FDA 510(k) Applications Received During August, 1998

FDA 510(k) Number Submission Date Device Name Applicant Contact
K982893 08/17/1998 3M TEGASORB HYDROCOLLOID DRESSING 3M COMPANY ANNA E MCRIGHT
K982892 08/17/1998 3M TEGASORB THIN HYDROCOLLOID DRESSING 3M COMPANY ANNA E MCRIGHT
K982754 08/06/1998 EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) A. STEIN - REGULATORY AFFAIRS CONSULTING AHAVA STEIN
K982868 08/14/1998 ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE AB BIODISK ANNE BOLMSTROM
K983027 08/31/1998 TRIMETHOPRIM/SULPHAMETHOXAZOLE AB BIODISK ANNE BOLMSTROM
K982786 08/10/1998 TRACCELL 2000 SLIDE MAPPING SYSTEM ACCUMED INTL., INC. NORMAN J PRESSMAN
K982911 08/18/1998 FORTE ADAC LABORATORIES DENNIS W HENKELMAN
K982793 08/10/1998 PIEZO TRONIC ADVANCED MEDICAL DEVICES, INC. GREG HOLLAND
K982890 08/17/1998 ADVANCED UROSCIENCE INJECTION NEEDLE ADVANCED UROSCIENCE, INC. KAREN E PETERSON
K982914 08/19/1998 AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS AESCULAP, INC. LIA S JONES
K983002 08/28/1998 MYSTIQUE ULTRASONIC NEBULIZER AIRSEP CORP. EDWARD VRANA
K982896 08/17/1998 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 ALEXANDER MFG. CO. KEN HEIMENDINGER
K982709 08/04/1998 MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY ALEXON - TREND, INC. KEN HOOD
K982722 08/05/1998 AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD AMBU, INC. SANJAY PARIKH
K982862 08/13/1998 RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE APPLICARE MEDICAL IMAGING, B.V. T. WHIT ATHEY
K982785 08/07/1998 FILM DIGITIZER MODEL 2905 ARRAY CORP. TAKASHI INAMI
K982997 08/27/1998 FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER) ASPECT VISION CARE, LTD. MARTIN S KNOPF
K982865 08/13/1998 ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT ATRIX LABORATORIES, INC. ELYSE WOLFF
K982805 08/10/1998 INTROCAN SAFETY IV CATHETER B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K983005 08/28/1998 PERFUSOR COMPACT B. BRAUN MEDICAL, INC. GARY A GULYAS
K982894 08/17/1998 MIC-KEY "G"LOW PROFILE GASTROSTOMY REPLACEMENT KIT BALLARD MEDICAL PRODUCTS E. MARTIN CHAMBERLAIN
K982690 08/03/1998 BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE BARCO NV FRANK FERGUSON
K982820 08/11/1998 BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV DISPLAY SYSTEMS FRANK FERGUSON
K982775 08/07/1998 BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K982822 08/11/1998 FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 BAXTER HEALTHCARE CORP. MARY ELLEN SNYDER
K982802 08/10/1998 BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP. GABRIEL J MURACA
K982714 08/04/1998 BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY BAYER CORP. GABRIEL J MURACA, JR.
