| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K972962 |
08/11/1997 |
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
3M COMPANY |
ANNE BUTEYN |
| K973036 |
08/14/1997 |
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES |
3M HEALTH CARE |
KAREN C HOLMEN |
| K973148 |
08/22/1997 |
MACOM |
A. STEIN - REGULATORY AFFAIRS CONSULTING |
AHAVA STEIN |
| K972971 |
08/11/1997 |
NPG + 2 |
AALBA DENT, INC. |
VINCENT M BENETTI |
| K973265 |
08/29/1997 |
VERABOND 2V |
AALBA DENT, INC. |
VINCENT M BENETTI |
| K972838 |
08/01/1997 |
POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED) |
ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. |
WOLFE BIRKIE |
| K972925 |
08/08/1997 |
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC |
ACCESS RADIOLOGY CORP. |
ALLAN M GREEN |
| K973079 |
08/18/1997 |
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM |
ACUSON CORP. |
WILLIAM WELCH |
| K973239 |
08/28/1997 |
DICOM 3.0 SOFTWARE VERSION 2.0 |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K973233 |
08/28/1997 |
IMAGE FUSION AND REVIEW SYSTEM |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K973000 |
08/12/1997 |
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM |
ALIMENTERICS, INC. |
JANET G MURNICK |
| K973106 |
08/19/1997 |
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR |
ALLIED HEALTHCARE PRODUCTS, INC. |
VERNON TRIMBLE |
| K972901 |
08/06/1997 |
AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD |
AMERICAN BIOSURGICAL, INC. |
MICHAEL SOCOLOFF |
| K973185 |
08/25/1997 |
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K973142 |
08/21/1997 |
DBEST REAGENT STRIP FOR URINALYSIS |
AMERITEK, INC. |
K.C. YEE |
| K972862 |
08/04/1997 |
AMPLAID 171S |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K972959 |
08/11/1997 |
AMPLAID MK22 |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K973107 |
08/19/1997 |
AMSINO I.V. ADMINISTRATION SET |
AMSINO INTL., INC. |
RICHARD Y LI |
| K973199 |
08/26/1997 |
AMSINO SUCTION CATHETER |
AMSINO INTL., INC. |
RICHARD Y LI |
| K972918 |
08/07/1997 |
RAPID FIRE HAIR IMPLANTER CAROUSEL |
APEX MEDICAL PRODUCTS, LLC. |
NORMAN R ESTRIN |
| K972966 |
08/11/1997 |
AXT 150M MANUAL COLLIMATOR (AXT 150M) |
APPLIED X-RAY TECHNOLOGIES, INC. |
HOWARD C THOMAS |
| K973249 |
08/29/1997 |
ENDOASSIST |
ARMSTRONG HEALTHCARE LTD. |
PATRICK A FINLAY |
| K973115 |
08/20/1997 |
ARRIPRO 35 ST/TV |
ARNOLD & RICHTER CINE TECHNIK |
THOMAS POPP |
| K973063 |
08/18/1997 |
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR |
ASPECT VISION CARE, LTD. |
MARTIN S KNOPF |
| K972996 |
08/12/1997 |
EASY ECG PC BASED ELECTROCARDIOGRAPH |
ATES MEDICAL S.R.L. |
MICHAEL DAVIDSON |
| K972964 |
08/11/1997 |
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE |
ATRION MEDICAL PRODUCTS, INC. |
DAN CLARK |
| K973037 |
08/14/1997 |
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 |
AVID N.I.T., INC. |
JOSEPH E HARMS |
| K973260 |
08/29/1997 |
HYDRASORB STERILE DRESSING |
AVITAR, INC. |
PAUL H PATRONE |
| K973227 |
08/27/1997 |
ASKINA HYDROCOLLOID/THIN |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K972846 |
08/01/1997 |
BMC RF CANNULA |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
| K973069 |
08/18/1997 |
SYNCHRON SYSTEMS METHADONE REAGENT |
BECKMAN INSTRUMENTS, INC. |
LUCINDA STOCKERT |
| K972929 |
08/08/1997 |
N ANTISERUM TO HUMAN ALBUMIN |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K972840 |
08/01/1997 |
N ANTISERUM TO HUMAN TRANSFERRIN |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K973043 |
08/15/1997 |
MODEL C-1 HEARING AID |
BETTER HEARING, INC. |
LOUIS T GNECCO |
| K973056 |
08/15/1997 |
BONE GRAFT SCREW SYSTEM |
BICON, INC. |
VINCENT J MORGAN |
| K973238 |
08/28/1997 |
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER |
BILL OLSON CORP. |
SCOTT RYAN |
| K972860 |
08/04/1997 |
CURVTEK TSR SYSTEM |
BIOLECTRON, INC. |
RICHARD S DUGOT |
| K972895 |
08/05/1997 |
VIDAS ROTAVIRUS (RTV) ASSAY |
BIOMERIEUX VITEK, INC. |
TERRY MCGOVERN |
| K972868 |
08/04/1997 |
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL |
BIONOSTICS, INC. |
BRUCE R WILLIAMS |
| K972919 |
08/07/1997 |
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW |
BIONX IMPLANTS, INC. |
JONATHAN S KAHAN |
| K973126 |
08/20/1997 |
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K973112 |
08/20/1997 |
ELECSYS DIGOXIN |
BOEHRINGER MANNHEIM CORP. |
YVETTE R LLOYD |
| K972876 |
08/04/1997 |
GLUCOTREND BASIC SYSTEM |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K972963 |
08/11/1997 |
MODIFIED CEDIA DAU PCP ASSAY |
BOEHRINGER MANNHEIM CORP. |
Yvette Lloyd |
| K973015 |
08/13/1997 |
MULTITAK SS SUTURE SYSTEM |
BONUTTI RESEARCH |
LYNNETTE WHITAKER |
| K972986 |
08/11/1997 |
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K972884 |
08/05/1997 |
ACCURUN 146 CMV IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K973008 |
08/13/1997 |
COURIER ST BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
MARY P LEGRAW |
| K973113 |
08/20/1997 |
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM |
BOSTON SCIENTIFIC CORP. |
DANIEL J DILLON |
| K972859 |
08/04/1997 |
FLUTTER D |
BRADSTREET CLINICAL RESEARCH ASSOC., INC. |
PATRICIA W BRADSTREET |
| K973178 |
08/25/1997 |
FLUORO-TEX SURGICAL MEMBRANE |
BRIDGER BIOMED, INC. |
BRUCE G RUEFER |
| K973133 |
08/21/1997 |
BIG BAG 3000 PRESSURE INFUSOR |
BYRON MEDICAL |
STEVE BOLLINGER |
| K973125 |
08/20/1997 |
MAMMOLOADER BY C.M.A. SRL |
C.M.A. |
CARL ALLETTO |
| K972904 |
08/06/1997 |
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL |
CASCO STANDARDS |
CHRISTINE V BEACH |
| K973257 |
08/29/1997 |
VERSAETCH |
CENTRIX, INC. |
JOHN DISCKO |
| K972992 |
08/12/1997 |
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS |
CERAMATEC, INC. |
GORDON ROTH |
| K973103 |
08/19/1997 |
CHARTERMED TPN-EVA BAGS |
CHARTERMED, INC. |
K. ALICE PREVILLE |
| K972993 |
08/12/1997 |
CHASE FEMORAL ACCESS CANNULATION SET |
CHASE MEDICAL, INC. |
BERT DAVIS |
| K973024 |
08/14/1997 |
INTELECT LEGEND ULTRASOUND |
CHATTANOOGA GROUP, INC. |
JOE ELROD |
| K973002 |
08/12/1997 |
HURRISEAL DENTIN DESENSITIZER |
CHENG & ASSOC., INC. |
AN-SHIH CHENG |
| K972968 |
08/11/1997 |
ROTOGRAPH PLUS |
CHICAGO X-RAY SYSTEMS, INC. |
AL SOSA |
| K973061 |
08/18/1997 |
CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) |
CITIZEN WATCH CO., LTD. |
JOSEPH D EDMONDSON |
| K973123 |
08/20/1997 |
EA-D IGG ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
WILLIAM L BOTELER |
| K973256 |
08/25/1997 |
JIMMY JOHN III RECTAL NOZZLE |
COLON THERAPEUTICS |
JIM GIROUARD |
| K973070 |
08/18/1997 |
CONVEEN EASICATH SET |
COLOPLAST CORP. |
SYDNEY LILLY |
| K973170 |
08/25/1997 |
SIS WOUND DRESSING |
COOK BIOTECH, INC. |
NEAL E FEARNOT |
| K972977 |
08/11/1997 |
INSULATOR WIRE GUIDE |
COOK UROLOGICAL, INC. |
TAMMY BACON |
| K972978 |
08/11/1997 |
VISTA BRITE TIP GUIDING CATHETERS |
CORDIS CORP. |
KATHERINE TREVISOL |
| K972881 |
08/05/1997 |
CES VASCULAR OCCLUSION SYSTEM |
CORDIS NEUROVASCULAR, INC. |
ELSA I CHI |
| K972995 |
08/12/1997 |
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM |
CORIN U.S.A. |
JACK THOMAS |
| K973231 |
08/27/1997 |
THE CORIFIX DYNAMIC HIP SCREW SYSTEM |
CORIN U.S.A. |
CRAIG CORRANCE |
| K973005 |
08/13/1997 |
THE CORIFIX LIGAMENT ANCHOR |
CORIN U.S.A. |
CRAIG CORRANCE |
| K973190 |
08/25/1997 |
ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHART |
| K972899 |
08/06/1997 |
CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTHONY L GIACCIO |
| K972849 |
08/01/1997 |
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTHONY L GIACCIO |
| K972883 |
08/05/1997 |
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTHONY L GIACCIO |
| K973100 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
REBECCA S AYASH |
| K973099 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN CONTROL |
DADE CHEMISTRY SYSTEMS, INC. |
REBECCA S AYASH |
| K973101 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
REBECCA S AYASH |
| K972997 |
08/12/1997 |
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION |
DAN MED, INC. |
THOMAS SANDGAARD |
| K973007 |
08/13/1997 |
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER |
DATASCOPE CORP. |
WHITNEY TORNING |
| K972910 |
08/07/1997 |
PORS ON LITE |
DEGUSSA CORP. |
HOLGER MEINICKE |
| K973221 |
08/27/1997 |
COMPOSITE 168 RESTORATIVE SYSTEM |
DENTSPLY INTL. |
JEFFERY LEHN |
| K973235 |
08/28/1997 |
