FDA 510(k) Decisions During August, 1998  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K981647 08/09/1998 3M DENT II SYSTEM 3M COMPANY LEAL PICKETT
K982456 08/24/1998 AMALCAP PLUS AB ARDENT CLYDE E INGERSOLL
K982460 08/24/1998 VIVACAP HR AB ARDENT CLYDE E INGERSOLL
K982458 08/24/1998 VIVALLOY HR AB ARDENT CLYDE E INGERSOLL
K981892 08/18/1998 QUICK & SURE ONESTEP HOME PREGNANCY TEST ABACUS DIAGNOSTICS PAMELA BAGARIA
K981653 08/28/1998 AMY ABBOTT LABORATORIES MARK LITTLEFIELD
K981224 08/03/1998 DIRECT HDL ABBOTT LABORATORIES MARK LITTLEFIELD
K981303 08/03/1998 DIRECT LDL ABBOTT LABORATORIES MARK LITTLEFIELD
K981181 08/03/1998 ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) ACTIMED LABORATORIES, INC. SUSAN MCGEEHAN
K981905 08/18/1998 STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 ACU-PAK CAROL THOMPSON
K981704 08/05/1998 AUREX-3 ADM TRONICS UNLTD, INC. JAMES E LENICK
K982615 08/24/1998 AIRDENT RADIANCE CURING LIGHT AIR TECHNIQUES, INC. JOSEPH CAREY
K981776 08/03/1998 ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X ALEXANDER MFG. CO. KEN HEIMENDINGER
K982369 08/24/1998 CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K982051 08/05/1998 KELOCATE SHEETING ALLIED BIOMEDICAL CORP. CATHERINE RIPLE
K981705 08/27/1998 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K981504 08/06/1998 DBEST AMPHETAMINES TEST KIT AMERITEK, INC. K.C. YEE
K980411 08/20/1998 NPB3900 SERIES PATIENT MONITORS ANALOGIC CORP. STEVEN A CLARKE
K981819 08/04/1998 ANGIOLAZ VES-1CAM ANGIOLAZ, INC. JOHN D PLUMADORE
K982409 08/21/1998 VES 1501-M ANGIOLAZ, INC. JOHN D PLUMADORE
K972689 08/27/1998 CAOW HEMOSTASIS SYSTEM ANLAM CORP. ANTHONY LAM
K971434 08/17/1998 A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE APPLIED MEDICAL TECHNOLOGIES THOMAS W PARKINSON
K982239 08/14/1998 CIRCUIT GUARD ARC MEDICAL, INC. HAROLD B NORRIS
K982141 08/31/1998 ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 ARROW INTL., INC. THOMAS D NICKEL
K981782 08/12/1998 LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM ARROW INTL., INC. BRADLEY J ENEGREN
K974847 08/06/1998 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 ARTHREX, INC. SCOTT M DURLACHER
K981870 08/20/1998 VISAGE COSMETIC SURGERY SYSTEM ARTHROCARE CORP. MARK SMUTKA
K982274 08/11/1998 NITRILE PATIENT EXAMINATION GLOVE POWDER FREE ASIA PACIFIC LATEX SDN BHD LEE SOON HONG
K982287 08/06/1998 ASLAN SENSOR MODULAR INSTRUMENT ASLAN MEDICAL TECHNOLOGIES, LTD. THOMAS J HOOGEBOOM
K981823 08/11/1998 OPERATING ROOM TOWELS BALDUR SYSTEMS CORP. STEVE WOODY
K981792 08/17/1998 SOLUTION ADMINISTRATION SET BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K982219 08/12/1998 MICROALBUSTIX REAGENT STRIPS BAYER CORP. ROSANNE M SAVOL
K981939 08/20/1998 AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR BCI INTL., INC. DONALD J ALEXANDER
K981877 08/11/1998 NITRILE POWDERFREE EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K982284 08/03/1998 POWDERED GREEN LATEX EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K981879 08/11/1998 POWDERED NITRILE EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K982285 08/03/1998 POWDERFREE GREEN LATEX EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE A LIM
