| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K973961 |
12/17/1997 |
3M DENT SYSTEM II PLUS |
3M COMPANY |
LAEL J PICKETT |
| K973472 |
12/08/1997 |
3M CDI H/S CUVETTES WITH HEPARON TREATMENT |
3M HEALTH CARE |
DIANA RHEA |
| K974032 |
12/22/1997 |
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
| K972925 |
12/05/1997 |
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC |
ACCESS RADIOLOGY CORP. |
ALLAN M GREEN |
| K973767 |
12/23/1997 |
HARMONIC IMAGING WITH CONTRAST |
ACUSON CORP. |
WILLIAM WELCH |
| K973355 |
12/05/1997 |
ADVANTAGE 3000 |
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX |
ROBERT SNOW |
| K973736 |
12/29/1997 |
AESCULAP HILAN MOTOR SYSTEM |
AESCULAP, INC. |
MARY E HOLDEN |
| K970851 |
12/09/1997 |
LYOPLANT DURA SUBSTITUTE(VARIOUS) |
AESCULAP, INC. |
VICTORIA MACKINNON |
| K964271 |
12/19/1997 |
IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID |
AIREL-WEST |
DANIEL A KRACOV |
| K973332 |
12/02/1997 |
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 |
ALCON LABORATORIES |
MICHAEL E PFLEGER |
| K973967 |
12/08/1997 |
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) |
ALDEN OPTICAL LABS., INC. |
MARTIN DALSING |
| K973703 |
12/04/1997 |
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN |
ALLEGIANCE HEALTHCARE CORP. |
JOSEPH A MERTIS |
| K973501 |
12/11/1997 |
EXPRESSE AND PREMIER POWERED BREAST PUMPS |
AMEDA MEDIZINTECHNIK AG |
JOSEPH S TOKARZ |
| K955893 |
12/30/1997 |
EVERYTIME TRANSFUCER COVER |
AMEDIC AB |
GINA AZARIC |
| K973873 |
12/29/1997 |
DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 |
AMERICAN TELECARE, INC. |
GERARD J PRUD'HOMME |
| K973957 |
12/17/1997 |
DBEST ONE-STEP HCG SERUM/URINE TEST |
AMERITEK, INC. |
K C YEE |
| K974042 |
12/19/1997 |
AMSURE CLEANSING ENEMA SET |
AMSINO INTL., INC. |
RICHARD Y LI |
| K974218 |
12/18/1997 |
DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES |
ANSELL PERRY |
JAMES R CHATTERTON |
| K973461 |
12/09/1997 |
ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE |
ANSELL PERRY |
JAMES R CHATTERTON |
| K973893 |
12/19/1997 |
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE |
APPLIED MEDICAL TECHNOLOGIES |
THOMAS W PARKINSON |
| K973950 |
12/12/1997 |
RETINAL CUBE |
APPLIED SPECTRAL IMAGING, LTD. |
MICHAEL ADEL |
| K970367 |
12/17/1997 |
THERMO-STAT SYSTEM |
AQUARIUS MEDICAL CORP. |
W. JEFFREY CHANDLER |
| K973653 |
12/12/1997 |
SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM |
AREEDA ASSOC., LTD. |
JOSEPH AREEDA |
| K970277 |
12/11/1997 |
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) |
ASTORIA-PACIFIC,INC. |
RAYMOND L PAVITT |
| K972946 |
12/19/1997 |
AURELUX 77 |
AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD |
J.D. DAVIS |
| K974127 |
12/19/1997 |
HYDRA METER |
AUTOMATA INSTRUMENTATION, INC. |
LINDA V MASANO |
| K973638 |
12/23/1997 |
N.I.T., INC. NEEDLE GUIDING TEMPLATE |
AVID N.I.T., INC. |
JOSEPH E HARMS |
| K971086 |
12/19/1997 |
RADIAL AND FEMORAL ARTERY CATHETER |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K964703 |
12/01/1997 |
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K973616 |
12/05/1997 |
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K973932 |
12/15/1997 |
BECKMAN CALIBRATOR 2 (CAL2) |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K973928 |
12/01/1997 |
BECKMAN URINE PROTEIN CALIBRATOR (UCAL) |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K974110 |
12/24/1997 |
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT |
BECKMAN INSTRUMENTS, INC. |
ANNETTE HELLIE |
| K974452 |
12/17/1997 |
VIGIL LIPID CONTROL |
BECKMAN INSTRUMENTS, INC. |
RICHARD T ROSS |
| K971205 |
12/01/1997 |
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES |
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS |
ANNA LONGWELL |
| K971339 |
12/24/1997 |
INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS |
BECTON DICKINSON VASCULAR ACCESS, INC. |
C.J. WELLE |
| K974069 |
12/15/1997 |
OPUS 2 - CANAL SERIES (ITC) |
BERNAFON-MAICO, INC. |
RAY ENROTH |
| K974152 |
12/15/1997 |
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) |
BERNAFON-MAICO, INC. |
RAY ENROTH |
| K974211 |
12/15/1997 |
OPUS 2 - FULL CONCHA SERIES - ITE |
BERNAFON-MAICO, INC. |
RAY ENROTH |
| K973609 |
12/18/1997 |
IDA-4 AND IPT-MC |
BIO-TEK INSTRUMENTS, INC. |
MICHAEL N SEVIGNY |
| K973706 |
12/24/1997 |
DURA-GUARD-DURAL REPAIR PATCH |
BIO-VASCULAR, INC. |
BARBARA ATZENHOEFER |
| K973552 |
12/16/1997 |
OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP |
BIO-VASCULAR, INC. |
JULIE SHERMAN |
| K973429 |
12/01/1997 |
BIODERM FOAM WOUND DRESSING |
BIODERM, INC. |
