FDA 510(k) Decisions During November, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K033022 11/21/2003 PROTEMP 3 GARANT 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K033041 11/21/2003 ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP ACON LABORATORIES, INC. EDWARD TUNG
K032879 11/13/2003 NAVIGATOR I ADAPTIVE HEALTHCARE TECHNOLOGIES, INC. JOAN JOHNSON
K033401 11/20/2003 MODIFICATION TO RESQPOD CIRCULATORY ENHANCER ADVANCED CIRCULATORY SYSTEMS, INC. GARY SYRING
K033597 11/25/2003 ATR 5000, LC 5000, IMPLANT SYSTEM ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. DANIELE POLI
K032481 11/04/2003 THERATEARS CONTACT LENS COMFORT DROPS ADVANCED VISION RESEARCH, INC. BEVERLEY D VENUTI
K032849 11/21/2003 AERONEB GO NEBULIZER, MODEL AG-AG2000 AEROGEN, INC. NANCY E ISAAC
K033013 11/25/2003 MDIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K032744 11/13/2003 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD L SCHRAYER
K033345 11/19/2003 AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS ANALOGIC CORP. MARVIN ROSENBAUM
K033443 11/19/2003 SPEEDLYSER INFUSION CATHETER KIT ANGIODYNAMICS, INC. TERI JUCKETT
K031385 11/10/2003 ANZAI AZ-733 RESPIRATORY GATING SYSTEM ANZAI MEDICAL CO, LTD. T. WHIT ATHEY
K033333 11/14/2003 SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K031553 11/18/2003 SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES ARCADIA MEDICAL CORPORATION ARTHUR WARD
K031153 11/25/2003 MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 ARROW INTL., INC. WILLIAM G MCLAIN
K031666 11/18/2003 ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS ARTHREX, INC. ANN WATERHOUSE
K033584 11/28/2003 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K032160 11/17/2003 ARTELON SURGICAL SUTURE ARTIMPLANT AB RUSS PAGANO
K033015 11/25/2003 AXIOM BIOLASER LLLT SERIES-3 AXIOM USA. INC JIM GIBSON
K031646 11/14/2003 BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 BAUSCH & LOMB, INC. PAUL G STAPLETON
K031676 11/20/2003 HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q BAXTER HEALTHCARE CORP. DAVID E CURTIN
K033007 11/14/2003 BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K033350 11/18/2003 BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER BECTON DICKINSON & CO. M. WENDY BALLESTEROS
K031375 11/20/2003 BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K031374 11/28/2003 BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K032874 11/24/2003 HBA SPERM-HYALURONAN BINDING ASSAY BIOCOAT, INC. JAMES B JOHNSTON
K032425 11/05/2003 INVISIJECT RESUSABLE AUTO-INJECTOR BIOGEN MICHAEL POIRIER
K032788 11/04/2003 VITEK 2 GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K032861 11/12/2003 VITEK 2 GRAM NEGATIVE MOXIFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K032286 11/20/2003 CALCIGEN PSI BONE GRAFT SUBSTITUTE BIOMET ORTHOPEDICS, INC. TRACY J BICKEL
K032895 11/20/2003 BI-ANGULAR SHOULDER SYSTEM BIOMET, INC. PATRICIA S BERES
K033233 11/05/2003 LACTOSORB TIBIAL L-15 SCREW AND WASHER BIOMET, INC. PATRICIA SANDBORN BERES
K032992 11/21/2003 UNIMARK HOME PREGNANCY TEST DEVICE BIOTECH ATLANTIC, INC. FRANCIS L DENG
K033320 11/19/2003 SCOUT PRO BIOTRONIK, INC. JON BRUMBAUGH
K032597 11/04/2003 BISCEM GI BISCO, INC. KATHY JOUNG
K032713 11/24/2003 BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K033441 11/21/2003 BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER BOSTON SCIENTIFIC CORP. HEIDI M ERICKSON
K032940 11/20/2003 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 11/20/2003 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K033438 11/20/2003 BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K032521 11/14/2003 BARD DUAL LUMEN URETERAL CATHETER C.R. BARD, INC. FRANCES HARRISON
K030792 11/14/2003 BARD ENDOTRACHEAL TUBE, CUFFED C.R. BARD, INC. FRANCES E HARRISON
K033245 11/06/2003 BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U C.R. BARD, INC. MICHAEL A PATZ
