FDA 510(k) Applications Received During September, 1985

FDA 510(k) Number Submission Date Device Name Applicant Contact
K853698 09/04/1985 SCOTCHPRIME CERAMIC PRIMER 3M COMPANY DON MCKENZIE
K853879 09/18/1985 TDX AMPHETAMINE METHAMPHETAMINE ABBOTT LABORATORIES MARY E ZORC
K853978 09/26/1985 TDX AMYLASE ABBOTT LABORATORIES MARY ZORC
K853677 09/04/1985 TDX REA BUN ABBOTT LABORATORIES MARY E ZORC
K853834 09/16/1985 VISION THEOPHYLLINE ABBOTT LABORATORIES MATT KLAMRZYNSKI
K853820 09/12/1985 SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE ABCO DEALERS, INC. PIYUSH M SHAH
K853658 09/03/1985 BURS FOR MICRO SURGICAL DRILL SYSTEM ACUMED INSTRUMENTS CORP. DAVE ESSLINGER
K853660 09/03/1985 MICRO SURGICAL DRILL SYSTEM ACUMED INSTRUMENTS CORP. DAVE ESSLINGER
K853659 09/03/1985 POWERED IRRIGATION FOR MICRO SURGICAL DRILL ACUMED INSTRUMENTS CORP. DAVE ESSLINGER
K853966 09/26/1985 ACUSON L312 TRANSDUCER ACUSON COMPUTED SONOGRAPHY GALLAGHER
K853916 09/23/1985 P.M. HIP-FEMORAL PROSTHESIS ADVANCED BIOSEARCH ASSN. BARRY M CALVARESE
K853746 09/09/1985 ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO ADVANCED CARDIOVASCULAR SYSTEMS, INC. JANE E BEGGS
K853856 09/16/1985 EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET AEQUITRON MEDICAL, INC. ROBERT C SAMEC
K853858 09/16/1985 IL TEST THEOPHYLLINE ASSAY ALLIED INSTRUMENTATION LABORATORY GEORGE A LYNA
K853766 09/09/1985 ALPHA SUPER KART ALPHA UNLIMITED, INC. PENNY LOCKETT
K853832 09/13/1985 LYTENING 1 AMDEV, INC. DONALD SCHWARTZ
K853944 09/24/1985 CPAP BLOWER AMERICAN AIR & PROCESS, INC. ROBERT C HANSEN
K853950 09/25/1985 ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL AMERICAN BENTLEY DONALD A RAIBLE
K853786 09/10/1985 OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 AMERICAN BENTLEY DONALD A RAIBLE
K854014 09/27/1985 ASSERA PLATE IX:AG KIT AMERICAN BIOPRODUCTS CO. B LE
K854016 09/27/1985 ASSERACHROM PROTEIN C KIT AMERICAN BIOPRODUCTS CO. B LE
K854015 09/27/1985 FS TEST KIT AMERICAN BIOPRODUCTS CO. B LE
K853752 09/09/1985 SUN KING AMERICAN CHASE COMPANY, INC. NYSTROM
K853986 09/27/1985 THROMBOPLASTIN-R REAGENT AMERICAN DADE JAMES E KELLER
K854012 09/30/1985 AMERICAN PHARMASEAL HUMIDAIR CONDENSER AMERICAN PHARMASEAL DIV. AHSC ROBERT T MERRICK
K853714 09/05/1985 PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA AMERICAN PHARMASEAL DIV. AHSC LAWRENCE W GETLIN
K853888 09/19/1985 AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & AMERICAN RESEARCH PRODUCTS CO. TIMOTHY J BELCASTRO
K853918 09/23/1985 THE SPORTSTER (ELECTRIFIED WHEELCHAIR) AMIGO SALES, INC. WARREN C LIGHT
K853870 09/17/1985 EASY EYES TM LENS CARRYING CASE APPLIED LABORATORIES, INC. ANTHONY J MORAVEC
K853802 09/11/1985 ATS 500 TOURNIQUET ASPEN LABORATORIES, INC. JOHNSON
K853801 09/11/1985 MENISCAL STITCHING KIT ASPEN LABORATORIES, INC. JOHNSON
K853734 09/06/1985 APOLLO DENSITOMETER ASTRAL MEDICAL SYSTEMS KEITH S FAIRCHILD
K853725 09/06/1985 ATRIUM PLASMA TFE SYNTHETIC ARTERY ATRIUM MEDICAL CORP. STEVE HERWECK
K853871 09/17/1985 QCA ENZYMATIC CHOLESTEROL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K853656 09/03/1985 QCA ENZYMATIC GLUCOSE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K853854 09/16/1985 ASTRA SYSTEMS CHOLESTEROL REAGENT BECKMAN INSTRUMENTS, INC. JACK E SOROKIN
K853805 09/11/1985 MICRO-MEDIA MICRODILUTION TEST PANELS BECKMAN INSTRUMENTS, INC. JERRY L COTTON
K853741 09/06/1985 INDONTINENCE PAD BEGHIN_SAY INTL., INC. SNIDER
K853740 09/06/1985 KAY PLUS ADULT DIAPER BEGHIN_SAY INTL., INC. SNIDER