K982935 08/21/1998 SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR BECKMAN COULTER, INC. LUCINDA STOCKERT
K982922 08/19/1998 VACUTAINER BRAND BLOOD COLLECTION SYRINGE BECTON DICKINSON VACUTAINER SYSTEMS KEITH M SMITH
K982723 08/05/1998 MAICO MA42 BERNAFON-MAICO, INC. SCOTT SAVRE
K982778 08/07/1998 BIODERM FOAM WOUND DRESSING BIODERM, INC. GEORGE WORTHLEY
K982939 08/21/1998 BTF THIN FILM WOUND DRESSING BIODERM, INC. MARIE B TEIXEIRA
K982954 08/24/1998 FREE T4 MICROWELL EIA, MODEL #7019 BIOMERICA, INC. JAY SINGH
K982869 08/14/1998 ASCENT SYSTEM BIOMET, INC. KARA MEZGER
K983035 08/31/1998 CUSTOM FLANGED ACETABULAR COMPONENT BIOMET, INC. PATRICIA SANDBORN BERES
K982982 08/26/1998 MINI-FIXATOR FOR COLLES FRACTURES BIOMET, INC. JULIE K RYAN
K983036 08/31/1998 SINGLE AXLE TOTAL ELBOW BIOMET, INC. FRED MCCLURE
K982953 08/24/1998 TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES BIOMET, INC. LONNIE WITHAM
K982721 08/04/1998 BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM BIONX IMPLANTS, INC. JONATHAN S KAHAN
K982729 08/05/1998 RENEW BISCO, INC. KATHY JOUNG
K982948 08/21/1998 ELECSYS PSA, MODEL # ELECSYS 1010 BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K982949 08/21/1998 ELECSYS PSA, MODEL 2010 BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K982840 08/12/1998 BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING BOSTON SCIENTIFIC CORP. DONNA K TEMPLEMAN
K982888 08/17/1998 VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM BOSTON SCIENTIFIC CORP. CHRISTINE M HARRIS
K982825 08/11/1998 BRENNEN MEDICAL BETA GLUCAN GEL BRENNEN MEDICAL, INC. KENNETH B HERLAND
K982696 08/03/1998 INTERPLANT BURDETTE MEDICAL SYSTEMS, INC. EVERETTE C BURDETTE
K982891 08/17/1998 CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K982985 08/26/1998 CITREX HOSPITAL SPRAY DISINFECTANT CALTECH INDUSTRIES, INC. DONALD JOHNSON
K982702 08/03/1998 VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD CAMINO NEUROCARE, INC. JODY J FLEMING
K983026 08/31/1998 PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 CARD GUARD SCIENTIFIC SURVIVAL, LTD. LEONID TRACHTENBERG
K982710 08/04/1998 AECD ARRHYTHMIA DETECTION SOFTWARE CARDIAC SCIENCE, INC. STAN E TILLMAN
K982803 08/10/1998 HEARTLINK, MODEL II CARDIAC TELECOM CORP. LEE G DENEAULT
K982835 08/12/1998 ELECTRODE SWITCHBOX, MODEL 11-081002 CARDIMA, INC. JACK P DOUGLAS
K982776 08/06/1998 9303 NEONATAL/ADULT VITAL SIGNS MONITOR CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K982950 08/21/1998 FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 CHALGREN ENTERPRISES, INC. RICHARD KAISER
K982761 08/06/1998 JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 CHAMCO, INC. JIM CUMMINS
K982829 08/11/1998 FORTE, MODEL CPS ULTRASOUND CHATTANOOGA GROUP, INC. JOE ELROD
K982830 08/11/1998 FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO CHATTANOOGA GROUP, INC. JOE ELROD
K982828 08/11/1998 FORTE, MODELS CPS 400 STIM, CPS 200 STIM CHATTANOOGA GROUP, INC. JOE ELROD
K982774 08/07/1998 SOFT (HYDROPHILIC) CONTACT LENSES CL-TINTERS MARTIN S KROPF
K983042 08/31/1998 SWEEN WOUN'DRES COLOPLAST CORP. HARVEY M ARBIT
K982962 08/24/1998 XENON LIGHT SOURCE, MODELS LS6180, LS6035 CONTEC MEDICAL VISION, LTD. ALBERT E AUSTIN
K983023 08/31/1998 MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM CORDIS CORP. ARIEL MACTAVISH
K983003 08/28/1998 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS CORDIS NEUROVASCULAR, INC. MARTINE D SCHNEIDER
K982740 08/06/1998 CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S CORDIS WEBSTER, INC. MARY ADAMS
K983020 08/31/1998 COMPACT KTP LASER COSMOS MEDICAL TECHNOLOGY JOHN P CLARK
K983017 08/28/1998 MODIFICATION TO SYSTEM 83 PLUS CUSTOM ULTRASONICS FRANK J WEBER
K983034 08/31/1998 CYNOSURE CO3 ER:YAG LASER CYNOSURE, INC. GEORGE CHO
K982707 08/03/1998 EC6 PLETHYSMOGRAPH D. E. HOKANSON, INC. D. EUGENE HOKANSON
