| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K962065 |
05/28/1996 |
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE |
3M COMPANY |
AMY FOWLER |
| K961752 |
05/06/1996 |
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) |
ACKRAD LABORATORIES |
BERNARD ACKERMAN |
| K961853 |
05/14/1996 |
PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER |
ACUFEX MICROSURGICAL, INC. |
SUSAN A FINNERAN |
| K962091 |
05/29/1996 |
POLARUS AF ROD |
ACUMED, INC. |
SHARI L JEFFERS |
| K962056 |
05/28/1996 |
ADVANCED MICRO-OSMOMETER MODEL 3300 |
ADVANCED INSTRUMENTS, INC. |
DOUGLAS GUERETTE |
| K961945 |
05/20/1996 |
TYMPANOSTOMY VENTILATION TUBE |
ADVANCED MICROBOTICS CORP. |
ANTHONY W HUMPAGE |
| K961972 |
05/20/1996 |
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR |
AEQUITRON MEDICAL, INC. |
ROBERT C SAMEC |
| K961742 |
05/06/1996 |
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM |
ALM SURGICAL EQUIPMENT, INC. |
SUSAN NIELSEN |
| K961886 |
05/15/1996 |
DRAGER GEMINA WALL-MOUNTED WORKPLACE |
ALM SURGICAL EQUIPMENT, INC. |
SUSAN NIELSON |
| K962017 |
05/23/1996 |
HYPODERMIC JET INJECTION APPARATUS |
AMERICAN JET INJECTOR CORP. |
ROBERT W HARRINGTON |
| K962052 |
05/28/1996 |
ORGENTEC ABTI-SS-BB(LA) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K962053 |
05/28/1996 |
ORGENTEC ANTI-JO-1 ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K962057 |
05/28/1996 |
ORGENTEC ANTI-RNP/SM ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K962055 |
05/28/1996 |
ORGENTEC ANTI-SCL 70 ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K962062 |
05/28/1996 |
ORGENTEC ANTI-SM ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K962054 |
05/28/1996 |
ORGENTEC ANTI-SS-A(RO) ELISA |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K961892 |
05/16/1996 |
SPECKTIN-LA TEST SET |
ANALYTICAL CONTROL SYSTEMS, INC. |
PAULINE W BONDERMAN |
| K961763 |
05/07/1996 |
PULSE SPRAY INFUSION SYSTEM |
ANGIODYNAMICS, DIV. E-Z-EM, INC. |
BRIAN KUNST |
| K961710 |
05/02/1996 |
AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM |
APPLIED OPTRONICS CORP. |
DOUGLASS MEAD |
| K961705 |
05/02/1996 |
AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM |
APPLIED OPTRONICS CORP. |
DOUGLASS MEAD |
| K961729 |
05/03/1996 |
ARGOSY PROGRAMMABLE |
ARGOSY ELECTRONICS |
DENNIS J DAVIS |
| K961712 |
05/02/1996 |
TBD AT-HOME PREGNANCY TEST |
ARMKEL, LLC. |
Maureen Garner |
| K961747 |
05/06/1996 |
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970) |
ARTHROCARE CORP. |
CHERLY L SHEA |
| K962086 |
05/29/1996 |
CPS, CEMENTED CUP SYSTEM |
ARTOS MEDICAL PRODUCTS GMBH |
DOUGLAS W STUART |
| K961899 |
05/16/1996 |
CPS, CEMENTED HIP SYSTEM |
ARTOS MEDICAL PRODUCTS GMBH |
DOUGLAS W STUART |
| K962034 |
05/24/1996 |
SC, CEMENTLESS HIP SYSTEM |
ARTOS MEDICAL PRODUCTS GMBH |
DOUGLAS W STUART |
| K962051 |
05/28/1996 |
ASPECT OPTICAM |
ASPECT ELECTRONICS, INC. |
GARY J ALLSEBROOK |
| K961821 |
05/10/1996 |
ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE MORGIDA |
| K961907 |
05/16/1996 |
RIONET HEARING AID HB53-K |
AUTHORIZED HEARING SYSTEMS, INC. |
HENRY SMITH |
| K962079 |
05/28/1996 |
HUMIDIFIER ADAPTER |
AUTOMATIC LIQUID PACKAGING, INC. |
JOHN BRDA |
| K961779 |
05/08/1996 |
MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER |
AVION MEDICAL PRODUCTS, INC. |
ROBERT L JAMES |
| K962084 |
05/29/1996 |
OMNICAN SYRINGE |
B. BRAUN MEDICAL AG |
MARK S ALSBERGE |
| K961711 |
05/02/1996 |
ASPISAFE GASTRIC TUBE |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K961745 |
05/06/1996 |
BRAUN PERCUTANEOUS INTRODUCER SET |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K961703 |
05/02/1996 |
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL) |
BAXTER HEALTHCARE CORP. |
TAMIMA ITANI, PH.D. |
| K962022 |
05/23/1996 |
POWERCUT GOLD SURGICAL SYSTEM |
BAXTER HEALTHCARE CORP. |
MARYALICE SMITH |
| K961825 |
05/10/1996 |
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 |
BAXTER HEALTHCARE CORP. |
DAVID C ROSS |
| K961968 |
05/20/1996 |
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
VIRGINIA C WEINKNECHT |
| K961730 |
05/03/1996 |
RAPID GRAM-POSITIVE ID SYSTEM |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
VIRGINIA C WEINKNECHT |
| K962523 |
05/30/1996 |
N LATEX CRP MONO REAGENT |
BEHRING DIAGNOSTICS, INC. |
KATHLEEN DRAY-LYONS |
| K962103 |
05/30/1996 |
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K961828 |
05/13/1996 |
LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) |
BIO-RAD |
ELIZABETH PLATT |
| K961941 |
05/20/1996 |
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 |
BIO-RAD |
ELIZABETH PLATT |
| K961862 |
05/14/1996 |
MODELS IDA-2 PLUS AND IPT-1 |
BIO-TEK INSTRUMENTS, INC. |
MICHAEL N SEVIGNY |
| K961811 |
05/10/1996 |
PERI-GUARD PERICARDIUM |
BIO-VASCULAR, INC. |
