCKER COOK, INC. APRIL LAVENDER
K021961 06/14/2002 POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE COPIOUMED INTL., INC. JANNA P TUCKER
K021898 06/10/2002 SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K021944 06/13/2002 COZART EIA COTININE URINE KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K022075 06/26/2002 DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 CP MEDICAL MARY ANN GREENAWALT
K022061 06/25/2002 CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER CRYO VASCULAR SYSTEMS INC. R. MICHAEL CROMPTON
K021854 06/06/2002 DFV CPG COLPOSCOPE D.F. VASCONCELLOS S.A. JEAN M BUCHWALD
K022104 06/28/2002 DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ DAAVLIN DISTRIBUTING CO. CHAD REYNOLDS
K021955 06/14/2002 TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES DATEX-OHMEDA, INC. MICHAEL A CHILBERT
K021999 06/19/2002 GRIPPER PLUS NEEDLE DELTEC, INC. LISA STONE
K021805 06/03/2002 SEAL & PROTECT PROTECTIVE SEALANT DENTSPLY INTL. P. JEFFERY LEHN
K021879 06/07/2002 CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) DEPUY ACROMED LISA GILMAN
K021880 06/07/2002 CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) DEPUY ACROMED LISA GILMAN
K021933 06/12/2002 TEMPFIX EXTERNAL FIXATION SYSTEM DEPUY ORTHOPAEDICS, INC. CHERYL K HASTINGS
K021869 06/06/2002 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP DIROS TECHNOLOGY, INC. LESLIE W ORGAN
K021959 06/14/2002 DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 DOLPHIN MEDICAL INC. JON WERNER
K022031 06/21/2002 NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 DRAEGER MEDICAL, INC. MICHAEL A KELHART
K021903 06/10/2002 KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE EASTMAN KODAK COMPANY PATRICIA B LANZONI
K021829 06/04/2002 MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM EASTMAN KODAK COMPANY CAROL RYERSON
K022109 06/28/2002 EIZO, MODEL FC-2091 EIZO NANAO CORPORATION YUUICHI SEKI
K022114 06/28/2002 IMPERIUM ELMSTECH, INC. TIM MANGERUGA
K022071 06/26/2002 EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 EMBOL-X, INC. ED LEE
K021881 06/07/2002 ENDIUS TITLE SPINAL FIXATION SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K021837 06/04/2002 BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) ENTIFIC MEDICAL SYSTEMS, INC. CONSTANCE BUNDY
K022029 06/21/2002 QUINCKE SPINAL NEEDLE EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K021878 06/07/2002 ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS ESKA AMERICA CORP. THOMAS P MONKUS
K022037 06/24/2002 XLTEK SLEEP SYSTEM EXCEL TECH. LTD. SONJA MARKEZ
K022063 06/25/2002 SAFEPRO SAFETY SYRINGE FORMOSA MEDICAL DEVICES, INC. JOSEPH J CHANG
K022112 06/28/2002 FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 FORTUNE MEDICAL INSTRUMENT CORP. JESSICA CHAN
K021990 06/18/2002 GALT MEDICAL GUIDEWIRE GALT MEDICAL CORP. DAVID CATLIN
K022069 06/25/2002 OEC FLUOROTRAK 9800 PLUS GE OEC MEDICAL SYSTEMS BILL GISLASON
K021882 06/07/2002 CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 GOOD BIOTECH CORP. VICTOR CHIOU
K021807 06/03/2002 GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM GRASS INSTRUMENT CO. PETER L FULLER
K021824 06/04/2002 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 GUIDANT CORP. MARTHA MURARI
K021931 06/12/2002 ENDOSCOPIC FIBEROPTIC CABLE GULF MEDICAL FIBEROPTICS MARCELINO AFANADOR
K021916 06/11/2002 HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 HARMAC MEDICAL PRODUCTS, INC. ROBERT F MORAN
K022099 06/27/2002 SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S HDC CORP. JONATHAN S KAHAN
K022049 06/24/2002 MODIFICATION TO RAICHEM CALCIUM REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K021923 06/11/2002 INRATIO SELF-TEST HEMOSENSE, INC. Judith Blunt