K982880 08/14/1998 DIMENSION(R) VALPROIC (VALP) ACID METHOD DADE BEHRING, INC. REBECCA S AYASH
K982871 08/14/1998 DRUG CALIBRATOR II DADE BEHRING, INC. REBECCA S AYASH
K982875 08/14/1998 MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM DANEK MEDICAL, INC. RICHARD W TREHARNE
K982975 08/26/1998 DIGITAL ECG HOLTER RECORDER, MODEL DR512 DATRIX JON BARRON
K982853 08/13/1998 SILK SUTURE DAVIS & GECK, INC. VANADA JOHNSON
K982867 08/14/1998 HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 DAVOL, INC., SUB. C.R. BARD, INC. ROBIN DRAGO
K982918 08/19/1998 DEPUY C-STEM SYSTEM DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K982900 08/17/1998 PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW DEPUY, INC. SALLY FOUST
K983019 08/31/1998 CARBON DIOXIDE-SL ASSAY, CAT # 253-01 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K982708 08/04/1998 SPQ TEST SYSTEM DIASORIN, INC. JUDITH J SMITH
K982855 08/06/1998 DIGIRAD 2020TC SPECT IMAGING SYSTEM DIGIRAD CORP. R. SCOTT HUENNEKENS
K982966 08/25/1998 DISETRONIC PEN DISETRONIC MEDICAL SYSTEMS LEE LEICHTER
K982789 08/10/1998 MEDICAL AIR COMPRESSOR, MODEL # 8413419 DRAGER, INC. HARALD KNEUER
K982800 08/10/1998 ECTON LYNX ULTRASOUND SYSTEM ECTON, INC. CHRISTOPHER B KNELL
K982908 08/18/1998 MODIFICATION TO EBI SPINELINK SYSTEM ELECTRO-BIOLOGY, INC. JONAS WILF
K982889 08/17/1998 MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 ELECTROMED, INC. CHET SIEVERT
K982713 08/04/1998 RT DESKTOP ELEKTA ONCOLOGY SYSTEMS, LTD. PAUL L SUMNER
K982842 08/12/1998 HUMAPEN AND HUMAPEN ERGO ELI LILLY AND CO. LEEANN CHAMBERS
K982832 08/12/1998 PROGUARD, RR-1, RR-2 EMERSON & CO. S.R.L. STEFANO COSTIGLTOLO
K982819 08/11/1998 ENDIUS SPINE ENDOSCOPE ENDIUS, INC. JOSEPH RESS
K982827 08/11/1998 DERMA K ER:YAG/CO2 LASER ESC MEDICAL SYSTEMS, INC. GEORGE J HATTUB
K983009 08/28/1998 BSM- BONE SUBSTITUTE MATERIAL ETEX CORP. MICHAEL SCHTTENBERG
K982817 08/11/1998 EWC: ECG CABLE AND LEADWIRE SYSTEMS EWC TIMOTHY M DAVIS
K983088 08/28/1998 INSTACINE D-2000 FIDELITY MEDICAL, INC. SPENCER J ANGEL
K982926 08/20/1998 FRESENIUS BLOOD VOLUME MONITOR FRESENIUS MEDICAL CARE NORTH AMERICA DONALD A LINCOLN
K982760 08/06/1998 COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET GAMBRO HEALTHCARE WILLIAM M TOWNSEND
K982818 08/11/1998 HOSPAL TIPSTOP GAMBRO HEALTHCARE JEFFREY R SHIDEMAN
K982695 08/03/1998 GC RELINE GC AMERICA, INC. TERRY L JORITZ
K982972 08/25/1998 SIGNA PROFILE SMALL HEAD COIL GE MEDICAL SYSTEMS LARRY A KROGER
K982955 08/24/1998 SILHOUETTE VR GE MEDICAL SYSTEMS LARRY A KROGER
K982772 08/07/1998 SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K982933 08/20/1998 VINYL EXAMINATION GLOVES, POWDER FREE GENERAL GLOVES CORP. DAVID HU
K982712 08/04/1998 RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) STEPHEN M PAGE
K982999 08/27/1998 GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE GREINER MEDITECH, INC. DOUG HARRIS
K982998 08/27/1998 GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE GREINER MEDITECH, INC. DOUG HARRIS
K983033 08/31/1998 ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDANT CORP. JENNIFER PAE RIGGS
K982876 08/14/1998 HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 GUIDANT CORP. SUSAN SILAVIN
K982738 08/06/1998 VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) GYNECARE, INC. SUSAN M ALOYAN
K982739 08/06/1998 GYNEX ELECTRODES GYNEX CORP. DAVID W SCHLERF
K982771 08/07/1998 GYRUS HYSTEROSCOPIC RESECTOSCOPE GYRUS MEDICAL LTD. DAVID KAY
K982910 08/18/1998 HAMILTON MEDICAL GALILEOVENTILATOR HAMILTON MEDICAL, INC. J. DAVID THOMPSON
K983022 08/31/1998 SMARTCELL PROCESSING SYSTEM HARVEST TECHNOLOGIES, LLC. RICHARD LARIVIERE
K983004 08/28/1998 CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI HAYES MEDICAL, INC. JOHN B STASSI
K982857 08/13/1998 HELAX-IMCON, VERSION 1.0 HELAX AB JAN TORNQVIST
K982929 08/20/1998 MAXAIR NASAL DILATOR SYSTEM HNL TECHNOLOGIES HANFORD N LOCKWOOD, JR.