BRUCE A MACFARLANE |
| K961810 |
05/10/1996 |
SUPPLE PERI-GUARD PERICARDIUM |
BIO-VASCULAR, INC. |
BRUCE A MACFARLANE |
| K961792 |
05/09/1996 |
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS |
BIOCIRCUITS CORP. |
SHEILA J RAMERMAN |
| K961901 |
05/16/1996 |
BONE & MARROW COLLECTION SYSTEM |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K961976 |
05/20/1996 |
THE BIOPLATE FIXATION SYSTEM |
BIOMEDICS |
BRUCE F MACKLER |
| K961928 |
05/17/1996 |
BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 |
BIOMEDIX, INC. |
KEITH E HOFFMAN |
| K961782 |
05/08/1996 |
BIO-BINKI |
BIOMNI MEDICAL SYSTEMS, INC. |
LAVON L BENNETT |
| K961903 |
05/16/1996 |
MAGELLAN |
BIOSENSE, LTD. |
SUSAN J ZACHMAN |
| K962060 |
05/28/1996 |
STREP A OIA MAX |
BIOSTAR, INC. |
LYNDAL K HESTERBERG |
| K961980 |
05/20/1996 |
BIPORE BALLOON DILATATION CATHETER |
BIPORE, INC. |
DURMUS KOCH |
| K961822 |
05/10/1996 |
WET-PREP |
BISCO, INC. |
JAMES L SANDRIK |
| K961832 |
05/13/1996 |
BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER |
BLUE RIDGE MEDICAL, INC. |
MARK J RICE |
| K962099 |
05/29/1996 |
CEDIA PROCAINAMIDE ASSAY |
BOEHRINGER MANNHEIM CORP. |
MARY KONING |
| K961846 |
05/13/1996 |
NEEDLE CATHETER |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K961999 |
05/22/1996 |
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS |
BOSTON SCIENTIFIC SCIMED, INC. |
MARIA BRITTLE |
| K961855 |
05/14/1996 |
POLAR CARE (MODEL 500/50000) |
BREG, INC. |
JAMES T KELLEY |
| K961843 |
05/13/1996 |
GENIE |
BURTON MEDICAL PRODUCTS CORP. |
GRETEL LUMLEY |
| K961725 |
05/03/1996 |
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION |
C.L. MCINTOSH & ASSOC., INC. |
ROBERT L SHERIDAN |
| K962077 |
05/28/1996 |
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER |
C.R. BARD, INC. |
CAROL VIERLING |
| K961841 |
05/13/1996 |
BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) |
C.R. BARD, INC. |
EVANS YI-WEN WUU |
| K962106 |
05/31/1996 |
SPLINE DENTAL IMPLANT SYSTEMS |
CALCITEK, INC. |
DONNA K HOWARD |
| K962115 |
05/31/1996 |
CAMBRIDGE HEART HI-RES ECG ELECTRODE |
CAMBRIDGE HEART, INC. |
ROBERT T MIRAGLIUOLO |
| K961777 |
05/07/1996 |
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 |
CARDIOMETRICS, INC. |
Claire Andrews |
| K961814 |
05/10/1996 |
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
James M Clinton |
| K961758 |
05/03/1996 |
CARASYN HYDROGEL WOUND PRODUCTS |
CARRINGTON LABORATORIES, INC. |
DENNIS R SPARKMAN |
| K961750 |
05/06/1996 |
DOCUMENT CARDIAC ASSAYED CONTROL |
CASCO STANDARDS |
CHRISTINE V BEACH |
| K961965 |
05/20/1996 |
SURE CHECK PREGNANCY TEST |
Chembio Diagnostic Systems, Inc. |
SUSAN D GOLDSTEIN-FALK |
| K962041 |
05/28/1996 |
ACS LH2 IMMUNOASSAY |
CIBA CORNING DIAGNOSTICS CORP. |
THOMAS F FLYNN |
| K961807 |
05/10/1996 |
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 |
CIBA CORNING DIAGNOSTICS CORP. |
William J Pignato |
| K962021 |
05/23/1996 |
CIBA CORNING 348 SYSTEM |
CIBA CORNING DIAGNOSTICS CORP. |
WILLIAM J PIGNATE |
| K962109 |
05/31/1996 |
SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL |
CLASSY LADY BY MEHL OF PUERTO RICO, INC. |
THOMAS BLAKE |
| K962074 |
05/28/1996 |
VM PLUS PEAK FLOWMETER |
CLEMENT CLARKE INTL., LTD. |
MICHAEL J WILKINSON |
| K962113 |
05/31/1996 |
ANTHOS PHACTS VERSION MICROPLATE READER |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K961812 |
05/10/1996 |
ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES |
CONMED CORP. |
IRA D DUESLER, JR. |
| K961815 |
05/10/1996 |
QUALITROL ANA CONTROL SERUM SET |
CONSOLIDATED TECHNOLOGIES, INC. |
WILLIAM CONE |
| K961829 |
05/13/1996 |
QUALITROL CRP CONTROL SET |
CONSOLIDATED TECHNOLOGIES, INC. |
WILLIAM CONE |
| K961998 |
05/22/1996 |
QUALITROL SYPHSERO CONTROL SET |
CONSOLIDATED TECHNOLOGIES, INC. |
WILLIAM CONE |
| K961912 |
05/17/1996 |
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET |
CONSOLIDATED TECHNOLOGIES, INC. |
WILLIAM CONE |
| K962078 |
05/28/1996 |
TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER |
CONTINENTAL MEDICAL LABORATORIES, INC. |
JOSEPH DUNN |
| K962073 |
05/28/1996 |
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY |
CONTINENTAL MEDICAL LABORATORIES, INC. |
JOSEPH DUNN |
| K961690 |
05/01/1996 |
CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 |
CONTINENTAL X-RAY CORP. |
OSCAR KHUTORYANSKY |
| K961748 |
05/06/1996 |
MEDLITE/ERBIUM LASER SYSTEM |
CONTINUUM BIOMEDICAL, INC. |
LAURIE A RIDENER |
| K962040 |
05/24/1996 |
RNS ARTHROGRAM TRAY |
CONTOUR FABRICATORS OF FLORIDA, INC. |
PAT LAMB |
| K961992 |
05/21/1996 |
NEEDLE'S EYE SNARE |
COOK PACEMAKER CORP. |
NEAL E FEARNOT |
| K961904 |
05/16/1996 |
AQ HYDROPHILIC DILATORS |
COOK UROLOGICAL, INC. |
TAMMY BACON |
| K962004 |
05/22/1996 |
AQ HYDROPHILIC UROLOGICAL CATHETERS |
