| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K971805 |
05/15/1997 |
ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE |
AARON MEDICAL INDUSTRIES |
J. ROBERT SARON |
| K971621 |
05/01/1997 |
RESISTICK SOLID LAPAROSCOPIC ELECTRODES |
AARON MEDICAL INDUSTRIES |
J. ROBERT SARON |
| K971674 |
05/07/1997 |
VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST |
AARON MEDICAL INDUSTRIES |
J. ROBERT SARON |
| K971694 |
05/07/1997 |
ETEST FOR CEFTAZIDIME |
AB BIODISK |
ANNE BOLMSTROM |
| K971697 |
05/08/1997 |
ETEST FOR LEVOFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K972182 |
05/29/1997 |
ABBOTT STREP A CONTROLS |
ABBOTT DIAGNOSTICS |
GRACE LEMIEUX |
| K972756 |
05/30/1997 |
MODIFICATION OF EST CULTURE SYSTEM II - MYCO |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K971980 |
05/29/1997 |
MCD-AC |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K971878 |
05/21/1997 |
VANTAGE 2.1 EXSPECT |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K971913 |
05/22/1997 |
GR100F URINE FLOWMETER |
ALBYN MEDICAL LTD. |
ROSS K MAXWELL |
| K971618 |
05/02/1997 |
ALCON CONTACT LENS CASE |
ALCON LABORATORIES |
MICHEAL E PFLEGER |
| K971888 |
05/21/1997 |
GLUTATECT |
ALDEN SCIENTIFIC, INC. |
ADOLPH E D'AMICO |
| K971828 |
05/16/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971604 |
05/01/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971826 |
05/16/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971865 |
05/20/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971866 |
05/20/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K971827 |
05/16/1997 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K972004 |
05/30/1997 |
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS |
ALKO DIAGNOSTIC CORP. |
JANET A MCGRATH |
| K971988 |
05/29/1997 |
ALLEN, ULTRA AND SMART SOCKETS |
ALLEN MEDICAL SYSTEMS, INC. |
SUZANNE KAY RATZLOFF |
| K972452 |
05/07/1997 |
RAMY INTEGRATED NEEDLE SYRINGE |
ALSHIFA MEDICAL SYRINGES MFG. CO., LTD. |
MILTON N BENEKE, JR. |
| K971664 |
05/06/1997 |
RAMY PISTON SYRINGE |
ALSHIFA MEDICAL SYRINGES MFG. CO., LTD. |
MILTON N BENEKE |
| K972190 |
05/19/1997 |
THYROGLOBULIN ASSAY SYSTEM |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
RICHARD CONLEY |
| K971853 |
05/20/1997 |
ENDOVIEW SPPHIRE LENS SET |
AMERICAN MEDICAL DEVICES, INC. |
FRANK J TIGHE |
| K971918 |
05/23/1997 |
AMERIGEL OINTMENT SATURATED WOUND DRESSING |
AMERX HEALTH CARE CORP. |
RON MADDIX |
| K971747 |
05/12/1997 |
AMPLAID 460 |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K971740 |
05/12/1997 |
AMPLAID MK12 |
AMPLIFON S.P.A. |
DANIEL KAMM |
| K971929 |
05/27/1997 |
AMSINO URINARY LEG BAG |
AMSINO INTL., INC. |
RICHARD Y LI |
| K971758 |
05/13/1997 |
CAUTERIZATION SMOKE EVACUATOR |
APPLIED MEDICAL TECHNOLOGIES |
THOMAS W PARKINSON |
| K971757 |
05/13/1997 |
LOW PROFILE FEEDING SET ACCESSORY |
APPLIED MEDICAL TECHNOLOGIES |
THOMAS W PARKINSON |
| K971699 |
05/08/1997 |
ARGOSY DYNAMEQ |
ARGOSY ELECTRONICS |
DENNIS J DAVIS |
| K971830 |
05/16/1997 |
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM |
ARGUS PHOTONICS GROUP |
KEVIN DICKENSON |
| K971723 |
05/09/1997 |
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) |
ARTHREX, INC. |
SCOTT M DURLACHER |
| K971693 |
05/07/1997 |
RIONET HB-79P |
AUTHORIZED HEARING SYSTEMS, INC. |
HENRY SMITH |
| K971645 |
05/05/1997 |
REGANES SPINAL NEEDLE (VARIOUS) |
AVID N.I.T., INC. |
JOSEPH E HARMS |
| K971851 |
05/20/1997 |
INTERPLEURAL ANESTHESIA CATHETER |
AXIOM MEDICAL, INC. |
RIDWAN HARDY |
| K971819 |
05/16/1997 |
EPOCH 2000 NEUROLOGICAL WORKSTATION |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K971935 |
05/27/1997 |
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) |
B & D CORP. |
LADISLAU BIRO |
| K971924 |
05/23/1997 |
BLUNT SYRINGE CANNULA |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K971999 |
05/30/1997 |
PERIPHERALLY INSERTED CENTRAL |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K971991 |
05/09/1997 |
GESCO PER-Q-CATH MIDLINE CATHETERS |
BARD ACCESS SYSTEMS, INC. |
JANE ANN MARTIN |
| K971990 |
05/09/1997 |
GESCO PER-Q-CATH PICC CATHETERS |
BARD ACCESS SYSTEMS, INC. |
JANE ANN MARTIN |
| K971701 |
05/08/1997 |
CONTINU-FLO SOLUTION SET |
BAXTER HEALTHCARE CORP. |
MARY ELLEN SNYDER |
| K971998 |
05/30/1997 |
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K971713 |
05/09/1997 |
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K971716 |
05/09/1997 |
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K971989 |
05/29/1997 |
