FDA 510(k) Decisions During December, 1998  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K983974 12/21/1998 OWEN MUMFORD 3ML AUTOPEN *OWNE MUMFORD USA, INC.** ROBERT SHAW
K982275 12/04/1998 RAPPORT V.T.D. *OWNE MUMFORD USA, INC.** ROBERT SHAW
K982142 12/30/1998 MOUNTABLE ENDOSCOPIC KNIFE A.M. SURGICAL, INC. EUGENE T KING
K983761 12/30/1998 AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 AARON MEDICAL INDUSTRIES J.ROBERT SARON
K983486 12/23/1998 SYSTEM U3 FOR NORFLOXACIN AB BIODISK ANNE BOLMSTROM
K983571 12/30/1998 SYSTEM U3 FOR TETRACYCLINE AB BIODISK ANNE BOLMSTROM
K983424 12/01/1998 ABBOTT ARCHEITECT TOTAL B-HCG ABBOTT LABORATORIES KAREN L GATES
K983759 12/07/1998 ABBOTT ARCHITECT FERRITIN ABBOTT LABORATORIES LAURA GRANITZ
K983306 12/18/1998 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN ACCUMED INTL., INC. CYNTHIA C KNAPP
K983310 12/17/1998 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN ACCUMED INTL., INC. CYNTHIA C KNAPP
K983309 12/14/1998 SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN ACCUMED INTL., INC. CYNTHIA C KNAPP
K983365 12/18/1998 AESCULAP MINOP SYSTEM AESCULAP, INC. MARY E HOLDEN
K983758 12/18/1998 YASARGIL TITANIUM ANEURYSM CLIPS AESCULAP, INC. VICTORIA MACKINNON
K983215 12/04/1998 MULTIPULSE CO2 LASER AESCULAP-MEDITEC GMBH WILLIAM T KELLEY
K974332 12/29/1998 VARIABLE PRESSURE SYRINGE PUMP ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K981054 12/07/1998 BROWNE GA INDICATOR FOR CIDEX PRODUCTS ALBERT BROWNE LTD. CYNTHIA J M NOLTE, PH.D
K983780 12/18/1998 MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 ALCON LABORATORIES MICHAEL PFLEGER
K983973 12/18/1998 OPTI-ONE MULTI-PURPOSE SOLUTION ALCON LABORATORIES MICHAEL PFLEGER
K984383 12/18/1998 ULTRACARE NEUTRALIZING TABLETS ALLERGAN, INC. PAUL J NOWACKI
K983146 12/07/1998 ARSOFT ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K983770 12/31/1998 'RAPID DRUG SCREEN' 9-PANEL AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K982076 12/10/1998 AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM AMIRA MEDICAL, INC. DAVID A HASKER
K983599 12/11/1998 SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT ANDWIN SCIENTIFIC NATALIE SARRAF
K983489 12/14/1998 ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) ANSELL PERRY JAMES R CHATTERTON
K983543 12/16/1998 ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM ARGUS PHOTONICS GROUP KEVIN DICKENSON
K983649 12/11/1998 MAX-ACT ARRAY MEDICAL, INC. MICHAEL F CORSELLO
K983623 12/18/1998 MODULAP ATC TECHNOLOGIES, INC. MARIAN HARDING COCHRAN
K982268 12/04/1998 ULNAR HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K984299 12/11/1998 AVL OPTI CRITICAL CARE ANALYZER AVL SCIENTIFIC CORP. RANDY BYRD
K983741 12/18/1998 EVERLAST NEUROSTIMULATION ELECTRODES 2"X 2",MODEL # EL2020 AXELGAARD MFG. CO., LTD. DAN P JEFFREY
K970736 12/16/1998 BRAUN PREFILLED SYRINGE B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K974845 12/08/1998 BTA STAT TEST PRESCRIPTION HOME USE BARD DIAGNOSTIC SCIENCES,INC. GLEN PAUL FREIBERG
K983526 12/11/1998 VERTICAL LIFT BARNES,RICHARDSON & COLBURN ALYSA CHUMMANVECH
K983317 12/02/1998 BARRON MICROKERATOME SYSTEM, MODEL B2000 BARRON PRECISION INSTRUMENTS, L.L.C. MARK BARRON