GEORGE WORTHLEY |
| K972064 |
12/01/1997 |
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV |
BIOLOGICAL CONTROLS, INC. |
GARY D MESSINA |
| K973644 |
12/23/1997 |
FLOSTAT VASCULAR LAB |
BIOMEDIX, INC. |
DAVID LERNER |
| K973857 |
12/29/1997 |
FLOSTAT VASCULAR REPORT GENERATOR (VRG) |
BIOMEDIX, INC. |
DAVID LERNER |
| K971824 |
12/04/1997 |
REACH FEMORAL HIP COMPONENT |
BIOMET, INC. |
DEBORAH M MATARAZZO |
| K974461 |
12/10/1997 |
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K973784 |
12/03/1997 |
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K973662 |
12/15/1997 |
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K974384 |
12/08/1997 |
ELECSYS CALCHECK FOLATE |
BOEHRINGER MANNHEIM CORP. |
Patricia M Klimley |
| K974383 |
12/08/1997 |
ELECSYS CALCHECK VITAMIN B12 |
BOEHRINGER MANNHEIM CORP. |
Patricia M Klimley |
| K974421 |
12/17/1997 |
ELECSYS CK-MB STAT |
BOEHRINGER MANNHEIM CORP. |
JODY J SAVAGE |
| K974261 |
12/11/1997 |
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL |
BOSTON BIOMEDICA, INC. |
PATRICIA E GARRETT |
| K971688 |
12/11/1997 |
IVT 0.014 PTFE-COATED TRACKWIRE |
BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES |
KEVIN E DALY |
| K972744 |
12/11/1997 |
COURIER ST BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
MARY P LEGRAW |
| K973008 |
12/15/1997 |
COURIER ST BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
MARY P LEGRAW |
| K973826 |
12/05/1997 |
SPHINCTEROTOME |
BOSTON SCIENTIFIC CORP. |
DANIEL J DILLON |
| K973818 |
12/16/1997 |
T-REX BIOPSY FORCEPS |
BOSTON SCIENTIFIC CORP. |
JOCELYN KERSTEN |
| K973567 |
12/11/1997 |
SOWELL COBALT-CHROME METAL ALLOY |
C.K. INTERNATIONAL TRADING |
ANNA CHIN |
| K973568 |
12/11/1997 |
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY |
C.K. INTERNATIONAL TRADING |
ANNA CHIN |
| K973569 |
12/11/1997 |
SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY |
C.K. INTERNATIONAL TRADING |
ANNA CHIN |
| K973566 |
12/08/1997 |
SOWELL PATENTED NON-PRECIOUS METAL ALLOY |
C.K. INTERNATIONAL TRADING |
ANNA CHIN |
| K972016 |
12/04/1997 |
AUTIMO 2.5-D AND AUTIMO 3-D |
C.L. MCINTOSH & ASSOC., INC. |
T. WHIT ATHEY |
| K972767 |
12/04/1997 |
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER |
CANDELA CORP. |
JAY CAPLAN |
| K971775 |
12/29/1997 |
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 |
CARDIAC CONTROL SYSTEMS, INC. |
TERRY C MCMAHON |
| K974638 |
12/18/1997 |
STERITITE SEALED CONTAINERS MODEL SCO4Q |
CASE MEDICAL, INC. |
LARRY R PILOT |
| K974325 |
12/08/1997 |
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K970727 |
12/17/1997 |
MPORT FOLDABLE LENS PLACEMENT SYSTEM |
CHIRON VISION CORP. |
JUDY F GORDON |
| K974198 |
12/22/1997 |
TAKY-SPIKE PLUS |
CLINICO |
REINHARD HOPF |
| K973420 |
12/09/1997 |
CLINITEX CAST PADDING |
CLINITEX MEDICAL CORP. |
HOWELL H MICHAEL |
| K973417 |
12/09/1997 |
CLINITEX STOCKINETTE |
CLINITEX MEDICAL CORP. |
HOWELL H MICHAEL |
| K963518 |
12/08/1997 |
COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR |
COBE CARDIOVASCULAR, INC. |
MARY L ARMSTRONG |
| K972699 |
12/19/1997 |
AESOP 3000 SYSTEM AND ACCESSORIES |
COMPUTER MOTION, INC. |
DOUGLAS P BUESCHEL |
| K973719 |
12/23/1997 |
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER |
CONTINUUM BIOMEDICAL, INC. |
LAURIE A RIDENER |
| K973688 |
12/23/1997 |
DUODERM CONTROL GEL FORMULA BORDER DRESSING |
CONVATEC LTD. |
ANDRIENNE MCNALLY |
| K973689 |
12/23/1997 |
DUODERM HYDROACTIVE DRESSING |
CONVATEC LTD. |
ADRIENNE MCNALLY |
| K973717 |
12/17/1997 |
COMBIDERM ACD |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
ADRIENNE MCNALLY |
| K973716 |
12/17/1997 |
DUODERM EXTRA THIN CGF DRESSING |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
ADRIENNE MCNALLY |
| K973806 |
12/29/1997 |
DUODERM HYDROACTIVE GEL |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
ADRIENNE MCNALLY |
| K973807 |
12/23/1997 |
DUODERM HYDROACTIVE PASTE |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
ADRIENNE MCNALLY |
| K973632 |
12/22/1997 |
DUODERM CGF CONTROL GEL FORMULA DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
ADRIENNE MCNALLY |
| K963013 |
12/19/1997 |
PREFERENCE 60 AND PREFERENCE 60 TORIC |
COOPERVISION, INC. |
BERNARD F HALLATT |
| K973595 |
12/19/1997 |
THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM |
CORIN U.S.A. |
CRAIG CORRANCE |
| K971920 |
12/04/1997 |
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) |
CUSTOMED, INC. |
GLADYNELL RODRIQUEZ |
| K971905 |
12/12/1997 |
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING |
DAKO CORP. |
GRETCHEN M MURRAY |
| K973954 |
12/22/1997 |
IMAGEN RESPIRATORY SCREEN |