K853951 09/25/1985 ISOTRAK AMYLASE TEST AMYLASE ISOENZYME BEHRING DIAGNOSTICS, INC. JOHN E HUGHES
K854001 09/30/1985 CERTI-FORM BELTONE ELECTRONICS CORP. JOHN J ZEI
K853887 09/19/1985 LIQUI-SERA CHEM. MULTIPLE CALIBRATORS BIO DIAGNOSTIC INTL. PAUL ANAND
K853906 09/20/1985 LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) BIO DIAGNOSTIC INTL. PAUL ANAND
K853760 09/09/1985 ADULT VENTILATOR TESTER VT-1 BIO-TEK INSTRUMENTS, INC. DAVID W KLYSZEIKO
K853920 09/23/1985 BIO-TEK EL 401 HANDHELD MICROPLATE WASHER BIO-TEK INSTRUMENTS, INC. DAVID W KLYSZEIKO
K853897 09/20/1985 CITREX H BIO/DATA CORP. JAMES EICHELBERGER
K853837 09/16/1985 LH/FSH RADIOIMMUNOASSAY KIT BIOCLINICAL GROUP MARK C ROESSEL
K853812 09/12/1985 PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) BIOSAN LABORATORIES, INC. JOHN DOWNING
K853697 09/04/1985 BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT BIOSTAR MEDICAL PRODUCTS, INC. JERRY W BERKSTRESSE
K854025 09/30/1985 HITACHI 704 BOEHRINGER MANNHEIM CORP. SUE SMITH
K853706 09/04/1985 BOMED-CDM BOMED MEDICAL MFR., LTD. BO SRAMEK
K853705 09/04/1985 BOMED-EEA BOMED MEDICAL MFR., LTD. BO SRAMEK
K853979 09/26/1985 CARDIMAX FX-1164 BRENTWOOD INSTRUMENTS, INC. JAMES OBERMAYER
K853972 09/26/1985 CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR CAMERON-MILLER, INC. JOHN W MARTIN
K853895 09/20/1985 AUDTEX 85 CAMI, INC. ROGER B MICHAUD
K853864 09/17/1985 INTRACRANIAL PRESSURE MONITORING KIT 070 CAMINO LABORATORIES, INC. DAN MCKAY
K853983 09/27/1985 CANON X-RAY 35MM CINE CAMERA CSI-35 CANON U.S.A., INC. TAMADA
K853861 09/17/1985 CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 CANON U.S.A., INC. TAMADA
K853984 09/27/1985 CANON X-RAY IMAGE DISTRIBUTOR CANON U.S.A., INC. TAMADA
K853928 09/24/1985 UNIVERSAL STAND FOR FILM CHANGER CANON U.S.A., INC. TAMADA
K853737 09/06/1985 VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) CAPINTEC, INC. JOEL ORLINSKY
K853673 09/04/1985 CARDIORATER CR 51 CARDIAC RECORDERS, LTD. BEVIS
K853771 09/09/1985 PINNACLE MULTI-PROGRAMMABLE PACING SYS CARDIO-PACE MEDICAL, INC. RONALD GMYREK
K853891 09/19/1985 INDIRECT OPHTHALMOSCOPE CARL ZEISS, INC. MARIE PEDERSON
K853720 09/05/1985 MOBILE OPERATING TABLE FOR ORL MICROSURGERY CARL ZEISS, INC. MARIE PEDERSON
K853723 09/05/1985 ZEISS OPERATING KERATOMETER CARL ZEISS, INC. JANE PEDERSON
K853965 09/26/1985 NEOGUARD CHEST PERCUSSOR CAS MEDICAL SYSTEMS, INC. JOEL N HELFER
K853794 09/11/1985 NEOGUARD REFLECTOR CAS MEDICAL SYSTEMS, INC. JOEL N HELFER
K853826 09/13/1985 GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS CATACHEM, INC. LUIS P LEON
K853825 09/13/1985 URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS CATACHEM, INC. LUIS P LEON
K853798 09/11/1985 BONE IMPACTORS CEDAR SURGICAL, INC. FRED S HALVERSON
K853797 09/11/1985 KNEELING ATTACHMENT & CUSHIONED FACE REST SYS FOR CEDAR SURGICAL, INC. FRED S HALVERSON
K853799 09/11/1985 NEUROSURGICAL HEADREST CEDAR SURGICAL, INC. FRED S HALVERSON
K853796 09/11/1985 RAYLOR RETRACTORS CEDAR SURGICAL, INC. FRED S HALVERSON
K853800 09/11/1985 UPPER-CHEST-SUPPORT CUSHION FOR OPERATIONS IN SITT CEDAR SURGICAL, INC. FRED S HALVERSON
K853759 09/09/1985 CUSTOM PROCEDURAL TRAY PROCEDURAL KIT CHARLES ATKINS & CO. CHARLES R ATKINS
K854003 09/30/1985 STERILE SOFT TISSUE BIOPSY NEEDLE CO-MEDICAL, INC. GARY BRUNNER
K853817 09/12/1985 COBE REN NEW-D DISPENSING KIT COBE LABORATORIES, INC. VERA BUFFALOE
K853770 09/09/1985 CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT CODMAN & SHURTLEFF, INC. DONALD A LINCOLN