K983345 12/07/1998 BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY BAYER CORP. GABRIEL J MURACA JR
K983340 12/14/1998 IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR BECKMAN COULTER, INC. RICHARD T ROSS
K983747 12/30/1998 SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II BECKMAN COULTER, INC. LUCINDA STOCKERT
K984014 12/23/1998 SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 BECKMAN COULTER, INC. LUCINDA STOCKERT
K983640 12/21/1998 SYNCHRON SYSTEMS LIPID CALIBRATOR BECKMAN COULTER, INC. LUCINDA STOCKERT
K981816 12/04/1998 CUE AMBULATORY VOLUMETRIC INFUSION PUMP BECTON DICKINSON CURLIN, LLC. CHARLES J WELLE
K983773 12/22/1998 BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS BENZ RESEARCH AND DEVELOPMENT CORP. MARTIN DALSING
K983183 12/10/1998 GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P BIEN AIR USA, INC. ARTHUR MATEEN
K981665 12/07/1998 SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE BIO-MEDICAL SCIENCES, INC. MARK E DILLON
K984325 12/17/1998 ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 BIO-RAD ELIZABETH PLATT
K984319 12/22/1998 ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 BIO-RAD ELIZABETH PLATT
K984318 12/15/1998 ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 BIO-RAD ELIZABETH PLATT
K984323 12/15/1998 ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 BIO-RAD ELIZABETH PLATT
K984324 12/15/1998 ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 BIO-RAD ELIZABETH PLATT
K984327 12/22/1998 ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 BIO-RAD ELIZABETH PLATT
K984397 12/18/1998 LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 BIO-RAD ELIZABETH PLATT
K984473 12/22/1998 LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 BIO-RAD ELIZABETH PLATT
K984398 12/18/1998 LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 BIO-RAD ELIZABETH PLATT
K984399 12/18/1998 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 BIO-RAD ELIZABETH PLATT
K984400 12/18/1998 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 BIO-RAD ELIZABETH PLATT
K984396 12/18/1998 LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 BIO-RAD ELIZABETH PLATT
K984464 12/22/1998 LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 BIO-RAD ELIZABETH PLATT
K984476 12/22/1998 LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 BIO-RAD ELIZABETH PLATT
K984475 12/22/1998 LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 BIO-RAD ELIZABETH PLATT
K984479 12/22/1998 LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 BIO-RAD ELIZABETH PLATT
K984470 12/22/1998 LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 BIO-RAD ELIZABETH PLATT
K984478 12/22/1998 LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 BIO-RAD ELIZABETH PLATT
K984462 12/22/1998 LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 BIO-RAD ELIZABETH PLATT
K984071 12/03/1998 LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 BIO-RAD ELIZABETH PLATT
K984225 12/14/1998 LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 BIO-RAD ELIZABETH PLATT
K983807 12/16/1998 LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 BIO-RAD ELIZABETH PLATT
K984268 12/17/1998 VARIANT II HEMOGLOBIN A1C PROGRAM BIO-RAD JULIET CARRARA
K980117 12/18/1998 NUVO BARRIER FILM BIOMEDICAL DEVELOPMENT CO. RICHARD A HAMER