K033294 11/26/2003 HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER C.R. BARD, INC. GLENN NORTON
K023452 11/20/2003 OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E CANOPUS MEDICAL SUPPLY CO., LTD. RUBY LIN
K032444 11/13/2003 NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY CARDINAL HEALTH ERICA SETHI
K021594 11/13/2003 COPC BAND CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC JOSEPH TERPENNING
K023874 11/20/2003 SYSTEM 100 ULTRAFILTRATION CATHETER CHF SOLUTIONS, INC. AMY PETERSON
K033593 11/20/2003 REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS CLEAR MEDICAL, INC. MIKE KOVACS
K031042 11/03/2003 ATAC HEMOGLOBIN A1C REAGENT KIT CLINICAL DATA, INC. WYNN STOCKING
K032662 11/03/2003 GUTTAFLOW COLTENE/WHALEDENT GMBH & CO. KG HENRY J VOGELSTEIN
K031007 11/14/2003 KWIKEZE MALE CONDOM APPLICATOR CONDAX LLC. ELI J CARTER
K033093 11/05/2003 ECHOCONNEX COMMUNICATOR CONNEXMD CURTIS LEBLEU
K032869 11/19/2003 COOK CODA BALLOON CATHETER COOK, INC. THEODORE HEISE
K031494 11/12/2003 DOC'S BEST WHITE COPPER CEMENT COOLEY & COOLEY, LTD. M. JOYCE HEINRICH
K032873 11/07/2003 PROCLEAR COMPATIBLES MULTIFOCAL COOPER VISION, INC. LISA HAHN
K033431 11/20/2003 LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K032383 11/28/2003 MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM CURELIGHT LTD JONATHAN S KAHAN
K032539 11/17/2003 CYNOSURE PHOTOGENICA SV LASER CYNOSURE, INC. GEORGE CHO
K032697 11/07/2003 DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) DADE BEHRING, INC. LORRAINE H PIESTRAK
K033482 11/26/2003 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K033281 11/26/2003 DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE DATEX-OHMEDA JOEL KENT
K033144 11/13/2003 DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES DEFIBTECH, LLC JOHN L ROGERS
K031793 11/13/2003 DENTATUS OSCIOMAT DENTATUS USA, LTD. RICHARD C LANZILLOTTO
K030644 11/21/2003 CONTEC DUO, CONTEC LC, CONTEC LCR DENTAURUM JAN W A DOORSCHODT
K021478 11/18/2003 DELTA SHOULDER DEPUY, INC. JANET G JOHNSON
K033329 11/14/2003 DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS DEPUY, INC. RHONDA MYER
K033057 11/20/2003 DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE DEROYAL SHARON COOK
K033385 11/07/2003 DGH 55 HANDHELD PACHYMETER (PACHMATE) DGH TECHNOLOGY, INC. M. LUTHER DETWEILER
K033061 11/07/2003 CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K032537 11/25/2003 DRAEGER MICRO2+ AND MASIMO MINISAT DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K031132 11/26/2003 CONSULTIVA CASE INPUT STATION, MODEL CIS-1 EASTMAN KODAK COMPANY WIDO MENHARDT
K031946 11/03/2003 EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE EDWARDS LIFESCIENCES, LLC. JEAN CHANG
K032935 11/20/2003 EPI-SCAN, MODEL P 100 EDX EPI-SCAN, INC. GREG HOLLAND
K033204 11/12/2003 ESG 4-WHEEL SCOOTER, ESG-03 EMG TECHNOLOGY CO., LTD. JEN KE-MIN
K023120 11/12/2003 OXYCON MOBILE ERICH JAEGER GMBH EARL DRAPER
K033134 11/17/2003 MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K033314 11/21/2003 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K032964 11/13/2003 EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS EXACTECH, INC. GARY J MILLER
K033452 11/28/2003 CWAS 1000 FASSTECH LEE BRODY
K033368 11/26/2003 FOSSA URETERAL OPEN LUMEN STENT FOSSA MEDICAL, INC. GLORIA KOLB
K033370 11/28/2003 POWERED WHEELCHAIR, MODEL FR168W FREERIDER, CORP. ROBERT S MCQUATE
K033561 11/26/2003 FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC. FRANK GIANELLI
K033365 11/06/2003 APEXPRO FH TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DIANA M THORSON
K033304 11/12/2003 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K033492 11/24/2003 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA LEE MICHELS
K033502 11/20/2003 LIGHTSPEED 6.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC JOHN W JAECKLE
K033504 11/25/2003 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER, PH.D.