K982286 08/11/1998 POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) BESGLOVE MEDICARE SDN. BHD. LEE A LIM
K981878 08/11/1998 POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K982238 08/21/1998 BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 BINAX, INC. PAMELA S ANGELL
K982036 08/06/1998 SILON SCAR STRIPS BIO MED SCIENCES, INC. MARK E DILLON
K981624 08/04/1998 FLO-THRU BIO-VASCULAR, INC. D.E. GARDNER
K971892 08/05/1998 BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 BIOMEDICAL HORIZONS, INC. WILLIAM J DONAHUE
K982398 08/11/1998 BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW BIOMET, INC. FRED MCCLURE
K982367 08/24/1998 REACH HIP COMPONENT BIOMET, INC. JULIE K RYAN
K961903 08/24/1998 MAGELLAN BIOSENSE, LTD. SUSAN J ZACHMAN
K980468 08/26/1998 AU5 ULTRASOUND IMAGING SYSTEM BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K981971 08/24/1998 TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 BIRD PRODUCTS CORP. NEIL BATTISTE
K980049 08/11/1998 BONETRAP BLADHS PLAST AB WILLIAM E MURPHY
K982079 08/28/1998 ACCU-CHECK VOICEMATE BOEHRINGER MANNHEIM CORP. MIKE FLIS
K982471 08/06/1998 B2-MICROGLOBULIN CONTROL SET SERUM BOEHRINGER MANNHEIM CORP. JULIE A SMITH
K980453 08/11/1998 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS BOSTON SCIENTIFIC SCIMED, INC. RON BENNETT
K982077 08/11/1998 SELECTOR DIAGNOSTIC CATHETER BOSTON SCIENTIFIC SCIMED, INC. JANELL A COLLEY
K980909 08/11/1998 VICHY SHOWER BOUVIER HYDRO, INC. JOYCE M DUQUETTE
K981969 08/20/1998 ULTIMA BODY POSITION SENSOR BRAEBON MEDICAL CORP. RICHARD A BONATO
K981808 08/11/1998 BREATHAID TONGUE SCRAPER BREATHAID, LLC. J. DOUGLAS NUNN, JR.
K973593 08/25/1998 BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5 BRIDGE MEDICAL, INC. DONALD V CANAL
K982158 08/31/1998 SCOUT BURKE, INC. DUWAYNE E KRAMER
K981628 08/05/1998 BARD QUANTUM SVR MODEL NUMBER H-6440VR C.R. BARD, INC. KAREN HEFFERNAN
K981846 08/18/1998 PARENCHYMAL BOLT PRESSURE MONITORING KIT CAMINO NEUROCARE, INC. JODY J FLEMING
K982710 08/10/1998 AECD ARRHYTHMIA DETECTION SOFTWARE CARDIAC SCIENCE, INC. STAN E TILLMAN
K982442 08/25/1998 C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) CARE WISE MEDICAL PRODUCTS CORP. ROBIN A WISE
K981568 08/21/1998 MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 CDC TECHNOLOGIES, INC. GEORGE J WALLACE
K981478 08/12/1998 ACS:CENTAUR CEA CHIRON DIAGNOSTICS CORP. THOMAS F FLYNN
K981839 08/12/1998 ACS:CENTAUR PSA2 IMMUNOASSAY CHIRON DIAGNOSTICS CORP. WILLIAM J PIGNATO
K981989 08/25/1998 THE WAVE DIGITAL PHACO SYSTEM CIRCUIT TREE MAURICE IMONTI
K981284 08/12/1998 BETTER-BLADDER (BB) CIRCULATORY TECHNOLOGY, INC. YEHUDA TAMARI
K980588 08/18/1998 CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 CLARUS MEDICAL SYSTEMS, INC. DALE SAPPENFIELD
K980786 08/24/1998 COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K982309 08/05/1998 SMOKE EVACUATION ATTACHMENT 130XXX TBD CONMED CORP. IRA D DUESLER JR
K980390 08/20/1998 PTA BALLOON CATHETER COOK, INC. APRIL LAVENDER
K982770 08/18/1998 6F ENVOY GUIDING CATHETER CORDIS CORP. MARTINE D SCHNEIDER