K983028 08/31/1998 FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W HOLOGIC, INC. NANDINI MURPHY
K982958 08/24/1998 ZETA MULTIZONE LOCKING NAIL SYSTEM HOWMEDICA CORP. VIVIAN KELLY
K982873 08/14/1998 ZETA MULTIZONE SCN LOCKING NAIL HOWMEDICA CORP. VIVIAN KELLY
K982946 08/21/1998 PAINBUSTER INFUSION KIT I-FLOW CORP. ROBERT J BARD
K982824 08/11/1998 X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID I.E.D., INC. DONALD R REILLY
K982898 08/17/1998 IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K982925 08/20/1998 LAMINOSS DENTAL IMPLANT IMPLADENT, LTD. MAURICE VALEN
K982751 08/06/1998 IMPLEX SCREW AND WASHER SYSTEM IMPLEX CORP. ROBERT POGGIE
K982951 08/24/1998 IMTEC BIOPIN IMTEC CORP. M.K. PATTERSON
K982843 08/12/1998 CMS-2000 INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE MING-CHENG CHANG
K982804 08/10/1998 SPYROGEL HYDROGEL WOUND AND BURN DRESSING INNOVATIVE TECHNOLOGIES (US), INC. JULIE CHAFFEE
K982790 08/10/1998 QUANTA LITE H. PYLORI IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K983024 08/31/1998 PROTON THERAPY SYSTEM ION BEAM APPLICATIONS S.A. JOHN B REISS
K982705 08/03/1998 MIDAS TOUCH BIPOLAR FORCEPS ITI MEDICAL TECHNOLOGIES, INC. ROGER WERNE
K982812 08/11/1998 G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) JOHNSON & JOHNSON PROFESSIONALS, INC. MARY E GRAY
K983014 08/28/1998 SUMMIT ACETABULAR SYSTEM JOHNSON & JOHNSON PROFESSIONALS, INC. JANET G JOHNSON
K982837 08/12/1998 KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS KARL STORZ ENDOSCOPY KEVIN KENNAN
K982905 08/18/1998 MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE KARL STORZ ENDOSCOPY KEVIN A KENNAN
K982813 08/11/1998 NATURALYTE, MODEL # 08-4004-1 KAYBATH, INC. BONNIE NAKAYAMA
K982927 08/20/1998 QUICK TAP SELF DRILLING SCREW KINAMED, INC. ROBERT BRUCE
K982995 08/27/1998 ACCUTRAX, MODEL EPF840 KORR MEDICAL TECHNOLOGIES, INC. SCOTT KOFOED
K982986 08/26/1998 TUBING BLOOD FLOW METER MODEL NUMBER HD-800 KOVEN TECHNOLOGY, INC. PAUL G KOVEN
K982724 08/05/1998 THERADYNE ROVER POWERED WHEELCHAIR KURT MFG. CO. PHIL SCHLANGEN
K982904 08/18/1998 ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS LES LABORATOIRES BLANCHARD JOHN M SZABOCSIK
K982924 08/20/1998 DUREX SENSIDOM LATEX CONDOM LONDON INTL. LLC. NEIL ANDERSON
K982983 08/26/1998 LSVP INTERNATIONAL BIOPSY FORCEPS LSVP INTL., INC. LEON PESOTCHINSKY
K982797 08/10/1998 BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB LUTHER MEDICAL PRODUCTS, INC. KATHLEEN ROBERTS
K982907 08/18/1998 MAGNATEK 40 MAGNA ADVANCED TECHNOLOGIES, INC. ANNIE VELEZ
K982846 08/12/1998 MTEK-1400 MAGNA ADVANCED TECHNOLOGIES, INC. ANNIE VELEZ
K982877 08/14/1998 MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE MATANG MFG. SDN. BHD. RONALD LEONG
K982779 08/07/1998 MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 MEDENTAL INTL. DEBRA OLSON
K983018 08/28/1998 ZINC PHOSPHATE CEMENT MEDENTAL INTL. DEBRA OLSON
K982978 08/25/1998 MODEL 340GE-21C QUADRATURE BRAIN COIL MEDICAL ADVANCES, INC. THOMAS E TYNES
K982960 08/24/1998 MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K982961 08/24/1998 MEDIPOINT MEDIPOINT LTD. JULES T MITCHEL
K982693 08/03/1998 MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K982694 08/03/1998 MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K982921 08/19/1998 MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA MEDRAD, INC. JIM FERGUSON, JR.