K983710 12/02/1998 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH BIOMET, INC. FRED MCCLURE
K983641 12/04/1998 HOLLAND FEMORAL NAIL SYSTEM BIOMET, INC. FRED MCCLURE
K983452 12/03/1998 NELSON RESURFACING HEAD BIOMET, INC. JULIE K RYAN
K983967 12/16/1998 PEDIATRIC CANNULATED OSTEOTOMY PLATES BIOMET, INC. LONNIE WITHAM
K981824 12/22/1998 OPTICOAT T3 EIA KIT BIOTECX LABORATORIES, INC. MOHAN MEHRA
K984112 12/22/1998 ADVENT BISCO, INC. STEVEN J DURAY
K984372 12/14/1998 ELECSYS CALCHECK TROPONIN T BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K984105 12/08/1998 ELECSYS TROPONIN T STAT TEST BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K983503 12/01/1998 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 BOEHRINGER MANNHEIM CORP. JENNIFER L TRIBBETT
K984431 12/30/1998 ULTIMA AIRFLOW PRESSURE SENSOR BRAEBON MEDICAL CORP. RICHARD A BONATO
K983454 12/16/1998 PAIN CARE 2000 BREG, INC. KATHLEEN BARBER
K983498 12/15/1998 BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE C.R. BARD, INC. GEORGIA C ABERNATHY
K971336 12/01/1998 CAIRD TECHNOLOGY SPIROMETER CAIRD TECHNOLOGY JAMES H BROWN
K983026 12/02/1998 PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 CARD GUARD SCIENTIFIC SURVIVAL, LTD. LEONID TRACHTENBERG
K983653 12/22/1998 RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D CARDIAC PATHWAYS CORP. ERIN DIGNAN
K983789 12/17/1998 CARESIDE CALCIUM, ORIGINAL CARESIDE, INC. KENNETH B ASARCH PHARM
K983182 12/10/1998 ALOE THERAPY ORAL RINSE CARRINGTON LABORATORIES, INC. E.J. SMITH
K984042 12/04/1998 QUADRANT CORE LC CAVEX HOLLAND B.V. BERNARD VAN DUIJN
K984044 12/16/1998 QUADRANT POSTERIOR DENSE CAVEX HOLLAND B.V. BERNARD VAN DUIJN
K984043 12/04/1998 QUADRANT TOTAL ETCH CAVEX HOLLAND B.V. BERNARD VAN DUIJN
K984041 12/04/1998 QUADRANT UNIVERSAL LC CAVEX HOLLAND B.V. BERNARD VAN DUIJN
K981746 12/07/1998 CELL ROBOTICS' LASETTE CELL ROBOTICS, INC. CONNIE WHITE
K981972 12/07/1998 GREEN-OR DENTIN DESENSITIZER CENTRIX, INC. JOHN DISCKO
K983685 12/04/1998 BONE BAND CHAPEL AND ASSOC. JAMES F CHAPEL
K983432 12/17/1998 SUPREME II CONTROL SOLUTIONS CHRONIMED, INC. JEFFREY P HEATON
K983463 12/11/1998 SURECAUT DIAMOND LASER KNIFE CLINICON CORP. GERALD S PALECKI
K983921 12/28/1998 AUTOSTAT II ENA SCREEN ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K983714 12/23/1998 SOLARTEC SOURCE 270, MODEL # 90123 COGENT LIGHT TECHNOLOGIES, INC. DON KNAEPPLE
K983173 12/16/1998 BIATAIN FOAM ADHESIVE DRESSING COLOPLAST CORP. M. SYDNEY LILLY
K983163 12/16/1998 BIATAIN FOAM DRESSING COLOPLAST CORP. M. SYDNEY LILLY
K983519 12/30/1998 COMFEEL SEASORB DRESSING COLOPLAST CORP. M.SYDNEY LILLY
K983553 12/07/1998 ANTI-TG IGG ELISA TEST SYSTEM COLUMBIA BIOSCIENCE, INC. NORMAN JENKINS
K983605 12/16/1998 IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM COLUMBIA BIOSCIENCE, INC. NORMAN JENKINS
K983606 12/16/1998 IS BORRELIA BURGDORFERI IGM TEST SYSTEM COLUMBIA BIOSCIENCE, INC. NORMAN JENKINS
K980378 12/09/1998 MELODIE INFUSION PUMP COMPAGNIE DE DEVELOPPEMENT AGUETTANT DIANE MCCOLL
K983568 12/21/1998 OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER CONTRACT LATEX DIPPERS SDN BHD VINAYAGAN RAMALINGAM
K983415 12/01/1998 DELIVERY SHEATH CONWAY STUART MEDICAL, INC. THOMAS WEHMAN