K982632 08/18/1998 ENVOY AND VISTA BRITE TIP CORDIS CORP. MARTINE D SCHNEIDER
K982740 08/28/1998 CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S CORDIS WEBSTER, INC. MARY ADAMS
K982415 08/10/1998 CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 CORDIS WEBSTER, INC. MARY ADAMS
K982342 08/14/1998 DINAMAP MPS SELECT PORTABLE MONITOR CRITIKON COMPANY,LLC ANNETTE M HILLRING
K981962 08/18/1998 CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE CUDA PRODUCTS CO. JOSEPH CUDA
K973426 08/12/1998 ANS 2000 ECG MONITOR AND RESPIRATION PACER D. E. HOKANSON, INC. D. EUGENE HOKANSON
K982707 08/26/1998 EC6 PLETHYSMOGRAPH D. E. HOKANSON, INC. D. EUGENE HOKANSON
K982591 08/05/1998 DADE TRU-LIQUID CARDIAC CONTROL DADE BEHRING, INC. JOHN CRAMER
K982880 08/25/1998 DIMENSION(R) VALPROIC (VALP) ACID METHOD DADE BEHRING, INC. REBECCA S AYASH
K982292 08/13/1998 PREALBUMIN CALIBRATOR DADE BEHRING, INC. REBECCA S AYASH
K981934 08/31/1998 THE BAGNOLI-4 EMG SYSTEM DELSYS, INC. GIANLUCA DE LUCA
K981948 08/18/1998 APOLLO 95E DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. GREG HOLLAND
K982395 08/18/1998 DYTRACT FLOW RESTORATIVE DENTSPLY INTL. P.JEFFEREY LEHN
K982347 08/31/1998 DEPUY ACE TIMAX PILON PLATE DEPUY ACE MEDICAL CO. PAUL DONER
K982011 08/06/1998 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K982900 08/31/1998 PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW DEPUY, INC. SALLY FOUST
K982465 08/11/1998 DEROYAL INDUSTRIES, INC. DEFOGGER DEROYAL INDUSTRIES, INC. LOIS MARSH
K982637 08/12/1998 IMMULITE PSA CONTROL MODULE, MODEL LPSCM DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K982473 08/12/1998 TUMOR MARKER CONTROL DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K973243 08/03/1998 ACTIVE PSA ELISA (DSL-10-9700) DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN CLASS
K973244 08/03/1998 ACTIVE PSA IRMA (DSL-9700) DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN CLASS
K981498 08/21/1998 IS-TOXOPLASMA IGG TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K980600 08/12/1998 D903 AVANT ADULT HOLLOW FIBER OXYGENATOR DIDECO S.P.A. MARCO MANTOVANI
K981663 08/10/1998 DIGITAL DOC DIGITAL DOC LLC W. EDWARD JOHANSEN
K982399 08/06/1998 DISETRONIC PENFINE INJECTION PEN NEEDLE DISETRONIC MEDICAL SYSTEMS PATRIK DE HAES
K972587 08/21/1998 ELECTROCARDIOGRAPHS DR. LEE CO., LTD. GREG HOLLAND
K980208 08/04/1998 DIVAN ANESTHESIA VENTILATOR DRAEGER MEDICAL, INC. JAMES J BRENNAN
K980553 08/04/1998 NARKOMED 6000 MODEL NUMBER NM6000 DRAEGER MEDICAL, INC. JAMES J BRENNAN
K982469 08/19/1998 HICHEM CHOLESTEROL REAGENT KIT ELAN PHARMA, INC. WYNN STOCKING
K981272 08/24/1998 ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES ELECTRO THERAPEUTIC DEVICES, INC. K C CHOONG
K982908 08/28/1998 MODIFICATION TO EBI SPINELINK SYSTEM ELECTRO-BIOLOGY, INC. JONAS WILF
K981790 08/07/1998 IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW ELEKTA ONCOLOGY SYSTEMS, LTD. PAUL L SUMNER
K980052 08/05/1998 RESPAIDE EMERGENCY FILTRATION PRODUCTS, INC. MICHAEL J CRNKOVICH
K980854 08/11/1998 RETROGRADE PEDIATRIC NAIL ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K981329 08/26/1998 FETH-R-KATH EPIMED INTERNATIONAL, INC. DONALD HENDERSON