K021952 06/13/2002 HIVOX DREAMATE DM-800 HIVOX BIOTEK, INC. Ke-Min Jen
K021998 06/19/2002 HORIZONS CYTOLOGY BRUSH HORIZONS INTL. CORP. RAFIC SALEH
K022077 06/26/2002 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K021911 06/11/2002 TRIDENT CROSSFIRE POLYUETHYLENE LINERS HOWMEDICA OSTEONICS CORP. DEBRA BING
K021949 06/13/2002 FULCRUM HOWTEK, INC. JOHN E ROSENSTENGEL
K021813 06/03/2002 HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM HYDROCISION, INC. DEBBIE IAMPIETRO
K022074 06/26/2002 SPHERZ I.Z.I. CORP. HELEN ZINREICH
K021907 06/10/2002 IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR IGEL VISION CARE PTE LTD. DEBBIE MCINTIRE
K022100 06/28/2002 NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K022062 06/25/2002 IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K022113 06/28/2002 3I DENTAL IMPLANT ACCESSORIES IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K022009 06/19/2002 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K021967 06/17/2002 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 IMPLEX CORP. ROBERT A POGGIE
K021970 06/17/2002 THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) IMPLEX CORP. ROBERT A POGGIE
K021984 06/18/2002 PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT INCEPTIO MEDICAL TECHNOLOGIES, LC ROSINA ROBINSON
K022032 06/21/2002 ACETAL INOVATIV, LLC ROBERT BOWERS
K022030 06/21/2002 POLY-CARB INOVATIV, LLC ROBERT BOWERS
K021867 06/06/2002 INSOUND XT SERIES HEARING AID INSOUND MEDICAL INC. SUSAN WHICHARD
K021989 06/18/2002 SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 INTEGRA NEUROSCIENCES NANCY MATHEWSON
K022048 06/24/2002 INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM INTERPORE CROSS INTL. LYNN M RODARTI
K021915 06/11/2002 TRANSITIONAL IMPLANTS INTRA-LOCK INTERNATIONAL JEFFREY SAKOFF
K022086 06/27/2002 AIM-V (R) MEDIUM, MODEL 087-0112 INVITROGEN CORPORATION KEITH D GITTERMAN
K022260 06/28/2002 FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS ISOLATION SYSTEMS, INC. TED ULATOWSKI
K021941 06/13/2002 SAMPLOK LUER KIT ITL CORPORATION, PTY LTD. WILIAM L MOBBS
K021892 06/07/2002 BRIGHT GOLD IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K022085 06/27/2002 J&S MEDICAL SENTRY URINE DIPSTICK CONTROL J & S MEDICAL ASSOC., INC. PAUL MACDONNELL
K022022 06/20/2002 JOSTRA VENT CATHETERS, MODELS LV & HKV JOSTRA AG KATHLEEN JOHNSON
K021851 06/05/2002 DIGITAL CLINICAL THERMOMETER, MODEL KD-193 K-JUMP HEALTH CO., LTD. JONATHAN S KAHAN
K022110 06/28/2002 KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. KAWASUMI LABORATORIES, INC. DONALD R STONE
K022011 06/19/2002 V.A.C. ABDOMINAL DRESSING KINETIC CONCEPTS, INC. JUDITH A HARBOUR
K022057 06/24/2002 KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX KYUNG GI MEDICAL IND. CO., LTD BYUNG DOO JEE
K021831 06/04/2002 OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB LACRIMEDICS, INC. JERRY HENDERSON
K022102 06/28/2002 CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR LATEXX MANUFACTURING SDN.BHD. LAW SIAU WOEI
K022101 06/28/2002 MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR LATEXX MANUFACTURING SDN.BHD. LAW SIAU WOEI
K021819 06/04/2002 ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. MARY ELLEN HOLDEN
K021887 06/07/2002 CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 Lin-Zhi International, Inc. CHIU CHIN CHANG
K021947 06/13/2002 CERANUM 87 LUCIUS METALS COM. DAE-KYU CHANG
K021948 06/13/2002 LUCIUS 62 LUCIUS METALS COM. DAE-KYU CHANG
K022060 06/25/2002 LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES LUMENIS, INC. ANNE WORDEN
K021904 06/10/2002 MAEDA SILVER ACUPUNCTURE NEEDLE MAEDA TOYOKICHI SHOTEN E.J. Smith