COOK UROLOGICAL, INC. |
TAMMY BACON |
| K961933 |
05/17/1996 |
CIRCLE NEPHROSTOMY CATHETER SET |
COOK UROLOGICAL, INC. |
RICK LYKINS |
| K962097 |
05/29/1996 |
VENTRICULAR CATHETER SET |
COOK, INC. |
APRIL LAVENDER, RAC |
| K961701 |
05/02/1996 |
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE |
DAKO CORP. |
GRETCHEN M MURRAY, PH.D., RAC |
| K962037 |
05/24/1996 |
IMAGEN RESPIRATORY SCREEN |
DAKO DIAGNOSTICS LTD. |
ELISABETH JOHNSON-PROCTOR |
| K961693 |
05/01/1996 |
DALE GASTROSTOMY TUBE HOLDER |
DALE MEDICAL PRODUCTS, INC. |
EGIDIA M VERGANO |
| K961919 |
05/17/1996 |
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE |
DATA MEDICAL ASSOCIATES, INC. |
C.H. MORRIS |
| K962020 |
05/23/1996 |
S-41 & S-41S VIDEO IMAGING SYSTEM |
DEL MEDICAL SYSTEMS CORP. |
KARL J WEYDIG |
| K962024 |
05/23/1996 |
S-57 VIDEO IMAGING SYSTEM |
DEL MEDICAL SYSTEMS CORP. |
KARL J WEYDIG |
| K961937 |
05/20/1996 |
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM |
DELPHI CONSULTING GROUP |
J. HARVEY KNAUSS |
| K961704 |
05/02/1996 |
MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM |
DENTATUS USA, LTD. |
STEPHEN B RUBINSKY |
| K961791 |
05/09/1996 |
DEPUY DISPOSABLE FILTER/HOOD |
DEPUY, INC. |
CHERYL HASTINGS |
| K962007 |
05/22/1996 |
PROTRUSION CAGES |
DEPUY, INC. |
CHERYL HASTINGS |
| K961773 |
05/08/1996 |
PROTEC STERILE GAUZE SPONGE |
DERIVADAS DEGASA S.A. DE C.V. |
PATRICK J LAMB |
| K962089 |
05/29/1996 |
DERMAMEND GEL |
DERMARX CORP. |
MARYANNE CARROLL |
| K961993 |
05/21/1996 |
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) |
DEVON INDUSTRIES, INC. |
GEORGE AUSTRIA |
| K961973 |
05/20/1996 |
DHD ACE WITH MASK KIT |
DHD DIEMOLDING HEALTHCARE DIV. |
JEAN WALLACE |
| K961889 |
05/16/1996 |
SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K961988 |
05/21/1996 |
VALPROIC ACID EIA TEST |
DIAGNOSTIC REAGENTS, INC. |
YUG-GENG TSAY, PH.D. |
| K962118 |
05/31/1996 |
DSL ACTIVE FSH IRMA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K961911 |
05/17/1996 |
DSL ACTIVE I-HCG ELISA |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K961718 |
05/02/1996 |
DEI MODEL 20 EEG |
DISCOVERY ENGINEERING INTL., INC. |
REX HARTZELL |
| K961975 |
05/20/1996 |
DISETRONIC D-MODEM |
DISETRONIC MEDICAL SYSTEMS |
WALTER PISKORSKI |
| K961714 |
05/02/1996 |
ASEPTYLUM, UNI-CARRIER |
DISTRIFLOR S.A. |
GLEN PUTNAM |
| K961687 |
05/01/1996 |
EVITA 4 |
DRAGER, INC. |
HARALD KNEUER |
| K961845 |
05/13/1996 |
PERCUPUMP II WITH EDA |
E-Z-EM, INC. |
PETER APRILE |
| K961757 |
05/06/1996 |
ECOGEL 100 ULTRASOUND GEL |
ECO-MED PHARMACEUTICALS, INC. |
PAUL L HOOEY |
| K962100 |
05/30/1996 |
VOLMETRIC COINCIDENCE DETECTION SYSTEM |
ELSCINT, INC. |
THOMAS J SPACKMAN |
| K961890 |
05/15/1996 |
FOUNDATION 9MM FORGED CEMENTED STEM |
ENCORE ORTHOPEDICS, INC. |
ASHLEY M BOCK |
| K961720 |
05/03/1996 |
CERAMCO CROWNS AND BRIDGES |
ERIC S. SMALL, DDS |
JOHN N POLITIS |
| K962012 |
05/23/1996 |
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER |
ETHICAL HEARING INSTRUMENTS |
DAVID J DELAGE |
| K961746 |
05/06/1996 |
CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY |
EUROTRENDS EYEWEAR, INC. |
DENISE KALIS |
| K962002 |
05/22/1996 |
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM |
EXACTECH, INC. |
MARTHA C MILLER |
| K961909 |
05/16/1996 |
READY-SET PUNCTAL PLUGS |
FCI OPHTHALMICS, INC. |
ANNE BOHSACK |
| K961943 |
05/20/1996 |
FLEXLENS |
FLEXLENS, INC. |
WALLY STIRLING |
| K962000 |
05/22/1996 |
FLEXLENS(METHAFILCON A) |
FLEXLENS, INC. |
WALLY STIRLING |
| K961706 |
05/02/1996 |
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR |
FRESENIUS USA, INC. |
TOM FOLDEN |
| K961754 |
05/06/1996 |
SAFETY RELEASE MODULE |
G & H WIRE CO. |
MICHAEL JAHNS |
| K962116 |
05/31/1996 |
GALILEO ENDOSCOPES |
GALILEO ELECTRO-OPTICS CORP. |
MARY MCNARMARA-CULLINANE |
| K961854 |
05/14/1996 |
SPR PLUS II OVERLAY SYSTEM (CL250/CL212 |
GAYMAR INDUSTRIES, INC. |
PETER SCOTT |
| K962035 |
05/24/1996 |
GE STERILE ARTHROGRAM TRAY |
GE MEDICAL SYSTEMS |
PATRICK J LAMB |
| K962061 |
05/28/1996 |
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K961857 |
05/14/1996 |
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 |
GRAHAM-FIELD, INC. |
SUSAN D GOLDSTEIN-FALK |
| K961896 |
05/16/1996 |
MICROLAB 4000, MICROLAB 4200 |
HAMILTON CO. |
WAYNE MCAULIFFE |
| K961934 |
05/17/1996 |
PURITAN FOAM TIP SWAB MODEL 2197 |
HARDWOOD PRODUCTS CO., LP |
WILLIAM M YOUNG |
| K961908 |
05/16/1996 |
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 |
HELENA LABORATORIES |
PAT FRANKS |
| K962075 |
05/28/1996 |
HSW GMBH ARTHROSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
JOHN M SMITH |
| K961995 |
05/21/1996 |
QUICKSPLINT |
HERAEUS KULZER, INC. |
SHARON PARKER |
| K962048 |
05/28/1996 |
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES J ROGERS |