K982916 08/19/1998 MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC MEDRAD, INC. JIM FERGUSON, JR.
K982932 08/20/1998 MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC MEDRAD, INC. JIM FERGUSON
K982959 08/24/1998 MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC MEDRAD, INC. JIM FERGUSON JR
K982919 08/19/1998 MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC MEDRAD, INC. JIM FERGUSON, JR.
K982814 08/11/1998 MEDRAD VISTRON CT INJECTOR SYSTEM MEDRAD, INC. JAN E DOBSCHA
K982902 08/14/1998 PERIPHERAL NERVE STIMULATION MEDTRONIC VASCULAR DAVID H MUELLER
K982883 08/17/1998 MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER MEDTRONICS INTERVENTIONAL VASCULAR MARK CHARTIER
K982826 08/11/1998 MEGA 2000 MEGADYNE MEDICAL PRODUCTS, INC. JOHN W SMITH
K982697 08/03/1998 MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR MENNEN MEDICAL, INC. KEN RAICHMAN
K982764 08/06/1998 PREMIER CRYPTOSPORIDIUM MERIDIAN DIAGNOSTICS, INC. ALLEN D NICKOL
K982711 08/04/1998 PREMIER GIARDIA MERIDIAN DIAGNOSTICS, INC. ALLEN D NICKOL
K983021 08/31/1998 METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC METROSOFT, INC. JIM WEBB
K982878 08/14/1998 EARSCAN 3 MICRO AUDIOMETRICS CORP. JASON R KELLER
K982984 08/26/1998 ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS MICROLINE PENTAX, INC. JACQUELINE E MASSE
K982735 08/05/1998 LIGHT SABER BONE BIOPSY NEEDLE MINRAD, INC. THOMAS L PARKER
K982841 08/12/1998 MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 MISONIX, INC. SUSAN D GOLDSTEIN-FALK
K982769 08/07/1998 MITRA IMAGING INC. EXHIBIT MITRA IMAGING, INC. GARY J ALLSEBROOK
K982845 08/12/1998 CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 MORE DIAGNOSTICS JAMES W SNIPES
K982970 08/25/1998 MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER MRI MANUFACTURING AND RESEARCH, INC. ED RANSON
K982821 08/11/1998 MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7 MULTIMEDIA MEDICAL SYSTEMS, INC. ALEXANDER CROSBY
K982728 08/05/1998 NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C NELLCOR PURITAN BENNETT, INC. SHERYLL A MATHEWS
K983007 08/28/1998 NEUROTUBE NEUROREGEN, L.L.C. JOHN E BARHAM
K982748 08/06/1998 BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224 NEW DEANTRONICS TAIWAN, LTD. LEWIS WARD
K982743 08/06/1998 DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH NEW DEANTRONICS TAIWAN, LTD. LEWIS WARD
K982744 08/06/1998 DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH NEW DEANTRONICS TAIWAN, LTD. LEWIS WARD
K982742 08/06/1998 DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH NEW DEANTRONICS TAIWAN, LTD. LEWIS WARD
K982749 08/06/1998 MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 NEW DEANTRONICS TAIWAN, LTD. LEWIS WARD
K982746 08/06/1998 MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 NEW DEANTRONICS TAIWAN, LTD. LEWIS WARD
K982884 08/17/1998 DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH NEW DEANTRONICS, LTD. LEWIS WARD
K982866 08/14/1998 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K982969 08/25/1998 NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 NONIN MEDICAL, INC. RICHARD P BENNETT
K982766 08/06/1998 PASTE OPAQUE EX-3 NORITAKE CO., INC. MARSHA C WERTZBERGER
K982947 08/21/1998 BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES PUERTO RICO, INC. RICHARD E LIPPMAN
K982725 08/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE OLYMPUS AMERICA, INC. LAURA STORMS-TAYLOR
K982716 08/04/1998 OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM OMNIGRACE (THAILAND) LTD. K.C. CHOONG
K982689 08/03/1998 WINSTATION RETINAL IMAGER OPHTHALMIC IMAGING SYSTEMS BETH A SOPER
K982750 08/06/1998 CORSAIRE OPTIWAY, INC. FRANK W LAVALLEY