K853822 09/13/1985 AMOENA BREAST FORMS COLOPLAST CORP. THOMAS B TAYLOR
K853735 09/06/1985 COLORADO MEDICAL MODEL CTM-3000 COLORADO MEDICAL, INC. SCOTT EVANS
K853964 09/16/1985 COMPUTERIZED RADIATION TREATMENT PLANNING SYS COMPUTERIZED MEDICAL SYSTEMS, INC. MELVIN MCCOLLUM
K853829 09/13/1985 MENISCAL REPAIR SYSTEM CONCEPT, INC. PENNY C RASMUSSEN
K853844 09/16/1985 DUODERM HYDROACTIVE DRESSING W/BORDER STERILE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS PETER C KALLOS
K853651 09/03/1985 COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER COOK PACEMAKER CORP. RICHARD E SHIREY
K853949 09/24/1985 DEMAND ACID PHOSPHATASE REAGENT COOPER BIOMEDICAL, INC. CARL DEATON
K853989 09/27/1985 COR DOT CMV CORDIS CORP. SEYMOUR P HALBERT
K853889 09/19/1985 CORDIA CMV-M CORDIS CORP. SEYMOUR P HALBERT
K854019 09/30/1985 PORT-GARD CORMED, INC., SUB. C.R.BARD, INC. ERIC ANKERUD
K854024 09/30/1985 CORNING MAGIC MAB HCG RADIOIMMUNOASSAY CORNING MEDICAL & SCIENTIFIC WILLIAM J PIGNATO
K853945 09/24/1985 CUI RHINOPLASTY IMPLANTS COX-UPHUFF INTL. DAVID J SCHUESSLER
K854006 09/30/1985 PLASTELAST AND/OR ELASTOPLASTE CP MEDICAL CARL GRODACH
K853701 09/04/1985 JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL CRITIKON COMPANY,LLC MELANIE SABO
K853939 09/24/1985 ECG-ELECTRODE(SWAROMED) D. SWAROVSKI & CO. SCHULER
K854005 09/30/1985 DEDO SUCTION CANNULA DEDO MANUFACTURER, INC. DOUGLAS D DEDO
K853707 09/04/1985 DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES DENTSPLY INTL. JOHN O SEMMELMAN
K853655 09/03/1985 NEW JERSEY MODULAR FEMORAL HIP DEPUY, INC. STEPHEN M DOYLE
K853699 09/04/1985 EASY ANALYZER & EASY-TEST REAGENT DIAGNOSTIC SYSTEMS RAYMOND L MILLER
K853784 09/09/1985 C-TERMINAL PTH RIA KIT DIAGNOSTIC SYSTEMS LABORATORIES, INC. GOPAL SAVJANI
K853943 09/24/1985 CRITIC C LEVEL I & II DIMENSION DIAGNOSTICS CLYDE E HAM
K853709 09/04/1985 A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM DOWNS SURGICAL LTD. JARVIS CRIBB
K853708 09/04/1985 LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE DOWNS SURGICAL LTD. JARVIS CRIBB
K853926 09/24/1985 NEOCARE MODEL 800 INFANT RADIANT WARMER DRAEGER MEDICAL, INC. EDWARD T GRIFFITH
K853788 09/10/1985 DB PRECISION IMPLANT SYSTEM DRISKELL BIOENGINEERING THOMAS D DRISKELL
K853667 09/03/1985 BRONCHIAL CYTOLOGY BRUSH E-Z-EM, INC. JACK T BERGER
K853680 09/04/1985 ENDODYNAMIC SIEGEL SPHINCTEROTOME E-Z-EM, INC. JACK T BERGER
K853666 09/03/1985 ENDODYNAMICS SIEGEL THERAPUTIC STENT E-Z-EM, INC. JACK T BERGER
K853917 09/23/1985 EGNELL COMPACT SUCTION PUMP EGNELL, INC. JOHN F LEMKER
K853909 09/20/1985 EGNELL UNIVERSAL SUCTION PUMP EGNELL, INC. JOHN F LEMKER
K853719 09/05/1985 TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 ELECTRO THERAPEUTIC DEVICES, INC. CHOONG
K853718 09/05/1985 TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 ELECTRO THERAPEUTIC DEVICES, INC. CHOONG
K853774 09/10/1985 EM ELECTRODE ELECTROMED INTL., LTD. HENRY SISUN
K853901 09/20/1985 ENDO-LASE CD 40 FOR DERMATOLOGY ENDO LASE, INC. JONATHAN KAHAN
K853877 09/17/1985 ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY ENDO LASE, INC. JONATHAN S KAHAN
K853874 09/17/1985 ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- ENDO LASE, INC. JONATHAN S KAHAN
K853878 09/17/1985 ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY ENDO LASE, INC. JONATHAN S KAHAN
K853875 09/17/1985 ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY ENDO LASE, INC. JONATHAN S KAHAN
K853903 09/20/1985 ENDO-LASE CD40 CO2 FOR GYNECOLOGY ENDO LASE, INC. JONATHAN S KAHAN