K980876 08/14/1998 ASTHMA MONITOR AM2 ERICH JAEGER GMBH & CO. KG DETLEF GROTHEER
K980995 08/20/1998 PLAQ-ATAQ-I ETHICARE SEYMOUR TROY
K982129 08/04/1998 ANTAGON PORCELAIN EUROPEAN DENTAL IMPORTS, INC. MICHAEL H EVERNGAM
K980888 08/13/1998 GLYCACOR EXOCELL, INC. MARGO P COHEN
K982201 08/10/1998 ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) FOREMOST DENTAL MFG., INC. D T WOLF
K981541 08/13/1998 CLEARSTAR ENTERAL NUTRITION PUMP FRANTZ MEDICAL DEVELOPMENT, LTD. J P HANSON
K974090 08/27/1998 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS FRESENIUS MEDICAL CARE NORTH AMERICA TOM FOLDEN
K981066 08/31/1998 FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K963271 08/19/1998 FUTREX-6100/XL FUTREX, INC. TORI TUNNELL
K982607 08/31/1998 MANUAL WHEELCHAIR G. HIRSCH AND CO., INC. GARY HIRSCH
K981928 08/06/1998 GALILEO DISPOSABLE ENDOSCOPES GALILEO ELECTRO-OPTICS CORP. MARY MCNAMARA-CULLINANE
K981681 08/11/1998 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) GAMBRO HEALTHCARE WILLIAM M TOWNSEND
K973649 08/31/1998 HEMOSITE TEST SYSTEM GDS TECHNOLOGY, LLC. JONATHAN A KOVACH
K973941 08/10/1998 IMMUNOWELL EBNA IGG TEST GENBIO BRYAN KIEHL
K973940 08/10/1998 IMMUNOWELL EBV VCA IGG TEST GENBIO BRYAN KIEHL
K973939 08/10/1998 IMMUNOWELL VCA IGM TEST GENBIO BRYAN KIEHL
K982004 08/18/1998 CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS GENERAL ELECTRIC CO. LARRY A KROGER
K980868 08/06/1998 GC IRRIGATOR GENTLE COLONICS, INC. KAREN U SALINAS
K980016 08/07/1998 MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) ROSINA ROBINSON
K981919 08/06/1998 BISSINGER CABLES, CAT. NO. 801000XX GUENTER BISSINGER MEDIZINTECHNIK GMBH DAGMAR S MASER
K980238 08/21/1998 GYNEX EXTENDED REACH NEEDLE GYNEX CORP. DAVID W SCHLERF
K982057 08/14/1998 BC 900 SLIT LAMP HAAG-STREIT AG JUERG H SCHNETZER
K980550 08/27/1998 WHISTLE WATCH HARWILL MEDICAL (PTY) LTD. E.J. SMITH
K981155 08/14/1998 FLAPMAKER DISPOSABLE MICROKERATOME HAWKEN INDUSTRIES GE0RGE MYERS
K974453 08/04/1998 NASAL INTERFACE MODEL 7910 HEALTHDYNE TECHNOLOGIES, INC. BETTY CORTELLONI
K981751 08/13/1998 SINUSCOPE AND ACCESSORIES HENKE SASS WOLF OF AMERICA, INC. ELLEN J HENKE
K982619 08/12/1998 HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 HEWLETT-PACKARD CO. ELISABETH M GEORGE
K973705 08/07/1998 CONTOR TABLE SURFACE HILL-ROM, INC. EDWIN BILLS
K980976 08/21/1998 AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP HOLLISTER, INC. JOESEPH S TOKARZ
K974848 08/06/1998 MINI-CISER HOUGEN MFG., INC. JEFFERY R MILLER
K974849 08/06/1998 X-AIR-CISER HOUGEN MFG., INC. JEFFERY R MILLER
K982068 08/31/1998 HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM HOWMEDICA CORP. SEAN LULAND
K982248 08/31/1998 HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A HOWMEDICA, INC. FRANK MAAS
K982249 08/07/1998 INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) DONNA WARD
K980083 08/17/1998 3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K982155 08/31/1998 SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM INFLUENCE, INC. JONATHAN S KAHAN
K982327 08/18/1998 INFRAMETRICS INFRACAM-MED INFRAMETRICS, INC. MARY MCNAMARA-CULLINANE