K982745 08/06/1998 AUTO-LYTE BARBITURATES EIA ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K982831 08/11/1998 AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K982759 08/06/1998 AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K982801 08/10/1998 AUTO-LYTE PCP EIA, MODEL #1254U ORASURE TECHNOLOGIES, INC. R.SAM NIEDBALA
K982971 08/25/1998 ORATEC TAC-C, MONOPOLAR CAUTERY PROBE ORATEC INTERVENTIONS, INC. SHEILA RAMERMAN
K983031 08/31/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
K982996 08/27/1998 POLYMER OBL SB ANCHOR / SUTURE COMBINATION ORTHOPAEDIC BIOSYSTEMS, LTD. JEFFRY B SKIBA
K982963 08/24/1998 POLYMER THREADED ANCHOR / SUTURE COMBINATION ORTHOPAEDIC BIOSYSTEMS, LTD. JEFFRY B SKIBA
K982886 08/17/1998 OTI MODULAR SHOULDER SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K982798 08/10/1998 OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM OSTEONICS CORP. KATE SUTTON
K982936 08/21/1998 OSTEONICS EXTENDED FEMORAL BEARING HEAD OSTEONICS CORP. MARYBETH NAUGHTON
K982897 08/17/1998 POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) P.T. MAJA AGUNG LATEXINDO EMMY TJOENG
K982980 08/26/1998 LIGHTSHEER LONG PULSE RUBY LASER PALOMAR MEDICAL PRODUCTS, INC. MARCY MOORE
K983008 08/28/1998 PERIPHERAL AVE STENT SYSTEM PERIPHERAL AVE PAUL MEYER
K982807 08/11/1998 "POLYMER COATED, POWDER-FREE" LATEX EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD BOB CHAN
K982806 08/11/1998 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE PERUSAHAAN GETAH ASAS SDN BHD BOB CHAN
K982691 08/03/1998 MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) PERUSAHAAN INTAN EMAS SDN. BHD. BIEN LONG NIEN
K982938 08/21/1998 QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 PHAMATECH TUAN PHAM
K982834 08/12/1998 RESTGRID PACKAGE/GYROSCAN NT PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K982795 08/10/1998 PHILIPS BUCKY VISION PHILIPS MEDICAL SYSTEMS, INC. PETER ALTMAN
K982706 08/04/1998 PHILIPS BV300 SERIES RELEASE 2.1 PHILIPS MEDICAL SYSTEMS, INC. PETER ALTMAN
K982993 08/27/1998 PHILIPS OMNIDIAGNOST PHILIPS MEDICAL SYSTEMS, INC. PETER ALTMAN
K982859 08/13/1998 UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM PLUS ORTHOPEDICS HARTMUT LOCH
K983000 08/27/1998 CRICOTHYROTOMY TUBE POLAMEDCO, INC. JERRY W HARRER
K983032 08/31/1998 CBC-5D HEMATOLOGY CONTROL R & D SYSTEMS, INC. SUE GALLO
K982791 08/10/1998 ROCS TPS RADIATION ONCOLOGY COMPUTER SYSTEMS CHARLENE NEBLETT
K982928 08/20/1998 NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM RADIOMETER AMERICA, INC. VINCE SIGMUND
K982854 08/13/1998 MR COMPATIBLE LEVEEN NEEDLE ELECTRODE RADIOTHERAPEUTICS CORP. COLIN J NICHOLS
K982767 08/06/1998 RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR RAICHEM MELISSA SANER
K982965 08/25/1998 ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K982848 08/12/1998 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC. MARIA FEIJOO
K983037 08/31/1998 ROEKO SEAL ROEKO ULM, ROESCHEISEN GMBH & CO. JAMES DELANEY
K982974 08/25/1998 DD URETERAL STENT, INTEGRAL STENT RUSCH INTL. KARENANN J BROZOWSKI
K983010 08/28/1998 SELF CATH SET/SAFETY CATH RUSCH INTL. KARENANN J BROZOWSKI
K983039 08/31/1998 EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF SCHNEIDER/NAMIC KARIN L SMITH
K982915 08/19/1998 SCI-PHARM DFV VARNISH SCIENTIFIC PHARMACEUTICALS, INC. JAN A ORLOWSKI
K982913 08/19/1998 ZINFOS ZINC PHOSPHATE CEMENT SCIENTIFIC PHARMACEUTICALS, INC. JAN A ORLOWSKI
K982752 08/06/1998 SEARE BIOMEDICAL CHIN IMPLANTS SEARE BIOMEDICAL CORP. WILLIAM JOHN SEARE JR
K982763 08/06/1998 SEARE BIOMEDICAL MALAR IMPLANTS SEARE BIOMEDICAL CORP. WILLIAM JOHN SEARE, JR.