K983116 12/03/1998 ELECTROSURGICAL INFLATABLE BASKET ELECTRODES CONWAY STUART MEDICAL, INC. THOMAS WEHMAN
K983609 12/16/1998 COOK TEST TUBE HEATER COOK OB/GYN BRENDA DAVIS
K983594 12/21/1998 EMBRYO TRANSFER CATHETERS/SETS COOK OB/GYN DEBBIE SCHMITT
K983590 12/21/1998 GIFT CATHETER SET/S COOK OB/GYN BRENDA DAVIS
K983587 12/16/1998 HYSTEROSCOPIC GIFT CATHETER SETS COOK OB/GYN BRENDA DAVIS
K983591 12/21/1998 INTRATUBAL TRANSFER SETS COOK OB/GYN DEBBIE SCHMITT
K984500 12/23/1998 CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM CORDIS CORP. ARIEL MACTAVISH
K980823 12/18/1998 CORDIS NITINOL STENT AND DELIVERY SYSTEM CORDIS CORP. JOAN MARTIN
K982434 12/22/1998 REAADS IGA ANTI-B2GP 1 TEST KIT CORGENIX, INC. NANCI DEXTER
K982391 12/07/1998 REAADS IGG ANTI-B2GPI TEST KIT CORGENIX, INC. NANCI DEXTER
K982433 12/07/1998 REAADS IGM ANTI-B2GP1 TEST KIT CORGENIX, INC. NANCI DEXTER
K983914 12/22/1998 REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT CORGENIX, INC. NANCI DEXTER
K982651 12/11/1998 COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER COROMETRICS MEDICAL SYSTEMS, INC. RICHARD CEHOVSKY
K983277 12/16/1998 LIGHTSOURCE OR ILLUMINATOR MODEL I-100 CUDA PRODUCTS CO. KIM REED
K984193 12/14/1998 DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR DADE BEHRING, INC. REBECCA S AYASH
K984191 12/10/1998 MYOGLOBIN FLEX REAGENT CARTRIDGE DADE BEHRING, INC. REBECCA S AYASH
K984093 12/14/1998 STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK DADE BEHRING, INC. REBECCA S AYASH
K984065 12/14/1998 STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK DADE BEHRING, INC. REBECCA S AYASH
K983392 12/15/1998 DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR DATA RAY GREG ROBERTS
K982091 12/22/1998 CS/3 COMPACT AIRWAY MODULE, M-COVX DATEX-ENGSTROM, INC. JOEL C KENT
K983366 12/23/1998 TRIP TONOMETRY CATHETER, 16F DATEX-ENGSTROM, INC. JOEL KENT
K981680 12/31/1998 ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS DAYTON WATER SYSTEMS CINDY HELTON
K984458 12/31/1998 DEPUY ACE SPIDER PLATE DEPUY ACE MEDICAL CO. KATHLEEN DRAGOVICH
K983853 12/22/1998 DEPUY ACE TIMAX META PLATE DEPUY ACE MEDICAL CO. KATHLEEN DRAGOVICH
K983491 12/02/1998 DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K983906 12/18/1998 DEPUY ORTHOTECH SPIKED WASHER DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K983583 12/03/1998 DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS DEPUY, INC. LYNETTE WHITAKER
K984378 12/30/1998 DEPUY ACROMED MOSS SPINAL SYSTEM DEPUY, INC. LYNNETTE WHITAKER
K972788 12/22/1998 CROSSLAPS ELISA DEVICES AND DIAGNOSTICS CONSULTING GROUP TOM TSAKARIS
K983954 12/17/1998 ALASTAT MICROPLATE MIXED ALLERGEN PANELS DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K983263 12/07/1998 IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K982078 12/11/1998 IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K983972 12/07/1998 IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K983880 12/18/1998 TRANSFERRIN SPQ III ANTIBODY REAGENT SET DIASORIN, INC. JUDITH J SMITH
K982650 12/16/1998 AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) DIDECO S.P.A. ROSINA ROBINSON
K981881 12/02/1998 DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K983219 12/07/1998 NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 DRAGER, INC. HARALD KNEUER