K982638 08/21/1998 3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214 INNOVATIVE TECHNOLOGIES LTD. CHRIS OAKES
K982366 08/27/1998 QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K980725 08/24/1998 EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A) INSTRUMENTATION INDUSTRIES, INC. LORI ZURAVLEFF
K981696 08/27/1998 IL TEST PLASMIN INHIBITOR INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K981263 08/06/1998 TOXOGEN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K964977 08/31/1998 IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) INTERACTIVE LIVING SYSTEMS, INC. ORVILLE K HOLLENBECK
K982336 08/21/1998 KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS INVACARE CORP. EDWARD A KROLL
K981244 08/13/1998 BW-1 (CODE NAME RD-0807) J.F. JELENKO & CO., INC. TRIDIB DASGUPTA
K981257 08/13/1998 JELFINE-52 (CODE NAME RD-0901) J.F. JELENKO & CO., INC. TRIBID DASGUPTA
K982377 08/18/1998 OPC LOWWEAR PORCELAIN JENERIC/PENTRON, INC. MURRAY G GAMBERG
K982597 08/20/1998 FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE JOHNSON & JOHNSON MEDICAL, INC. TERRY J DAGNON
K981703 08/12/1998 KSEA UNIMAT 45 KARL STORZ ENDOSCOPY KEVIN KENNAN
K981130 08/19/1998 KSEA ENDO TIP SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K982164 08/10/1998 ESTENIA KURARAY AMERICA, INC. KOJI FUJITA
K981636 08/20/1998 INTEGRATED DRIVE/PUMP SYSTEM LINVATEC CORP. CAROL A WEIDEMAN
K980174 08/13/1998 DUREX COLORS AND SCENTS LONDON INTL. LLC. NEIL ANDERSON
K982267 08/18/1998 DPX-RX BONE DENSITOMETER LUNAR CORP. KENNETH D BUROKER
K961798 08/05/1998 CT 200 ELECTROCARDIOGRAPH MACQUARIE MEDICAL SYSTEMS FRANK FERGUSON
K981898 08/03/1998 ORTHOVU-1000 MAGNEVU BOB ROSE
K974535 08/14/1998 DISCAM DIGITAL IMAGING SYSTEM MARCHER ENTERPRISES, LTD. TIM DAWSON
K982260 08/12/1998 MARKWELL GAUZE SPONGE MARKWELL INTL., INC. SEAN WANG
K980489 08/31/1998 VAPAMASTA 6 MEDICAL INDUSTRIAL EQUIPMENT HENRY MARSHALL
K982587 08/24/1998 MPS FIXED FLOW RATE SET MEDICAL PRODUCT SPECIALISTS DAN HYUN
K974269 08/21/1998 SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, MEDISON AMERICA, INC. PETER KLEIN
K982755 08/20/1998 MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) MEDTRONIC BLOOD MANAGEMENT STEPHEN MCKELVEY
K981642 08/05/1998 STABLEMAPR STEERABLE INTRACARDIAC CATHETERS MEDTRONIC CARDIORHYTHM KRISTEN HONL
K981198 08/07/1998 MEDTRONIC ZUMA GUIDING CATHETER MEDTRONICS INTERVENTIONAL VASCULAR MARK CHARTIER
K982628 08/21/1998 MEDWORKS INSEMINATION CATHETER MEDWORKS CORP. PAMELA PAPINEAU
K982626 08/20/1998 URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 MEDWORKS CORP. PAMELA PAPINEAU
K982697 08/12/1998 MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR MENNEN MEDICAL, INC. KEN RAICHMAN
K982066 08/31/1998 MP-3 POWER BASE CHAIR MERITS HEALTH PRODUCTS., INC. WINSTON ANDERSON
K981364 08/13/1998 PYRILINKS-D ASSAY KIT METRA BIOSYSTEMS, INC. JILL VISOR
K981966 08/14/1998 NOSEBLEED NOSECLIP MICHAEL M. KNOTT, M.D. MICHAEL M KNOTT
K974220 08/25/1998 MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE MICROMEDICAL, INC. MALCOM CASTLE
K982018 08/07/1998 LIGHT SABER ASPIRATION NEEDLE MINRAD, INC. JOHN MCNEIRNEY