K853900 09/20/1985 ENDO-LASE CD40 FOR NEUROSURGERY ENDO LASE, INC. & HARTSON
K853902 09/20/1985 ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY ENDO LASE, INC. JONATHAN S KAHAN
K853904 09/20/1985 ENDO-LASE CD40 FOR UROLOGY ENDO LASE, INC. JONATHAN S KAHAN
K853876 09/17/1985 ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY ENDO LASE, INC. JONATHAN S KAHAN
K853824 09/13/1985 DIGITAL THERMOMETER EPSON AMERICA, INC. ELON A POLLACK
K853911 09/20/1985 UV-A SUNTANNING EQUIPMENT EUROTAN INTL. HANS-WILLI ROTHEUDT
K853649 09/03/1985 POWER DRIVE WHEELCHAIR EVEREST & JENNINGS, INC. WILLIAM CALHOUN
K853652 09/03/1985 BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT FISHER IMAGING CORP. MURRAY BLOOM
K853828 09/13/1985 FLS MED. PROD. RACINE TYPE ADAPTOR FLS MEDICAL PRODUCTS, INC. FRANCIS L SANDEL
K853988 09/27/1985 FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI FORAN INDUSTRIES, INC. ROBERT J WAGNER
K854020 09/30/1985 G-T 1000 G-T PRODUCTS GEORGE DENNIS
K853733 09/06/1985 MED-PEN/MED-POINT GARID, INC. BERTRAM J HUDSON
K853711 09/05/1985 5.0 MHZ INTRACAVITARY SECTOR PROBE GENERAL ELECTRIC CO. JAMES M HOWARD
K853710 09/05/1985 THERACUSHION GENERAL PHYSIOTHERAPY, INC. THOMAS P MUCHISKY
K853869 09/17/1985 TITANIUIM BONE SCREW GEORGE TIEMANN & CO. RICHARD MORIARTY
K853731 09/06/1985 HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX GISH BIOMEDICAL, INC. JEANNE PIERSON
K853758 09/09/1985 PY-RITE GOLDEN DENTAL PRODUCTS, INC. DON WHITE
K854008 09/30/1985 STATLOCK HEALTHTEK, INC. CLIFF TYNER
K853789 09/10/1985 ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR HEMOTEC, INC. WILLIAM A MORTON
K853769 09/09/1985 IRREGULAR CURVE TRACING REVISITION & DOPPLER HEWLETT-PACKARD CO. JOSEPH M LUSZEZ
K853669 09/03/1985 MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL HEWLETT-PACKARD CO. RICHARD W STRAYER
K853967 09/26/1985 HI-TECH LAB MODEL CONCHA ALL IN EAR HI-TECH LABORATORIES, INC. HOWARD E SANDER
K853726 09/06/1985 LARYNGEAL HOOD LABORATORIES BRUCE BARBER
K853940 09/24/1985 THE GRONINGEN VOICE PROSTHESIS HOOD LABORATORIES BRUCE BARBER
K853886 09/19/1985 P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM HOWMEDICA CORP. ROBERT E SMITH
K853653 09/03/1985 SANA-LUBE HUNTINGTON LABORATORIES, INC. ROBERT MACDONALD
K853938 09/24/1985 LX 300 TISSUE PROCESSOR INNOVATIVE MEDICAL SYSTEMS, INC. JOSEPH CATARIOUS
K853953 09/25/1985 CARDIOCAP MONITOR INSTRUMENTARIUM CORP. OLLI RIIKKALA
K853942 09/24/1985 INT'L MODEL XE BEHIND-THE-EAR HEARING AID INT'L HEARING AIDS, INC. PATRICIA J BING
K853941 09/24/1985 INT'L MODEL XG BEHIND-THE-EAR HEARING AID INT'L HEARING AIDS, INC. PATRICIA J BING
K853713 09/05/1985 FIRST TEMP INTELLIGENT MEDICAL SYSTEMS DAVID B PHILLIPS
K853991 09/27/1985 HOFMANN KNEE INTERMEDICS ORTHOPEDICS THOMAS L CRAIG
K853981 09/27/1985 INFUSAID INFUSE-A-PORT (MODIFIED) INTERMEDICS/INFUSAID, INC. VINCENT A BUCCI
K853927 09/24/1985 LASE SYSTEM II JAMES L. GERACI & ASSOCIATES, INC. JAMES GERACI
K853702 09/04/1985 ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN JOHNSON & JOHNSON PROFESSIONALS, INC. RAYMOND F CHASE
K853847 09/16/1985 SUPER MICRO BLADES KDANS SURGICAL, INC. KANU SKUKLA
K853795 09/11/1985 KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD KIRSCHNER MEDICAL CORP. SAM SON
K853696 09/05/1985 RUBELLA IGG EIA TEST KIT LABSYSTEMS, INC. NANCY SKOWRONSKI
K853977 09/26/1985 BETA-TSH-IRMA LEECO DIAGNOSTICS, INC. JAMES P LEE
K853694 09/04/1985 XYLENE SUBSTITUTE LERNER LABORATORIES, INC. SUSAN E SEGAL