K984023 12/08/1998 MAXVIEW DIAGNOSTIC WORKSTATION DYNAMIC HEALTHCARE TECHNOLOGIES, INC. KAREN W WHITE
K983348 12/11/1998 DYNAREX TRACHEOSTOMY SPONGE DYNAREX CORP. JOHN G MOULDEN
K974259 12/01/1998 VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES RESEARCH MEDICAL R D HIBBERT
K983313 12/11/1998 ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY ELSCINT, INC. STEVEN M KAY
K983473 12/17/1998 FERTILMARQ TEST KIT EMBRYOTECH LABORATORIES, INC. ANN D MCGONIGLE
K982832 12/23/1998 PROGUARD, RR-1, RR-2 EMERSON & CO. S.R.L. STEFANO COSTIGLTOLO
K983484 12/28/1998 DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE EMPI CAROLYN M STEELE HUSTEN
K974617 12/01/1998 PERIPHERAL VASCULAR DILATOR ENDOVASCULAR INSTRUMENTS, INC. JACK SPEER
K983414 12/16/1998 EVERBOND ESPE DENTAL AG A. PETERMANN
K983536 12/18/1998 PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS ETHICON ENDO-SURGERY, INC. EDWIN O BILLIPS
K983199 12/14/1998 FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL FIBRA SONICS, INC. ROBERT BROHM
K983561 12/16/1998 FUJINON EVL-F VIDEO LAPROSCOPE FUJINON, INC. GARY A ADLER
K983256 12/15/1998 ADVANTAGE WINDOWS (AW) FUSION GE MEDICAL SYSTEMS LARRY A KROGER
K982712 12/18/1998 RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) STEPHEN M PAGE
K983847 12/01/1998 MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT GERMIPHENE CORP. LESLIE DRAKE
K984218 12/17/1998 OASIS GLIMEX CORP. JEFF HACKETT
K983952 12/28/1998 GREINER VACUETTE BLOOD COLLECTION TUBE GREINER MEDITECH, INC. DOUG HARRIS
K983055 12/30/1998 RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 GUIDANT CORP. SUSAN SILAVIN
K982337 12/29/1998 CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER HAIDYLENA MEDICAL EGYPT SAMEH TAMIM
K983535 12/29/1998 THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 HANS HERMANN GMBH DAGMAR S MASER
K983752 12/10/1998 ALUMINA-ZINC OXIDE POWDERS F AND R HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K982426 12/17/1998 SPIFE ALKALINE HEMOGLOBIN HELENA LABORATORIES PAT FRANKS
K984286 12/17/1998 HEARTSTREAM ELECTRODE ADAPTER HEWLETT-PACKARD CO. WILLIAM D JORDAN
K981781 12/04/1998 ELECTROSURGICAL UNIT HILL-MED, INC. ERNESTO ACKERMAN
K984278 12/11/1998 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES JOCHEN ROGERS
K984272 12/11/1998 MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES JOCHEN ROGERS
K980926 12/16/1998 DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION HOWMEDICA CORP. MARGARET F CROWE
K980626 12/11/1998 DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION HOWMEDICA CORP. MARGARET F CROWE
K980632 12/11/1998 DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION HOWMEDICA CORP. MARGARET F CROWE
K980925 12/16/1998 DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION HOWMEDICA CORP. MARGARET F CROWE
K983528 12/23/1998 MICRO DYNAMIC MESH HOWMEDICA CORP. VIVIAN KELLY
K983404 12/22/1998 TYPE 3 FEMORAL COMPONENTS HOWMEDICA CORP. FRANK MAAS
K983559 12/24/1998 BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR ICU MEDICAL, INC. SHERYL SAENZ
K983924 12/18/1998 HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO IMMUNO CONCEPTS, INC. ERIC S HOY
K980637 12/16/1998 IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT IMPLEX CORP. ROBERT POGGIE, PH.D.
