FDA 510(k) Decisions During September, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K021913 09/06/2002 CALSCOR SOFTWARE 3D MED CO., LTD. MARY MCNAMARA-CULLINANE
K022287 09/23/2002 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS 3T MEDICAL SYSTEMS, LLC. ROBERT P EATON
K022312 09/05/2002 PICCOLO PHOSPHORUS TEST SYSTEM ABAXIS, INC. ROBERT MILDER
K022180 09/06/2002 DIRECT BILIRUBIN ABBOTT LABORATORIES MICHELE SMITH-WAHEED
K022182 09/09/2002 MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM ABBOTT LABORATORIES JANET CONNOLLY
K022339 09/13/2002 TOTAL BILIRUBIN ABBOTT LABORATORIES MICHELE SMITH-WAHEED
K023062 09/30/2002 GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT ABBOTT LABORATORIES INC FRANK POKROP
K023020 09/26/2002 AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE AGFA CORP. PAMELA K GWYNN
K022292 09/12/2002 IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO AGFA CORP. DAVID LEDWIG
K022658 09/06/2002 LR DICOM CONTROLLER AGFA CORP. JEFF JEDLICKA
K022677 09/11/2002 MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K022619 09/06/2002 POWDER FREE NITRILE EXAMINATION GLOVES AR ALLIANCE HEALTHCARE SDN. BHD. CHUA CHOON CHUAN
K022664 09/10/2002 PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. CHARLES F ANDREWS
K022386 09/17/2002 POCKETCHEM UA AUTION STICKS 10TA ARKRAY, INC. FRAN WHITE
K020345 09/06/2002 ARTHREX UNIVERS FRACTURE PROSTHESIS ARTHREX, INC. VERNON BROWN
K021975 09/13/2002 LASERSYSTEM BEAUTYSTAR 532 ASCLEPION-MEDITEC AG WILLIAM KELLY
K020457 09/26/2002 AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE AXIAMED, INC. W ALLEN PUTNAM
K021929 09/10/2002 AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM AXYA MEDICAL, INC. HOWARD L SCHRAYER
K022408 09/06/2002 CEREC VITABLOCKS MK2 B.B.'S PROPHY SHOP HORST MICHAEL BIRKHOFF
K022912 09/20/2002 POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM BASIC DENTAL IMPLANT SYSTEMS, INC. DAN BLACKLOCK
K022331 09/11/2002 ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K022968 09/24/2002 ADVIA TESTPOINT CSF CONTROL BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K021814 09/27/2002 ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 BECKMAN COULTER, INC. BRENT TABER
K022875 09/11/2002 MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BECTON DICKINSON & CO. M. WENDY BOSSHARDT
K020624 09/12/2002 BREAST BOLSTER BEEKLEY CORP. MAEGHAN E ARCHAMBAULT
K022833 09/09/2002 BENJAMIN ENVOY PHACO HANDPIECE BENJAMIN BIOMEDICAL, INC. ARTHUR WARD
K022273 09/09/2002 CRANIAL SYMMETRY SYSTEM BEVERLY HILLS PROSTHETICS ORTHOTICS, INC. KEITH E VINNECOUR
K021649 09/19/2002 BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK BINAX, INC. ANNE JEPSON
K021646 09/19/2002 BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK BINAX, INC. ANNE JEPSON
K021687 09/13/2002 BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK BINAX, INC. ANNE JEPSON
K021843 09/03/2002 EYEFEEL OPHTHALMIC WARMER BIO-LIPID, INC. DAVID J BLOCH
K013839 09/30/2002 BIO-RAD PLATELIA TOXO IGG TMB BIO-RAD CHRISTOPHER BENTSEN
K013837 09/30/2002 BIO-RAD PLATELIA TOXO IGM TMB BIO-RAD CHRISTOPHER BENTSEN
K022991 09/17/2002 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 BIO-RAD MARIA ZEBALLOS
K020712 09/24/2002 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K022515 09/17/2002 BIOMET CALCANEAL PLATE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K011531 09/06/2002 CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER BIOMET, INC. DALENE T BINKLEY
K022079 09/24/2002 SHORT AND LONG SOFT TISSUE ATTACHMENT BIOMET, INC. KACY ARNOLD
K022890 09/06/2002 MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. CAROL E JONES
K021847 09/03/2002 BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES BIOPSY SCIENCES, LLC SHARON ROCKWELL
K022076 09/24/2002 FIRST CHOICE & FIRST CHOICE PLUS BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K022067 09/11/2002 CONVOY ADVANCED DELIVERY SHEATH BOSTON SCIENTIFIC ANDREA L RUTH
K022621 09/04/2002 BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. HEIDI M ERICKSON