K982753 08/06/1998 SEARE BIOMEDICAL NASAL IMPLANTS SEARE BIOMEDICAL CORP. WILLIAM JOHN SEARE JR
K982762 08/06/1998 SEARE BIOMEDICAL PECTORALIS IMPLANT SEARE BIOMEDICAL CORP. WILLIAM JOHN SEARE, JR.
K983043 08/31/1998 SEARE BIOMEDICAL SILICONE BLOCK SEARE BIOMEDICAL CORP. WILLIAM J SEARE, JR
K983041 08/31/1998 SEARE BIOMEDICAL SILICONE SHEETING SEARE BIOMEDICAL CORP. WILLIAM J SEARE, JR
K982931 08/20/1998 THREADED FIXATION PIN SGARLATO LABORATORIES, INC. THOMAS SGARLATO
K982687 08/03/1998 DISPOSABLE VINYL EXAM GLOVES, POWDERED SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K982704 08/03/1998 DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K982885 08/17/1998 PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. DON MORRIS
K982810 08/11/1998 SHELHIGH NO-REACT VASCUPATCH SHELHIGH, INC. SHLOMO GABBAY
K982879 08/14/1998 SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY SHIELD DIAGNOSTICS, LTD. EILEEN A MCCAFFERTY
K982720 08/04/1998 H-RAY SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. LIN CHIN YU
K982952 08/24/1998 IMFAST SIEMENS MEDICAL SOLUTIONS USA, INC. KATHRYN B DODD
K982838 08/12/1998 CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 SIMS DELTEC, INC. EDWARD W NUMAINVILLE
K982839 08/12/1998 CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 SIMS DELTEC, INC. EDWARD W NUMAINVILLE
K982836 08/12/1998 CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM SIMS DELTEC, INC. EDWARD W NUMAINVILLE
K982849 08/12/1998 PANTHER WHEELCHAIR SNUG SEAT, INC. KIRK MACKENZIE
K982686 08/03/1998 MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM SOFAMOR DANEK USA,INC. BAILEY LIPSCOMB
K982990 08/26/1998 TSRH SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K982717 08/04/1998 SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 SOMNUS MEDICAL TECHNOLOGIES, INC. EVE CONNER
K982773 08/07/1998 QUICKSET LIQUID AND POWDER SPECIALITES SEPTODONT PETER S REICHERTZ
K983015 08/28/1998 VIRILIS PENILE PROSTHESIS SPECIALTY SURGICAL PRODUCTS, INC. T.JAN VARNER
K982688 08/03/1998 SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK SPECTRUM DESIGNS, INC. JIM DISHMAN
K982945 08/21/1998 DUAL PURPOSE CLOSED CATHETER SPIRIT MEDICAL SYSTEMS, INC. JEFF SAWYER
K982956 08/24/1998 FLOWMATE II PLUS, MODEL #4000 SPIROMETRICS MEDICAL EQUIPMENT CO. DONALD HENTON
K982940 08/21/1998 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM STAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K982692 08/03/1998 STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC STERNGOLD/IMPLAMED PAMELA PAPINEAU
K982895 08/17/1998 STERNOMEGA COMPOMER CEMENT STERNGOLD/IMPLAMED PAMELA PAPINEAU
K983006 08/28/1998 OSTEO 5.0MM CANNULATED SCREW SYSTEM STRYKER OSTEONICS ELIZABETH A STAUB
K982903 08/18/1998 SULZER ORTHOPEDICS FLUTED STEMS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K982989 08/26/1998 QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR SUNRISE MEDICAL, INC. REBECCA ANDERSEN
K982719 08/04/1998 THE BONE TIE SURGICRAFT LTD. SIMON FITZER