| K961876 |
05/15/1996 |
AIRIS |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES J ROGERS |
| K961969 |
05/20/1996 |
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES J ROGERS |
| K961872 |
05/15/1996 |
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K961787 |
05/09/1996 |
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS |
HOLOGIC, INC. |
R. MICHAEL CROMPTON |
| K962026 |
05/23/1996 |
PREPOWDER VINYL PATIENT EXAMINATION GLOVES |
HONG HUANG TANG INDUSTRIAL CO., LTD. |
HUAN CHUNG LI |
| K961719 |
05/02/1996 |
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES |
HOWMEDICA LEIBINGER, INC. |
ANDREW B ROGERS |
| K961916 |
05/17/1996 |
HOFFMANN II CARBON CONNECTING ROD |
HOWMEDICA, INC. |
JOHN DICHIARA |
| K961914 |
05/17/1996 |
BACTERIA/VIRAL FILTER |
HUDSON RESPIRATORY CARE, INC. |
ARDEN MORLEY |
| K961716 |
05/02/1996 |
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE |
IDEAS FOR MEDICINE, INC. |
ELIZABETH M PAUL |
| K961883 |
05/15/1996 |
VERSA-CATH ARTERIAL CATHETER |
IDEAS FOR MEDICINE, INC. |
ELIZABETH M PAUL |
| K961753 |
05/06/1996 |
SHARED VISION(PART NUMBER SV 0015) |
IMAGELABS, INC. |
LISA BERGEN |
| K961688 |
05/01/1996 |
MICROSPAN HYSTEROSCOPE |
IMAGYN MEDICAL, INC. |
DEBRA A RINDERER |
| K961765 |
05/07/1996 |
MPO ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
WILLIAM L BOTELER |
| K961764 |
05/07/1996 |
PR-3 ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
WILLIAM L BOTELER JR. |
| K962014 |
05/23/1996 |
3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC. |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K961861 |
05/14/1996 |
VARIOUS DENTAL IMPLANTS WITH COVER SCREWS |
IMPLANT MANAGEMENT OF AMERICA |
WILLIAM SIMMONS |
| K961689 |
05/01/1996 |
INFINET |
INFIMED, INC. |
MORTEZA MINAEE |
| K961940 |
05/20/1996 |
INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP |
INNERDYNE, INC. |
RICK GAYKOWSKI |
| K961913 |
05/17/1996 |
QUANTA LITE ENA 6 ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K961991 |
05/21/1996 |
ACL 6000 SYSTEM (ACL 6000) |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K961859 |
05/14/1996 |
NOVUS STANDARD AND PEDIATRIC VALVES |
INTEGRA NEUROCARE LLC. |
TERRY N LAYTON |
| K961921 |
05/17/1996 |
APR OVERSIZED HIP STEM |
INTERMEDICS ORTHOPEDICS |
SHAVAWN PARDUHN |
| K961799 |
05/09/1996 |
NATURAL HIP SYSTEM - DRG HIP STEM |
INTERMEDICS ORTHOPEDICS |
SAM MIRZA |
| K961727 |
05/03/1996 |
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM |
INTERMEDICS ORTHOPEDICS |
SAM MIRZA |
| K962101 |
05/30/1996 |
ZWEYMUELLER SL FEMORAL HIP STEM |
INTERMEDICS ORTHOPEDICS |
SAM MIRZA |
| K961835 |
05/13/1996 |
PROTIME MICROCOAGULATION SYSTEM |
INTERNATIONAL TECHNIDYNE CORP. |
ROBERT N BORGHESE |
| K961924 |
05/17/1996 |
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM |
IRVINE BIOMEDICAL, INC. |
PETER CHEN |
| K962042 |
05/28/1996 |
GLASS SYRINGE |
ISPG, INC. |
LORETTA LUHMAN |
| K962297 |
05/17/1996 |
VIVAGLASS CEM |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K961910 |
05/17/1996 |
VIVAGLASS FIL |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K961683 |
05/01/1996 |
JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY |
J.J. SKINNER, INC. |
CARLANN KOTULA |
| K961685 |
05/01/1996 |
P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JOHN D FERROS |
| K961939 |
05/20/1996 |
S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
J. THERESA DORRIETY, ESQ. |
| K961713 |
05/02/1996 |
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
| K962090 |
05/29/1996 |
KARL STORZ MODEL 203210 O1 UNIMAT PLUS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
| K962030 |
05/24/1996 |
KARL STORZ REMORGIDA FORCEPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
| K962083 |
05/29/1996 |
KARL STORZ REMORGIDA FORCEPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
| K962032 |
05/24/1996 |
KARL STORZ TWIN TRANSILLUMINATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARIKA ANDERSON |
| K961702 |
05/02/1996 |
KSEA VAPORIZATION ELECTRODES |
KARL STORZ ENDOSKOP GMBH |
BETTY M JOHNSON |
| K961977 |
05/20/1996 |
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K962098 |
05/29/1996 |
ESOPHAGEAL INTUBATION DETECTOR |
KIRK SPECIALTY SYSTEMS |
DALE B ICKLEY |
| K961768 |
05/08/1996 |
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) |
KODAK HEALTH IMAGING SYSTEMS, INC. |
EDWARD A WEAVER |
| K961739 |
05/03/1996 |
KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT |
KODAK HEALTH IMAGING SYSTEMS, INC. |
NANCY BUTCHER |
| K961740 |
05/03/1996 |
KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT |
KODAK HEALTH IMAGING SYSTEMS, INC. |
NANCY BUTCHER |
| K961817 |
05/10/1996 |
B SMART MODEL 1 |
KOVEN TECHNOLOGY, INC. |
PAUL G KOVEN |
| K962009 |
05/22/1996 |
UROSTYM |