K981796 08/05/1998 LIGHT SABER CORE TISSUE NEEDLE MINRAD, INC. THOMAS L PARKER
K982420 08/24/1998 MITEK MICRO ANCHOR MITEK PRODUCTS EDWARD F KENT
K982845 08/21/1998 CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 MORE DIAGNOSTICS JAMES W SNIPES
K981742 08/25/1998 ONE UP DISPOSABLE KERATOME HEAD MORIA, INC. ALAIN DUPRAT
K980734 08/11/1998 MYELOTEC VIDEO GUIDED CATHETER MYELOTEC, INC. THOMAS A DUNKLE
K980423 08/07/1998 SONOPSY LA SYSTEM NEOVISION CORP. JAMIE YIEH
K982130 08/07/1998 RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 NEW DEANTRONICS, LTD. LEWIS WARD
K981910 08/24/1998 SUCTION CATHETER NI-MED, INC. MICHAEL GIBLIN
K982635 08/07/1998 CAREDOP II NICOLET BIOMEDICAL DAVID W WAGNER
K982295 08/06/1998 NIDEK LIGHTSCAN NIDEK, INC. KEN KATO
K981640 08/05/1998 S2LO ODYSSEY OPTICAL SYSTEMS, LLC. MAUREEN O'CONNELL
K982289 08/19/1998 HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K981854 08/18/1998 OLYMPUS SERUM PROTEIN MULTICALIBRATOR, OLYMPUS DIAGNOSTICA GMBH LAURA STORMS-TYLER
K982061 08/25/1998 STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) ORASURE TECHNOLOGIES, INC. SAM R NIEDBALA
K982263 08/18/1998 MB/BACT BLOOD CULTURE BOTTLE ORGANON TEKNIKA CORP. REBECCA A RIVAS
K982649 08/12/1998 VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III ORTHO-CLINICAL DIAGNOSTICS, INC. CHARLES C MORGANSON, JR.
K981953 08/18/1998 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS PARAGON TRADE BRANDS, INC. ROBERT J STAAB
K981907 08/04/1998 V.F.I.-VISCOUS FLUID INFUSION TUBING SET PEREGRINE SURGICAL LTD. TODD RICHMOND
K980916 08/18/1998 "POWDER-FREE" LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM PERUSAHAAN GETAH ASAS SDN BHD BOB CHAN
K980831 08/27/1998 IMAGE POST-PROCESSING TECHNIQUES PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K982383 08/19/1998 PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS PLAYTEX PRODUCTS, INC. MARK ROSENGARTEN
K981805 08/07/1998 POS T-7000 POS TECHNOLOGIES, INC. MICHAEL BRODY
K981011 08/28/1998 POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) POS-T-VAC, INC. MARK A HELLER
K981180 08/28/1998 REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT POS-T-VAC, INC. MARK A HELLER
K980559 08/24/1998 PEGASUS ND:YAG LASER SYSTEM PREMIER LASER SYSTEMS, INC. MARCIA VAN VALEN
K981855 08/10/1998 PRINCE MEDICAL CEMENT PLUG PRINCE MEDICAL, INC. MICHAEL PRINCE
K981801 08/25/1998 ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA PRINCETON BIOMEDITECH CORP. JEMO KANG
K981869 08/11/1998 PRO-FLEX DISPOSABLE PROPHY ANGLE PROFESSIONAL DENTAL MFG., INC. BOB ZAHRADNIK
K980106 08/03/1998 THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES PROMA, INC. FRANK A BETUSH
K982364 08/05/1998 WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) RADIONICS, INC. LISA MISTERKA BENATI
K974539 08/06/1998 SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM RESMED LTD. SCOTT DUDEVOIR
K973943 08/27/1998 INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K982677 08/31/1998 UNI/MONOPOLAR HF CABLE RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K974588 08/07/1998 INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD RIMED LTD. AHAVA STEIN