DAKO DIAGNOSTICS LTD. |
ELISABETH SILVER |
| K974114 |
12/18/1997 |
DASH, VITAL GARD |
DASH MEDICAL GLOVES SDN BHD |
ROBERT J SULLIVAN |
| K971650 |
12/04/1997 |
RHYTHMSTAT XL |
DATA CRITICAL CORP. |
LISA S JONES |
| K970078 |
12/11/1997 |
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM |
DAVOL, INC., SUB. C.R. BARD, INC. |
ROBIN M DRAGO |
| K970419 |
12/22/1997 |
DAXOR MAX100 SYRINGE (MAX100) |
DAXOR CORPORATION |
RONALD H BALDRY |
| K973421 |
12/05/1997 |
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} |
DEJARNETTE RESEARCH SYSTEMS |
ERIC J FINEGAN |
| K971696 |
12/30/1997 |
SENTINEL RECORDER, MODELS 471/472 |
DEL MAR AVIONICS |
RAPHAEL HENKIN |
| K973781 |
12/11/1997 |
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K973782 |
12/04/1997 |
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K974035 |
12/17/1997 |
CENTURY ALLOY |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K974223 |
12/18/1997 |
NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES |
DERLIN COMPANY LTD. |
JOHN BUCHER |
| K974003 |
12/05/1997 |
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974053 |
12/08/1997 |
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K974396 |
12/18/1997 |
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE |
DIAMETRICS MEDICAL, INC. |
STEVE BOEH |
| K972314 |
12/19/1997 |
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM |
DIAMETRICS MEDICAL, LTD. |
KARIMA HEBRI |
| K973485 |
12/08/1997 |
CLEARVIEW BLOWER/MISTER |
DLP, INC. |
GRETCHEN HARTLAGE |
| K973727 |
12/19/1997 |
ELECTRODE, ELECTROCARDIOGRAPH |
DON TAY INDUSTRIES |
EDWARD ARNDT |
| K973291 |
12/19/1997 |
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES |
DYNAMIC TECHNOLOGY CORP. |
ERIC LUO |
| K973833 |
12/30/1997 |
CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL |
DYNARAD CORP. |
RAYMOND MANEZ |
| K973683 |
12/24/1997 |
OMEGA 21 SYSTEM |
EBI ELECTRO BIOLOGY |
JON CAPAROTTA |
| K973682 |
12/18/1997 |
BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, |
ELECTROSCOPE, INC. |
JANE E JOHNSON |
| K973540 |
12/17/1997 |
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS |
ELEKTA ONCOLOGY SYSTEMS, INC. |
PETER ALTMAN |
| K973672 |
12/18/1997 |
FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K973302 |
12/02/1997 |
FOUNDATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K973614 |
12/18/1997 |
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K973685 |
12/19/1997 |
REVELATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K973686 |
12/22/1997 |
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM |
ENDOCARE, INC. |
VIN CUTARELLI |
| K974516 |
12/22/1997 |
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE |
ENDOLAP, INC. |
TONY GILSTRAP |
| K974515 |
12/22/1997 |
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE |
ENDOLAP, INC. |
TONY GILSTRAP |
| K973424 |
12/09/1997 |
ENFRESH TONGUE BRUSH |
ENFRESH PRODUCTS LLC. |
HOWARD M HOLSTEIN, ESG |
| K973576 |
12/09/1997 |
EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM |
EPULSE TECHNOLOGIES, INC. |
SANFORD DAMASCO |
| K973513 |
12/22/1997 |
SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER |
ESPE GMBH & CO. KG. |
BARBARA WAGNER-SCHUH |
| K973803 |
12/16/1997 |
FLEXVIEW CO2 BLOWER WITH MIST |
ETHICON ENDO-SURGERY, INC. |
LORRI CHAVEZ |
| K973384 |
12/05/1997 |
ETHICON NON-STICK BIPOLAR FORCEPS |
ETHICON, INC. |
GREGORY JONES |
| K974322 |
12/16/1997 |
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM |
EUROPA SCIENTIFIC, LTD. |
ROBERT F MARTIN |
| K972365 |
12/12/1997 |
COMPACT OR COMP-X |
EUROTEC, S.R.L. |
CHRISTIAN BONAZZI |
| K963659 |
12/16/1997 |
EXEL I.V. ADMINISTRATION SET |
EXEL INTL. |
ARMAND HAMID |
| K974007 |
12/12/1997 |
SHAH PERMAVENT |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K971528 |
12/12/1997 |
ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) |
FUJINON, INC. |
GARY A ADLER |
| K971440 |
12/02/1997 |
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH |
FUKUDA DENSHI USA, INC. |
DAVID J GERAGHTY |
| K970901 |
12/22/1997 |
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEMS |
DAVID DUERSTELER |
| K970465 |
12/18/1997 |
BOUSER'S URINAL |
GENERAL POLYMERS |
MILTON N BENEKE JR. |
| K973411 |
12/04/1997 |
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) |
GENERAL SCANNING, INC. |
WALTER J LESLIE |
| K972555 |
12/22/1997 |
CATHETER TUNNELER |
GERARD MEDICAL, INC. |
RICHARD CAYER |
| K973825 |
12/19/1997 |
MIDSTREAM HOME REGNANCY TEST |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOR |
| K961289 |
12/04/1997 |
VAPOPHENE |
GERMIPHENE CORP. |
PETER WILK |
| K965016 |