DYRACT AP RESTORATIVE |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K973129 |
08/21/1997 |
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS |
DENVER BIOMATERIALS, INC. |
BONNIE VIVIAN |
| K973060 |
08/18/1997 |
DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM |
DEPUY, INC. |
JOHN D VAN VLEET |
| K973108 |
08/19/1997 |
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K973214 |
08/27/1997 |
FRESH CELLS HFF |
DIAGNOSTIC HYBRIDS, INC. |
J. L. BROWN |
| K973213 |
08/27/1997 |
FRESH CELLS LLC-MK2 |
DIAGNOSTIC HYBRIDS, INC. |
J. L. BROWN |
| K973211 |
08/27/1997 |
FRESH CELLS MV1LU |
DIAGNOSTIC HYBRIDS, INC. |
J. L. BROWN |
| K973210 |
08/27/1997 |
FRESH CELLS NCI H292 |
DIAGNOSTIC HYBRIDS, INC. |
J. L. BROWN |
| K973209 |
08/27/1997 |
FRESH CELLS VERO |
DIAGNOSTIC HYBRIDS, INC. |
J. L. BROWN |
| K973212 |
08/27/1997 |
FRESH CELLS WI-38 |
DIAGNOSTIC HYBRIDS, INC. |
J. L. BROWN |
| K973186 |
08/25/1997 |
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE PH.D. |
| K973102 |
08/19/1997 |
LIDOCAINE EIA ASSAY |
DIAGNOSTIC REAGENTS, INC. |
YUH-GENG TSAY |
| K973243 |
08/29/1997 |
ACTIVE PSA ELISA (DSL-10-9700) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K973244 |
08/29/1997 |
ACTIVE PSA IRMA (DSL-9700) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K973177 |
08/25/1997 |
MAGO AUTOMATED EIA PROCESSOR |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K973044 |
08/15/1997 |
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS |
JIM MYERS |
| K973038 |
08/14/1997 |
ADJUSTABLE THERASNORE |
DISTAR, INC. |
STEPHEN A BROWN |
| K973051 |
08/15/1997 |
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K972848 |
08/01/1997 |
NARKOMED MRI ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K973047 |
08/15/1997 |
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K973269 |
08/29/1997 |
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K973229 |
08/27/1997 |
D.O.R.C. HEXON ILLUMINATION SYSTEM |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
| K972847 |
08/01/1997 |
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) |
EASTMAN KODAK COMPANY |
ROBERT L HILLER |
| K973266 |
08/29/1997 |
Z DEQ-II |
ELECTONE, INC. |
JIM NEE |
| K973054 |
08/15/1997 |
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
EMD CHEMICALS INC. |
ANNA G BENTLEY |
| K973119 |
08/20/1997 |
FOUNDATION POROUS ACETABULAR SYSTEM |
ENCORE ORTHOPEDICS, INC. |
ASHLEY M BOCK |
| K973395 |
08/21/1997 |
EPISCREEN ORAL SPECIMEN COLLECTION DEVICE |
EPITOPE, INC. |
CAROLINE SAYRE |
| K972872 |
08/04/1997 |
DERMA K LASER SYSTEM |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K972892 |
08/05/1997 |
CAVIT-LC |
ESPE GMBH & CO. KG. |
BARBARA WAGNER-SCHUH |
| K973262 |
08/29/1997 |
KETAC-FIL APLICAP PLUS |
ESPE GMBH & CO. KG. |
BARBARA WAGNER-SCHUH |
| K973139 |
08/21/1997 |
ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR |
ETHICON ENDO-SURGERY, INC. |
LONNIE PACE |
| K973173 |
08/25/1997 |
POWERSTAR BIPOLAR SCISSORS |
ETHICON, INC. |
GREGORY R JONES |
| K973161 |
08/22/1997 |
CPAP HUMIDIFIER (HC 200) |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
| K972885 |
08/05/1997 |
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
| K973220 |
08/27/1997 |
RODENSTOCK LASER SLITLAMP |
G. RODENSTOCK INSTRUMENTE GMBH |
DAVID M LINK |
| K973152 |
08/22/1997 |
GALLINI ABS DEVICE |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
| K973039 |
08/14/1997 |
LEGACY/LEGACY-D TABLE |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K972990 |
08/12/1997 |
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGERR |
| K973168 |
08/25/1997 |
SMARTVIEW OPTIONS FOR HISPEED CT/I |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K973046 |
08/15/1997 |
SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK |
GENERAL SURGICAL INNOVATIONS |
CATHLEEN MANTOR |
| K973225 |
08/27/1997 |
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) |
GETINGE/CASTLE, INC. |
MICHAEL J PALLADINO |
| K973179 |
08/25/1997 |
FEMINIQUE SONIC HAIR REMOVER |
GLOBAL TV CONCEPTS, LTD. |
SAMIA N RODRIGUEZ |
| K973174 |
08/25/1997 |
SONIQUE HAIR REMOVER |
GLOBAL TV CONCEPTS, LTD. |
SAMIA N RODRIGUEZ |
| K972839 |
08/01/1997 |