K033393 11/10/2003 ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM GUIDANT CORP. KELLY PIKE
K033554 11/24/2003 SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS GYRUS ENT L.L.C. GREGORY SREDIN
K024286 11/17/2003 GYRUS OPEN FORCEPS GYRUS MEDICAL, INC. MARK JENSEN
K033112 11/05/2003 WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS HAND BIOMECHANICS LAB, INC. TIMOTHY R STALLINGS
K032802 11/19/2003 HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III HK SURGICAL, INC. SALLY M BOWDON
K033224 11/05/2003 HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER HOLOGIC, INC. DANIEL F PHELAN
K033473 11/18/2003 MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K033145 11/05/2003 HOFFMANN II PELVIC CLAMP HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K030978 11/20/2003 SCORPIO NRG KNEE SYSTEM HOWMEDICA OSTEONICS CORP. DENISE DUCHENE
K033188 11/19/2003 TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 IDEV TECHNOLOGIES, INC. LYNNE A DAVIES
K033292 11/26/2003 AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 IGC-MEDICAL ADVANCES, INC. ANTHONY DIETZLER
K030263 11/24/2003 IMMUNICON CELLTRACKS ANALYZER IMMUNICON CORP. PETER SCOTT
K033430 11/07/2003 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 IMPLANT INNOVATIONS, INC. TAMARA NELSON
K033384 11/19/2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ IMPLEX CORP. MARCI HALEVI
K030802 11/25/2003 CAPHOSOL INPHARMA A.S. BRUCE MANNING
K033187 11/19/2003 INTERLAB IMMUNOFIXATION TEST(S) INTERLAB S.R.L. GARY LEHNUS
K032784 11/18/2003 ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K031842 11/21/2003 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K033199 11/12/2003 COMPACT DIGITAL CARDIAC CAMERA (CDCC) IS2 MEDICAL SYSTEMS, INC. VICTOR WOODBURN
K032519 11/12/2003 ENDO PAT 2000 ITAMAR MEDICAL DORIT WINITZ
K032470 11/05/2003 MULTILINK IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K031722 11/25/2003 JSA REPROCESSED COMPRESSION SLEEVE DEVICES JACK SPEER AND ASSOC., INC. JACK SPEER
K032087 11/26/2003 KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 KEELER INSTRUMENTS, INC. EUGENE VANARSDALE
K033021 11/12/2003 KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS KIMBERLY-CLARK CORP. RICHARD V WOLFE
K032670 11/14/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR KINGSWELL INTERNATIONAL INC. D.C. CHANG
K030359 11/06/2003 KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K032455 11/07/2003 PANAVIA F 2.0 KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K031419 11/24/2003 GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K032871 11/10/2003 PLANET MONITORING SYSTEM LARSEN & TOUBRO LIMITED E.J. SMITH
K032867 11/10/2003 STAR (LUNAR SERIES) MONITORING SYSTEM LARSEN & TOUBRO LIMITED E.J. SMITH
K024206 11/17/2003 AURA ISURGICAL LASER SYSTEM & ACCESSORIES LASERSCOPE PAUL HARDIMAN
K032774 11/26/2003 RENOVA INTERNAL HEX IMPLANT SYSTEM LIFECORE BIOMEDICAL, INC. DIANE BRINZA