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA |
| K971602 |
05/01/1997 |
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K971958 |
05/28/1997 |
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT |
BECKMAN INSTRUMENTS, INC. |
LUCINDA STOCKERT |
| K971788 |
05/14/1997 |
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K971994 |
05/29/1997 |
B-D ASSURE EAR THERMOMETER |
BECTON DICKINSON CONSUMER PRODUCTS |
PETER ZURLO |
| K971600 |
05/01/1997 |
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) |
BEHRING DIAGNOSTICS, INC. |
DAVID KOLEJAIL |
| K971596 |
05/01/1997 |
EMIT II OPIATES 300/2000 ASSAY |
BEHRING DIAGNOSTICS, INC. |
DAVID KOLESAR |
| K972011 |
05/30/1997 |
OPUS ETHANOL |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K971725 |
05/09/1997 |
OPUS PROGESTERONE |
BEHRING DIAGNOSTICS, INC. |
Ruth Forstadt |
| K971852 |
05/20/1997 |
AIR CONDUCTION HAEARING AIDS |
BELTONE ELECTRONICS CORP. |
ROBERT A KRATOCHVIL |
| K971744 |
05/12/1997 |
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) |
BERKLEY MEDICAL RESOURCES, INC. |
FRANK R DASTOLI |
| K971629 |
05/02/1997 |
PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K971954 |
05/28/1997 |
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) |
BIO-RAD |
ELIZABETH PLATT |
| K971691 |
05/07/1997 |
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 |
BIO-RAD |
ELIZABETH PLATT |
| K971952 |
05/28/1997 |
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) |
BIO-RAD |
ELIZABETH PLATT |
| K971726 |
05/09/1997 |
CV PERI-GUARD - CARDIOVASCULAR PATCH |
BIO-VASCULAR, INC. |
BARBARA ATZENHOEFER |
| K971761 |
05/12/1997 |
PERSONALLAB AUTOMATED MICROPLATE ANALYZER |
BIOCHEM IMMUNOSYSTEMS (U.S.), INC. |
JAMES SAFRANKO |
| K971782 |
05/14/1997 |
BONE AND MARROW COLLECTION SYSTEM KIT |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K971892 |
05/22/1997 |
BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 |
BIOMEDICAL HORIZONS, INC. |
WILLIAM J DONAHUE |
| K971816 |
05/16/1997 |
ATLAS FRACTURE PROXIMAL HUMERAL NAIL |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K971870 |
05/21/1997 |
LACTOSORB TRAUMA PLATING SYSTEM |
BIOMET, INC. |
MARY VERSTYNEN |
| K971824 |
05/16/1997 |
REACH FEMORAL HIP COMPONENT |
BIOMET, INC. |
DEBORAH M MATARAZZO |
| K971890 |
05/22/1997 |
RECOVERY PROTRUSIO CAGE |
BIOMET, INC. |
DEBORAH M MATARAZZO |
| K971938 |
05/27/1997 |
REPICCI II UNICONDYLAR KNEE |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K971841 |
05/19/1997 |
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST |
BIONIKE LABORATORIES, INC. |
JANIS FREESTONE |
| K971942 |
05/27/1997 |
SLED, FINGER, HANDLE |
BIOSOUND ESAOTE, INC. |
GERALD A RICHARDSON |
| K971700 |
05/08/1997 |
BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER |
BIOSOUND, INC. |
GERALD A RICHARDSON |
| K971930 |
05/27/1997 |
BK-N SEALING CAP |
BIOTRONIK, INC. |
KENNETH JENSEN |
| K971971 |
05/29/1997 |
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK |
BOARD OF DIRECTORS, ALBERT BROWNE LTD. |
CYNTHIA J. M. NOLTE |
| K971833 |
05/19/1997 |
ELECSYS FERRITIN |
BOEHRINGER MANNHEIM CORP. |
LEEANN CHAMBERS |
| K971657 |
05/06/1997 |
ACCURUN 121 HAV IGM POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K971688 |
05/07/1997 |
IVT 0.014 PTFE-COATED TRACKWIRE |
BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES |
KEVIN E DALY |
| K971673 |
05/07/1997 |
40 CC SUMO |
BOSTON SCIENTIFIC CORP. |
LEO BASTA |
| K971906 |
05/23/1997 |
JEJENOSTOMY FEEDING TUBE |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K971607 |
05/01/1997 |
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS |
BOSTON SCIENTIFIC CORP. |
ANGELA RAUN |
| K971941 |
05/27/1997 |
AQUA SPRAY |
BOYD INDUSTRIES, INC. |
BRUCE V LIVINGSTON |
| K971793 |
05/15/1997 |
VERY PRIVATE INTIMATE MOISTURE |
BRANDWYNNE CORP. |
JACQUELINE B BRADWYNNE |
| K972016 |
05/30/1997 |
AUTIMO 2.5-D AND AUTIMO 3-D |
C.L. MCINTOSH & ASSOC., INC. |
T. WHIT ATHEY |
| K971775 |
05/13/1997 |
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 |
CARDIAC CONTROL SYSTEMS, INC. |
TERRY C MCMAHON |
| K971975 |
05/29/1997 |
CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER |
CARDIMA, INC. |
JACK P DOUGLAS |
| K971748 |
05/12/1997 |
TAS PT-NCTEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
James M Clinton |
| K971967 |
05/28/1997 |
BUN |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971907 |
05/23/1997 |
CALCIUM REAGENT |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971908 |
05/23/1997 |
CREA OR CREATININE |
CAROLINA LIQUID CHEMISTRIES CORP. |
CYNTHIA SHUGART |