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET |
GLOBE ENT., INC. |
STEPHEN Y JAN |
| K972843 |
08/01/1997 |
PROTOS BLOOD TRANSFUSION SET |
GLOBE ENT., INC. |
STEPHEN Y JAN |
| K972854 |
08/01/1997 |
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY |
GLOBE ENT., INC. |
STEPHEN Y JAN |
| K972970 |
08/11/1997 |
MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE |
GRAPHIC CONTROLS CORP. |
KATHLEEN SELOVER |
| K973197 |
08/26/1997 |
FIRE STICK |
H.S. INTL. CO., INC. |
HENRY SHAPIRO |
| K973267 |
08/29/1997 |
TTM5000 TELEPHONIC EKG MONITOR |
HDS MEDICAL, INC. |
SEMIH CIRIT |
| K973226 |
08/27/1997 |
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR S MASER |
| K973040 |
08/14/1997 |
SPIFE IFE-6 |
HELENA LABORATORIES |
PAT FRANKS |
| K973466 |
08/15/1997 |
HANAULUX BLUE 75 AND HANAULUX BLUE 120 |
HERAEUS MED GMBH |
MARK SCHULZ |
| K972931 |
08/08/1997 |
PLUS EPF ACETABULAR CUP |
HHL CONSULTING |
HARTMUT LOCH |
| K973162 |
08/22/1997 |
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE |
HOGAN & HARTSON |
HOWARD M HOLSTEIN |
| K973023 |
08/14/1997 |
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K973163 |
08/25/1997 |
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE |
HOWMEDICA CORP. |
FRANK MAAS |
| K972864 |
08/04/1997 |
DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS |
HOWMEDICA CORP. |
FRANK MAAS |
| K972863 |
08/04/1997 |
DURATION STABILIZED UHMWPE KNEE COMPONENTS |
HOWMEDICA CORP. |
FRANK MAAS |
| K973164 |
08/25/1997 |
HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K973121 |
08/20/1997 |
INTERAX TOTAL KNEE SYSTEM |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K972893 |
08/05/1997 |
PARTNERSHIP REVISION FEMORAL STEMS |
HOWMEDICA CORP. |
FRANK MAAS |
| K972928 |
08/08/1997 |
KERBOULL CROSS |
HOWMEDICA, INC. |
FRANK MAAS |
| K973081 |
08/18/1997 |
DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) |
HOWTEK, INC. |
RUSSELL LEONARD |
| K973167 |
08/25/1997 |
POSITIVE PRESSURE CONNECTOR |
ICU MEDICAL, INC. |
SALVADORE F PALOMARES |
| K972903 |
08/06/1997 |
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS |
IMATRON, INC. |
J.A. CODUTO |
| K972879 |
08/05/1997 |
ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION |
IMATRON, INC. |
J. A. CODUTO |
| K973049 |
08/15/1997 |
IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM |
IMCOR |
ROBERT S URA |
| K972873 |
08/04/1997 |
IMMUSTRIP HAMA IGG |
IMMUNOMEDICS, INC. |
JOSEPH E PRESSLITZ |
| K973248 |
08/29/1997 |
IMTEC BONE COLLECTOR SYSTEM |
IMTEC CORP. |
M.K. PATTERSON |
| K973180 |
08/25/1997 |
IMTEC BONE TAC |
IMTEC CORP. |
M. K. PATTERSON |
| K972850 |
08/01/1997 |
SUNGLASSES |
INDOPTICA, S.A. |
JOHN R HONEY |
| K973035 |
08/14/1997 |
VIOLA II DENTAL CAMERA SYSTEM |
INNOVATIVE MEDICAL SYSTEMS, INC. |
KEVIN T SPURGEON |
| K972969 |
08/11/1997 |
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM |
INNOVATIVE MEDICAL TECHNOLOGIES, INC. |
BRADLEY V BROWN |
| K973006 |
08/13/1997 |
QUANTA LITE B2 GPI IGA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K973014 |
08/13/1997 |
QUANTA LITE B2GPI IGM |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K973066 |
08/18/1997 |
NON-REBREATHING 'T' (BE 117) |
INSTRUMENTATION INDUSTRIES, INC. |
LORI ZURAVLEFF |
| K972861 |
08/04/1997 |
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K972994 |
08/12/1997 |
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS |
INTEGRA NEUROCARE LLC. |
LORI L HAYS |
| K973253 |
08/29/1997 |
ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE |
INTERNATIONAL MEDICAL PRODUCTS, INC. |
JEFFREY R SHIDEMAN |
| K972866 |
08/04/1997 |
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT |
INTERNATIONAL TECHNIDYNE CORP. |
ROBERT H MATLAND |
| K972842 |
08/01/1997 |
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE |
INTERPORE INTL. |
DAVID P BALDING |
| K972923 |
08/08/1997 |
SUPER SILIPLUGS EAR PLUGS |
INTERVIEW MEDICAL TECHNOLOGY CORP. |
LOU MATSON |
| K972922 |
08/08/1997 |
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K |
INTERVIEW MEDICAL TECHNOLOGY CORP. |
LOU MATSON |
| K973022 |
08/14/1997 |
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 |
ISLAND BIOSURGICAL, INC. |
HUNTER A MCKAY |
| K973234 |
08/28/1997 |