12/02/1997 |
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) |
GIBECK, INC. |
BILL BRILEY |
| K973495 |
12/01/1997 |
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES |
GLENROE |
JOHN BOZMAN |
| K972839 |
12/17/1997 |
PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET |
GLOBE ENT., INC. |
STEPHEN Y JAN |
| K972843 |
12/16/1997 |
PROTOS BLOOD TRANSFUSION SET |
GLOBE ENT., INC. |
STEPHEN Y JAN |
| K972854 |
12/17/1997 |
PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY |
GLOBE ENT., INC. |
STEPHEN Y JAN |
| K974227 |
12/12/1997 |
HOSPITAL'S CLAMP |
GPS |
LOUIS PAGLIARA |
| K974228 |
12/12/1997 |
HOSPITAL'S SPEC |
GPS |
LOUIS PAGLIARA |
| K973620 |
12/17/1997 |
VACUETTE MULTI-SAMPLE NEEDLE |
GREINER MEDITECH, INC. |
DOUGLAS L HARRIS |
| K973494 |
12/12/1997 |
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG |
GUIDANT CORP. |
MARGARET ANDERSON |
| K973730 |
12/24/1997 |
DURASIL I AND DURASIL II |
HANSON MEDICAL, INC. |
GERALD HANSON |
| K973729 |
12/24/1997 |
POWERFLEX PEC IMPLANT |
HANSON MEDICAL, INC. |
ERIK HANSON |
| K973871 |
12/11/1997 |
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K973778 |
12/11/1997 |
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES |
HARTALEGA SDN BHD |
KAM H KUAN |
| K972198 |
12/17/1997 |
DENT-TEMP ACRYLIC |
HEALTH-DENT INTL., INC. |
JASHAN SETH |
| K974175 |
12/16/1997 |
HEARTPORT ENDOAORTIC CLAMP CATHETER |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K973491 |
12/04/1997 |
MECHANICAL FOLDING WHEEL CHAIR |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
KENNY HO |
| K973437 |
12/03/1997 |
HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K974048 |
12/23/1997 |
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K973484 |
12/02/1997 |
CHIN DISTRACTOR |
HOWMEDICA, INC. |
JOHN DICHIARA |
| K974054 |
12/23/1997 |
DISTAL CENTRALIZER, EXETER II HIP SYSTEM |
HOWMEDICA, INC. |
FRANK MAAS |
| K972228 |
12/05/1997 |
MERIDIAN TITANIUM FEMORAL STEMS |
HOWMEDICA, INC. |
FRANK MAAS |
| K973927 |
12/11/1997 |
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL |
HYUNJAE CORP. |
DAN MODICA |
| K972406 |
12/22/1997 |
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
WILLIAM L BOTELER |
| K973510 |
12/08/1997 |
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) |
IMMUNO-U.S., INC. |
DAVID WEST |
| K972457 |
12/01/1997 |
MONOCOL/LEX-IM TEST |
IMMUNOSTICS, INC. |
DAVID MYCOCK |
| K972480 |
12/23/1997 |
3I BIORESORBABLE FIXATION TACK |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K973771 |
12/04/1997 |
DENTAL/SURGICAL DRILLS, BURS, TAPS |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K972470 |
12/11/1997 |
CRIT-LINE MONITOR (CLMIII) |
IN-LINE DIAGNOSTICS CORP. |
THOMAS J BOUCHARD |
| K963969 |
12/23/1997 |
INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB |
INDIGO MEDICAL, INC. |
SHARON STAROWICZ |
| K973323 |
12/01/1997 |
ACL CLIP-IN |
INNOVASIVE DEVICES, INC. |
ERIC BANNON |
| K973313 |
12/01/1997 |
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP |
INNOVASIVE DEVICES, INC. |
ERIC BANNON |
| K973855 |
12/01/1997 |
IT HYDROCOLLOID WITH ZINC |
INNOVATIVE TECHNOLOGIES LTD. |
PRISCILLA WHITEHEAD COX |
| K971335 |
12/01/1997 |
QUANTA LITE CMV IGG ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K971441 |
12/02/1997 |
QUANTA LITE TOXOPLASMA IGG |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K973755 |
12/17/1997 |
PILOT TUBE REPAIR KIT |
INSTRUMENTATION INDUSTRIES, INC. |
EDWARD C HOREY, JR. |
| K974125 |
12/17/1997 |
IL TEST AMYLASE |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K974337 |
12/17/1997 |
IL TEST UREA NITROGEN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K973525 |
12/16/1997 |
MAURICE WORLDWIDE SHUNT SYSTEM |
INTEGRA NEUROCARE LLC. |
LORI L HAYS, MT (ASCP) |
| K973468 |
12/08/1997 |
MODEL IRC 1199 SCOUT NEBULIZER |
INVACARE CORP. |
EDWARD A KROLL |
| K963982 |
12/05/1997 |
ACIST ANGIOGRAPHIC INJECTOR |
INVASATEC |
DOUG DUCHON |
| K973580 |
12/10/1997 |
INVOTEC CLEAN PAD |
INVOTEC INTERNATIONAL, INC. |
JEFFREY L AULL |
| K971242 |
12/17/1997 |
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) |
IPAX, INC. |
PHIL PENNELL |
| K974197 |
12/17/1997 |
ELITE LIGHTWEIGHT WHEELCHAIR |
JAKEN CO., INC. |
SAMANTHA LIN |
| K974131 |
12/17/1997 |
ALERT |
JENERIC/PENTRON, INC. |
MURRAY C GAMBERG |
| K973528 |
12/08/1997 |
SUNGLASSES |
JEOU JEOU LONG INDUSTRIAL CO., LTD. |
C K LIU |
| K973699 |
12/16/1997 |
ULTRALON POWDER FREE LATEX SURGICAL GLOVE |
JOHNSON & JOHNSON MEDICAL, INC. |
MAGARET MARSH |
| K973774 |
12/29/1997 |
CODMAN HAKIM MICRO PRECISION VALVE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JANET G JOHNSON |