K022648 09/05/2002 ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521 BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K022135 09/13/2002 URETERAL ACCESS SHEATH SET (UASS) BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K021057 09/17/2002 BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS BRAHMS DIAGNOSTICA, LLC. WILLIAM G FRANK
K020631 09/09/2002 IPLAN BRAINLAB AG RAINER BIRKENBACH
K022878 09/17/2002 BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K020851 09/23/2002 TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D C&H INTERNATIONAL YUANHUI LUO
K002612 09/03/2002 BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON C.R. BARD, INC. GEORGIA C ABERNATHY
K022983 09/25/2002 BARDPORT X-PORT ISP PORT C.R. BARD, INC. JOHN C KNORPP
K022368 09/05/2002 DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E CANOPUS MEDICAL SUPPLY CO., LTD. RUBY LIN
K022042 09/03/2002 MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) CARDEON CORP. JANE BEGGS
K022297 09/27/2002 GLOBAL ECG MANAGEMENT SYSTEM (GEMS) CARDIOCOMM SOLUTIONS, INC. ANGELA HALWAS
K021905 09/05/2002 CLASSIC NMS CARE REHAB, INC. CHRISTIAN E HUNT
K021946 09/11/2002 CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM CELL ROBOTICS, INC. GLEN GOFF
K022344 09/24/2002 TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM CENTERPULSE SPINE-TECH, INC. TIM MILLER
K021131 09/26/2002 CHLORAPREP CENTRIX, INC. JOHN DISCKO
K022093 09/20/2002 CHASE CARDIOVASCULAR PATCH KIT CHASE MEDICAL, INC. DAVE HERNON
K012138 09/30/2002 MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) CHROMAVISION MEDICAL SYSTEMS, INC. DAVID DAVIS
K021848 09/03/2002 CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 CLARUS MEDICAL, LLC. TOM BARTHEL
K022758 09/17/2002 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER CLINIQA CORPORATION CAROL RUGGIERO
K022537 09/13/2002 PRESS-MATE PM-2100 VITAL SIGN MONITOR COLIN MEDICAL INSTRUMENTS CORP. MARK RISON
K022224 09/18/2002 COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM COLTENE AG H.J. VOGELSTEIN
K021152 09/24/2002 ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES COMPUTER MOTION, INC. DAVID MUNJAL
K021977 09/12/2002 HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR CONTAMAC LTD. KEVIN WALLS
K022649 09/06/2002 COOK-SWARTZ DOPPLER FLOW PROBE COOK VASCULAR, INC. THOMAS J KARDOS
K022552 09/27/2002 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K022992 09/25/2002 REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 CORGENIX, INC. NANCI DEXTER
K022990 09/25/2002 REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 CORGENIX, INC. NANCI DEXTER
K022075 09/19/2002 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
K022387 09/19/2002 CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC CRAFTMATIC ORGANIZATION, INC. PAUL D RUBIN
K022061 09/20/2002 CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER CRYO VASCULAR SYSTEMS INC. R. MICHAEL CROMPTON
K022104 09/10/2002 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
K022796 09/06/2002 CERCON CERAM S PORCELAIN DENTSPLY INTL. P. JEFFERY LEHN
K020647 09/05/2002 DIDECO ELECTA DIDECO S.P.A. ROSINA ROBINSON
K014141 09/13/2002 DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 DIGIBIO TECHNOLOGY CORP. ERIC LUO
K022831 09/11/2002 MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP DISETRONIC MEDICAL SYSTEMS AG SANDRA SONIEC
K021740 09/23/2002 TOTAL KNEE CEMENTED, SEMI-CONSTRAINED DJ ORTHOPEDICS, LLC NORA C.R. YORK
K020903 09/26/2002 DOCXS B SERIES ELECTRODES DOCXS, LLC RICHARD RIZZOLO
K022114 09/17/2002 IMPERIUM ELMSTECH, INC. TIM MANGERUGA
K020693 09/05/2002 AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 EMBOL-X, INC. EDWIN LEE
K022502 09/05/2002 INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 EQUIDYNE SYSTEMS, INC. JIM BARELY
K022684 09/11/2002 PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) ESSEX CRYOGENICS OF MISSOURI, INC. ELIZABETH HUNNICUT
K021266 09/27/2002 ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 ETHICON ENDO-SURGERY, INC. KEN CHARAK
K022269 09/13/2002 COATED VICRYL* (POLYGLACTIN 910) SUTURE ETHICON, INC. LEA ANN CONWAY
K022037 09/10/2002 XLTEK SLEEP SYSTEM EXCEL TECH. LTD. SONJA MARKEZ