| K971889 |
05/21/1997 |
CHAD TOTAL O2 DELIVERY SYSTEM |
CHAD THERAPEUTICS, INC. |
LOUIE GORYOKA |
| K972012 |
05/30/1997 |
CHOLESTECH BUN/CREATININE TEST SYSTEM |
CHOLESTECH CORP. |
GARY HEWETT |
| K971653 |
05/06/1997 |
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM |
CLINICAL DIAGNOSTICS, INC. |
RHONDA P BLANTON |
| K971669 |
05/06/1997 |
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR |
COBE CARDIOVASCULAR, INC. |
MARY L ARMSTRONG |
| K971712 |
05/09/1997 |
COEUR 130 ML ANGIOGRAPHIC SYRINGE |
COEUR LABORATORIES, INC. |
CHRISTINE L PANZL |
| K971597 |
05/01/1997 |
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) |
COLOPLAST CORP. |
RICHARD A HAMER |
| K971881 |
05/20/1997 |
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS |
COMEG ENDOSCOPY |
KAELYN HADLEY |
| K971903 |
05/23/1997 |
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
ROBERT S ANDERSON |
| K971879 |
05/21/1997 |
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
ROBERT S ANDERSON |
| K971838 |
05/19/1997 |
MICRO ELECTRODES |
COOPERSURGICAL, INC. |
DEBRA A PEKAR |
| K971837 |
05/19/1997 |
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 |
COOPERSURGICAL, INC. |
DEBRA A PEKAR |
| K971836 |
05/19/1997 |
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR |
COOPERSURGICAL, INC. |
DEBRA A PEKAR |
| K971646 |
05/05/1997 |
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER |
CORDIS CORP. |
ELENA JUGO |
| K971608 |
05/01/1997 |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
CORDIS CORP. |
ELENA S JUGO |
| K971985 |
05/29/1997 |
N-ASSAY TIA PLASMINOGEN TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
MARY REES |
| K971920 |
05/23/1997 |
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) |
CUSTOMED, INC. |
GLADYNELL RODRIQUEZ |
| K972002 |
05/30/1997 |
CYNOSURE DERMATOLOGY LASER COOLING TIP |
CYNOSURE, INC. |
GEORGE CHO |
| K971737 |
05/12/1997 |
CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K971905 |
05/23/1997 |
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING |
DAKO CORP. |
GRETCHEN M MURRAY |
| K971650 |
05/06/1997 |
RHYTHMSTAT XL |
DATA CRITICAL CORP. |
LISA S JONES |
| K971616 |
05/02/1997 |
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) |
DATA SCIENCES INTL., INC. |
JIM HUHN |
| K971591 |
05/01/1997 |
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) |
DAVID C. BISHOP, PH.D. |
DAVID C BISHOP |
| K971745 |
05/12/1997 |
BARD COMPOSITE PROSTHESIS |
DAVOL, INC., SUB. C.R. BARD, INC. |
JEANNETTE G CLOUTIER |
| K971696 |
05/08/1997 |
SENTINEL RECORDER, MODELS 471/472 |
DEL MAR AVIONICS |
RAPHAEL HENKIN |
| K971727 |
05/09/1997 |
DCI WATER PURIFIER |
DENTAL COMPONENTS, INC. |
RICHARD W HANSON |
| K971869 |
05/21/1997 |
FINESSE ALL-CERAMIC SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K971606 |
05/01/1997 |
STERILE FLEXOFILE FILES AND INSTRUMENTS |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K971603 |
05/01/1997 |
STERILE SUREFLEX FILES AND INSTRUMENTS |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K971753 |
05/12/1997 |
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 |
DENVER BIOMATERIALS, INC. |
LYNNE LEONARD |
| K971730 |
05/09/1997 |
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY, INC. |
ARLENE C SAULL |
| K971742 |
05/12/1997 |
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT |
DEPUY, INC. |
ARLENE C SAULL |
| K971976 |
05/29/1997 |
DIASCREEN REAGENT STRIPS |
DIA-SCREEN CORP. |
VICKI FRAWLEY |
| K971792 |
05/15/1997 |
IMMULITE FREE T4 (2-STEP) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K971823 |
05/16/1997 |
ACTIVE TESTOSTERONE EIA (DSL-10-4000) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN WILLIS |
| K971877 |
05/21/1997 |
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K971586 |
05/01/1997 |
DIGENE CERVICAL BRUSH |
DIGENE CORP. |
CONSTANCE A FINCH |
| K971855 |
05/20/1997 |
POTTY PAL AND FOREVER-DRY |
DIGITAL APPLICATIONS, INC. |
D. LYNN SHEPPARD |
| K971641 |
05/02/1997 |
ANTIBACTERIAL GUTTA PERCHA |
DR. HOWARD MARTIN, P.A. |
KYLE H SIBINOVIC |
| K971923 |
05/23/1997 |
DRAGER-VAPOR 2000 |
DRAEGER MEDICAL, INC. |
JAMES J BRENNAN |
| K971926 |
05/27/1997 |
QUIKSTRIP ONE STEP COCAINE TEST |
DRIAL CONSULTANTS, INC. |
CLEVE W LAIRD |
| K971619 |
05/01/1997 |
MICROFUSE MEMBRANE INFUSION CATHETER |
E-MED CORP. |
JOHN DOCKTER |
| K971829 |
05/16/1997 |
MIS ELECTROSURGICAL ELECTRODE |
E-TEK, INC. |
DANIEL S BROWN |
| K971948 |
05/28/1997 |
PATIENT RESTRAINT |
E.M. ADAMS CO., INC. |
RICHARD K DONAHUE |
| K971894 |
05/22/1997 |