| K971944 |
12/17/1997 |
LACTEST I |
JWT, INC. |
JAMES B JOHNSTON |
| K962985 |
12/19/1997 |
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K973304 |
12/02/1997 |
MVM 3.3 MM MICROENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K973876 |
12/19/1997 |
PROPHYFLEX 2, MODEL 2012 |
KAVO AMERICA |
GREGORY W BOWMAN |
| K973509 |
12/04/1997 |
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
JAN L EFFLANDT |
| K973763 |
12/31/1997 |
KENDALL CURITY IODOFORM PACKING STRIP |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K973619 |
12/10/1997 |
KENDALL CURITY NON-ADHERING DRESSING |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K973511 |
12/16/1997 |
KENDALL CURITY PETROLATUM GAUZE |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K973507 |
12/15/1997 |
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
DAVID A OLSON |
| K973853 |
12/19/1997 |
KOLPLAST VAGINAL SPECULUM |
KOLPLAST COMERCIAL E INDUSTRIAL LTDA |
E J SMITH |
| K974089 |
12/17/1997 |
ALLOY PRIMER |
KURARAY AMERICA, INC. |
KEJI FUJITA |
| K973415 |
12/02/1997 |
CURVILINEAR SUTURE PLACEMENT SYSTEM |
LAURUS MEDICAL CORP. |
RICHARD A BASLER |
| K973951 |
12/23/1997 |
LEVO COMPACT-EASY LCE |
LEVO USA |
THOMAS RAEBER |
| K963817 |
12/23/1997 |
LEVO MOBIL LCM |
LEVO USA |
THOMAS RAEBER |
| K972473 |
12/16/1997 |
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK |
LIFESCAN, INC. |
JOHN E HUGHES |
| K973631 |
12/23/1997 |
LORAD M-III ELITE (M-III E) |
LORAD CORP. |
PHILIP G JUHAS |
| K973470 |
12/09/1997 |
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS |
LUMENIS, INC. |
KAREN BAKER |
| K974254 |
12/16/1997 |
BENEFIT B3--- SERIES |
M.C. HEALTHCARE PRODUCTS, INC. |
R N THOMPSON |
| K973657 |
12/01/1997 |
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING |
MAERSK MEDICAL, LTD. |
EVAN DICK |
| K972258 |
12/29/1997 |
HI-CARE CLOSED SUCTION SYSTEM |
MALLINCKRODT MEDICAL |
MICHAEL B SCHOECK |
| K972914 |
12/22/1997 |
SYVEK PATCH |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K973847 |
12/08/1997 |
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS |
MARTIN DALSING |
MARTIN J DALSING |
| K973919 |
12/16/1997 |
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) |
MEDENTAL INTL. |
DEBRA GILLASPY |
| K974164 |
12/18/1997 |
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE |
MEDICAL DEVICE CONSULTANTS, INC. |
ROSINA ROBINSON |
| K972148 |
12/10/1997 |
B.U.S. ENDOTRON |
MEDICAMAT S.A. |
ANDREW S KRULWICH |
| K972887 |
12/11/1997 |
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG |
MEDLINE INDUSTRIES, INC. |
CHRISTINE GALEA |
| K972081 |
12/17/1997 |
SUPERSKIN |
MEDLOGIC GLOBAL CORP. |
JUR STROBOS |
| K973787 |
12/30/1997 |
MEDRAD 1.5T EXTREMITY ARRAY |
MEDRAD, INC. |
MARY A GREENAWALT |
| K973842 |
12/05/1997 |
CARBON FIBER CONFORMAL COUCH TOP |
MEDTEC, INC. |
DONALD F RIIBE |
| K973146 |
12/04/1997 |
MENTOR SUPER ABSORBENT DRAPE |
MENTOR OPHTHALMICS, INC. |
DONNA A CRAWFORD |
| K973708 |
12/19/1997 |
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL |
MERIT MEDICAL SYSTEMS, INC. |
DENNIS REIGLE |
| K973761 |
12/24/1997 |
MICRO-STRIP FOR OPIATE METABOLITES |
MICRODIAGNOSTICS, INC. |
ROY CHUNG |
| K973712 |
12/12/1997 |
MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT |
MINXRAY, INC. |
KEITH R KRETCHMER |
| K973340 |
12/03/1997 |
TWEEZER-TYPE EPILATOR |
MOBIT, INC. |
JAMES R MARSHALL |
| K974414 |
12/08/1997 |
MULTI |
MORNING CALM CORP. |
ALEXANDER B KIM |
| K971663 |
12/30/1997 |
WELLCOLEX E.COLI O157:H7 |
MUREX BIOTECH LTD. |
REBECCA VINE |
| K965158 |
12/09/1997 |
HEART PROTECTOR (VER 1996) |
N.P.N.T., INC. |
KEN NUSBAUM |
| K973621 |
12/17/1997 |
PRE-VIEW CHOLANGIOGRAPHY CLAMP |
NASHVILLE SURGICAL INSTRUMENTS |
S.S. KUMAR |
| K974047 |
12/05/1997 |
ACCUWELL PHENYLALANINE ASSAY |
NEOMETRICS, INC. |
DAVID SCHWARTZ |
| K964622 |
12/01/1997 |
MEDI-DX 7000 |
NEURO-DIAGNOSTIC ASSOC. |
JAMES HEDGECOCK |
| K973764 |
12/31/1997 |
TEMPERATURE DIAGNOSTIC ACCESSORY |
NEW STAR LASERS, INC. |
DAVE HENNINGS |
| K971582 |
12/22/1997 |
NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
| K952267 |
12/02/1997 |
CRITERION, CRITERION I.V., MODIFIED |
NOVA-VENTRX |
BERNARD R PALUCH |
| K971243 |
12/02/1997 |
OHMEDA INFANT RESUSCITATION SYSTEM |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
| K973959 |
12/22/1997 |
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE |
OLICON IMAGING SYSTEMS, INC. |
HERMAN OOSTERWIJCK |
| K973793 |
12/17/1997 |
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE |
OLICON IMAGING SYSTEMS, INC. |
HERMAN OOSTERWIJCK |
| K973325 |
12/02/1997 |