LABORIE MEDICAL TECHNOLOGIES, LTD. |
MIKE BARRE |
| K961732 |
05/03/1996 |
KAR |
LANDOS, INC. |
NORMAN F ESTRIN |
| K962112 |
05/31/1996 |
NEW COMFORT CONTACT LENS CARE ACCESSORY |
LENS COMFORT, INC. |
JAMES DEMESTICHAS |
| K962107 |
05/31/1996 |
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5 |
LEONACHI, INC. |
JORGE UJUETA |
| K961918 |
05/17/1996 |
MULTI-TEST II |
LINCOLN DIAGNOSTICS, INC. |
GARY L HENI |
| K962123 |
05/31/1996 |
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM |
LUMEX, INC. |
JOE Z ANETTI |
| K961944 |
05/20/1996 |
LUNAR REPORT GENERATOR |
LUNAR CORP. |
Gary Syring |
| K961798 |
05/09/1996 |
CT 200 ELECTROCARDIOGRAPH |
MACQUARIE MEDICAL SYSTEMS |
FRANK FERGUSON |
| K961759 |
05/07/1996 |
CEMENT AND BONE REMOVAL KIT |
MAILLEFER INSTRUMENTS S.A. |
LEONARD A LERITZ |
| K962045 |
05/28/1996 |
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT |
MALLINCKRODT MEDICAL |
MICHAEL B SCHOECK |
| K961986 |
05/21/1996 |
MANAN D BAG |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
| K962001 |
05/22/1996 |
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE |
MANAN MEDICAL PRODUCTS, INC. |
MICHAEL PLISHKA |
| K961884 |
05/15/1996 |
CATH CADDIE |
MARK-CLARK |
KEN WEDDLE |
| K961838 |
05/13/1996 |
RESPIRGARD II, SPIROGARD |
MARQUEST MEDICAL PRODUCTS, INC. |
TOM DIELMANN |
| K961694 |
05/01/1996 |
IMPACT |
MATRIX TECHNOLOGIES CORP. |
MAR HAMEL |
| K961894 |
05/16/1996 |
MDI TUTOR |
MDI TUTOR, INC. |
DIANE E MINEAR |
| K961847 |
05/13/1996 |
HEMASHIELD VANTAGE (VASCULAR GRAFT |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
CAROLYN TAUBER |
| K961880 |
05/15/1996 |
MEDCARE SUCTION CONNECTING TUBING |
MEDCARE MEDICAL GROUP, INC. |
CRAIG J BELL |
| K961809 |
05/10/1996 |
SHE-LI TENS STIMULATOR MODEL SL-101 RX |
MEDI CONSULTANTS, INC. |
SAUL LISS |
| K961697 |
05/02/1996 |
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE |
MEDICAL DEVICE INTL., INC. |
GREG SACHS |
| K961959 |
05/20/1996 |
MD TECH BIOPSY SET FOR BONE AND BONE MARROW |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K961724 |
05/03/1996 |
U-DOA CONTROLS |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
MICHAEL D BICK |
| K961867 |
05/15/1996 |
PEEP VALVE |
MEDICAL MARKETING CONCEPTS |
BOB MARTIN |
| K961868 |
05/15/1996 |
RESPOSABLE CHILD RESUSCITATOR |
MEDICAL MARKETING CONCEPTS |
BOB MARTIN |
| K961882 |
05/15/1996 |
RESPOSABLE INFANT RESUSCITATOR |
MEDICAL MARKETING CONCEPTS |
BOB MARTIN |
| K961920 |
05/17/1996 |
CROSS PIN |
MEDICINE LODGE, INC. |
WADE FALLIN |
| K961905 |
05/16/1996 |
MEDICINELODGE, INC. SET SCREW |
MEDICINE LODGE, INC. |
WADE F ALLIN |
| K962087 |
05/28/1996 |
SERVOTRONIC EC100 SYSTEM |
MEDICON, INC. |
HOWARD M HOLSTEIN, ESQ. |
| K962295 |
05/16/1996 |
PRECISION QID BLOOD GLUCOSE TEST STRIP |
MEDISENSE, INC. |
MICHAEL HALPIN |
| K962095 |
05/28/1996 |
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES |
MEDLINE INDUSTRIES, INC. |
BETTY LOCK |
| K962094 |
05/28/1996 |
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES |
MEDLINE INDUSTRIES, INC. |
BETTY LOCK |
| K962069 |
05/28/1996 |
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES |
MEDLINE INDUSTRIES, INC. |
BETTY A LOCK |
| K962076 |
05/28/1996 |
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6) |
MEDLINE INDUSTRIES, INC. |
BETTY LOCK |
| K962016 |
05/23/1996 |
MEDLINE TITANIUM HEMOCLIPS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K962096 |
05/28/1996 |
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES |
MEDLINE INDUSTRIES, INC. |
BETTY LOCK |
| K961836 |
05/13/1996 |
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR |
MEDTRONIC VASCULAR |
DEBRA KRIDNER |
| K962036 |
05/24/1996 |
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD |
MEDTRONIC VASCULAR |
TODD A FONSECA |
| K961936 |
05/20/1996 |
MODEL 2188 CORONARY SINUS LEAD. |
MEDTRONIC VASCULAR |
NORA K HADDING |
| K961679 |
05/01/1996 |
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS |
MEDTRONIC VASCULAR |
NORA K HADDING |
| K961917 |
05/17/1996 |
MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) |
MEDTRONICS INTERVENTIONAL VASCULAR |
MARY DE ARMOND |
| K962006 |
05/22/1996 |
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
MENICON CO. LTD. |
A. WES SIEGNER,, JR. |
| K962013 |
05/23/1996 |
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT |
MENTOR CORP. |
LYNN BRECKENRIDGE |
| K961794 |
05/09/1996 |
FLUID ADMINISTRATION SET - CONTRAST MANAGER |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS (DAN) REIGLE |
| K961803 |
05/09/1996 |
SPUNCRIT (MODEL DRC-40) |
MICRO DIAGNOSTICS CORP. |
RODNEY A KATZER |
| K962119 |
05/31/1996 |
RE-NEW LAPAROSCOPIC INSTRUMENTS |
MICROLINE PENTAX, INC. |
HUGHES DE LAFORCADE |
| K961848 |
05/13/1996 |
3M LITTMANN ELECTRONIC STETHOSCOPE |
MINNESOTA MINING AND MFG. CO. |