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM |
EASTMAN KODAK COMPANY |
JUDITH A WALLACE |
| K971973 |
05/29/1997 |
KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER |
EASTMAN KODAK COMPANY |
HERMANN ARNDT |
| K971831 |
05/16/1997 |
QUICK CHECK INSTANT THERMOMETER |
EJB MEDICAL, INC. |
EDWARD J BUZBY |
| K971588 |
05/01/1997 |
EVI SUTURED-CLIP APPLIER |
ELECTIVE VASCULAR INTERVENTION INC. (EVI) |
MICHAEL A DANIEL |
| K971970 |
05/29/1997 |
EBI SPINELINK SYSTEM |
ELECTRO-BIOLOGY, INC. |
JON CAPAROTTA |
| K971799 |
05/15/1997 |
PRECISION FLOW OSV II |
ELEKTA IMPLANTS, SA |
BARBARA RAMSEYER |
| K971598 |
05/01/1997 |
STERICHEK CHLORINE REAGENT STRIPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
DAVID A MORRIS |
| K971640 |
05/02/1997 |
LEADCARE BLOOD LEAD TESTING SYSTEM |
ESA, INC. |
JAMES MAYOL |
| K971738 |
05/12/1997 |
ENDOPATH RESPOSABLE TROCAR SYSTEM |
ETHICON ENDO-SURGERY, INC. |
IVAN S PLACKO |
| K971689 |
05/07/1997 |
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT |
EURO-DIAGNOSTICA AB |
KARL A POSSELT |
| K971690 |
05/07/1997 |
IMMUNOSCAN PR3-ANCA |
EURO-DIAGNOSTICA AB |
KARL A POSSELT |
| K972008 |
05/30/1997 |
ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES |
EUROPEAN SURGICAL, INC. |
ELLEN HENKE-KNUPP |
| K971702 |
05/08/1997 |
FAR-EAST BARRIER GOWNS |
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
DAVID SONG |
| K971813 |
05/16/1997 |
EMBLA |
FERGUSON MEDICAL |
FRANK FERGUSON |
| K971695 |
05/08/1997 |
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER |
FISHER & PAYKEL ELECTRONICS LTD. |
CHRIS MANDER |
| K971919 |
05/23/1997 |
EZCHEK/HBA BLOOD COLLECTION KIT |
FLEXSITE DIAGNOSTICS, INC. |
DONALD R STONE |
| K971794 |
05/15/1997 |
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE |
FRANTZ DESIGN, INC. |
DONALD FRANTZ |
| K971670 |
05/06/1997 |
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
JORDAN GAVRIELIDES |
| K971667 |
05/06/1997 |
CARDIAC PHASED ARRAY COIL |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K971668 |
05/06/1997 |
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K971759 |
05/12/1997 |
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER |
GREEN FIELD MEDICAL SOURCING, INC. |
DONALD R GORSUCH |
| K971815 |
05/16/1997 |
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE |
GUIDANT CORP. |
MONA MIRAPURI |
| K971857 |
05/20/1997 |
MUMPS IGG ELISA TESTY |
GULL LABORATORIES, INC. |
FRED W RACHFORD |
| K971867 |
05/20/1997 |
ALICE 4R SYSTEM |
HEALTHDYNE TECHNOLOGIES, INC. |
TIMOTHY Y COWART |
| K971807 |
05/15/1997 |
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL |
HEAR-RIGHT, INC. |
CRAIG BLOOMINGBURG |
| K971671 |
05/07/1997 |
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) |
HEIDELBERG ENGINEERING |
GERHARD ZINSER |
| K971909 |
05/23/1997 |
VIRGO AMA ELISA KIT |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K971733 |
05/09/1997 |
2 BOND 2 |
HERAEUS KULZER, INC. |
SHARON PARKER |
| K971910 |
05/23/1997 |
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K971887 |
05/21/1997 |
BREATH TAKER |
HOFA LLC. |
ZUDHIR NADKARNI |
| K971741 |
05/12/1997 |
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE |
HOWMEDICA CORP. |
FRANK MAAS |
| K971755 |
05/12/1997 |
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM |
HOWMEDICA CORP. |
JOHN DICHIARA |
| K971854 |
05/20/1997 |
OSTEOLOCK ACETABULAR SHELL SYSTEM |
HOWMEDICA CORP. |
FRANK MAAS |
| K971789 |
05/14/1997 |
IMPLEX CONTINUUM POROUS PATELLAR |
IMPLEX CORP. |
GLENN N BYRD |
| K971705 |
05/08/1997 |
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED |
IMPLEX CORP. |
GLENN N BYRD |
| K971950 |
05/28/1997 |
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER |
INFINITECH, INC. |
ALAN T BECKMAN |
| K971922 |
05/23/1997 |
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN M PAGE |
| K971614 |
05/02/1997 |
QUANTA LITE RF IGM |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K971620 |
05/01/1997 |
QUANTA LITE RUBEOLA (MEASLES) IGG |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K971777 |
05/14/1997 |
QUANTEX ASO-CRP-RF CONTROL |
INSTRUMENTATION LABORATORY CO. |
BETTY J LANE |
| K971617 |
05/02/1997 |
ENDOSCOPIC VENTRICULAR CATHETER |
INTEGRA NEUROCARE LLC. |
LORI L HAYS |
| K972006 |
05/30/1997 |
ACTA OEM MODULE |
INTERACTIVE CONSULTING, INC. |
JACKIE MASSE |
| K971840 |
05/19/1997 |
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM |
INVIVO RESEARCH, INC. |
FRANCIS X CASEY |
| K971809 |
05/15/1997 |
ISOLATE |
IRVINE SCIENTIFIC SALES CO., INC. |
KEN LYDERSEN |
| K971708 |
05/08/1997 |