BACT/ALERT FAN CULTURE BOTTLES |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K972698 |
12/16/1997 |
TOF-WATCH |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K974158 |
12/09/1997 |
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY |
ORTHO DEVELOPMENT CORP. |
CAROL FRASIER |
| K973944 |
12/19/1997 |
ORTHOFIX FEMORAL NAILING SYTEM |
ORTHOFIX SRL |
ROBERT L SHERIDAN |
| K973438 |
12/09/1997 |
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION |
OSTEONICS CORP. |
KATE SUTTON |
| K973406 |
12/08/1997 |
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT |
OSTEONICS CORP. |
DONNA S WILSON |
| K973463 |
12/02/1997 |
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE |
OTECH, INC. |
HERMAN OOSTERWIJCK |
| K973899 |
12/04/1997 |
UNIFINE PENTIPS |
Owen Mumford USA, Inc. |
ROBERT E SHAW |
| K973479 |
12/01/1997 |
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K971637 |
12/23/1997 |
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K973315 |
12/02/1997 |
THERAPAX DXT 300 MODEL HF-300 |
PANTAK, INC. |
GREG MOREAU |
| K973976 |
12/04/1997 |
EPIC-FLO |
PARKELL, INC. |
NELSON J GENDUSA |
| K973693 |
12/18/1997 |
AQUA PATCH |
PCI TECHNOLOGY |
ROGER LIEBELT |
| K972192 |
12/17/1997 |
PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM |
PERCEPTION, INC. |
SUSAN D GOLDSTEIN-FALK |
| K972915 |
12/19/1997 |
ERBIUM 2000 LASER FAMILY |
PHANTOM TECHNOLOGIES, INC. |
JAMES A NATIONS |
| K974016 |
12/19/1997 |
CERCLAGE CABLE WITH HEX BUTTON |
PIONEER SURGICAL TECHNOLOGY |
BURNS O SEVERSON |
| K971118 |
12/16/1997 |
ARAGO |
PREMIER LASER SYSTEMS, INC. |
LISA MOJICA |
| K974181 |
12/11/1997 |
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K974425 |
12/24/1997 |
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K971900 |
12/18/1997 |
LATERAL FLARE INTERNAL COLLAR (LFIC) |
PRO-LFIC LLC. |
IRVING WIESEN |
| K972150 |
12/10/1997 |
OSMOCYTE ISLAND WOUND DRESSING |
PROCYTE CORP. |
PAUL KETTERIDGE |
| K972329 |
12/10/1997 |
OSMOCYTE RA WOUND DRESSING |
PROCYTE CORP. |
PAUL KETTERIDGE |
| K970773 |
12/04/1997 |
POWDER-FREE EXAM GLOVES |
PT. SARANA INDOPROTEX |
MD YUSOF BIN IBRAHIM |
| K974014 |
12/17/1997 |
PULPDENT DENTASTIC UNO |
PULPDENT CORP. |
KENNETH J BERK |
| K973913 |
12/18/1997 |
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE |
PWA INDUSTRIES SDN. BHD. |
AZMAN ISMAIL |
| K973610 |
12/19/1997 |
SKYVAL |
PYRAMID AIR SYSTEMS |
MARK MCKEE |
| K972230 |
12/02/1997 |
QUICKIE P90 SERIES |
QUICKIE DESIGNS, INC. |
REBECCA ANDERSEN |
| K973841 |
12/01/1997 |
QUICKVUE ONE-STEP HCG-COMBO |
QUIDEL CORP. |
ROBING WEINER |
| K974052 |
12/19/1997 |
QUICKVUE SEMI-Q HCG-COMBO |
QUIDEL CORP. |
Robin Weiner |
| K971570 |
12/29/1997 |
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 |
QUINTON ELECTROPHYSIOLOGY CORP. |
MATTHEW HEDLUND |
| K973995 |
12/08/1997 |
RANDOX BILIRUBIN |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K973988 |
12/22/1997 |
RDI HOMOGENEOUS HDL CHOLESTEROL TEST |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K974257 |
12/12/1997 |
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) |
RESOUND CORP. |
KRISTA M BUCKLES |
| K974081 |
12/12/1997 |
RESOUND STEALTH CIC |
RESOUND CORP. |
KRISTA M BUCKLES |
| K972649 |
12/04/1997 |
CARDIOCALL CARDIAC EVENT RECORDER |
REYNOLDS MEDICAL LTD. |
GEORGE MYERS |
| K973648 |
12/17/1997 |
MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K973737 |
12/12/1997 |
MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K964663 |
12/11/1997 |
FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX |
RMDS, INC. |
DELBERT L RICE |
| K973284 |
12/18/1997 |
COBAS INTEGRA HDL-CHOLESTEROL DIRECT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K974129 |
12/12/1997 |
HI-69E, HI-69N, HI-69P |
ROCKWIN CORP. |
KEITH TAYLOR |
| K972372 |
12/11/1997 |
GERM TRAPPER SUCTION TUBE HOLDER |
RZV MEDICAL SPECIALTIES, INC. |
LINDA K RUVO |
| K974154 |
12/19/1997 |
CHOICE ACCU-TEST PREGNANCY TEST KIT |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K974021 |
12/19/1997 |
SIGNAL PREGNANCY TEST KIT |
SA SCIENTIFIC, INC. |
HARBI SHADFAN |
| K974306 |
12/23/1997 |
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA |
SANGUI BIOTECH, INC. |
JOHN J KIANG |
| K974262 |
12/24/1997 |
SYSCOS IDC - G, IDC, BSC, IDC - G |
SCANTIBODIES LABORATORY, INC. |
RICHARD LENART |
| K971735 |
12/02/1997 |
ACCUDEXA BONE DENSITOMETER |
SCHICK TECHNOLOGIES, INC. |
T. WHIT ATHEY |
| K973603 |
12/19/1997 |
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM |
SCHWARTZ ELECTRO-OPTICS, INC. |
TIMOTHY J SHEA |
| K971362 |
12/04/1997 |
PERSONAL INFUSOR |
SCIENCE INCORPORATED |
RALPH E HOGANCAMP |