LINDA JONSEN |
| K962028 |
05/23/1996 |
WELLCOLEX E-COLI OI57 ZC60 |
MUREX DIAGNOSTICS, INC. |
KEN SHOCKLEY, PH.D. |
| K961717 |
05/02/1996 |
NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS |
NALTIAC MEDICAL, INC. |
WENDEL LLOYD |
| K962081 |
05/28/1996 |
COMBILINES HEMODIALYSIS BLOOD TUBING SET |
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
DEBRA L BING |
| K962033 |
05/24/1996 |
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
| K961678 |
05/01/1996 |
HUMAN GROWTH HORMONE IMMUNOASSAY KIT |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE D SMITH |
| K961736 |
05/03/1996 |
17 ANGULATED ABUTMENT |
NOBELPHARMA USA, INC. |
MARY EDWARDS |
| K961737 |
05/03/1996 |
CERA ONE ABUTMENT SYSTEM |
NOBELPHARMA USA, INC. |
MARY EDWARDS |
| K961728 |
05/03/1996 |
MIRUSCONE ABUTMENT SYSTEM |
NOBELPHARMA USA, INC. |
MARY EDWARDS |
| K961982 |
05/20/1996 |
TRI-FLOW THREE WAY STOPCOCK |
NORTH, INC. |
JIM POKORNEY |
| K961938 |
05/20/1996 |
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K961895 |
05/16/1996 |
FLEXILOG LS 13921 |
OAKFIELD INSTRUMENTS, LTD. |
JOHN GIDDINGS |
| K961860 |
05/14/1996 |
A4907 LENS CLEANING SHEATH |
OLYMPUS AMERICA, INC. |
BARRY E SANDS |
| K961790 |
05/09/1996 |
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM |
OPTICAL SENSORS, INC. |
DENISE A SSCHOTTLER |
| K962104 |
05/30/1996 |
AIRLIFT BALLOON RETRACTON SYSTEM |
ORIGIN MEDSYSTEMS, INC. |
ANTHONY DURSO |
| K962005 |
05/22/1996 |
EXTRAHAND BALLOON RETRACTOR |
ORIGIN MEDSYSTEMS, INC. |
ANTHONY DURSO |
| K961793 |
05/09/1996 |
BI-LOC BIPOLAR CUP |
ORTHO DEVELOPMENT CORP. |
MICHELLE M PERRY |
| K962082 |
05/29/1996 |
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT |
OSTEONICS CORP. |
ROBERT A KOCH |
| K962072 |
05/28/1996 |
PRONEB TURBO COMPRESSOR MODEL 38V0200 |
PARI HOLDING CO. |
MIGUEL A ARRIZON |
| K961743 |
05/03/1996 |
ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR |
PDG PRODUCT DESIGN GROUP, INC. |
PHIL MUNDY |
| K962071 |
05/28/1996 |
SPIRIT S1/S2 |
PELTON & CRANE CO. |
KRISTI KUNKEL |
| K961974 |
05/20/1996 |
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K961893 |
05/16/1996 |
DURAFLOR |
PHARMASCIENCE, INC. |
LOUIS HLAVINKA |
| K961770 |
05/08/1996 |
PHILIPS 71 SERIES |
PHILIPS HEARING INSTRUMENTS CO. |
ROBERT MARTIN |
| K962010 |
05/23/1996 |
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K962117 |
05/31/1996 |
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K961834 |
05/13/1996 |
PHILIPS EASYGUIDE NEURO |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
| K961888 |
05/15/1996 |
PILLAR 4-WHEEL SCOOTER |
PILLAR TECHNOLOGY, INC. |
CHRIS TINSLEY |
| K962105 |
05/31/1996 |
PLANNED SOPHIED CLASSIC |
PLANMED OY |
LARS MORING |
| K961870 |
05/10/1996 |
PLAYTEX SLIMFIT TAMPONS |
PLAYTEX PRODUCTS, INC. |
IRWIN BUTENSKY, PH.D. |
| K962049 |
05/28/1996 |
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT |
POLYMEDCO, INC. |
JOHN H OLSEN |
| K961682 |
05/01/1996 |
ARGON CURING LASER |
PREMIER LASER SYSTEMS, INC. |
MARILYN T HAIRE |
| K962038 |
05/24/1996 |
PES HOT/COLD COMPRESS |
PRINCETON ELECTRONIC SYSTEMS, INC. |
CHARLES H SEIDEL, JR. |
| K961755 |
05/06/1996 |
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM |
PROTEINS INTL., INC. |
NAOMI ELIEZER |
| K961756 |
05/06/1996 |
CYTOQUANT VIRAL TRANSPORT MEDIUM |
PROTEINS INTL., INC. |
NAOMI ELIEZER |
| K961827 |
05/13/1996 |
IN-THE-EAR |
QUALITONE |
BRUCE BROWN |
| K961673 |
05/01/1996 |
R&D RETIC-PG HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
JOHN G YAGER |
| K961931 |
05/17/1996 |
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP |
R.K. MEDICAL, L.L.C. |
BRENDA M KELLY |
| K961925 |
05/17/1996 |
POLYESTER NONABSORBABLE SURGICAL SUTURES USP |
R.K. MEDICAL, L.L.C. |
BRENDA M KELLY, M.D. |
| K961844 |
05/13/1996 |
OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] |
RADIONICS SOFTWARE APPLICATIONS, INC. |
AMY J LAFORTE, PH.D. |
| K961858 |
05/14/1996 |
COSGROVE DEPTH ELECTRODE KIT(CDEK) |
RADIONICS, INC. |
AMY J LAFORTE PH.D. |
| K961942 |
05/20/1996 |
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI |
RADIONICS, INC. |
AMY J LAFORTE |
| K961922 |
05/17/1996 |
RDP-2 |
RANFAC CORP. |
RAYMOND D LANGLEY |
| K962068 |
05/28/1996 |
LIGHTSTIC MODEL 180 |
RARE EARTH MEDICAL, INC. |
RICHARD G HUNTER |
| K961695 |
05/01/1996 |
ENDO-TECH LTD., TIPS |
RATIO DESIGN LAB |
TIM B LUSBY |
| K961818 |
05/10/1996 |
GENTAMICIN DISK (120MCG) |
REMEL, L.P. |
MARY ANN SILVIUS |
| K961819 |
05/10/1996 |
STREPTOMYCIN DISK (300MCG) |
REMEL, L.P. |
MARY ANN SILVIUS |
| K961766 |
05/03/1996 |
WOUND HYDROGEL & STERILE WOUND HYDROGEL |
RENAISSANCE PHARMACEUTICAL, INC. |
DARLENE TAYLOR-MCCORD |
| K961927 |
05/17/1996 |
RMI HEMOCONCENTRACTOR TUBING SET |
RESEARCH MEDICAL, INC. |
RD HIBBERT |
| K961783 |