K022406 09/30/2002 EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET EXELINT INTL. CO. ARMAND HAMID
K022154 09/30/2002 LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D FISCHER INDUSTRIES, INC. PHIL O'KEEFE
K022771 09/23/2002 TWIN FIX FIXANO SA FRANK FERGUSON
K022700 09/13/2002 DELUXE MANUAL WHEELCHAIR HW 4000 FOREVER YOUNG ENT. CO., LTD. JEN KE-MIN
K022699 09/13/2002 TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR FOREVER YOUNG ENT. CO., LTD. JEN KE-MIN
K022669 09/06/2002 8 CHANNEL CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS LARRY KROGER
K022919 09/19/2002 SMART BREATH RESPIRATORY COMPENSATION OPTION GE MEDICAL SYSTEMS LARRY A KROGER
K022960 09/19/2002 GE QUASAR NUCLEAR MEDICINE SYSTEM GE MEDICAL SYSTEMS F.I. HAIFA HEMY NEUMAN
K022069 09/17/2002 OEC FLUOROTRAK 9800 PLUS GE OEC MEDICAL SYSTEMS BILL GISLASON
K022874 09/17/2002 GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. ALAN MADERAZO
K022872 09/12/2002 GE ROAD WARRIOR PET CT IMAGING SYSTEM GENERAL ELECTRIC CO. DAVID DUERSTELER
K022725 09/23/2002 CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 GOOD BIOTECH CORP. VICTOR CHIOU
K022738 09/13/2002 AGILTRAC .035 PERIPHERAL DILATATION CATHETER GUIDANT CORP. NADINE SAKAKINI
K022880 09/13/2002 GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 GUIDANT CORP. JEFF SCHAKENRAAD
K021931 09/06/2002 ENDOSCOPIC FIBEROPTIC CABLE GULF MEDICAL FIBEROPTICS MARCELINO AFANADOR
K022099 09/20/2002 SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S HDC CORP. JONATHAN S KAHAN
K022772 09/17/2002 RAICHEM LDL-CHOLESTEROL DIRECT REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K022767 09/03/2002 RAICHEM LIPID CALIBRATOR HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K022549 09/23/2002 RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K022786 09/19/2002 DVT60 HUNTLEIGH HEALTHCARE, INC. AUDREY WITKO
K022869 09/20/2002 SOAKER CATHETER I-FLOW CORP. SHANE NOEHRE
K021623 09/10/2002 UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS IAME, INC. DAVID W SCHLERF
K021907 09/04/2002 IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR IGEL VISION CARE PTE LTD. DEBBIE MCINTIRE
K021248 09/24/2002 ICASE IKEEPS, INC. E. J. SMITH
K022100 09/25/2002 NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K021698 09/19/2002 MY ALLERGY TEST IMMUNETECH CORPORATION VIVIANNE NOETZEL
K022512 09/30/2002 CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 IMMUNICON CORP. PETER SCOTT
K022113 09/19/2002 3I DENTAL IMPLANT ACCESSORIES IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K022981 09/12/2002 INION CPS 2.5/2.8 SCREW INION LTD. HANNA MARTTILA
K013705 09/09/2002 ACT III VENTRICULAR CATHETER INNERSPACE, INC. DONALD E BOBO
K021648 09/20/2002 QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K022275 09/12/2002 DELTA 32; DELTA 32 TACT INSTRUMENTARIUM CORP. IMAGING DIVISION DARREN GREBE
K022158 09/10/2002 IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K022127 09/10/2002 AVAGEN WOUND DRESSING INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K021989 09/13/2002 SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 INTEGRA NEUROSCIENCES NANCY MATHEWSON
K020879 09/25/2002 IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001 INTEGRATED VASCULAR SYSTEMS, INC. SUSAN TURNER
K022876 09/11/2002 MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 INTERNATIONAL BIOMEDICAL, INC. GERLAD MANNING
K022528 09/11/2002 IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ IQ CORP. H.G. HAINES
K020583 09/17/2002 IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 IVD RESEARCH, INC. DAVE LAMBILLOTTE
K022519 09/30/2002 LDL CHOLESTEROL (AUTOMATED) JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K022022 09/11/2002 JOSTRA VENT CATHETERS, MODELS LV & HKV JOSTRA AG KATHLEEN JOHNSON
K022110 09/12/2002 KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS. KAWASUMI LABORATORIES, INC. DONALD R STONE
K022617 09/13/2002 COMFY HIGH RISER WHEELCHAIR LENJOY MEDICAL ENGINEERING, INC. LEAH ROTTER
K022922 09/30/2002 HARMONY INR MONITORING SYSTEM LIFESCAN, INC. JOHN E HUGHES
K022724 09/12/2002 SURESTEP BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. JOHN E HUGHES