| K973749 |
12/08/1997 |
FRAG COMMANDER |
SCIERAN TECHNOLOGIES, INC. |
ROD ROSS |
| K974551 |
12/22/1997 |
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY |
SEALITE SCIENCES, INC. |
CATHRYN N CAMBRIA |
| K973742 |
12/03/1997 |
SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM |
SENDX MEDICAL, INC. |
RUBEN CHAIREZ |
| K970795 |
12/18/1997 |
SHANG HO |
SHANG HO INDUSTRIAL CORP. LTD. |
CHENG KO LIN |
| K974120 |
12/17/1997 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHANGHAI SUPER GLOVES CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K974151 |
12/18/1997 |
VINYL PATIENT EXAMINATION GLOVES (POWDERED) |
SHANGHAI SUPER GLOVES CO., LTD. |
SUSAN D GOLDSTEIN-FALK |
| K973354 |
12/04/1997 |
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) |
SHARPLAN LASERS, INC. |
GEORGE J HATTUB |
| K971360 |
12/22/1997 |
SYNTEX |
SHINEMOUND ENTERPRISE, INC. |
HUAN-CHUNG LI |
| K973630 |
12/05/1997 |
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K971681 |
12/04/1997 |
SMC FEMORAL HIP COMPONENT |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN |
| K974013 |
12/17/1997 |
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K973862 |
12/29/1997 |
PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS |
SIMS DELTEC, INC. |
LISA STONE |
| K973965 |
12/12/1997 |
SMART MOTORIZED VIEWER |
SMARTLIGHT, LTD. |
DAN BEN-ZEEV |
| K972979 |
12/11/1997 |
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K971818 |
12/18/1997 |
SNOREX |
SNOREX (NZ) LTD. |
VERNON PRIBBLE |
| K973618 |
12/19/1997 |
SOMNOPLASTY SYSTEM |
SOMNUS MEDICAL TECHNOLOGIES, INC. |
EVE CONNER |
| K973798 |
12/03/1997 |
S-357 VIDEO IMAGING SYSTEM |
SOPRO |
PIERRE MONTILLOT |
| K973677 |
12/15/1997 |
DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH |
SORRENTO BIOCHEMICAL, INC. |
ZAK HASSANEIN |
| K973676 |
12/16/1997 |
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH |
SORRENTO BIOCHEMICAL, INC. |
ZAK HASSANEIN |
| K973678 |
12/15/1997 |
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH |
SORRENTO BIOCHEMICAL, INC. |
ZAK HASSANEIN |
| K973089 |
12/08/1997 |
FREEDOM |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973092 |
12/08/1997 |
STAE |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K973091 |
12/08/1997 |
WAVE |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K965008 |
12/16/1997 |
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM |
SPACELABS MEDICAL, INC. |
ANTHONY CALDERONI |
| K973611 |
12/02/1997 |
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS |
SPECTRASCIENCE, INC. |
JOHN G YAGER |
| K974020 |
12/19/1997 |
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM |
SPINAL CONCEPTS, INC. |
TEENA M AUGOSTINO |
| K974184 |
12/18/1997 |
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K973904 |
12/17/1997 |
POLYMER LATEX EXAMINATION GLOVES |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K974185 |
12/18/1997 |
POLYMER NITRILE EXAMINATION GLOVES |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K974183 |
12/18/1997 |
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K974182 |
12/17/1997 |
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K973903 |
12/17/1997 |
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K973324 |
12/03/1997 |
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM |
STAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K973423 |
12/05/1997 |
STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT |
STERI-OSS, INC. |
JEFF HAUSHEER |
| K973433 |
12/05/1997 |
STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT |
STERI-OSS, INC. |
JEFF HAUSHEER |
| K973206 |
12/04/1997 |
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY |
STERLING DIAGNOSTIC IMAGING, INC. |
ELAINE H KINDELL |
| K974423 |
12/22/1997 |
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL |
STERLING DIAGNOSTIC IMAGING, INC. |
JEAN E BARLETT |
| K973353 |
12/02/1997 |
BONDING BASE |
STRAUMANN USA |
LINDA JALBERT |
| K970714 |
12/16/1997 |
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) |
STRYKER INSTRUMENTS |
TAMMY LOUNDS |
| K973681 |
12/19/1997 |
NATURAL-HIP COCR OFFSET STEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K973675 |
12/19/1997 |
NATURAL-HIP POROUS STEM WITH OFFSET |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K973412 |
12/08/1997 |
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM |
SULZER ORTHOPEDICS, INC. |
LORI KLEINSCHRODT HOLDER |
| K973942 |
12/12/1997 |
SWIFT DELIVERY PRODUCT #300 |
SWIFT DELIVERY PRODUCTS |
RICHARD G LINDSAY |
| K973710 |
12/18/1997 |
DIGITAL ADD ON MULTI SYSTEM |
SWISSRAY INTERNATIONAL, INC. |
MORTEZA MINAEE |