05/08/1996 |
SULLIVAN VPAP II ST NASAL VPAP SYSTEM |
RESMED LTD. |
HELEN MELER |
| K961915 |
05/17/1996 |
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE |
RESPIRONICS, INC. |
FRANCIS X DOBSCHA |
| K961769 |
05/08/1996 |
AIR-MEDEX I |
ROBERT GOLD ASSOC. |
ERIC FLAM |
| K961726 |
05/03/1996 |
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K961824 |
05/10/1996 |
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K961674 |
05/01/1996 |
ROCHE UNIMATE FRUCTOSAMINE REAGENT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K961990 |
05/21/1996 |
NON-PRESCRIPTION SUNGLASSES |
ROKKO STARS CO., LTD. |
H. IKEDA |
| K961840 |
05/13/1996 |
RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K961837 |
05/13/1996 |
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K961953 |
05/20/1996 |
SAS SALMONELA H Z24 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961961 |
05/20/1996 |
SAS SALMONELLA H F,G,T ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961956 |
05/20/1996 |
SAS SALMONELLA H G,M,Q ANTISERMU |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961954 |
05/20/1996 |
SAS SALMONELLA H Z35 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961958 |
05/20/1996 |
SAS SALMONELLA H Z4 COMPLEX ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961960 |
05/20/1996 |
SAS SALMONELLA H Z4, Z24 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961957 |
05/20/1996 |
SAS SALMONELLA H Z4, Z32 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961955 |
05/20/1996 |
SAS SALMONELLA H Z42 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961952 |
05/20/1996 |
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961949 |
05/20/1996 |
SAS SALMONELLA O FACTOR 14 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961950 |
05/20/1996 |
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961948 |
05/20/1996 |
SAS SALMONELLA O FACTOR 20 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961951 |
05/20/1996 |
SAS SALMONELLA O FACTOR 6 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961964 |
05/20/1996 |
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961962 |
05/20/1996 |
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961963 |
05/20/1996 |
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961966 |
05/20/1996 |
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K961967 |
05/20/1996 |
SAS SALMONELLA O POLY B ANTISERUM |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K962085 |
05/29/1996 |
SALTER LABS 8990 SERIES NEBULIZER |
SALTER LABS |
JAMES N CURTI |
| K961926 |
05/17/1996 |
SANPOINT MENSTRUAL TAMPON |
SANPOINT AB |
HANS FEIKES DE GROOT |
| K961735 |
05/03/1996 |
ACTA |
SATELEC |
JACKIE MASSE |
| K961738 |
05/03/1996 |
VIT COMMANDER SYSTEM |
SCIERAN TECHNOLOGIES, INC. |
ROD ROSS |
| K961983 |
05/20/1996 |
TRS 2000 TELERADIOLOGY SYSTEM |
SECTRA-IMTEC AB |
HERMAN OOSTERWIJK |
| K961985 |
05/21/1996 |
ELECT BLOOD GLUCOSE MONITORIG SYSTEM |
SELFCARE, INC. |
CAROL A ADILETTO |
| K962122 |
05/31/1996 |
SENTRY RADIOTRANSLUCENT ECG ELECTRODES |
SENTRY MEDICAL PRODUCTS, INC. |
JAMES G STROKES |
| K961849 |
05/13/1996 |
THE ROBOGUIDE |
SHAI SYG MOTION AND INNOVATIONS, LTD. |
ELI M ORBACH |
| K961935 |
05/20/1996 |
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K961871 |
05/15/1996 |
FLOUROSPOT T.O.P. |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHY RUTHERFORD |
| K961902 |
05/16/1996 |
SIEMENS BEAM SHAPER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KENNETH R MICHAEL, PH.D. |
| K961833 |
05/13/1996 |
SONOLINE ELEGRA WITH SIESCAPE FEATURE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE HESLER |
| K961784 |
05/02/1996 |
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS |
SIENNA BIOTECH, INC. |
JUDITH J SMITH |
| K961775 |
05/08/1996 |
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT |
SMITH & NEPHEW UNITED, INC. |
JIM IRVIN |
| K962080 |
05/28/1996 |
RPS-50 BEAM SCANNER |
SOFIELD SCIENCE SERVICES, INC. |
JACK C SOFIELD |
| K961692 |
05/01/1996 |
SONOSCAN |
SONOTECH, INC. |
MARGARET J LARSON |
| K962093 |
05/29/1996 |
ULTRAMIX |
SONOTECH, INC. |
MARGARET J LARSON |
| K961680 |
05/01/1996 |
SONY DKR-700 DIGITAL STILL RECORDER |
SONY MEDICAL SYSTEMS |
CYNTHIA A SINCLAIR |
| K961707 |
05/02/1996 |
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM |
SORENSON CRITICAL CARE |
R. DOUGLAS JACOB |
| K961869 |
05/15/1996 |
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 |
SORIN BIOMEDICAL, INC. |
SUSAN J REIMERS |
| K961906 |
05/16/1996 |
UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 |
SPECTRUM MEDSYSTEMS CORP. |
THOMAS L HURSMAN |
| K962120 |
05/31/1996 |
TOMOGRAPH ACCESSORIES |
STERI-OSS, INC. |
PAUL GASSER |
| K961721 |
05/03/1996 |
STERITEC DISPOSABLE BIOLOGICAL TEST PACK |
STERITEC PRODUCTS MFG. CO., INC. |