K983128 12/03/1998 IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY IMPLEX CORP. JOHN SCHALAGO
K983769 12/15/1998 DISTAFLO BYPASS GRAFT IMPRA, INC. KRISTI M KISTNER
K982804 12/16/1998 SPYROGEL HYDROGEL WOUND AND BURN DRESSING INNOVATIVE TECHNOLOGIES (US), INC. JULIE CHAFFEE
K983303 12/09/1998 INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS INNOVATIVE TECHNOLOGIES LTD. CHRISTOPHER OAKES
K983073 12/16/1998 I.V. EXTENSION SET OR I.V. ADMINISTRATION SET INTEGRA BIOTECHNICAL LLC. WILLIAM BERGELIN
K982562 12/28/1998 BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER INTEGRATED ORBITAL IMPLANTS, INC. JEANNE DUNHAM
K973328 12/10/1998 INTERSOURCE INTERNATIONAL BRACHYTHERAPY, SA VINCENT E CONIGLIONE
K981253 12/11/1998 ULTRACON ULTRAFILTRATOR INTERPORE INTL. LYNN M RODARTI
K982311 12/14/1998 BARTELS CINAKIT CMV ANTIGENEMIA INTRACEL CORP. FEDORA DAYE CONTRERAS
K983777 12/18/1998 MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM INVACARE CORP. EDWARD A KROLL
K982612 12/14/1998 "ESP7 VENOUS IMAGE" IRONMASTER, INC. FRED DAWSON
K984164 12/29/1998 JELBOND NP JELENKO CO. TRIDIB DASGUPTA
K983362 12/16/1998 NU-GEL * WOUND DRESSING JOHNSON & JOHNSON MEDICAL, INC. TERRY J DAGNON
K982812 12/04/1998 G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) JOHNSON & JOHNSON PROFESSIONALS, INC. MARY E GRAY
K982379 12/18/1998 SUNDT SLIM-LINE ANEURYSM CLIP APPLIER JOHNSON & JOHNSON PROFESSIONALS, INC. JANET G JOHNSON
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K980878 12/28/1998 PULMOTRACK,MODEL 1010 KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. CHARLES S IRVING
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K982995 12/04/1998 ACCUTRAX, MODEL EPF840 KORR MEDICAL TECHNOLOGIES, INC. SCOTT KOFOED
K983723 12/07/1998 CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE KOSSAN LATEX INDUSTRIES (M) SDN. BHD. BOB CHAN
K983721 12/07/1998 POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE KOSSAN LATEX INDUSTRIES (M) SDN. BHD. BOB CHAN
K984019 12/23/1998 POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS) KOSSAN LATEX INDUSTRIES (M) SDN. BHD. BOB CHAN
K984020 12/23/1998 POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) KOSSAN LATEX INDUSTRIES (M) SDN. BHD. BOB CHAN
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K983965 12/22/1998 CO2 LASER COUPLER LASER, INC. WILLIAM K PRZBYBLA
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K972975 12/22/1998 LIGHT DIAGNOSTICS RABIES DFA REAGENT LIGHT DIAGNOSTICS CINDY D PENNY
K983724 12/08/1998 ORCA-DX BONE DENSITOMETER LUNAR CORP. KENNETH D BUROKER
K983564 12/08/1998 PRODIGY TOTAL BODY SOFTWARE LUNAR CORP. KENNETH D BUROKER
K981942 12/14/1998 LATEX POWDER FREE EXAMINATION GLOVES MAIKA RUBBER PRODUCTS SDN BHD RAVI ANBIL
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K980845 12/14/1998 MS-900S, MS-900SPM & MS-900SFM MARS MEDICAL PRODUCTS E J SMITH
K983448 12/18/1998 ML UNIVERSAL TUBING MED-LOGICS, INC. BETTY ROSS
K981992 12/15/1998 ELECTRON WEDGE MODEL MT-EW-1000 MED-TEC,INC. DONALD F RIIBE
K984277 12/09/1998 CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 MEDICAL ANALYSIS SYSTEMS, INC. SCOT D KINGHORN
K983412 12/10/1998 MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T MEDICAL COMPONENTS, INC. JEANNE M CUSH