K032764 11/03/2003 BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K032607 11/10/2003 POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 LINVATEC CORP. LAURA KREJCI
K033565 11/21/2003 LMT NOMAG IC 1,5 LMT LAMMERS MEDICAL TECHNOLOGY GMBH THOMAS M BOHNEN
K031170 11/13/2003 POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS LONG FIRST (XIAMEN) CO.,LTD. STONE CHEN
K031997 11/25/2003 MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM MALLINCKRODT DAR S.R.L. GIUSEPPE TOMASINI
K031463 11/18/2003 MARINA MEDICAL SILICONE PESSARY MARINA MEDICAL INSTRUMENTS, INC. JAY MANSOUR
K031876 11/21/2003 ELECTRO FLO PERCUSSOR, MODEL 5000 MED SYSTEMS DANIEL KAMM
K011261 11/17/2003 STONE EXTRACTOR BALLOON CATHETER MEDI-GLOBE CORP. SCOTT KARLER
K032094 11/14/2003 PASSMED SPINAL SYSTEM MEDICREA J.D. WEBB
K033102 11/05/2003 MEDIC COLON MODEL, RELEASE 1 MEDICSIGHT CAROL MACDONALD
K032823 11/10/2003 MEDICHEART, MODEL RELEASE 1 MEDICSIGHT CAROL MACDONALD
K032308 11/10/2003 BLOOD PRESSURE MONITOR, MODEL M100 MEDITEK TECHNOLOGY, INC. TONY C.S. CHANG
K033247 11/05/2003 MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM MEDRAD, INC. TROY A JACK
K033334 11/10/2003 PROFILE -ER MEDTOX DIAGNOSTICS, INC. ALAN MORRIS
K033468 11/14/2003 AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE MEDTRONIC PERFUSION SYSTEMS MICHELE PYFFEROEN
K033416 11/05/2003 SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K033275 11/06/2003 LIFEPAK 12, 20, 500, CR PLUS MEDTRONIC PHYSIO-CONTROL CORP. MICHELLE ACKERMANN
K033271 11/06/2003 DYNALOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K032811 11/24/2003 CEDIA VANCOMYCIN ASSAY MICROGENICS CORP. DAVID CASAL
K031024 11/14/2003 MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K032995 11/20/2003 SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) MICRON CORP. TAKASHI TERUI
K033390 11/04/2003 COLIBRI DISPOSABLE VITRECTOMY CUTTER MICROWORLD MEDICAL INSTRUMENTS, INC. SEMYON GAMBARIN
K032872 11/28/2003 MICRUS MICROCOIL SYSTEM MICRUS CORP. MARGARET WEBBER
K031799 11/12/2003 MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 MIELE, INC. STEVE POLINSKI
K031541 11/18/2003 PARADIGMPAL, MODEL MMT-7330 MINIMED, INC. GERDA P RESCH
K033277 11/04/2003 HYDRAGEL CSF ISOFOCUSING KITS MORAX BOREK JANIK
K032934 11/13/2003 MPS ACACIA SAFEGUARD HUBER DEVICE MPS ACACIA FERGIE F FERGUSON
K033567 11/25/2003 MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS MRI DEVICES CORP. THOMAS SCHUBERT
K031820 11/12/2003 ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660 MULTINATIONAL GRACE HOLLAND
K030787 11/14/2003 SHILEY FLEXTRA TRACHEOSTOMY TUBE NELLCOR PURITAN BENNETT, INC. GINA TO
K033321 11/05/2003 SELECTIVA SB GUIDEWIRE NEO METRICS, INC. MARK PEDERSON
K033427 11/10/2003 MODIFICATION TO EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORP. SHERRIE COVAL-GOLDSMITH
K032777 11/14/2003 MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE NIPRO MEDICAL CORP. RICHARD D BLISS
K031073 11/05/2003 PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE NOVABONE PRODUCTS, LLC DAVID M GAISSER