TOM ROLL |
| K961820 |
05/10/1996 |
STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK |
STORZ INSTRUMENT CO. |
AUDREY SWEARINGEN |
| K961874 |
05/15/1996 |
STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK |
STORZ INSTRUMENT CO. |
AUDREY SWEARINGEN |
| K961831 |
05/13/1996 |
STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK |
STORZ INSTRUMENT CO. |
AUDREY SWERINGEN |
| K961970 |
05/20/1996 |
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM |
STRYKER CORP. |
DIANE DAVIS |
| K961971 |
05/20/1996 |
Q-5000 |
Stryker Endoscopy |
BADER-E BELLAHSENE, PH.D. |
| K961708 |
05/02/1996 |
LIFE AND LIFE FAST SET |
SYBRON DENTAL SPECIALTIES, INC. |
WILLIAM R PIKE |
| K962011 |
05/23/1996 |
SYNTHES 7.0/7.3 MM CANNULATED SCREWS |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K962047 |
05/28/1996 |
TITANIUM CANNULATED TIBIAL NAIL (TI CTN) |
SYNTHES (USA) |
ANGELA SILVESTRI |
| K961923 |
05/17/1996 |
BERENSTEIN COIL |
TARGET THERAPEUTICS |
LARAINE PANGELINA |
| K962003 |
05/22/1996 |
TUAT SPLATTER CONTROL SHIELD SCS-300 |
TAUT, INC. |
GLENN B MILLER |
| K962019 |
05/23/1996 |
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST |
TECO DIAGNOSTICS |
K.C. CHEN |
| K961864 |
05/14/1996 |
CSF/URINE TOTAL PROTEIN |
TECO DIAGNOSTICS |
K.C. CHEN, PH.D. |
| K962015 |
05/22/1996 |
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST |
TECO DIAGNOSTICS |
K.C. CHEN, PH.D. |
| K961734 |
05/03/1996 |
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
| K961930 |
05/17/1996 |
CHONDROPROTEC |
THE HYMED GROUP CORP. |
GEROGE D PETITO |
| K962023 |
05/23/1996 |
PLASTIC PROTECTION HEALING CAPS |
THE STRAUMANN CO. |
AMY M GARNDER |
| K962050 |
05/28/1996 |
THERATEST EL-RFSCR |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU, MD., PH.D. |
| K961780 |
05/08/1996 |
HEMODIALYSIS INTRODUCER SET |
THOMAS MEDICAL PRODUCTS, INC. |
THOMAS J CHAPMAN |
| K961805 |
05/10/1996 |
TOMEY DTL ELECTRODE |
TOMEY CORPORATION USA |
SUSUMU NOZAWA |
| K961842 |
05/13/1996 |
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM |
TOSHIBA AMERICA MRI, INC. |
STEVEN M KAY |
| K961984 |
05/21/1996 |
PORPHOBILINOGEN (PBG) |
TRACE AMERICA, INC. |
David Johnston |
| K961863 |
05/14/1996 |
PARACENTESIS TRAYS |
TRI-MED, INC. |
MIKE KNOTH |
| K961826 |
05/13/1996 |
DIGIPAN |
TROPHY RADIOLOGIE |
MARIE-PIERRE LABAT-CAMY |
| K962031 |
05/24/1996 |
QUANTEC SERIES 2000 ENDODONTIC FILES |
TYCOM DENTAL |
CAROL L PATTERSON |
| K961762 |
05/07/1996 |
REUSABLE ENDOSCOPIC ACCESSORY HANDLE |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN YOUNKER |
| K961856 |
05/14/1996 |
AUTO SUTURE CHEMOSITE TUNNELER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JANET G JOHNSON |
| K962043 |
05/28/1996 |
AUTO SUTURE MODIFIED VCS CLIP APPLIER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K961771 |
05/08/1996 |
AUTO SUTURE SURGIWAND |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K961699 |
05/02/1996 |
EQUIPMENT COVERS |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JANET JOHNSON |
| K961997 |
05/22/1996 |
USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JONATHAN GILBERT |
| K961877 |
05/10/1996 |
PISTON SYRINGE |
UNIVEC, INC. |
RICHARD SAVADSKY |
| K961929 |
05/17/1996 |
FACTOR DEFICIENT PLASMA |
UNIVERSAL REAGENTS, INC. |
JORGE MILLER |
| K962044 |
05/28/1996 |
VALLEYLAB COATED ELECTRODES |
VALLEYLAB, INC. |
HERBERT VINSON |
| K961800 |
05/09/1996 |
HEAD MOUNTED DISPLAY |
VISTA MEDICAL TECHNOLOGIES, INC. |
DEBBIE IAMPIETRO |
| K961802 |
05/09/1996 |
PRECLUDE SYNBLOC MEMBRANE |
W.L. GORE & ASSOCIATES,INC |
JOHN W NICHOLSON |
| K962114 |
05/31/1996 |
ARTHRO-SURGIMAT |
W.O.M. WORLD OF MEDICINE, GMBH |
ROBERT REZNICK |
| K961751 |
05/06/1996 |
W.M.E. GPS 1001 |
WEAVER MEDICAL ELECTRONICS, INC. |
BENSON C WEAVER |
| K962121 |
05/31/1996 |
HORIZON/WESTHIN 55-G |
WESTCON CONTACT LENS CO., INC. |
MARTIN DALSING |
| K961897 |
05/16/1996 |
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
| K961879 |
05/15/1996 |
ELECTRONIC THERMOMETER |
WILTEC INDUSTRIES LTD. |
PAUL E DRYDEN |
| K961878 |
05/15/1996 |
SHARPS-TAINER |
WINFIELD INDUSTRIES |
DAVID OLMSTEAD |
| K961797 |
05/09/1996 |
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE |
WRIGHT LINEAR PUMP, INC. |
JOE SORIERO |
| K961891 |
05/09/1996 |
WLP SINGLE-SEGMENT VERSION WLP SOLO VII |
WRIGHT LINEAR PUMP, INC. |
JOE SORIERO |
| K961900 |
05/16/1996 |
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KIM TOMPKINS |
| K961873 |
05/15/1996 |
ACTIVENT ANTIMICROBIAL VENTILATION TUBES |
XOMED, INC. |
DAVID TIMLIN |
| K962070 |
05/28/1996 |
YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE |
YELLOW SPRINGS INSTRUMENT CO., INC. |
JAMES R GRAVER |
| K961789 |
05/09/1996 |
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE |
ZIMMER, INC. |
LYNETTE WHITAKER |