K854037 09/11/1985 PULMANEX LIFE DESIGN SYSTEMS, INC. GILBERT M KIRK
K854022 09/30/1985 LPA-1 PRESSURE MONITOR LIFE PRODUCTS, INC. DOUGLAS BARNES
K853936 09/24/1985 1351 UROFLOW AUTO START LIFE-TECH INTL., INC. ALFRED C COATS
K854004 09/30/1985 FLUORESCENT T12 UVA TANNING LAMP LIGHT SOURCES, INC. GENE CZAKO
K853704 09/04/1985 LINK DYNAMIC STAPLE LINK AMERICA, INC. EDWARD SCHUSSLER
K854017 09/30/1985 ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) LMD LABORATORIES DAVID LAMBILLOTTE
K853919 09/23/1985 MA25 PORTABLE AUDIOMETER MAICO HEARING INSTRUMENTS, INC. PAUL M D'AMICO
K853747 09/09/1985 NAVIGATOR MAINSFIELD SCIENTIFIC, INC. BRUCE BEAUCHEMIN
K853850 09/16/1985 EXPLORER MANSFIELD SCIENTIFIC, INC. BRUCE BEAUCHEMIN
K853807 09/11/1985 ALL-IN-ONE HARD CONTACT LENS SOLUTION MAURRY BIOLOGICAL CO. DES ROCHERS
K853809 09/11/1985 DAILY HARD CONTACT LENS CLEANER MAURRY BIOLOGICAL CO. DES ROCHERS
K853808 09/11/1985 HARD CONTACT LENS CLEANING & SOAKING SOLUTION MAURRY BIOLOGICAL CO. DES ROCHERS
K853811 09/11/1985 HARD CONTACT LENS SOAKING SOLUTION MAURRY BIOLOGICAL CO. DES ROCHERS
K853810 09/11/1985 WETTING SOLUTION FOR HARD CONTACT LENSES MAURRY BIOLOGICAL CO. DES ROCHERS
K853785 09/10/1985 SERIES 2000 MEDS MASK MED SYSTEMS DAVIS
K853849 09/16/1985 MEDAR APM FORCE TRANSDUCER MEDAR CORP., INC. GEORGE STANEC
K853767 09/09/1985 FLOSPIK MEDELCO LTD. WILLIAM J SEIDEL
K854007 09/30/1985 MICROTHERM MT-501 & MT-502 MEDEQUI, DIVISION OF KING YIP CO., INC. ALICE YAN
K853814 09/12/1985 MP0400 ADULT, PERISTALIC INFUSION PUMP MEDEX, INC. MESSINGER
K853868 09/17/1985 ALBUMIN SR LIQUID STABLE REAGENT SET MEDICAL ANALYSIS SYSTEMS, INC. DONNA L ANDERSON
K853883 09/19/1985 TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR MEDICAL CORP. OF AMERICA THOMAS V KEELEY
K853848 09/16/1985 RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR MEDICAL GRAPHICS CORP. RONALD BERGESON
K853776 09/10/1985 MSI-HB HEMOGLOBIN CONTROL MEDICAL SPECIALTIES, INC. RICHARD COCCO
K854013 09/30/1985 TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE MEDRAND, INC. JAMES T GOURZIS
K853843 09/16/1985 IV MATE MEDTECH INTL., INC. JONATHAN ROSEN
K853818 09/12/1985 MEDTRONIC MODEL 6405 MEDTRONIC VASCULAR ALAN MARGUARDT
K853736 09/06/1985 MENTOR BRIGHTNESS ACUITY TESTER MENTOR O & O, INC. DAVID M LINK
K853952 09/25/1985 METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME METRIFLOW, INC. GALE E DAVIS
K853750 09/09/1985 SYS*STIM 207 MODEL ME 207 METTLER ELECTRONICS CORP. ROB FLEMING
K854018 09/30/1985 ANGIOGRAPHY CATHETERS MICOR, INC. STEPHEN BRUSHEY
K853690 09/04/1985 COLUMBIZ BLOOD AGAR MICRO MEDIA LABORATORIES PETER G MARTIN
K853691 09/04/1985 TERGITOL 7 AGAR MICRO MEDIA LABORATORIES PETER G MARTIN
K853777 09/09/1985 THE NEW MCINTYRE CANNULA MICROSURGICAL TECHNOLOGY, INC. NELSSON
K853745 09/09/1985 MIC-CONCEPT VIEWBOX MICROTECH MEDICAL SYSTEMS, INC. JERRY G KILGORE
K853948 09/24/1985 MINNESOTA SCIENTIFIC, INC. OMNI-BEAM MINNESOTA SCIENTIFIC, INC. BRUCE A LEVAHN
K853947 09/24/1985 OMNI-TRACT CHEST WALL & LUNA RETRACTOR MINNESOTA SCIENTIFIC, INC. BRUCE A LEVAHN
K853890 09/19/1985 OPHTHALMIC LASER PHOTOCOAGULATOR MIRA, INC. MARK W FURLONG
K853757 09/09/1985 MOLDTEC STIMULATOR MOLDTEC, INC. ANDREWS
K853692 09/04/1985 SUN TANNING BED MODEL EC-3RF MOTTEK INTL. CORP. HARRY H MOTTEK
K853985 09/27/1985 MVM 4000 HOLTER IV RECORDER MOUNTAIN VIEW MEDICAL JAMES C BECHLER
K853852 09/16/1985 MULTISCAN 7 MULTISCAN, INC. PENNY ESTES
K853836 09/17/1985 NEURO PULSE II NAGATA ENGINEERING CO. TAKAO NAGATA