| K973439 |
12/08/1997 |
ENDO ANALYZER, MODEL 8005 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K974179 |
12/01/1997 |
NON-PRESCRIPTION SUNGLASSES |
TAIPAN OPTICAL COMPANY LTD. |
HENRY HSU |
| K972496 |
12/09/1997 |
PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER |
TAO & TAO TECHNOLOGYT, INC. |
PAULINE TAO |
| K972112 |
12/01/1997 |
INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 |
TAUT, INC. |
GLENN MILLER |
| K970163 |
12/10/1997 |
ALPHA MX (20)/ULTRA PC (30) |
TECHNICAL MEDICAL PRODUCTS, INC. |
JIM R MOORE |
| K973385 |
12/05/1997 |
OVAL SHAPES |
TECHNICAL PRODUCTS, INC. |
NORBERT D THOMPSON |
| K974068 |
12/22/1997 |
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL |
TECNOL MEDICAL PRODUCTS, INC. |
RUTH JONES |
| K974300 |
12/19/1997 |
TELEMED SYSTEMS RETRIEVAL BASKET |
TELEMED SYSTEMS, INC. |
SAMUEL D WADE |
| K970708 |
12/19/1997 |
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS |
TERUMO MEDICAL CORP. |
KEITH M SMITH |
| K974171 |
12/19/1997 |
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS |
TEVA MEDICAL, LTD. |
HARRY LEINWAND |
| K973537 |
12/17/1997 |
PATHWAY ELECTROMYOGRAPH |
THE PROMETHEUS GROUP |
PETER A SULLIVAN |
| K974036 |
12/22/1997 |
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE |
THE PROMETHEUS GROUP |
RICHARD HORTON |
| K973882 |
12/05/1997 |
EL-B2GP1SCR |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K972790 |
12/05/1997 |
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K973453 |
12/09/1997 |
TORNIER CEMENT RESTRICTOR |
TORNIER |
DAVID W SCHLERF |
| K973908 |
12/22/1997 |
AUKLET CT SCANNER, TSX-003A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K974286 |
12/12/1997 |
CIRCUMCISION TRAY, CAT. NO. 70340 |
TRINITY LABORATORIES, INC. |
PARTHA BASUMALLIK |
| K963391 |
12/12/1997 |
SPECULITE |
TRYLON CORP. |
A. THOMAS DOYLE |
| K974454 |
12/18/1997 |
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 |
TUCSON MEDICAL CORP. |
JIM PATKO |
| K973083 |
12/09/1997 |
ULTRACELL NEURO SPONGES |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K972633 |
12/17/1997 |
ULTRACELL SUCTION SPONGE |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K972634 |
12/17/1997 |
ULTRACELL SUCTION SPONGE |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
GEORGE P KORTEWEG |
| K973496 |
12/01/1997 |
THE AUTO SUTURE* MIBB** SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
| K974338 |
12/12/1997 |
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) |
UNITRON INDUSTRIES, INC. |
SUSAN ARCHER |
| K974339 |
12/12/1997 |
UNITRON MODEL SOUND F/XD PROGRAMMABLE |
UNITRON INDUSTRIES, INC. |
SUSAN ARCHER |
| K974340 |
12/12/1997 |
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE |
UNITRON INDUSTRIES, INC. |
SUSAN ARCHER |
| K971790 |
12/17/1997 |
KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) |
UROMETRICS, INC. |
PHILLIP A MESSINA |
| K973554 |
12/19/1997 |
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K973659 |
12/17/1997 |
VASOCOR PVR 100 |
VASOCOR, INC. |
JEFFERY RAINES |
| K974290 |
12/19/1997 |
MICROPROTEIN STANDARD KIT |
VERICHEM LABORATORIES, INC. |
ANTHONY J DIMONTE |
| K973436 |
12/09/1997 |
VISTA HEAD MOUNTED DISPLAY |
VISTA MEDICAL TECHNOLOGIES, INC. |
MARTIN NEWMAN |
| K973594 |
12/17/1997 |
GORE RESOLUT XT REGENERATIVE MATERIAL |
W.L. GORE & ASSOCIATES,INC |
JOHN W NICHOLSON |
| K973432 |
12/09/1997 |
SURGIFLATOR-30 |
W.O.M. WORLD OF MEDICINE, GMBH |
ROBERT P REZNICK |
| K973773 |
12/17/1997 |
DAPELLE HAIR REMOVER |
WELLQUEST INTL., INC. |
STEVEN MISHAN |
| K971580 |
12/09/1997 |
UAS ULTRASONIC ASPIRATOR SYSTEM |
WELLS JOHNSON CO. |
BRENDA HUNT |
| K973370 |
12/02/1997 |
AQUAPLAST PALATAL STENT |
WFR/AQUAPLAST CORP. |
JOHN R KIRK |
| K972280 |
12/11/1997 |
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES |
WILSON GREATBATCH TECHNOLOGIES, INC. |
GARY J SFEIR |
| K973538 |
12/16/1997 |
N-TERFACE |
WINFIELD LABORATORIES, INC. |
GARY W CUMMINGS |
| K973524 |
12/12/1997 |
ADVANCE MODULAR TIBIAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KIM TOMPKINS |
| K974240 |
12/22/1997 |
LIGHTLINE-M |
WUESTEC MEDICAL, INC. |
KRISTI WHITE |
| K974159 |
12/24/1997 |
OSOM HCG-URINE TEST MODEL 101 |
WYNTEK DIAGNOSTICS, INC. |
SHU-CHING CHENG |
| K973744 |
12/29/1997 |
UNICATH SP BI-PLANE (MODEL M269 & M289) |
XRE CORP. |
WAYNE V LOOMER |
| K974191 |
12/24/1997 |
EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
MOH UNG NANG |
| K974518 |
12/12/1997 |
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
LEONARD FRIER |
| K973714 |
12/24/1997 |
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS |
ZIMMER, INC. |
KAREN CAIN |