K983601 12/15/1998 DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC MEDICAL ELECTRONIC DEVICES, INC. THOMAS WENZEL
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K982303 12/08/1998 PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST MEDISENSE, INC. MICHAEL HALPIN
K982694 12/14/1998 MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K984211 12/23/1998 MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 MEDSCAND AB TENNY P TSE
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K983297 12/18/1998 MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE MEDTRONIC INSTENT, INC. NOEL MESSENGER
K983331 12/16/1998 MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 MEDTRONIC PS MEDICAL JEFFREY HENDERSON
K980973 12/10/1998 MEDTRONIC ANGIOGRAPHIC CATHETER MEDTRONICS INTERVENTIONAL VASCULAR MARK CHARTIER
K983065 12/01/1998 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM MENTOR CORP. DONNA A CRAWFORD
K983255 12/17/1998 MODIFICATION TO: PREMIER PLATINUM HPSA MERIDIAN DIAGNOSTICS, INC. ALLEN D NICKOL
K982764 12/03/1998 PREMIER CRYPTOSPORIDIUM MERIDIAN DIAGNOSTICS, INC. ALLEN D NICKOL
K983976 12/30/1998 METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM METAGEN, L.L.C. WESLEY D JOHNSON
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K982535 12/21/1998 INSIGHT DIAGNOSTIC IMAGING WORKSTATION NEO IMAGERY TECHNOLOGIES, INC. GARY J ALLSEBROOK
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K983072 12/01/1998 AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 NIHON KOHDEN AMERICA, INC. GARY REASONER
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K983811 12/24/1998 UNIPOLAR OPTICAL BIOPSY FORCEPS OLYMPUS WINTER & IBE GMBH LAURA STORMS-TYLER
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K983031 12/18/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
K983990 12/29/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
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K983881 12/04/1998 COBRA EXTERNAL FIXATOR ORTHOPAEDIC INNOVATIONS, INC. TODD J HEIN
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K983413 12/21/1998 MODEL MS-1 HANDPIECE PARKELL, INC. NELSON J GENDUSA
K983729 12/11/1998 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD BOB CHAN
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K983821 12/11/1998 PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
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K983342 12/21/1998 MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
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K974096 12/08/1998 CRX DIAMOND VALVE PHOENIX BIOMEDICAL CORP. DAVID KUNIN
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K982549 12/30/1998 RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC RADIONICS, INC. DAVID CROMWICK
K974064 12/07/1998 MICRO X RESIDUAL TEST STRIPS REPROCESSING PRODUCTS CORP. WALTER JANSEN
K983236 12/04/1998 BIPOLAR HF CABLE RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K983279 12/02/1998 ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
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K983305 12/17/1998 SCI-PHARM DESENSITIZING VARNISH SCIENTIFIC PHARMACEUTICALS, INC. JAN A ORLOWSKI
K983630 12/11/1998 SEARE BIOMEDICAL SILICONE RODS SEARE BIOMEDICAL CORP. WILLIAM JOHN SEARE, JR.