K982917 08/19/1998 B-SYSTEM SILICONE SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K982732 08/05/1998 SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) SYNTHES SHERI L MUSGNUNG
K982987 08/26/1998 SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES SPINE JONATHAN M GILBERT
K982815 08/11/1998 ALPHATRAC, MODEL A200 TEFTEC CORP. THOMAS E FINCH, III
K982957 08/24/1998 SENSIFLEX POWDERFREE SURGEON'S GLOVE TERANG NUSA SDN BHD CHIN GUAN LOW
K982872 08/14/1998 TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TG MEDICAL SDN BHD W.C. LIM
K982991 08/27/1998 ANSPACH ACCESS CRANIAL PERFORATOR THE ANSPACH EFFORT, INC. LISA KREIDER
K982733 08/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE THE OLYMPUS OPTICAL CO. LAURA STORMS-TAYLOR
K982734 08/05/1998 OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE THE OLYMPUS OPTICAL CO. LAURA STORMS-TAYLOR
K982781 08/07/1998 DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER THERMAL WASTE TECHNOLOGY, INC. BILL RANSONE
K982787 08/10/1998 ASTEION CT SCANNER, TSX-021A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K982976 08/26/1998 ULTRASOUND WORKSTATION, UIWS-300A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K983029 08/31/1998 POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 TPC ADVANCED TECHNOLOGY, INC. CAROL PATTERSON
K982943 08/21/1998 TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 TRANSTRACHEAL SYSTEMS LEWIS W WARD
K983097 08/24/1998 TENS/FES/NMES ELECTRODES UNI-PATCH, INC. MANAGER J GEOLAT
K982699 08/03/1998 UNIGRAFE UNICARE BIOMEDICAL STAN YANG
K982860 08/13/1998 UM-L20/ UM-L30 UNION MEDICAL ENGENEERING CO., LTD. ANNIE VALEZ
K982783 08/07/1998 VAIL 1000 ENCLOSED BED VAIL PRODUCTS, INC. NANCY VAIL
K982937 08/21/1998 MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER VICTOREEN, INC. EDWARD W SIUREK, III
K982994 08/27/1998 SKULL BASE INSTATRAK SYSTEM VISUALIZATION TECHNOLOGY, INC. MARY MCNAMARA-CULLINANE
K983016 08/28/1998 GAUZE, SPONGES, CAT # 11-003 VITALCARE GROUP, INC. GINGER TALLEY
K982901 08/17/1998 LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED VITALCARE GROUP, INC. GINGER TALLEY
K982816 08/11/1998 VNUS CLOSURE SYSTEM VNUS MEDICAL TECHNOLOGIES, INC. JOHN D'ANGELO
K982906 08/18/1998 LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K982944 08/21/1998 HEM-O-LOCK, MODEL 523935 WECK CLOSURE SYSTEMS BRIAN J YOUNG
K982941 08/21/1998 HEM-O-LOK MODEL NUMBERS 523900, 523970 WECK CLOSURE SYSTEMS JAMES L LUCKY
K982988 08/26/1998 PRECISION UV (VASURFILCON A) WESLEY JESSEN CORP. JOSEPH FOOS
K982967 08/25/1998 RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R WOODSIDE BIOMEDICAL, INC. CAROL PATTERSON
K982870 08/14/1998 EPIFILM OTOLOGIC LAMINA XOMED, INC. ROY BERENS
K982731 08/05/1998 MEROGEL NASAL DRESSING AND SINUS STENT XOMED, INC. ROY BERENS
K983025 08/31/1998 XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT XOMED, INC. DEBRA N CORTNER
K982981 08/26/1998 NEW ZIMMER SHOULDER SYSTEM ZIMMER, INC. LAURA D WILLIAMS
K982992 08/27/1998 ZOLL M SERIES SPO2 OPTION ZOLL MEDICAL CORP. MAURA MCGUIRE


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