MIDAS TOUCH ELECTROSURGICAL ELECTRODE |
ITI MEDICAL TECHNOLOGIES, INC. |
ROGER WERNE |
| K972875 |
08/04/1997 |
COSMOPOST |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K972933 |
08/08/1997 |
VOX/BASE FOR WINDOWS |
J-MAC SYSTEM, INC. |
SHEILA W PICKERING |
| K972985 |
08/11/1997 |
SPLINT IT |
JENERIC/PENTRON, INC. |
MURRAY G GAMBERG |
| K973030 |
08/14/1997 |
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
ANN M QUINN |
| K972855 |
08/01/1997 |
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARIKA ANDERSON |
| K973251 |
08/29/1997 |
KSEA CALCUSON |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K972926 |
08/08/1997 |
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K973068 |
08/18/1997 |
KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING |
KARL STORZ ENDOSKOP GMBH |
KEVIN KENNAN |
| K973252 |
08/29/1997 |
KARL STORZ DIRECT COUPLED CAMERA HEAD |
KARL STORZ IMAGING, INC. |
TERRY FERNANDEZ |
| K973064 |
08/18/1997 |
KEELER TEARSCOPE-PLUS |
KEELER INSTRUMENTS, INC. |
EUGENE R VAN ARSDALE |
| K972844 |
08/01/1997 |
TEMP BOND CLEAR |
KERR DENTAL MATERIALS CENTER |
WILLIAM R PIKE |
| K973215 |
08/27/1997 |
STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM |
LAURUS MEDICAL CORP. |
RICHARD A BASLER |
| K972984 |
08/11/1997 |
LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE |
LERNER MEDICAL, INC. |
MICHAEL POLLACK |
| K972975 |
08/11/1997 |
LIGHT DIAGNOSTICS RABIES DFA REAGENT |
LIGHT DIAGNOSTICS |
CINDY D PENNY |
| K973176 |
08/25/1997 |
SEIZURE EMERGENCY EQUIPMENT KIT; SEIZURE KIT |
LOTUS TECHNOLOGIES |
DILIP J KARNIK |
| K973110 |
08/20/1997 |
LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD |
LUDLOW TECHNICAL PRODUCTS |
PATRICK A MALIA |
| K973193 |
08/25/1997 |
LUXSCOPE |
LUXTEC CORP. |
JOSEPH RESS |
| K973140 |
08/21/1997 |
DUET GLUCOSE CONTROL MONITORING SYSTEM |
LXN CORP. |
VIVIANNE T NOETZEL |
| K972958 |
08/11/1997 |
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS |
LYSONIX, INC. |
MICHAEL J SARRASIN |
| K972914 |
08/07/1997 |
SYVEK PATCH |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K973012 |
08/13/1997 |
MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM |
MDC RESEARCH LTD. |
JAMES M DONEGAN |
| K973259 |
08/29/1997 |
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) |
MEDICAL CREATIVE TECHNOLOGIES, INC. |
PERK CROOK |
| K973071 |
08/18/1997 |
TRI TALON RETRIEVAL FORCEPS |
MEDICAL ENGINEERING LABORATORY, INC. |
WILLIAM J YOUNG |
| K973120 |
08/20/1997 |
READYCATH CATHETER |
MEDICAL TECHNOLOGIES OF GEORGIA |
RICHARD STARKE |
| K973198 |
08/26/1997 |
VGF-7 VASCULAR GRAFT FLOWMETER |
MEDICARD LTD. |
STEVEN A CLARKE |
| K972857 |
08/01/1997 |
SERVOTRONIC EC100 SYSTEM |
MEDICON, E.G. |
HOWARD M HOLSTEIN |
| K973062 |
08/18/1997 |
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE |
MEDIDENTA INTL., INC. |
ROBERT T POSTAL |
| K973171 |
08/25/1997 |
NIR BILIARY STENT |
MEDINOL LTD. |
TAMI ABUDI |
| K972887 |
08/05/1997 |
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG |
MEDLINE INDUSTRIES, INC. |
CHRISTINE GALEA |
| K973011 |
08/13/1997 |
BPX80 BIO-PUMP (BPX80) |
MEDTRONIC BIO-MEDICUS, INC. |
THOMAS K JOHNSEN |
| K973237 |
08/28/1997 |
CSS-CARDIOPLEGIA SAFETY SYSTEM |
MEDTRONIC BIO-MEDICUS, INC. |
THOMAS K JOHNSON |
| K972894 |
08/05/1997 |
AUTOTRANSFUSION APPARTUS (AUTOLOG) |
MEDTRONIC BLOOD MANAGEMENT |
JOYCE THOMAS |
| K972906 |
08/06/1997 |
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
| K972944 |
08/11/1997 |
MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT |
MEDTRONICS INTERVENTIONAL VASCULAR |
MARY DE ARMOND |
| K973146 |
08/22/1997 |
MENTOR SUPER ABSORBENT DRAPE |
MENTOR OPHTHALMICS, INC. |
DONNA A CRAWFORD |
| K973230 |
08/27/1997 |
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS REIGLE |
| K973268 |
08/29/1997 |
MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
CCARL ANGLES |
| K973073 |
08/18/1997 |
DRTS IMAGE INTENSIFIER DRAPE |
MINRAD, INC. |
JOHN MCNEIRNEY |
| K973067 |
08/18/1997 |
DRTS REMOTE CONTROL DRAPE |
MINRAD, INC. |
JOHN MCNEIRNEY |
| K973009 |
08/13/1997 |
MITEK NON ABSORBABLE POLYPROPYLENE H FIX |
MITEK PRODUCTS |
EDWARD F KENT |
| K972976 |
08/11/1997 |