K021876 06/07/2002 MAS WITH OR WITHOUT SYRINGE MARINA MEDICAL INSTRUMENTS, INC. JAY MANSOUR
K022043 06/24/2002 SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 MEDENNIUM, INC. JULIAN ABADIA
K021988 06/18/2002 MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM MEDRAD, INC. LORRAINE R FREDES
K022026 06/21/2002 MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) MEDTRONIC AVE, INC. KEVIN DRISKO
K022015 06/20/2002 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K022070 06/26/2002 XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K021980 06/17/2002 HIP MODULE FOR THE STEALTHSTATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES VICTORIA G RENDON
K021902 06/10/2002 MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 MEDTRONIC VASCULAR LUCY TAN
K021804 06/03/2002 PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM MEDTRONIC VASCULAR JULIE GOODE
K021985 06/18/2002 MEDX LCS LASER SERIES MEDX ELECTRONICS, INC. ANITA SALTMARCHE
K021956 06/13/2002 MHS MED LIGHT 1000 MICRO HEALTH SYSTEMS INC. ROBERT BARNES
K022003 06/19/2002 TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 MICRO THERAPEUTICS, INC. Bill Hyatt
K021914 06/11/2002 MICROPLEX COIL SYSTEMS (MCS) MICROVENTION, INC. VINCENT CUTARELLI
K022025 06/20/2002 MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT MILTON HODOSH, M.D. MILTON HODOSH
K021974 06/17/2002 MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 MINIMED, INC. GERDA RESCH
K022027 06/21/2002 CALIBRATING MATERIAL, BUFFERS, STANDARD MISSION DIAGNOSTICS LINDA STUNDTNER
K021883 06/07/2002 BIOFASTIN RC THREADED SUTURE ANCHOR MITEK WORLDWIDE RUTH C FORSTADT
K021953 06/13/2002 MITEK PDS/PGA STAPLE MITEK WORLDWIDE PETRA C SMIT
K021834 06/04/2002 SUTURE FIXATION DEVICE; MESH FIXATION DEVICE MLE, INC. CHRISTINE E NICHOLS
K021936 06/12/2002 MOIST PUNCTAL PLUG SYSTEM MOIST MEDICAL INC. GEORGE W MURRAY
K022068 06/25/2002 TUBING, DIALYSATE (AND CONNECTOR) MOLDED PRODUCTS INC. ELISE JOHNSTON
K021811 06/03/2002 UNIDRIVE II PLUS DISPOSABLE TUBING SET MTP MEDICAL TECHNICAL PROMOTION GMBH JAMES A LEE
K021971 06/17/2002 CERALOY NEIRYNCK & VOGT NV JOSH ANDRACHEK
K021968 06/17/2002 CERALOY SOLDER NEIRYNCK & VOGT NV JOSH ANDRACHEK
K021969 06/17/2002 CHROLOY NEIRYNCK & VOGT NV JOSH ANDRACHEK
K021965 06/17/2002 CHROLOY SOLDER NEIRYNCK & VOGT NV JOSH ANDRACHEK
K021986 06/18/2002 BRAINET NICOLET BIOMEDICAL, INC. Gary Syring
K021978 06/17/2002 PETIT SOPHIA NISHITOMO CO., INC. LLOYD DUPLANTIS
K022052 06/24/2002 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K021823 06/04/2002 CARDIOSPECT D90/CARDIO CAM NUCLEAR CARDIOLOGY SYSTEMS, INC. CHARLIE H ROSE
K021852 06/05/2002 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K021886 06/07/2002 OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K021918 06/11/2002 CLARREN HELMET (ORTHOMERICA) ORTHOMERICA PRODUCTS, INC. DEANNA FISH
K021919 06/11/2002 SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO ORTHOTEC,LLC KAREN E WARDEN
K022047 06/24/2002 PHLEBOTEST 2000 OSBORN MEDICAL CORP. BILL DAVIS
K021822 06/04/2002 R120 MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K022035 06/21/2002 OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB OSTEOMEDICS, INC. ALBERT ENYATI
K022097 06/27/2002 THERMIQUE PARKELL, INC. DANIEL R SCHECHTER
K022038 06/24/2002 SPI ONETIME DENTAL IMPLANT PAXMED INTERNATIONAL FLOYD G LARSON
K021912 06/11/2002 M2376 DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS, INC. DENISE HADLEY
K021945 06/13/2002 PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) PLANMED OY BOB PIENKOWSKI
K021875 06/07/2002 MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM PLEASURE LATEX PRODUCTS SDN. BHD. KOI-YONG LIM