K853683 09/04/1985 UMS-100 NARCO BIO-SYSTEMS HARVEY KNAUSS
K853962 09/25/1985 ERIKA ARTERIAL LINE 03-9837-0 NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. DEL DONNA
K853968 09/26/1985 DIATEMP ELECTROSURGICAL PEN NDM CORP. JOHN E SHUMWAY
K853643 09/03/1985 MULTISTIM LAMINECTOMY ELECTRODE NEUROMED, INC. FRANK LISKA
K853717 09/05/1985 ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM NICHOLS INSTITUTE DIAGNOSTICS ELAINE WALTON
K853645 09/03/1985 NITTO SURGICAL CLOTH TAPE ST-330 NITTO DENKO AMERICA, INC. KOGAMI
K853646 09/03/1985 NITTO SURGICAL NON-WOVEN TAPE ST-320 NITTO DENKO AMERICA, INC. KOGAMI
K853647 09/03/1985 NITTO SURGICAL PAPER TAPE ST-310 NITTO DENKO AMERICA, INC. KOGAMI
K853644 09/03/1985 NITTO SURGICAL PLASTIC TAPE ST-356 NITTO DENKO AMERICA, INC. KOGAMI
K853925 09/24/1985 QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA NMS PHARMACEUTICALS, INC. PERRY G RUCKER
K853845 09/16/1985 ALLOY B NORTH AMERICAN ALLOYS, INC. MANNY CALERO
K853791 09/11/1985 NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 NORTON PERFORMANCE PLASTICS CORP. CHRISTINE D ENGER
K853912 09/20/1985 MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS NUCLETRON-OLDELFT CORP. MILES MOUNT
K853665 09/03/1985 SPLASH ADAPTOR OHIO MEDICAL RESEARCH, INC. ROBERT E DUNLAP
K853905 09/20/1985 OHMEDA OXYGEN BLENDER OHMEDA MEDICAL RAYMOND T RIDDLE
K853668 09/03/1985 ORC ORACLE OPTICAL RADIATION CORP. CHARMAINE HENDERSON
K853738 09/06/1985 ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST ORTHO DIAGNOSTIC SYSTEMS, INC. LARRY D MCCLAIN
K853761 09/09/1985 DRILLING TEMPLATE ORTHOPEDIC SYSTEMS, INC. ROBERT R MOORE
K853762 09/09/1985 ISOMETRIC ACL DRILL GUIDE ORTHOPEDIC SYSTEMS, INC. ROBERT R MOORE
K853764 09/09/1985 TENDON LEADER ORTHOPEDIC SYSTEMS, INC. ROBERT R MOORE
K853763 09/09/1985 TENDON STRIPPER ORTHOPEDIC SYSTEMS, INC. ROBERT R MOORE
K853804 09/11/1985 VICON (MODIFICATION) OXFORD METRICS, INC. CRAIG SMITH
K853914 09/23/1985 PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI PACESETTER SYSTEMS RITA BROWN
K854273 09/20/1985 SILICONE OIL 350 CNETISTOKE PACIFIC MEDICAL INDUSTRIES CHARLES W KERBER
K853987 09/27/1985 PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE PALL BIOMEDICAL PRODUCTS CO. SIDNEY KRAKAUER
K853867 09/17/1985 PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY PANTEX, DIV. BIO-ANALYSIS, INC. NEIL Y CHIAMORI
K853866 09/17/1985 PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS PANTEX, DIV. BIO-ANALYSIS, INC. NEIL Y CHIAMORI
K853865 09/17/1985 PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO PANTEX, DIV. BIO-ANALYSIS, INC. NEIL Y CHIAMORI
K853715 09/04/1985 PARA CON TM PARA SCIENTIFIC CO. BONNY J CARLSON
K853862 09/17/1985 PASCO RESISTANT 5 PANEL PASCO LABORATORIES, INC. LINDA K DILLON
K853898 09/20/1985 SKYLARK MODEL 1001 TENS DEVICE PELEG INTL. CO. AMI PELEG
K853775 09/10/1985 PENOX HIGH FLOW MANIFOLD PENOX TECHNOLOGIES, INC. THANA A FRANCE
K853969 09/26/1985 PHADEBAS RAST TEST ALLERGEN DISCS PHARMACIA, INC. ALBERT P MAYO
K854023 09/30/1985 NORELCO ELECTRONIC DIGITAL BP METER HC3501 PHILIPS PARK TED FLOWERS
K853993 09/27/1985 DOBE (MODIFIED) PHOENIX MEDICAL TECHNOLOGY, INC. SAUVE
K853732 09/06/1985 LIFEPAK 8 MODIFICATION PHYSIO-CONTROL CORP. MICHAEL B GROPP
K853678 09/03/1985 KAMBIN SPINAL INSTRUMENT SET PILLING CO. LELAND J WIMER
K853749 09/09/1985 CUSTOM CORONARY MANIFOLD KITS PROCEDURE PRODUCTS, INC. KURT GEORGE
K853880 09/18/1985 ATTENDS DISPOS. UNDERPAD PROCTER & GAMBLE MFG. CO. JAMES T O'REILLY