K033486 11/19/2003 GE PRECISION MPI NRT-NORDISK RONTGEN TEKNIK A/S JAN MALLING
K032476 11/13/2003 NUVASIVE MESH NUVASIVE, INC. LAETITIA BERNARD
K033386 11/26/2003 NXSTAGE PUREFLOW SOLUTION NXSTAGE MEDICAL, INC. NORMA LEMAY
K022304 11/14/2003 ACCUMAP AUTOMATIC PERIMETER OBJECTIVISION PTY LTD. FRED HENRY
K031380 11/14/2003 OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K032665 11/21/2003 OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K033300 11/05/2003 VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. CHARLOTTE BAKER
K030958 11/20/2003 ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS ORTHOTEC, L.L.C. PATRICK BERTRANOU
K032130 11/05/2003 VITOSS-FILLED CARTRIDGE ORTHOVITA, INC. ANDREINA ANGIE IDE
K031708 11/03/2003 OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM OSTEOMED L.P. DAWN T HOLDERMAN
K033119 11/18/2003 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA E DILLON
K032753 11/18/2003 GLUCOSE TOLERANCE BEVERAGE PERK SCIENTIFIC, INC. MARK BARTOSH
K032613 11/20/2003 TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE PETER M. ROTHENBERG, M.D. PETER M ROTHENBERG
K033444 11/21/2003 PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER PHILIPS MEDICAL SYSTEMS TAPAN D SHAH
K032636 11/14/2003 PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) PLAYTEX PRODUCTS, INC. KAREN A COSTA
K032716 11/28/2003 PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) PORTEX LTD. STEVE OGILVIE
K032804 11/03/2003 CRYOCHECK WEAK LUPUS POSITIVE CONTROL PRECISION BIOLOGIC STEPHEN DUFF
K032331 11/20/2003 DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) PRO-MED INSTRUMENTS GMBH JIM BAZZINOTTI
K032260 11/20/2003 ARAMIS II DERMATOLOGICAL LASER QUANTEL MEDICAL ROGER W BARNES
K032379 11/20/2003 QUASAR, MODEL MD21 QUANTUM SKINCARE, INC. J. HARVEY KNAUSS
K031795 11/10/2003 RELIANT LASER SYSTEM RELIANT TECHNOLOGIES, INC. HEATHER TANNER
K031965 11/14/2003 XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 REMEL INC RICHARD TYSON
K031942 11/18/2003 XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 REMEL INC RICHARD TYSON
K031834 11/10/2003 XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY REMEL INC EARLEEN C PARKS
K031559 11/12/2003 RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES RENU MEDICAL, INC. L. BRUCE PIERSON
K022750 11/20/2003 PLV CONTINUUM VENTILATOR, MODEL P1000 RESPIRONICS CALIFORNIA, INC. MARY FUNK
K032809 11/13/2003 HOSPITAL SPACER RESPIRONICS HEALTHSCAN, INC. SUSAN D GOLDSTEIN-FALK
K032852 11/12/2003 MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 REVIVANT CORP. BOB H KATZ
K032646 11/12/2003 ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K033501 11/20/2003 MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K033548 11/24/2003 ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K031236 11/14/2003 AUTO-BAND LIGATOR SCANDIMED. A.S. KRISTIAN K JENSEN
K032460 11/13/2003 PROFILE BBL SYSTEM SCITON, INC. JAY M PATEL
K032739 11/20/2003 UCR SPINAL SYSTEM SEASPINE DIANA SMITH
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