K981844 08/07/1998 SLEEP MANAGEMENT SYSTEM RMP, INC. TERRY G MAHN
K982551 08/18/1998 ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K981897 08/26/1998 ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K982087 08/18/1998 ROCHE CRP T CONTROL N ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K981931 08/25/1998 CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH PATRICIA M KLIMLEY
K980619 08/20/1998 SABRATEK PATIENT HOME MANAGEMENT SYSTEM SABRATEK CORP. EDWARD WADDELL
K980782 08/05/1998 STAT-SIMPLE PYLORI SALIVA DIAGNOSTIC SYSTEMS, INC. PAUL D SLOWEY
K980477 08/06/1998 IMAGE VUE EEG SAM TECHNOLOGY, INC. DANIEL KAMM
K980109 08/18/1998 CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER SANGSTAT MEDICAL CORP. DEREK WILLIAMS
K982608 08/19/1998 SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT SANGUI BIOTECH, INC. JOHN J KIANG
K973735 08/25/1998 MICROVIT MT-100 SCHILLER AMERICA, INC. MARKUS MARITZ
K973751 08/25/1998 MT-200 SCHILLER AMERICA, INC. MARKUS MARITZ
K980504 08/07/1998 EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET SCHNEIDER/NAMIC KARIN L SMITH
K981788 08/18/1998 SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER SCIMED LIFE SYSTEMS, INC. MELANIE RASKA
K981756 08/05/1998 SHELHIGH NO-REACT PNEUMOPLEDGETS SHELHIGH, INC. SHLOMO GABBAY
K980885 08/21/1998 SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K982579 08/11/1998 LATEX EXAMINATION GLOVES POWDER FREE SHIVA MEDICARE LTD. JAMES F LOGAN
K982586 08/11/1998 POWDER FREE SURGEONS GLOVE SHIVA MEDICARE LTD. JAMES F LOGAN
K981807 08/19/1998 CARDIOVISION SOFTWARE, MODEL S-CV5-96 SHL TELEMEDICINE INTERNATIONAL LTD. ALROY YARIV
K982461 08/24/1998 GLASIONOMER CEMENT CX PLUS SHOFU DENTAL CORP. THOMAS D YANKELITIS
K982730 08/24/1998 SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR SIEMENS MEDICAL SOLUTIONS USA, INC. JACQUELINE E EMERY
K980287 08/12/1998 SIEMENS SC9000/SC9015 TCP02/C02 MODULE SIEMENS MEDICAL SOLUTIONS USA, INC. JACQUELINE E EMERY
K980884 08/19/1998 SIEMENS SEVOFLURANE VAPORIZER SV 953 SIEMENS MEDICAL SOLUTIONS USA, INC. DAVID SIMARD
K982236 08/05/1998 SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K982251 08/18/1998 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K981852 08/05/1998 SILIMED TISSUE EXPANDER SILIMED, LLC. E.J. SMITH
K974479 08/05/1998 SILIMED VAGINAL STENT SILIMED, LLC. E J SMITH
K964437 08/14/1998 GB-1002 TENS WITH MASSAGE SKYLARK DEVICE CO., LTD. GEORGE K CHEN
K982686 08/07/1998 MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM SOFAMOR DANEK USA,INC. BAILEY LIPSCOMB
K982378 08/26/1998 HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE SOLUTION TECHNOLOGIES WILLIAM J GRISWOLD, JR
K981028 08/21/1998 ULTRA IMAGE AND ULTRA SCAN SONOTECH, INC. MARGARET J LARSON
K982065 08/12/1998 STERILE SILICONE EXTERNAL WOUND COVER SPECIALTY SURGICAL PRODUCTS, INC. T. JAN VARNER
K980197 08/04/1998 ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR SPECIALTY ULTRAVISION, INC. IVALEE I COHEN
K981451 08/21/1998 ARGOMEDICAL BIPOLAR SYSTEM STELKAST COMPANY DONALD A STEVENS
K974648 08/04/1998 SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR SULZER CARBOMEDICS, INC. EDWARD E NEWTON