K021948 09/03/2002 LUCIUS 62 LUCIUS METALS COM. DAE-KYU CHANG
K022413 09/24/2002 LUNEAU 3 MIRROR LENS LUNEAU SA JEAN NOEL YOUNG
K022806 09/19/2002 DUOPRO SAFETY SYRINGE (DUOPROSS) M.K. MEDITECH CO. LTD. ROSINA ROBINSON
K022825 09/13/2002 MANUAL WHEELCHAIR MAJOR MOBILITY PRODUCTS, INC. GARRY BITTNER
K013875 09/27/2002 MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE MED-TEC,INC. DONALD F RIIBE
K020581 09/18/2002 COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 MEDICAL CONCEPTS DEVELOPMENT, INC. ERIC EUTENEUER
K022744 09/18/2002 REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS MEDICAL DEVICE SERVICES MARK ALDANA
K021746 09/20/2002 SQA V, SPERM QUALITY ANALYZER MEDICAL ELECTRONIC SYSTEMS, LLC ERICA B AMMIRATI
K022431 09/05/2002 MEDRAD TRANSFER SET MEDRAD, INC. FRANK W PELC III
K022755 09/24/2002 LIFEGUARD MEDTEK LLC. DEBORAH N BALLARD
K021761 09/17/2002 PREMIER ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHAME
K022778 09/18/2002 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K021985 09/10/2002 MEDX LCS LASER SERIES MEDX ELECTRONICS, INC. ANITA SALTMARCHE
K023045 09/26/2002 MICRORUPTER V MERIDIAN AG KURT FREY
K022458 09/26/2002 AUTO*THERM 395, MODEL ME 395 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K022003 09/13/2002 TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 MICRO THERAPEUTICS, INC. BILL HYATT
K022735 09/06/2002 MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT MICROVENTION, INC. VINCENT CUTAURELLI
K022068 09/23/2002 TUBING, DIALYSATE (AND CONNECTOR) MOLDED PRODUCTS INC. ELISE JOHNSTON
K020280 09/24/2002 PULMOLAB EX671 EXERCISE TESTING SYSTEM MORGAN MEDICAL LTD. JONATHAN S KAHAN
K022560 09/27/2002 M2 SINGLE USE MICROKERTOME MORIA S.A. MELANIE RENAUD-SAMIRI
K022618 09/06/2002 X-SCRIBE II MORTARA INSTRUMENT, INC. HARLAN VAN MATRE
K022720 09/06/2002 CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K022883 09/27/2002 HRK-63 KNEE ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K022588 09/04/2002 HRW-63-INT WRIST ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K022196 09/19/2002 NATUS BLUE LIGHT PHOTOTHERAPY UNIT NATUS MEDICAL, INC. SHEILA RAMERMAN
K022819 09/24/2002 NELLCOR N-200 PULSE OXIMETER, MODEL N-200 NELLCOR PURITAN BENNETT, INC. GINA TO
K020848 09/23/2002 NAFD 100 NEOMATRIX, LLC SALVADORE F PALOMARES
K022776 09/11/2002 NESS SYSTEM NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS JONATHAN S KAHAN
K022424 09/27/2002 REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 NOBEL BIOCARE UAS INC RICHARD T ROSS
K023113 09/26/2002 REPLACE TIUNITE ENDOSSEOUS IMPLANT NOBEL BIOCARE UAS INC HERBERT CRANE
K022858 09/06/2002 SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM NOVASONICS, INC. CHERYL A BLAKE
K022635 09/06/2002 KUSKE BREAST APPLICATOR SET, MODEL 189.006 NUCLETRON CORPORATION LISA DIMMICK
K022722 09/13/2002 PTA AND PTV NUMED, INC. NICHELLE R LAFLESH
K022229 09/06/2002 SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 OPUS MEDICAL, INC. JAMES W HART
K022901 09/27/2002 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS MARLENE HANNA
K022139 09/23/2002 HIP TOOL IMPLANT ORTHOPEDIC SCIENCES, INC FLOYD G LARSON
K022231 09/13/2002 NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM OSTEOMEDICS, INC. ALBERT ENAYATI
K022230 09/10/2002 NORMED MINI EXTERNAL FIXATOR SYSTEM OSTEOMEDICS, INC. ALBERT ENAYATI
K022324 09/17/2002 NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM OSTEOMEDICS, INC. ALBERT ENAYATI
K022325 09/09/2002 NORMED TITANIUM OSTEOTOMY PLATING SYSTEM OSTEOMEDICS, INC. ALBERT ENAYATI
K022323 09/09/2002 NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM OSTEOMEDICS, INC. ALBERT ENAYATI
K021485 09/11/2002 BIOSOMNIA OXFORD BIOSIGNALS LIMITED PAUL A HOBDAY
K021793 09/27/2002 EBV EA-D IGG ELISA KIT, MODEL EBG-100 PAN BIO PTY. LTD. HELEN JENNINGS
K022097 09/06/2002 THERMIQUE PARKELL, INC. DANIEL R SCHECHTER
K021278 09/06/2002 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K021276 09/12/2002 FG-36UX FIBER ULTRASOUND GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K022701 09/17/2002 POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHANG
K020808 09/23/2002 FERTILITE OV PHEROMONE SCIENCES CORP. JEFFREY T SOLATE
K022920 09/17/2002 M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS BARRY WYSHOGROD
K013644 09/12/2002 ACQPLAN 5.0 PHILIPS MEDICAL SYSTEMS, INC. ROBERT L TUROCY
K022726 09/06/2002 STAYFUSE GT-IP PIONEER SURGICAL TECHNOLOGY KATHY MORAN
K022882 09/16/2002 MODIFICATION TO PLAYTEX TAMPONS #24002 PLAYTEX PRODUCTS, INC. PAUL A SIRACUSA
K021875 09/05/2002 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
K022898 09/24/2002 PTS PANELS LIPID PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
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K022103 09/27/2002 PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM PURITAN BENNETT CORP. JAMES BONDS
K022659 09/25/2002 ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) PURNABINA SDN BHD LIEW YOON FONG
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K020464 09/17/2002 SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 ROLOR ELECTRONICS CORP. KE-MIN JEN
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K022138 09/23/2002 SPECTRANETICS 0.035" SUPPORT CATHETER, MODEL 518-028 SPECTRANETICS CORP. MICHAEL J RYAN
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K020542 09/27/2002 DAYTRIPPER DIALYSATE WARMER STICKMAN INDUSTRIES INC. JEAN CLERMONT
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K022146 09/03/2002 SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K022092 09/03/2002 SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K022090 09/03/2002 SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K021928 09/06/2002 SYNTHES (USA) RESORBABLE FIXATION SYSTEM SYNTHES (USA) BONNIE J SMITH
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K022278 09/12/2002 TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML) TAIJECT MEDICAL DEVICE CO., LTD. JIM-SON CHOU
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K022115 09/27/2002 CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR TERUMO CORP. GARRY A COURTNEY
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K022241 09/11/2002 VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX VERTIS NEUROSCIENCE, INC. LORI GLASTETTER
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K021890 09/06/2002 G-2 VERSION 3, MODEL 10049 VITROLIFE SWEDEN AB GARY L YINGLING
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K022318 09/19/2002 VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES VOMED VOLZER MEDIZINTECHNIK GMBH & CO. DAGMAR MASER
K022782 09/10/2002 DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL W.L. GORE & ASSOCIATES,INC R. LARRY PRATT
K020972 09/09/2002 WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET WAKO CHEMICALS, USA, INC. TONYA MALLORY
K022084 09/26/2002 ATLAS MONITOR, MODELS 200,210,220 WELCH ALLYN, INC. SHAWN EARLE
K022163 09/17/2002 WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 WELCH ALLYN, INC. DAVID KLEMENTOWSKI
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K022459 09/12/2002 AUROPAL SOLDER M-1 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022451 09/11/2002 AUROPAL SOLDER W-2 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022462 09/18/2002 BIOPORTA SOLDER 1020 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
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K022456 09/17/2002 PORTA IP SOLDER V-1 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022467 09/17/2002 PORTA IP SOLDER V-2 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022452 09/11/2002 PORTA OP SOLDER M-1 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022454 09/12/2002 PORTA OP SOLDER W-2 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022457 09/17/2002 PORTA OPTIMUM SOLDER 710 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
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K021334 09/10/2002 WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
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K022444 09/17/2002 POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K021891 09/05/2002 ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM ZIMMER, INC. FRED MCCLURE


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