K853730 09/06/1985 FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP PROTEK, INC. KENNETH EPLING
K853662 09/03/1985 MUELLER CURVED STEM HEMI-PROSTHESIS PROTEK, INC. KENNETH EPLING
K853768 09/09/1985 MULLER SELF LOCKING TOTAL HIP PROTEK, INC. KENNETH EPLING
K853930 09/24/1985 QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT QUANTIMETRIX CORP. LYNETTE SCHNEIDER
K853931 09/24/1985 QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL QUANTIMETRIX CORP. LYNETTE SCHNEIDER
K853933 09/24/1985 QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL QUANTIMETRIX CORP. LYNETTE SCHNEIDER
K853932 09/24/1985 QUANTTEST TOTAL PROTEIN ASSAY QUANTIMETRIX CORP. LYNETTE SCHNEIDER
K853860 09/17/1985 REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE QUINTON, INC. DONALD L ANDERSEN
K853990 09/27/1985 OSM3 HEMOXIMETER RADIOMETER AMERICA, INC. GERALD L VEDAA
K854011 09/30/1985 RENALFO HEMOFILTER CAVHD RENAL SYSTEMS, INC. LEROY FISCHBACH
K853922 09/23/1985 PLOTTER FOR AS-500 RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP. NORMAN KANESAKA
K854009 09/30/1985 ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP ROCHE DIAGNOSTIC SYSTEMS, INC. KAFADER II
K854010 09/30/1985 FRUCTOSAMINE TEST (ROCHE) ROCHE DIAGNOSTIC SYSTEMS, INC. GRIFFIN FITZGERALD
K853970 09/26/1985 ALPHA CHUCK ROCKY MOUNTAIN MEDICAL CORP. RICHARD J ROSENBAUM
K853790 09/10/1985 BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER ROCKY MOUNTAIN MEDICAL CORP. RICHARD ROSEBAUM
K853980 09/27/1985 EROSA DISPOSABLE HYPODERMIC NEEDLE ROSE KG LOTHAR GRIESSBACH
K853728 09/06/1985 KESTREL CONTACT LENS STORAGE CASE(NORYL) RYDER INTL. CORP. ANTHONY J MORAVEC
K853729 09/06/1985 KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) RYDER INTL. CORP. ANTHONY J MORAVEC
K853727 09/06/1985 KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) RYDER INTL. CORP. ANTHONY MORAVEC
K853839 09/16/1985 PENNINE LINK TUBING SAMCO INDUSTRIES, INC. DAVID S LOCKE
K853910 09/20/1985 SUTURE REMOVAL KIT SCIENTIFIC & MEDICAL CARE CO. BAYO OSHINNAIYE
K853851 09/16/1985 FRESENIUS DISPOSABLE BLOOD LINES SERATRONICS, INC. SCOTT N WALKER
K853946 09/24/1985 SONOLINE LX SIEMENS MEDICAL SOLUTIONS USA, INC. THOMAS R KIRKHAM
K853896 09/20/1985 GRAM STAIN KIT SIGMA DIAGNOSTICS, INC. STARKWEATHER
K853681 09/04/1985 SIGMA 610 FOR PROTEIN IN URINE & CSF SIGMA DIAGNOSTICS, INC. LEO BRESSLER
K853742 09/06/1985 GAUZE SPONGE SOUTH MOUNTAIN MEDICAL CLAIRE BRANCH
K853806 09/11/1985 MA-400 EMB FEEDBACK DEVICE SPECTRAL DATA SYSTEMS LARRY WOODARD
K853971 09/26/1985 REGULATOR-INHALATOR SYSTEM STEPHENSON INDUSTRIES, INC. LASLEY
K853778 09/09/1985 THE DEXTRA PRECISION POWER UNIT STORZ INSTRUMENT CO. DAN REGAN
K853827 09/13/1985 LIFE-PORT IMPLANTABLE VASCULAR ACCESS STRATO MEDICAL CORP. ROBERT L MILLER
K853679 09/04/1985 SUNJET MODELS 240/280 SUNJET MANUFACTURER, INC. CHARLES F DAVIS
K853648 09/03/1985 SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO SYNECTICS-DANTEC ANERS ESSEN-MOLLER
K853872 09/17/1985 EMIT CAFFEINE ASSAY SYVA CO. JOAN KURJIAN
K853835 09/16/1985 EMIT QST CARBAMAZEPINE ASSAY SYVA CO. JOAN KURJIAN
K853846 09/16/1985 SUN TANNING BED TAN AMERICA MFG. JAMES DILLARD
K853882 09/19/1985 SUPER SLICK TANG PRODUCTS JOHN HALFEN
K853999 09/30/1985 GUIDE WIRE TARGET THERAPEUTICS MARIE DANIELS
K853998 09/30/1985 GUIDING CATHETER TARGET THERAPEUTICS MARIE DANIELS
K853997 09/30/1985 INFUSION CATHETER TARGET THERAPEUTICS MARIE DANIELS
K854000 09/30/1985 INFUSION CATHETER W/SIDE HOLES TARGET THERAPEUTICS MARIE DANIELS