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE |
J & J ENGINEERING, INC. |
ANAND AKERKAR |
| K971682 |
05/06/1997 |
J-FX CERCLAGE SYSTEM |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JOHN FERROS |
| K971652 |
05/06/1997 |
P.F.C. SIGMA INSET PATELLA |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JOHN D FERROS |
| K971944 |
05/27/1997 |
LACTEST I |
JWT, INC. |
JAMES B JOHNSTON |
| K971982 |
05/29/1997 |
KARL STORZ MODEL 203020 20 EQUIMAT |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K971977 |
05/29/1997 |
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MARLENA ALLEN PIERCY |
| K971649 |
05/06/1997 |
KSEA ARTHROPUMP PLUS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K971917 |
05/23/1997 |
KENTRON'S ISOLATION GOWN |
KENTRON HEALTH CARE, INC. |
NARI SADARANGANI |
| K971843 |
05/14/1997 |
LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES |
LASERSCOPE |
LISA MCGRATH |
| K971873 |
05/20/1997 |
LEVO ACTIVE-EASY LAE |
LEVO USA |
THOMAS RAEBER |
| K971647 |
05/05/1997 |
LL BI-FOCAL, DAILY WEAR CONTACT LENS |
LOMBART LENSES, LTD. |
LISA HAHN |
| K971797 |
05/15/1997 |
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
| K971801 |
05/15/1997 |
LAPAROTOMY BLADDER NECK SUSPENSION KIT |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
| K971796 |
05/15/1997 |
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
| K971802 |
05/15/1997 |
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
| K971791 |
05/15/1997 |
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION |
LOUISVILLE LABORATORIES, INC. |
MARY MCNAMARA-CULLINANE |
| K971832 |
05/19/1997 |
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK |
M-PACT WORLDWIDE MANAGEMENT CORP. |
BARRY HALE |
| K971868 |
05/20/1997 |
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM |
MARQUETTE ELECTRONICS, INC. |
DIANNE SCHMITZ |
| K971683 |
05/07/1997 |
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET |
MARQUETTE ELECTRONICS, INC. |
DIANNE SCHMITZ |
| K971844 |
05/19/1997 |
MCKINLEY OUTBOUND-2 SYSTEM |
MCKINLEY, INC. |
BRIAN D ZDEB |
| K971859 |
05/20/1997 |
EARCHECK |
MDI INSTRUMENTS, INC. |
SANDRA KIMBALL |
| K971966 |
05/28/1997 |
CORONARY VEIN GRAFT TAG MARKER |
MED-EDGE, INC. |
STEVE OWENBY |
| K971914 |
05/23/1997 |
TECA NCS ELECTRODE SYSTEM 2000 |
MEDELEC, INC. D.B.A. TECA CORP. |
JAMES P HURLMAN |
| K971933 |
05/27/1997 |
PORT-NEB |
MEDIC-AID LTD. |
PAUL E DRYDEN |
| K971925 |
05/23/1997 |
MEDCOMP BIO-FLEX CS CATHETER (CS100) |
MEDICAL COMPONENTS, INC. |
JEANNE CUSH |
| K971916 |
05/23/1997 |
MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL |
MEDICAL Z, S.A. |
EMALEE G MURPHY |
| K971812 |
05/16/1997 |
PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP |
MEDISENSE, INC. |
MICHAEL HALPIN |
| K971860 |
05/20/1997 |
MEDISYSTEMS DIALYSIS PRIMING SETS |
MEDISYSTEMS CORP. |
LARRY R PILOT |
| K971996 |
05/30/1997 |
MEDIVISION ARTHROSCOP |
MEDIVISION SCOPE SERVICE CENTER, INC. |
WAYNE B STERNER |
| K971995 |
05/30/1997 |
MEDIVISION SINOSCOPE |
MEDIVISION SCOPE SERVICE CENTER, INC. |
WAYNE B STERNER |
| K971943 |
05/27/1997 |
MYRINGOTOMY TUBE |
MEDNET LOCATOR, INC. |
JUDY S CHANDLER |
| K971897 |
05/22/1997 |
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) |
MEDRON, INC. |
RON WORTLEY |
| K971756 |
05/12/1997 |
MEDTRONIC MODEL 3998 LEAD |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
| K971814 |
05/15/1997 |
IMPROVEMENTS TO THE MEHL RUBY LASER |
MEHL/BIOPHILE INTL., INC. |
THOMAS BLAKE |
| K971585 |
05/01/1997 |
IMMUNOCARD STAT! ROTAVIRUS |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K971984 |
05/29/1997 |
AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) |
MICROVENA CORP. |
JANELL COLLEY |
| K972017 |
05/30/1997 |
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) |
MINNTECH CORP. |
LYNN LUEDERS |
| K971808 |
05/15/1997 |
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES |
MONARCH MEDICAL |
MO SHARIFF |
| K971835 |
05/19/1997 |
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA |
MONOBIND |
FREDERICK R JEROME |
| K971834 |
05/19/1997 |
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA |
MONOBIND |
FREDERICK R JEROME |
| K971921 |
05/23/1997 |
PROLACTIN (PRL) HORMONE MICROPLATE ELISA |
MONOBIND |
DREDERICK R JEROME |
| K971780 |
05/14/1997 |
THYROTROPIN(TSH) ELISA |
MONOBIND |
FREDERICK R JEROME |
| K971709 |
05/08/1997 |
TOTAL THROXINE MICROPLATE EIA(225-300) |
MONOBIND |
FREDERICK R JEROME |
| K971779 |
05/14/1997 |
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA |
MONOBIND |
FREDERICK R JEROME |