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K022072 06/26/2002 PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS PRECISION SYSTEMS, INC. BILL HADEN
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K022103 06/28/2002 PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM PURITAN BENNETT CORP. JAMES BONDS
K021972 06/17/2002 FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY Qualigen, Inc. DOROTHY DEINZER
K021906 06/10/2002 QUINTON Q-CATH, MODEL 000460 QUINTON, INC. KAREN BROWNE
K021942 06/13/2002 RADIONICS POLE NEEDLES RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP KEVIN J O'CONNELL
K021897 06/10/2002 RANDOX HAEMOGLOBIN A1C RANDOX LABORATORIES, LTD. P ARMSTRONG
K021861 06/06/2002 REMSTAR PRO WITH C-FLEX CPAP SYSTEM RESPIRONICS, INC. ZITA A YURKO
K021845 06/05/2002 STARDUST II, MODEL 1011176 RESPIRONICS, INC. ZITA YURKO
K022018 06/20/2002 RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 RHIGENE, INC. YUSUKE KOBE
K022017 06/20/2002 RHIGENE MESACUP-2 TEST RNP, MODEL M7741 RHIGENE, INC. YUSUKE KOBE
K021827 06/04/2002 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP. MIKE FLIS
K021987 06/18/2002 PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY S&S PAR SCIENTIFIC SUSAN D GOLDSTEIN-FALK
K021963 06/14/2002 BIOSORB RESORBABLE VOID FILLER SCIENCES ET BIO MATERIAUX (SBM) DENIS CLEMENT
K022053 06/24/2002 HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 SEBIA BOREK JANIK
K021993 06/18/2002 SHANCHUAN SYRINGE SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO. HAIRONG CHE
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K022087 06/27/2002 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. PETER WANG
K022013 06/20/2002 LUNGCARE CT SOFTWARE PACKAGE SIEMENS MEDICAL SOLUTIONS USA, INC. PRAVEEN P NADKARNI
K022036 06/24/2002 SIEMENS VIRTUAL SIMULATION (VSIM) SIEMENS MEDICAL SOLUTIONS USA, INC. SEAN M CURRY
K022065 06/25/2002 SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X SINTEA BIOTECH, INC. MARIANNE GRUNWALDT
K021979 06/17/2002 SMISSON STABILIZATION SYSTEM SMISSON-CARTLEDGE GRACE HOLLAND
K021803 06/03/2002 REFLECTION CONSTRAINED LINER SMITH & NEPHEW, INC. JANET JOHNSON GREEN
K021815 06/03/2002 SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS SMITH & NEPHEW, INC. GINO J ROUSS
K022010 06/19/2002 TOTAL KNEE FEMORAL COMPONENT SMITH & NEPHEW, INC. KIM KELLY
K022078 06/26/2002 SOLA, COUNTER-PULSATION, MODEL SECP-S SOLA MEDICAL DEVICES, LLC GREG HOLLAND
K022051 06/24/2002 SOUNDVASER SYSTEM SOUND SURGICAL TECHNOLOGIES LLC. WILLIAM W CIMINO
K021995 06/18/2002 ESCAPE CONTROL MODULE SPECIALTY DRIVES TECHNOLOGIES, INC. SCOTT KERSEY
K021885 06/07/2002 ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE SPECTRAL DIAGNOSTICS, INC. TOM TSAKERIS
K022000 06/19/2002 POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) SPIRE BIOMEDICAL INC DONALD FICKETT
K021908 06/10/2002 PROVEN MODULAR POSTERIOR STABILIZED FEMORAL STELKAST COMPANY DONALD A STEVENS
K021802 06/03/2002 STEREOTAXIS CATHETER ADVANCER SYSTEM STEREOTAXIS, INC. GARY M RAUVOLA
K021922 06/11/2002 MODIFICATION TO PARA 5X STRECK LABORATORIES, INC. PAUL KITTELSON
K021925 06/11/2002 SUNPEX TECHNOLOGIES MODEL SE 01 SUNPEX TECHNOLOGY CO., LTD. LEONARD FRIER
K021889 06/07/2002 SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) SURGICAL TECHNOLOGY LABORATORIES, INC. CAMERON J FORDYCE
K021991 06/18/2002 MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE SYNCRO MEDICAL INNOVATIONS, INC. SABRY A GABRIEL
K022088 06/27/2002 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K022092 06/27/2002 SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K022090 06/27/2002 SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K021850 06/05/2002 SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS SYNTHES (USA) MATTHEW M HULL