K853743 09/06/1985 TECHNA VISION, INC. ELECTRIC CHAIR TECHNA VISION JAMES T KELLEY
K853744 09/06/1985 TECHNA VISION, INC.ELECTRIC TABLE TECHNA VISION JAMES T KELLEY
K853853 09/16/1985 TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC TECHNICON INSTRUMENTS CORP. LEONARD A DWARICA
K853857 09/16/1985 V-TREND ASO PLUS LATEX TEST TEXAS IMMUNOLOGY, INC. CHARLES W GILL
K853722 09/05/1985 PLT-4 PLATELET ANALYZER TEXAS INTL. LABORATORIES, INC. ROBERT P COGAN
K853840 09/16/1985 LIFE WATCH RESPIRATORY MONITOR THE PERKIN-ELMER CORP. HAERR
K853833 09/16/1985 TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 TOP SUN AMERICA, INC. LARRY N YELVERTON
K853739 09/06/1985 SONOLAYER SAL-55A/55AS TOSHIBA MEDICAL SYSTEMS WYATT CANNADY
K853996 09/30/1985 DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE TRANSAMERICA DELAVAL, INC. RICHARD G EKSTROM
K853663 09/03/1985 ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR TRAVENOL LABORATORIES, S.A. JOHN BRDA
K853830 09/13/1985 SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST TRAVENOL LABORATORIES, S.A. PATRICIA BARSANTI
K853881 09/19/1985 THE TRAVENOL 5 ML/HR INFUSOR TRAVENOL LABORATORIES, S.A. PATRICIA S BARSANTI
K853841 09/16/1985 HARMO SONIC U.S. SHIZAI CORP. TOM YOSHIDA
K853885 09/19/1985 MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA UNIKING INTL. CORP. TOSHI CHEN
K853650 09/03/1985 AUTO SUTURE TITANIUM HEMOSTATIC CLIP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC WALTER HENNING
K853780 09/09/1985 UNITRON MODEL UM60-D UNITRON INDUSTRIES, INC. WILLIAM D HOOPER
K853781 09/09/1985 UNITRON MODEL UM60-PP UNITRON INDUSTRIES, INC. WILLIAM D HOOPER
K853992 09/27/1985 VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE & VALLEY FORGE SCIENTIFIC CORP. JERRY L MALIS
K853755 09/09/1985 ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410 VICTOREEN, INC. GLASSER
K853671 09/04/1985 BEAMSCAN VICTOREEN, INC. GLASSER
K853753 09/09/1985 DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302 VICTOREEN, INC. GLASSER
K853756 09/09/1985 DYNAMIC CARDIAC PHANTOM 74-347 VICTOREEN, INC. GLASSER
K853754 09/09/1985 MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 VICTOREEN, INC. GLASSER
K853695 09/04/1985 RESPIRATORY SYNCYTIAL VIRUS ID REAGENT VIROMED LABORATORIES, INC. BONITA BASKIN
K853863 09/17/1985 MODEL 310 IMPEDANCE SYSTEM VIRTUAL CORP. JONATHAN D BIRCK
K853961 09/25/1985 VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 VISITEC CO. THOMAS B GIVENS
K853892 09/19/1985 VISTA MED-URISTAT VISTA MED JAY F SCHAEFER
K853748 09/09/1985 VENTRESCREEN HCG URINE VXR, INC. JAMES W CHAMPLIN
K853703 09/04/1985 VENTREZYME T3 IMMUNOASSAY T3 VXR, INC. JAMES W CHAMPLIN
K853973 09/26/1985 WESCOR MODEL 3700 WEBSTER SWEAT INDUCER WESCOR, INC. WAYNE K BARLOW
K853793 09/11/1985 WIDEX MODEL M1 WIDEX HEARING AID CO., INC. HENRY MELTSNER
K853982 09/27/1985 GOLDEN CERAMIC WILIAMS GOLD REFINING CO., INC. LAWRENCE A WILLIAMS
K853921 09/23/1985 ALL KINDS OF SUNGLASSES WINSBURN COMPANY LTD. GRABOWSKY
K853682 09/04/1985 MOUNT TUBE RADIOGRAPHIC X-RAY SYSTEMS DRUMB
K853641 09/03/1985 GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE XOMED, INC. THOMAS A SMITH
K853855 09/16/1985 XTAL X-150 OPERATING MICROSCOPE XTAL CORP. ALAN P SCHWARTZ
K853664 09/03/1985 HEPARIN MICRO-INFUSOR Y ROBERT J BARD
K853803 09/11/1985 FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB Z.L. BOCKNEK LABORATORIES, INC. PAUL HAFFENDEN
K853661 09/03/1985 MILLAR/GALANTE PRECOATED TOTAL KNEE ZIMMER, INC. MAX SHERMAN


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