| K972015 |
05/30/1997 |
HYDRAGEL 7,15,30, CHOL-HDL KIT |
MORAX |
BOREK JANIK |
| K971622 |
05/02/1997 |
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM |
MPL TECHNOLOGIES, INC. |
DANIEL J OSTERBY |
| K971663 |
05/06/1997 |
WELLCOLEX E.COLI O157:H7 |
MUREX BIOTECH LTD. |
REBECCA VINE |
| K971714 |
05/09/1997 |
NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO |
NATIONAL DATA CORP. |
SANDRA BARNES |
| K972013 |
05/30/1997 |
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS |
NATIONAL HEALTHCARE MFG. CORP. |
CAROLANN KOTULA |
| K971687 |
05/02/1997 |
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME |
NATIONAL MEDICAL CARE, INC. |
DEBRA L BING |
| K971946 |
05/27/1997 |
NPB-190 PULSE OXIMETER (NPB-190) |
NELLCOR PURITAN BENNETT, INC. |
ROGER D BROWN |
| K971642 |
05/02/1997 |
DENTALIS KEZ ENDODONITC SEALER |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
KYLE H SIBINOVIC |
| K971896 |
05/22/1997 |
GALILEO HIGH RESOLUTION MICRO COUPLER |
NETOPTIX CORP. |
KIN WONG |
| K971803 |
05/12/1997 |
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 |
NEUROTRONICS, INC. |
JACK R SMITH |
| K972001 |
05/30/1997 |
NICAS(TM) ELECTRODE |
NI MEDICAL |
BARRY SALL |
| K971707 |
05/06/1997 |
SUNGLASSES (NON-PRESCRIPTION) |
NIKO SUNGLASSES CORP. |
FU-HSING LIU |
| K971706 |
05/08/1997 |
TIADAPT ABUTMENT SYSTEM |
NOBEL BIOCARE UAS INC |
BETSY A BROWN |
| K971774 |
05/13/1997 |
NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K971601 |
05/01/1997 |
OLYMPIC BILI-BASSINET |
OLYMPIC MEDICAL CORP. |
JOSEPH P STEFANILE |
| K971817 |
05/16/1997 |
OLYMPUS CK-MB REAGENT |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K971660 |
05/06/1997 |
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT |
OLYMPUS AMERICA, INC. |
SUBHASH R PATEL |
| K971679 |
05/07/1997 |
I-SCOPE OPHTHALMIC ENDOSCOPE |
OPHTHALMIC TECHNOLOGIES, INC. |
RICHARD WEITZ |
| K971993 |
05/29/1997 |
ODI COMPRESSION HIP SCREW SYSTEM |
ORTHOPAEDIC DESIGNS, INC. |
RANDY LAWSON |
| K971692 |
05/07/1997 |
OSTEOPOWER SYSTEM AND ACCESSORIES |
OSTEOMED CORP. |
CINDY WALTERS |
| K971800 |
05/15/1997 |
OSTEO CANNULATED SCREW SYSTEM |
OSTEONICS CORP. |
KATE SUTT0N |
| K971654 |
05/06/1997 |
OSTEO COMPRESSION HIP SCREW SYSTEM |
OSTEONICS CORP. |
DONNA S WILSON |
| K971962 |
05/28/1997 |
OSTEO KIRSCHNER WIRES |
OSTEONICS CORP. |
TERRY SHERIDAN |
| K971778 |
05/14/1997 |
OSTEO SMALL AND MINI BONE SCREWS |
OSTEONICS CORP. |
DONNA S WILSON |
| K971964 |
05/28/1997 |
OXLIFE EXCELL OXYGEN CONCENTRATORS |
OXLIFE, INC. |
STUART BASSINE |
| K971635 |
05/02/1997 |
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971631 |
05/02/1997 |
CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971638 |
05/02/1997 |
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971637 |
05/02/1997 |
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971633 |
05/02/1997 |
PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971636 |
05/02/1997 |
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971632 |
05/02/1997 |
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971795 |
05/15/1997 |
AUTOMATED CHAMBER MAINTENANCE MODULE |
PARADIGM MEDICAL INDUSTRIES, INC. |
RICHARD DIRKSON |
| K971951 |
05/28/1997 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K971732 |
05/09/1997 |
DENTAL HANDPIECE |
PAULINE M. NICHOLLS |
PAULINE M NICHOLLS |
| K971589 |
05/01/1997 |
REACH ANTIBACTERIAL TOOTHBRUSH |
PERSONAL PRODUCTS CO. |
LORNA-JANE BREMER |
| K971804 |
05/14/1997 |
PHILIPS S1694, S1695 |
PHILIPS HEARING INSTRUMENTS CO. |
TED MIKSIEWICZ |
| K971965 |
05/28/1997 |
PHILIPS EASYVISION |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
| K971884 |
05/22/1997 |
ASSET APOLLO |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K971728 |
05/09/1997 |
PIONEER ELEC-TROCAR DEVICE |
PIONEER SURGICAL TECHNOLOGY |
BURNS SEVERSON |
| K971979 |
05/29/1997 |
PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS |
PLAYTEX PRODUCTS, INC. |
MARK E ROSENGARTEN |
| K971754 |
05/12/1997 |
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K971749 |
05/12/1997 |
EASYGO ASPIRATOR |
PRECISION MEDICAL, INC. |
CONLEY WALLACE |
| K971900 |
05/23/1997 |
LATERAL FLARE INTERNAL COLLAR (LFIC) |
PRO-LFIC LLC. |
IRVING WIESEN |
| K971612 |
05/02/1997 |
OSMO/PCA PILLOW WOUND DRESSING |
PROCYTE CORP. |
PAUL KETTERIDGE |
| K971722 |
05/09/1997 |
TRANS VAGINAL NEEDLE GUIDE |
PROTEK MEDICAL PRODUCTS, INC. |
RICK L PRUTER |
| K971594 |
05/01/1997 |
FLOW-RITE |
PULPDENT CORP. |
KENNETH J BERK |
| K971710 |
05/08/1997 |
ULTRACON ULTRAFILTRATOR |