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL |
MORE DIAGNOSTICS |
JAMES W SNIPES |
| K973254 |
08/29/1997 |
J-TIP INJECTOR |
NATIONAL MEDICAL PRODUCTS, INC. |
DANNY PATEL |
| K973057 |
08/15/1997 |
1.4 FR MAPCATH SENSOR STYLET |
NAVION BIOMEDICAL CORP. |
DONALD A KAY |
| K973147 |
08/22/1997 |
NPB-295 PULSE OXIMETER |
NELLCOR PURITAN BENNETT, INC. |
ROGER D BROWN |
| K972974 |
08/11/1997 |
ACCUWELL T4-EIA |
NEOMETRICS, INC. |
DAVID SCHWARTZ |
| K973096 |
08/19/1997 |
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM |
NEOTONUS, INC. |
SHELIA HEMEON-HEYER |
| K973218 |
08/27/1997 |
NIDEK HANDY |
NIDEK, INC. |
KEN KATO |
| K972882 |
08/05/1997 |
APOLLO |
NORLAND CORP. |
TERRY SCHWALENGERG |
| K973104 |
08/19/1997 |
NORLAND MODEL PDEXA BONE DENSITOMETER |
NORLAND CORP. |
TERRY SCHWALANBERG |
| K973025 |
08/14/1997 |
FLUID CENTURION (4-100-00) |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K972924 |
08/08/1997 |
SURGIC II IMPLANT CONTROL UNIT |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K973219 |
08/27/1997 |
AMBER DU |
OLDELFT CORP. OF AMERICA |
L. DON PHILLIPS |
| K973128 |
08/21/1997 |
OLYMPUS NA-10J-1 ASPIRATION NEEDLE |
OLYMPUS AMERICA, INC. |
SUBHASH R PATEL |
| K973232 |
08/28/1997 |
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT |
OLYMPUS WINTER & IBE GMBH |
SUBHASH R PATEL |
| K973134 |
08/21/1997 |
OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED |
OMNIGRACE LTD. |
WILLIAM E PATTON |
| K973016 |
08/13/1997 |
NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS |
OPTIMAXX INTL. |
MAUREEN MARCASON |
| K972989 |
08/12/1997 |
STC METHAMPHETAMINE MICRO-PLATE EIA |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K973159 |
08/22/1997 |
ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR |
ORATEC INTERVENTIONS, INC. |
MICHAEL KWAN |
| K973158 |
08/22/1997 |
ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE |
ORATEC INTERVENTIONS, INC. |
MICHAEL KWAN |
| K973204 |
08/26/1997 |
OSTEO BOS SYSTEM IN STAINLESS STEEL |
OSTEONICS CORP. |
KATE SUTTON |
| K972967 |
08/11/1997 |
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT |
OSTEONICS CORP. |
DONNA S WILSON |
| K973141 |
08/21/1997 |
HEART ACCESS PLUS CARDIAC EVENT RECORDER |
PACEART, INC. |
GEORGE MYERS |
| K972913 |
08/07/1997 |
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) |
PACIFIC MATERIALS AND INTERFACES |
FLOYD G LARSON |
| K972871 |
08/04/1997 |
GENESIS |
PACIFIC RIM DENTAL, INC. |
KATHY L EPPEN |
| K973200 |
08/26/1997 |
CARIES STAIN |
PARKELL, INC. |
NELSON J GENDUSA |
| K972973 |
08/11/1997 |
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM |
PERCEPTION, INC. |
SUSAN D GOLDSTEIN-FALK |
| K973122 |
08/20/1997 |
QUICKSCREEN ONE STEP THC SCREENING TEST |
PHAMATECH |
CARL A MONGIOVI |
| K972915 |
08/07/1997 |
ERBIUM 2000 LASER FAMILY |
PHANTOM TECHNOLOGIES, INC. |
JAMES A NATIONS |
| K972851 |
08/01/1997 |
ZIPPY |
PILLAR TECHNOLOGY, INC. |
CHRIS TINSLEY |
| K973098 |
08/19/1997 |
COMPRESSION CERCLAGE GUNDOLF CCG-GF |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K973077 |
08/18/1997 |
PLUS-FIT ACETABULAR CUP |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K973157 |
08/22/1997 |
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K973217 |
08/27/1997 |
BOSTON LIQUID ENZYMATIC CLEANER |
POLYMER TECHNOLOGY CORP. |
DOUGLAS J FORTUNATO |
| K973236 |
08/28/1997 |
CREST TOOTHBRUSH WITH MICROSHIELD |
PROCTER & GAMBLE CO. |
MARLENE B FEDER |
| K973090 |
08/18/1997 |
MEDSTATION |
PROGRAM S.R.L. |
DIANA UPTON |
| K972865 |
08/04/1997 |
PROMEX ENT TISSUE REMOVAL SYSTEM |
PROMEX, INC. |
JOSEPH L MARK |
| K973184 |
08/25/1997 |
PROSTATE SEEDING NEEDLE |
PROMEX, INC. |
JOSEPH L MARK |
| K973191 |
08/25/1997 |
THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM |
PULMONX |
ROBERT KOTMEL |
| K973004 |
08/13/1997 |
KNIGHTSTAR 335 |
PURITAN BENNETT CORP. |
C. MARSHALL SMITH |
| K972991 |
08/12/1997 |
MONITOR ONE NDX |
QMED, INC. |
JOSEPH HANNA |
| K973138 |
08/21/1997 |
SPIROCARD |
QRS DIAGNOSTIC, LLC. |
KEVIN J DRISCOLL |
| K973183 |
08/25/1997 |
WOUND DRAINAGE HOLDER |
R & D MEDICAL PRODUCTS, INC. |
|
| K973031 |
08/14/1997 |
STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE |
R. THOMAS GROTZ, M.D., INC. |
R. THOMAS GROTZ |
| K972905 |
08/06/1997 |
XPLAN-1 |
RADIONICS SOFTWARE APPLICATIONS, INC. |
LINDA TALBERT |
| K972927 |
08/08/1997 |
ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K973216 |
08/27/1997 |
FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) |
RMDS, INC. |
DELBERT L RICE |
| K972891 |
08/05/1997 |
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
| K973075 |
08/18/1997 |
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
| K972867 |
08/04/1997 |
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT |
ROCKET MEDICAL PLC |
L TODD |
| K972856 |
08/01/1997 |
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS |
ROCKET MEDICAL PLC |
L. TODD |
| K973201 |
08/26/1997 |
PROVI CEMENT |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
| K972935 |
08/08/1997 |
SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL |
S.S. WHITE MFG., LTD. |
HUGH SAVELL |
| K972877 |
08/04/1997 |
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD |
SAFETY SYRINGES, INC. |
ANTHONY PEREZ |
| K972878 |
08/04/1997 |
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 |
SAFETY SYRINGES, INC. |
ANTHONY PEREZ |
| K972900 |
08/06/1997 |
ULTRASAFE MODEL T200 INJECTOR |
SAFETY SYRINGES, INC. |
ANTHONY PEREZ |
| K972908 |
08/06/1997 |
SANDS SERIES III HYPERBARIC CHAMBER |
SANDS HYPERBARICS |
LACHLAN SANDS |
| K973203 |
08/26/1997 |
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES |
SANGSTAT MEDICAL CORP. |
HANA BERGER MORAN |
| K972921 |
08/08/1997 |
SANKO INTRAORAL DENTAL X-RAY |
SANKO X-RAY MANUFACTURING CO., LTD. |
WARREN E SACHS |
| K972886 |
08/05/1997 |
MIRAGE |
SEGAMI CORP., INC. |
PHILIPPE BRIANDET |
| K973078 |
08/18/1997 |
WRIST BLOOD PRESSURE METER MODEL SE-330 |
SEIN ELECTRONICS CO., LTD. |
BRENDA M KELLY |
| K972981 |
08/11/1997 |
SHIELD HELICO-G2 ELISA KIT |
SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
| K973247 |
08/29/1997 |
VINTAGE HALO |
SHOFU DENTAL CORP. |
THOMAS D YANKELITIS |
| K972998 |
08/12/1997 |
PRISMA |
SIEMENS HEARING INSTRUMENTS, INC. |
ROBERT H BEA |
| K973010 |
08/13/1997 |
REALTIME 3D DIAGNOSTIC WORKSTATION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K973222 |
08/21/1997 |
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Jacqueline Emery |
| K973131 |
08/21/1997 |
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
AMY SHAW HOSLER |
| K972979 |
08/11/1997 |
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K973228 |
08/27/1997 |
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700) |
SMITH & NEPHEW, INC. |
JIM G IRVIN |
| K973145 |
08/22/1997 |
TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K973175 |
08/25/1997 |
TONGUE KLEAN |
SOFTEK ENT. |
PROMILA GUPTA |
| K973089 |
08/18/1997 |
FREEDOM |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973086 |
08/18/1997 |
PLA-96P |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973088 |
08/18/1997 |
PLS-96P |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973092 |
08/18/1997 |
STAE |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973091 |
08/18/1997 |
WAVE |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973169 |
08/25/1997 |
PRESSURE GUARD SITE SELECT (A) |
SPAN-AMERICA MEDICAL SYSTEMS, INC. |
WANDA TOTTON |
| K973114 |
08/20/1997 |
SILICONE BILIARY STENT/BILIARY CATHETER |
SPECIALTY SURGICAL PRODUCTS, INC. |
T. JAN VARNER |
| K973082 |
08/18/1997 |
VENTRAL WALL DEFECT REDUCTION SILO |
SPECIALTY SURGICAL PRODUCTS, INC. |
T. JAN VARNER |
| K973192 |
08/25/1997 |
FLEXLENS, FLEXLENS TORIC |
SPECIALTY ULTRAVISION, INC. |
MARTIN S KNOPF |
| K973059 |
08/18/1997 |
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K973058 |
08/18/1997 |
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K972961 |
08/11/1997 |
STELKAST BIPOLAR SYSTEM |
STELKAST COMPANY |
DONALD A STEVENS |
| K973223 |
08/27/1997 |
STELLAR MODEL HS-04 |
STELLAR MEDICAL CORP. |
T. WHIT ATHEY |
| K972965 |
08/11/1997 |
STERI-OSS UNTIL IMPLANT CEMENT |
STERI-OSS, INC. |
DON KENNARD |
| K973028 |
08/14/1997 |
HELIOS LASER IMAGER 1417 |
STERLING DIAGNOSTIC IMAGING, INC. |
TIMOTHY W CAPEHART |
| K973206 |
08/26/1997 |
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY |
STERLING DIAGNOSTIC IMAGING, INC. |