K021928 06/12/2002 SYNTHES (USA) RESORBABLE FIXATION SYSTEM SYNTHES (USA) BONNIE J SMITH
K021932 06/12/2002 SYNTHES 6.5 MM CANNULATED SCREW SYNTHES (USA) BONNIE J SMITH
K022012 06/20/2002 SYNTHES LOW PROFILE NEURO SYSTEM SYNTHES (USA) MATTHEW M HULL
K022005 06/19/2002 SYNTHES MIDFACE DISTRACTOR SYNTHES (USA) MATTHEW M HULL
K021849 06/05/2002 TAGG DISPOSABLE VAGINAL SPECULUM TAGG INDUSTRIES TERRY L SHIRLEY
K022091 06/27/2002 BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. DAVID HU
K022083 06/26/2002 HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER THE BINDING SITE, LTD. JAY H GELLER
K022006 06/19/2002 CONDUCTIVE GEL THE DEZAC GROUP WENDY PARSLEY
K021962 06/14/2002 OLYMPUS ULTRASONIC SURGICAL SYSTEM THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K022108 06/28/2002 THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 THERMO DMA, INC. THOMAS DOLLAR
K022020 06/20/2002 JUSTWO MODEL TME-601 ROOT APEX LOCATOR TOEI ELECTRIC CO., LTD. DANIEL KAMM
K022016 06/20/2002 POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE TOP GLOVE MEDICAL (THAILAND) CO., LTD. AUDIE SEOW
K021950 06/13/2002 TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES TOP GLOVE MEDICAL (THAILAND) CO., LTD. AUDIE SEOW
K021855 06/06/2002 TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) TOP GLOVE SDN. BHD. LIM WEE CHAI
K022050 06/24/2002 CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K021997 06/19/2002 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K021937 06/12/2002 TGDC-01 PRA TRUEVISION INSTRUMENTS RALF THOMAIER
K021983 06/18/2002 ULTI GUARD HOME INSULIN SYRINGE CONTAINER ULTI MED, INC. CHARLES W ERICKSON
K021825 06/04/2002 MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM UNITED STATES SURGICAL TINA RIDEOUT
K022007 06/19/2002 LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K022028 06/21/2002 VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER VASCULAR ONE, INC. SUSAN D GOLDSTEIN-FALK
K021981 06/17/2002 IVENT 201 PORTABLE VENTILATOR VERSAMED LTD. KEN RAICHMAN
K021866 06/06/2002 KARMA 800 SERIES MANUAL WHEELCHAIR VESTIL MANUFACTURING CORP. RICK MICHAEL
K021976 06/17/2002 FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON VITAL SCIENTIFIC N.V. ISRAEL M STEIN
K022021 06/20/2002 VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT VITAL SCIENTIFIC N.V. ISRAEL M STEIN
K022046 06/24/2002 VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL VITAL SCIENTIFIC N.V. ISRAEL M STEIN
K021939 06/12/2002 VITALCARE FOLEY CATHETER VITALCARE, INC. MICHAEL MCAVENIA
K021938 06/12/2002 VITALCARE URETHRAL CATHETER VITALCARE, INC. MICHAEL MCAVENIA
K021890 06/10/2002 G-2 VERSION 3, MODEL 10049 VITROLIFE SWEDEN AB GARY L YINGLING
K021894 06/10/2002 G-MM, MODEL 10038 VITROLIFE SWEDEN AB GARY L YINGLING
K021893 06/10/2002 G-MOPS, MODEL 10030 VITROLIFE SWEDEN AB GARY L YINGLING
K021896 06/10/2002 HSA-SOLUTION, MODEL 10034/10064 VITROLIFE SWEDEN AB GARY L YINGLING
K021844 06/05/2002 ADMIRA PROTECT VOCO GMBH GERALD W SHIPPS
K021842 06/05/2002 ADMIRA SEAL VOCO GMBH GERALD W SHIPPS
K022066 06/25/2002 REGISTRADO X-TRA VOCO GMBH GERALD W SHIPPS
K021808 06/03/2002 WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER WECK JAMES LUCKY
K022084 06/27/2002 ATLAS MONITOR, MODELS 200,210,220 WELCH ALLYN, INC. SHAWN EARLE
K021926 06/12/2002 AUROPAL 60 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022095 06/27/2002 DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE WILSHIRE TECHNOLOGIES STEVE REITZLER
K021826 06/04/2002 TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES ZIMMER, INC. KAREN CAIN
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