QUANTIC BIOMEDICAL, INC. |
ANDREW G HOOD |
| K971672 |
05/07/1997 |
SERAQUEST TOXOPLASMA IGM |
QUEST INTL., INC. |
ROBERT A CORT |
| K971928 |
05/27/1997 |
QUEST VESSEL CATHETER |
QUEST MEDICAL, INC. |
KRISTA OAKES |
| K971901 |
05/23/1997 |
RADIUS LOW PROFILE GASTROSTOMY TUBE KIT |
RADIUS INTL., INC. |
ED RANSOM |
| K972000 |
05/30/1997 |
X-RAY ASSIST BAR |
RALPH LINDEL, D.C. |
SUSAN D GOLDSTEIN-FALK |
| K971825 |
05/16/1997 |
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST |
RANDOX LABORATORIES, LTD. |
PONE ARMSTRONG |
| K972005 |
05/30/1997 |
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT |
REAADS MEDICAL PRODUCTS, INC. |
NANCI DEXTER |
| K971821 |
05/16/1997 |
UNICA 315 M CO2 SURGICAL LASER SYSTEM |
RELIANT TECHNOLOGIES, INC. |
DAVID W SCHLERF |
| K971968 |
05/28/1997 |
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) |
REMINGTON MEDICAL, INC. |
DON ROSVOLD |
| K971605 |
05/01/1997 |
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION |
RESOUND CORP. |
KRISTA M BUCKLES |
| K971763 |
05/13/1997 |
BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER |
RETRACTABLE TECHNOLOGIES, INC. |
TERANCE GRISSO |
| K971902 |
05/23/1997 |
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
| K971627 |
05/02/1997 |
SILICONE ANTIBACTERIAL FOLEY CATHETER |
ROCHESTER MEDICAL CORP. |
RICHARD D FRYAR |
| K971643 |
05/05/1997 |
RUSCH BRILLANT BALLOON CATHETER |
RUSCH INTL. |
JAMES R WHITNEY |
| K971639 |
05/02/1997 |
PLUSTRON ION TOOTHBRUSH SYSTEM |
SAS GROUP, INC. |
MICHAEL D SOBO |
| K971735 |
05/12/1997 |
ACCUDEXA BONE DENSITOMETER |
SCHICK TECHNOLOGIES, INC. |
T. WHIT ATHEY |
| K971760 |
05/12/1997 |
COLORPOINT OR PROFESSIONAL COLORPOINT |
SEIKO INSTRUMENTS USA, INC. |
TOMOHIKO SAKAI |
| K971590 |
05/01/1997 |
TACTYLON CONDOM |
SENSICON CORP. |
JORGE HAIDER |
| K971609 |
05/01/1997 |
SCULPTURE |
SERVIZI MEDICO ESTETICI ITALINAI SRL. |
TONIA LATHAM |
| K971743 |
05/12/1997 |
SHARPLAN CO2 SURGICAL LASER SYSTEM |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K971874 |
05/20/1997 |
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K971648 |
05/05/1997 |
SHARPLAN ERBIUM: YAG LASER (4020) |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K971624 |
05/02/1997 |
DYE STOP AND SAVE - QUICKFILL |
SHEPHERD LABORATORIES, INC. |
PAUL S TEIRSTEIN |
| K971927 |
05/27/1997 |
HI DENSE TC |
SHOFU DENTAL CORP. |
HIDEAKI KUMAZAWA |
| K971717 |
05/09/1997 |
FLY THROUGH |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JING ZHANG |
| K971684 |
05/07/1997 |
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K971858 |
05/20/1997 |
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K971681 |
05/06/1997 |
SMC FEMORAL HIP COMPONENT |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
| K971947 |
05/28/1997 |
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY) |
SIM ITALIA S.R.L. |
SUSAN D GOLDSTEIN-FALK |
| K971665 |
05/06/1997 |
SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES |
SJ MEDICAL PRODUCTS (M) SDN BHD |
FOO KHON PU |
| K971666 |
05/06/1997 |
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES |
SJ MEDICAL PRODUCTS (M) SDN BHD |
FOO KHON PU |
| K971939 |
05/27/1997 |
SMITH & NEPHEW SUTURE COLLET |
SMITH & NEPHEW ENDOSCOPY, INC. |
AMY L WALTERS |
| K971676 |
05/07/1997 |
LIMITED REUSE ENDOSCOPIC BLADES |
SMITH & NEPHEW, INC. |
ELIZABETH A RYAN |
| K971850 |
05/20/1997 |
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K971818 |
05/16/1997 |
SNOREX |
SNOREX (NZ) LTD. |
VERNON PRIBBLE |
| K971628 |
05/02/1997 |
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K971711 |
05/08/1997 |
SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
EVE CONNER |
| K971845 |
05/19/1997 |
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC |
SOUND HEARING INSTRUMENTS, INC. |
DALE WOODARD |
| K971770 |
05/13/1997 |
APOLLO KNEE FEMORAL SPACERS |
SULZER ORTHOPEDICS, INC. |
JACQUELYN HUGHES |
| K971715 |
05/09/1997 |
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS |
SULZER ORTHOPEDICS, INC. |
JACQUELYN HUGHES |
| K971893 |
05/22/1997 |
SNT LINAC ACCESSORIES |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K971675 |
05/07/1997 |
SNT STEREOTACTIC LOCALIZATION SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K971644 |
05/05/1997 |
CEBE |
SUUNTO USA |
HENRI SYVANEN |
| K971762 |
05/13/1997 |
BELLEGLASS HP ENAMEL REPAIR MATERIAL |
SYBRON DENTAL SPECIALTIES, INC. |
WILLIAM R PIKE |
| K971987 |
05/29/1997 |
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K971783 |
05/14/1997 |
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K971883 |