ELAINE H KINDELL |
| K973195 |
08/26/1997 |
TOTAL PERFORMANCE SYSTEM SHAVER |
Stryker Endoscopy |
ERIC FINLEY |
| K973124 |
08/20/1997 |
APR POROUS HA HIP SYSTEM |
SULZER ORTHOPEDICS, INC. |
LORI K HOLDER |
| K973087 |
08/18/1997 |
MOST HEX INTRAMEDULLARY (I/M) STEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K974161 |
08/27/1997 |
STEALTHSTATION SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
DAVID A MIRE |
| K972890 |
08/05/1997 |
ENLIGHT (TENTATIVE NAME) |
SYBRON DENTAL SPECIALTIES, INC. |
WILLIAM R PIKE |
| K972858 |
08/04/1997 |
KERR NEXUS ONE BOTTLE ADHESIVE |
SYBRON DENTAL SPECIALTIES, INC. |
WILLIAM R PIKE |
| K973109 |
08/19/1997 |
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
SYNERMED, INC. |
MARCIA J ARENTZ |
| K973017 |
08/13/1997 |
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP |
SYNTHES (USA) |
KEVIN J O'CONNELL |
| K973018 |
08/13/1997 |
SYNTHES MINI LENGTHENING APPARATUS |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K973240 |
08/28/1997 |
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K972960 |
08/11/1997 |
HEALTH CHECK URI-TEST PROTEIN IN URINE |
TCPI, INC. |
FRAN WHITE |
| K973166 |
08/25/1997 |
DOW CORNING SILASTIC ELASTOMER Q7-4750 |
TECHNICAL PRODUCTS, INC. |
NORBERT D THOMPSON |
| K973208 |
08/27/1997 |
FIRST SIGN |
TEXAS IMMUNOLOGY, INC. |
CHARLES W GILL |
| K973189 |
08/25/1997 |
RETINOL BINDING PROTEIN RBP RID KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K973245 |
08/29/1997 |
TOKUSO REBASE MR. BOND |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K973050 |
08/15/1997 |
MICRO21 WITH WBC ESTIMATE |
TRIANGLE BIOMEDICAL SCIENCES, INC. |
R. OTTO STELLNER |
| K973172 |
08/25/1997 |
RESPOSABLE BARE FIBERS |
TRIMEDYNE, INC. |
SUSAN H GAMBLE |
| K973132 |
08/21/1997 |
EZ HOLD 1 LBS., EZ HOLD 2 LBS |
TZ MEDICAL, INC. |
BYRON ZAHLER |
| K973396 |
08/25/1997 |
QUEST PET IMAGING SYSTEM |
UGM MEDICAL SYSTEMS, INC. |
GERD MUEHLLEHNER |
| K973083 |
08/18/1997 |
ULTRACELL NEURO SPONGES |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K973085 |
08/18/1997 |
ULTRACELL PACKING WITH SLEEVE |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K973153 |
08/22/1997 |
UBI MAGIWEL AMPHETAMINE METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K973156 |
08/22/1997 |
UBI MAGIWEL COCAINE METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K973154 |
08/22/1997 |
UBI MAGIWEL MARIJUANA METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K973155 |
08/22/1997 |
UBI MAGIWEL OPIATE METABOLITES |
UNITED BIOTECH, INC. |
WUAN T LU |
| K972911 |
08/07/1997 |
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K973143 |
08/22/1997 |
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA |
UNIVERSAL REAGENTS, INC. |
JORGE MILLER |
| K973076 |
08/18/1997 |
EUROMEDICAL HAEMATURIA FOLEY CATHETER |
UNOMEDICAL SDN BHD |
PATRICK J LAMB |
| K973013 |
08/13/1997 |
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER |
VAS-CATH, INC. |
DONNA J WILSON |
| K973065 |
08/18/1997 |
REALVIEW TELEMEDICINE SYSTEM |
VCOM SYSTEMS, INC. |
WAYNE B JACOBS |
| K972880 |
08/05/1997 |
MDP2000 MEDICAL DATA PROCESSOR |
VIDCO, INC. |
BRADLEY COHEN |
| K972957 |
08/11/1997 |
SA-EF MULTI-LUMEN EXTENSION SET |
VLV ASSOCIATES, INC. |
VINCENT VAILLANCOURT |
| K972889 |
08/05/1997 |
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) |
W & H DENTALWERK |
HERBERT TRASCHWANDTNER |
| K973055 |
08/15/1997 |
WAKO CH50 LINEARITY SET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K973072 |
08/18/1997 |
WAKO NEFA LINEARITY SET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K973080 |
08/18/1997 |
SURGICAL VASCULAR CLAMP |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K973074 |
08/18/1997 |
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR |
WATERS CORPORATION |
VIRGINIA L CORBIN |
| K973020 |
08/13/1997 |
PATIENT EXAMINATION POWDER-FREE GLOVES |
WEAR SAFE MALAYSIA SDN. BHD. |
CLAUDE COTTET |
| K973261 |
08/29/1997 |
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL |
| K973205 |
08/26/1997 |
WILSON-COOK STRICTURE MEASURING CATHETER |
WILSON-COOK MEDICAL, INC. |
SOPHIA ROUSE |
| K973196 |
08/26/1997 |
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