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K982885 12/04/1998 PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. DON MORRIS
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K982316 12/16/1998 LASEAWAY ALEXANDRITE LASER SYSTEM SILVER CREEK, INC. LORNA K LINVILLE
K983242 12/11/1998 SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES SIRONA DENTAL SYSTEMS GMBH SHEILA HAMEON-HEYER
K983964 12/09/1998 BATCH #6060 CONDUCTIVE GEL SKYLARK DEVICE CO., LTD. GEORGE CHEN
K981449 12/11/1998 SD-956 ULTRASOUND THERAPY SKYLARK DEVICE CO., LTD. GEORGE K C CHEN
K983210 12/10/1998 ALGISITE M SMITH & NEPHEW, INC. JIM G IRVIN
K983942 12/04/1998 INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP SMITH & NEPHEW, INC. JOANN KUHNE
K980184 12/18/1998 CD SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K983672 12/16/1998 DYNA-LOK SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
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K980675 12/22/1998 SUMMIT KRUMEICH-BARRAQUER MICROKERATOME SUMMIT TECHNOLOGY, INC. ERIC ANKERUD
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K983397 12/04/1998 STEALTHSTATION TREATMENT GUIDANCE PLAFFORM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER N WHITE
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K983873 12/30/1998 SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM SYNTEC SCIENTIFIC CORP. TED Y SHI
K983757 12/04/1998 SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 SYNTEC SCIENTIFIC CORP. TED Y SHI
K983485 12/21/1998 SYNTHES 1.3 MM SELF-DRILLING SCREW SYNTHES (USA) SHERI L MUSGNUNG
K983530 12/16/1998 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES (USA) JONATHAN M GILBERT
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K971981 12/22/1998 LS SERIES 200 FLOVISION SYSTEM SYSTAM ED RANSOM
K981363 12/22/1998 ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST TCPI, INC. JEFFREY BOLTS
K981912 12/04/1998 HUMAN IGA SUBCLASS BNII COMBI KIT THE BINDING SITE, LTD. JAY H GELLER
K983622 12/30/1998 BODYFORM THORACO-LUMBAR FIXATION SYSTEM THEKEN SURGICAL,LLC LUKAS EISERMANN
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K983917 12/04/1998 THERATRON ELITE THERATRONICS, INC. E.S. MARTELL
K984384 12/23/1998 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 THERMO BIOANALYSIS CORP. JANET A MCGRATH
K983825 12/04/1998 NITRILE LATEX POWDER FREE EXAMINATION GLOVE TOP GLOVE SDN. BHD. T.S. PUON
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K970829 12/22/1998 PHUSIS ABSORBABLE INTERFERENCE SCREW TORNIER DAVID W SCHLERF
K983514 12/23/1998 POSITRON OPTION, MODEL NSCO-050A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DONNELLE KRAJEWSKI
K983516 12/23/1998 TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DONELLE KRAJEWSKI
K984359 12/23/1998 AIA-PACK TROPONIN I ASSAY TOSOH MEDICS, INC. LORI ROBINSON
K984414 12/30/1998 XRE COLLIMATOR WITH SPECTRAL FILTER TREX MEDICAL CORP. WAYNE V LOOMER
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K984342 12/30/1998 ANTERIOR CERVICAL PLATING SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC KAREN F JURCZAK
K983293 12/16/1998 AUTO SUTURE LAPAROSCOPES DEVICE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JAMIE YIEH
K983904 12/22/1998 ROGOZINSKI SPINAL ROD SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SHARON L MURPHY
K983899 12/22/1998 THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SHARON L MURPHY
K982140 12/08/1998 CLINICAL ELECTRONIC THERMOMETER VALEO CORP. PHIL ZULUETA
K983529 12/31/1998 INSTATRAK 3000 VISUALIZATION TECHNOLOGY, INC. MARY MCNAMARA-CULLINANE
K982901 12/21/1998 LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED VITALCARE GROUP, INC. GINGER TALLEY
K983716 12/23/1998 VITALCARE DISPOSABLE VAGINAL SPECULUM VITALCARE GROUP, INC. GINGER TALLEY
K983525 12/10/1998 GORE REVOX THYROPLASTY IMPLANT W.L. GORE & ASSOCIATES,INC JOHN NICHOLSON
K983663 12/18/1998 C.T.M. MOBILITY SCOOTER, MODEL # HS-666 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K983662 12/18/1998 C.T.M. MOBILITY SCOOTER, MODEL # HS-686 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
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K983833 12/10/1998 ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE WESTAIM BIOMEDICAL, INC. JONATHAN S KAHAN
K984157 12/08/1998 MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE WILSON-COOK MEDICAL, INC. PAULA JOYCE
K983765 12/11/1998 INJECTION NEEDLE PROBE/DEVICE-TUNIS XIMED/PROSURE/INJECTX ASHVIN DESAI
K983200 12/11/1998 INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX XIMED/PROSURE/INJECTX ASHVIN DESAI
K984173 12/22/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K984347 12/17/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
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