05/22/1997 |
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM |
SYNTHES (USA) |
BARRY E SANDS |
| K971736 |
05/12/1997 |
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER |
SYSMEX CORP. |
CATHERINE M TRESTER |
| K971981 |
05/29/1997 |
LS SERIES 200 FLOVISION SYSTEM |
SYSTAM |
ED RANSOM |
| K972014 |
05/30/1997 |
SUNGLASSES (NON-PRESCRIPTION) |
TAMFORT, LTD. |
CAROLYN Z SLOVIS |
| K971875 |
05/20/1997 |
OPTIM-EYES 450 |
TAYLOR/FOX ENTERPRISES, LLC. |
ELIZABETH S CROCKETT |
| K971848 |
05/19/1997 |
TDK MEDICAL GRADE CD-R |
TDK ELECTRONICS CORPORATION OF AMERICA |
KOYO YOKOI |
| K971849 |
05/19/1997 |
CYTOLOGY BRUSH |
TEAM TECHNOLOGIES, INC. |
BOB WALTON |
| K971613 |
05/02/1997 |
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING |
TECHNICAL PRODUCTS, INC. |
NORBERT D THOMPSON |
| K971949 |
05/28/1997 |
POWDER-FREE PATIENT EXAMINATION GLOVES |
TEKMEDIC (M) SDN BHD |
KOPK-KEE HON |
| K971937 |
05/27/1997 |
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE |
TERUMO MEDICAL CORP. |
KRISTINE WAGNER |
| K972237 |
05/01/1997 |
HAND HELD MEDISPACER |
THAYER MEDICAL CORP. |
JOE LIX |
| K971593 |
05/01/1997 |
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT |
THE SILCRAFT CORP. |
HOWARD M HOLSTEIN |
| K971592 |
05/01/1997 |
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM |
THE SILCRAFT CORP. |
HOWARD M HOLSTEIN |
| K971719 |
05/09/1997 |
THEROX INFUSION GUIDEWIRES |
THEROX, INC. |
PAUL J ZALESKY |
| K972009 |
05/30/1997 |
PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE |
TILLOTSON HEALTHCARE CORP. |
EDWARD MARKOVIC |
| K971945 |
05/27/1997 |
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE |
TILLOTSON HEALTHCARE CORP. |
EDWARD MARKOVIC |
| K971953 |
05/28/1997 |
CONFOSCAN |
TOMEY CORPORATION USA |
DAVE MACLELLAN |
| K971685 |
05/07/1997 |
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM |
TOMEY CORPORATION USA |
HOWARD M HOLSTEIN |
| K971677 |
05/07/1997 |
ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD |
TRANSAMERICAN TECHNOLOGIES INTL. |
ALLEN R HOWES |
| K971615 |
05/02/1997 |
PATTISON ESOPHAGEAL DILATOR |
TRI-MED SPECIALTIES, INC. |
MIKE KNOTH |
| K971899 |
05/22/1997 |
ENDO-SEAL |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
| K971898 |
05/22/1997 |
PERMALUTE, TRY-IN PASTE |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
| K971731 |
05/09/1997 |
UNIGLOVES |
UNI-GLOVE (USA), INC. |
ROBERT D VANDER LEEK |
| K971842 |
05/19/1997 |
COAXIAL NEEDLE |
UNITED STATES ENDOSCOPY GROUP, INC. |
GRETCHEN Y COHEN |
| K971680 |
05/07/1997 |
AUTO SUTURE BONE WAX |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
MELISSA MAZZONI |
| K971861 |
05/20/1997 |
ULTRASONIC HAND INSTRUMENTS |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K971886 |
05/22/1997 |
ACCUTEST HCG-URINE |
UNOTECH DIAGNOSTICS, INC. |
KEN WU |
| K971992 |
05/29/1997 |
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) |
UROMED CORP. |
NANCY MACDONALD |
| K971790 |
05/14/1997 |
KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) |
UROMETRICS, INC. |
PHILLIP A MESSINA |
| K971986 |
05/29/1997 |
VALLEY FORGE BIPOLAR LOOP |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K971839 |
05/19/1997 |
VARIAN RADIATION THERAPY IMAGING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
CHARLES H WILL |
| K971776 |
05/13/1997 |
ECHOVACS |
VMI TECHNOLOGIES |
DOUG SEABORN |
| K971768 |
05/13/1997 |
RELIANT CHARGER |
WALLING MEDICAL EQUIPMENT CO. |
ALLAN WALLING |
| K971734 |
05/12/1997 |
VG 200 VIDEO GASTROSCOPE |
WELCH ALLYN, INC. |
LAWRENCE E MAROCCO |
| K971750 |
05/12/1997 |
WELCH ALLYN PHACO ILLUMINATOR |
WELCH ALLYN, INC. |
COLIN WOLFF |
| K971764 |
05/13/1997 |
WELCON HUE-VU URINARY DRAINAGE BAG |
WELCON, INC. |
GEORGE HIRD |
| K971956 |
05/27/1997 |
CRT2000 THERMOGRAPHIC SYSTEM |
WERNER EIDAM MEDIZIN-TECHNOLOGIE GMBH |
EMALEE G MURPHY |
| K971718 |
05/09/1997 |
MICRO-SEAL ACETABULAR SYSTEM |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL |
| K971721 |
05/09/1997 |
WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD |
WHITESIDE BIOMECHANICS, INC. |
MICHAEL C WALL |
| K971781 |
05/14/1997 |
GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES |
WILSON GREATBATCH TECHNOLOGIES, INC. |
GARY J SFEIR |
| K971978 |
05/29/1997 |
GRAFT HARVESTING SAWBLADES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
CRISTIE MANUEL |
| K971784 |
05/14/1997 |
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K971752 |
05/12/1997 |
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER) |
ZIMMER, INC. |
KAREN CAIN |