K981747 08/20/1998 BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX SUNSCOPE INTL., INC. JOHN SHULZE
K981041 08/27/1998 SLT BIPOLAR SHEATH SURGICAL LASER TECHNOLOGIES, INC. MONICA FERRANTE
K981686 08/07/1998 STEALTHSTATION SYSTEM DIGITIZER CHANGE SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER WHITE
K981684 08/06/1998 STEALTHSTATION TREATMENT GUIDANCE PLATFORM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER N WHITE
K981809 08/14/1998 CAROLINE GUIDE SURGICAL SOLUTIONS, INC. MATTHEW A HOWARD, III
K981890 08/18/1998 SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES SYNTHES (USA) SHERI L MUSGNUNG
K980761 08/04/1998 SYNTHES SPINE PEDIATRIC ROD SYSTEM SYNTHES SPINE BARRY E SANDS
K981761 08/14/1998 SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER SYSMEX CORP. NINA GAMPERLING
K982257 08/03/1998 VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED TAIAN PLASTICS PRODUCTS (JINGXING) CO., LTD. CHIN-YU LIN
K982015 08/03/1998 VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE TAIAN PLASTICS PRODUCTS (JINGXING) CO., LTD. MR.LIN CHIN-YU
K980148 08/05/1998 NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR THE MAGSTIM COMPANY LTD. CHRIS HOVEY
K981993 08/21/1998 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K981923 08/24/1998 THE SNORE PEACE THE SNORE PEACE GROUP DAVID V SHEEHAN
K982150 08/13/1998 EL-ANA PROFILES: EL-ENA/4 THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K982622 08/13/1998 EL-ANA PROFILES: EL-ENA/5 THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K982112 08/20/1998 THERMATREK IRIS-3 INFRARED IMAGING SYSTEM THERMATREK, INC. DAVID R BALZER
K982537 08/24/1998 TOKUYAMA SOFRELINER TOKUYAMA AMERICA, INC. DANIEL J MANELLI
K982265 08/26/1998 AQUILION CT SCANNER, MODEL TSX-101A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K982301 08/07/1998 MICRO21 WITH URINE SEDIMENT ANALYSIS TRIANGLE BIOMEDICAL SCIENCES, INC. R OTTO STELLNER
K981908 08/05/1998 UM-150A UMECO UNION MEDICAL ENGINEERING ANNIE VELEZ
K982229 08/13/1998 BI-DENT VALLEY FORGE SCIENTIFIC CORP. THOMAS J GILLOWAY
K981916 08/28/1998 LIGASURE VESSEL SEALING SYSTEM VALLEYLAB, INC. CHARLES COPPERBERG
K981944 08/24/1998 BREATHERITE VENTLAB CORP. E.J. SMITH
K982664 08/02/1998 VITA TITANIUM PORCELAIN VIDENT RAY E MORROW
K981998 08/21/1998 PEDIATRIC INSTATRAK SYSTEM VISUALIZATION TECHNOLOGY, INC. MARY MCNAMARA-CULLINANE
K982498 08/07/1998 DIAGNOSTIC ULTRASOUND SYSTEM VOLUMETRICS MEDICAL IMAGING, INC. JIM MUNDELL
K982313 08/10/1998 HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS WECK CLOSURE SYSTEMS BRIAN YOUNG
K981937 08/24/1998 WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM WELCH ALLYN, INC. KATHY LOWTHER
K981238 08/21/1998 BIPOLAR FEMORAL HEAD WHITESIDE BIOMECHANICS, INC. MICHAEL C WALL
K982464 08/11/1998 SCC-23 SAFETY CLAMP AND CUTTER WOMEN FIRST HEALTHCARE, INC. JEANNE-MARIE VARGE
K982594 08/27/1998 ENDO-SCRUB/ENDO-SCRUB 2 XOMED, INC. DEBRA B CORTNER
K981120 08/21/1998 ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K982429 08/25/1998 ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES ZYMETX, INC. CRAIG D SHIMASAKI


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact