| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K982142 |
12/30/1998 |
MOUNTABLE ENDOSCOPIC KNIFE |
A.M. SURGICAL, INC. |
EUGENE T KING |
| K983761 |
12/30/1998 |
AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 |
AARON MEDICAL INDUSTRIES |
J.ROBERT SARON |
| K983486 |
12/23/1998 |
SYSTEM U3 FOR NORFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K983571 |
12/30/1998 |
SYSTEM U3 FOR TETRACYCLINE |
AB BIODISK |
ANNE BOLMSTROM |
| K983424 |
12/01/1998 |
ABBOTT ARCHEITECT TOTAL B-HCG |
ABBOTT LABORATORIES |
KAREN L GATES |
| K983759 |
12/07/1998 |
ABBOTT ARCHITECT FERRITIN |
ABBOTT LABORATORIES |
LAURA GRANITZ |
| K983306 |
12/18/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K983310 |
12/17/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K983309 |
12/14/1998 |
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN |
ACCUMED INTL., INC. |
CYNTHIA C KNAPP |
| K983215 |
12/04/1998 |
MULTIPULSE CO2 LASER |
AESCULAP-MEDITEC GMBH |
WILLIAM T KELLEY |
| K983365 |
12/18/1998 |
AESCULAP MINOP SYSTEM |
AESCULAP, INC. |
MARY E HOLDEN |
| K983758 |
12/18/1998 |
YASARGIL TITANIUM ANEURYSM CLIPS |
AESCULAP, INC. |
VICTORIA MACKINNON |
| K974332 |
12/29/1998 |
VARIABLE PRESSURE SYRINGE PUMP |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K981054 |
12/07/1998 |
BROWNE GA INDICATOR FOR CIDEX PRODUCTS |
ALBERT BROWNE LTD. |
CYNTHIA J M NOLTE, PH.D |
| K983780 |
12/18/1998 |
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 |
ALCON LABORATORIES |
MICHAEL PFLEGER |
| K983973 |
12/18/1998 |
OPTI-ONE MULTI-PURPOSE SOLUTION |
ALCON LABORATORIES |
MICHAEL PFLEGER |
| K984383 |
12/18/1998 |
ULTRACARE NEUTRALIZING TABLETS |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K983146 |
12/07/1998 |
ARSOFT |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA HOOI KOON |
| K983770 |
12/31/1998 |
'RAPID DRUG SCREEN' 9-PANEL |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K982076 |
12/10/1998 |
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM |
AMIRA MEDICAL, INC. |
DAVID A HASKER |
| K983599 |
12/11/1998 |
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT |
ANDWIN SCIENTIFIC |
NATALIE SARRAF |
| K983489 |
12/14/1998 |
ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) |
ANSELL PERRY |
JAMES R CHATTERTON |
| K983543 |
12/16/1998 |
ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM |
ARGUS PHOTONICS GROUP |
KEVIN DICKENSON |
| K983649 |
12/11/1998 |
MAX-ACT |
ARRAY MEDICAL, INC. |
MICHAEL F CORSELLO |
| K983623 |
12/18/1998 |
MODULAP |
ATC TECHNOLOGIES, INC. |
MARIAN HARDING COCHRAN |
| K982268 |
12/04/1998 |
ULNAR HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K984299 |
12/11/1998 |
AVL OPTI CRITICAL CARE ANALYZER |
AVL SCIENTIFIC CORP. |
RANDY BYRD |
| K983741 |
12/18/1998 |
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 |
AXELGAARD MFG. CO., LTD. |
DAN P JEFFREY |
| K970736 |
12/16/1998 |
BRAUN PREFILLED SYRINGE |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
| K974845 |
12/08/1998 |
BTA STAT TEST PRESCRIPTION HOME USE |
BARD DIAGNOSTIC SCIENCES,INC. |
Glen Paul Freiberg |
| K983526 |
12/11/1998 |
VERTICAL LIFT |
BARNES,RICHARDSON & COLBURN |
ALYSA CHUMMANVECH |
| K983317 |
12/02/1998 |
BARRON MICROKERATOME SYSTEM, MODEL B2000 |
BARRON PRECISION INSTRUMENTS, L.L.C. |
MARK BARRON |
| K983345 |
12/07/1998 |
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY |
BAYER CORP. |
GABRIEL J MURACA JR |
| K983340 |
12/14/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K983747 |
12/30/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K984014 |
12/23/1998 |
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K983640 |
12/21/1998 |
SYNCHRON SYSTEMS LIPID CALIBRATOR |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K981816 |
12/04/1998 |
CUE AMBULATORY VOLUMETRIC INFUSION PUMP |
BECTON DICKINSON CURLIN, LLC. |
CHARLES J WELLE |
| K983773 |
12/22/1998 |
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS |
BENZ RESEARCH AND DEVELOPMENT CORP. |
MARTIN DALSING |
| K983183 |
12/10/1998 |
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P |
BIEN AIR USA, INC. |
ARTHUR MATEEN |
| K981665 |
12/07/1998 |
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE |
BIO-MEDICAL SCIENCES, INC. |
MARK E DILLON |
| K984325 |
12/17/1998 |
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984319 |
12/22/1998 |
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984318 |
12/15/1998 |
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984323 |
12/15/1998 |
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984324 |
12/15/1998 |
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984327 |
12/22/1998 |
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 |
BIO-RAD |
ELIZABETH PLATT |
| K984397 |
12/18/1998 |
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 |
BIO-RAD |
ELIZABETH PLATT |
| K984473 |
12/22/1998 |
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 |
BIO-RAD |
ELIZABETH PLATT |
| K984398 |
12/18/1998 |
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 |
BIO-RAD |
ELIZABETH PLATT |
| K984399 |
12/18/1998 |
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 |
BIO-RAD |
ELIZABETH PLATT |
| K984400 |
12/18/1998 |
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 |
BIO-RAD |
ELIZABETH PLATT |
| K984396 |
12/18/1998 |
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 |
BIO-RAD |
ELIZABETH PLATT |
| K984464 |
12/22/1998 |
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 |
BIO-RAD |
ELIZABETH PLATT |
| K984476 |
12/22/1998 |
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 |
BIO-RAD |
ELIZABETH PLATT |
| K984475 |
12/22/1998 |
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 |
BIO-RAD |
ELIZABETH PLATT |
| K984479 |
12/22/1998 |
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 |
BIO-RAD |
ELIZABETH PLATT |
| K984470 |
12/22/1998 |
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 |
BIO-RAD |
ELIZABETH PLATT |
| K984478 |
12/22/1998 |
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 |
BIO-RAD |
ELIZABETH PLATT |
| K984462 |
12/22/1998 |
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 |
BIO-RAD |
ELIZABETH PLATT |
| K984071 |
12/03/1998 |
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 |
BIO-RAD |
ELIZABETH PLATT |
| K984225 |
12/14/1998 |
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 |
BIO-RAD |
ELIZABETH PLATT |
| K983807 |
12/16/1998 |
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 |
BIO-RAD |
ELIZABETH PLATT |
| K984268 |
12/17/1998 |
VARIANT II HEMOGLOBIN A1C PROGRAM |
BIO-RAD |
JULIET CARRARA |
| K980117 |
12/18/1998 |
NUVO BARRIER FILM |
BIOMEDICAL DEVELOPMENT CO. |
RICHARD A HAMER |
| K983710 |
12/02/1998 |
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH |
BIOMET, INC. |
FRED MCCLURE |
| K983641 |
12/04/1998 |
HOLLAND FEMORAL NAIL SYSTEM |
BIOMET, INC. |
FRED MCCLURE |
| K983452 |
12/03/1998 |
NELSON RESURFACING HEAD |
BIOMET, INC. |
JULIE K RYAN |
| K983967 |
12/16/1998 |
PEDIATRIC CANNULATED OSTEOTOMY PLATES |
BIOMET, INC. |
LONNIE WITHAM |
| K981824 |
12/22/1998 |
OPTICOAT T3 EIA KIT |
BIOTECX LABORATORIES, INC. |
MOHAN MEHRA |
| K984112 |
12/22/1998 |
ADVENT |
BISCO, INC. |
STEVEN J DURAY |
| K984372 |
12/14/1998 |
ELECSYS CALCHECK TROPONIN T |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K984105 |
12/08/1998 |
ELECSYS TROPONIN T STAT TEST |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K983503 |
12/01/1998 |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 |
BOEHRINGER MANNHEIM CORP. |
JENNIFER L TRIBBETT |
| K984431 |
12/30/1998 |
ULTIMA AIRFLOW PRESSURE SENSOR |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K983454 |
12/16/1998 |
PAIN CARE 2000 |
BREG, INC. |
KATHLEEN BARBER |
| K983498 |
12/15/1998 |
BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE |
C.R. BARD, INC. |
GEORGIA C ABERNATHY |
| K971336 |
12/01/1998 |
CAIRD TECHNOLOGY SPIROMETER |
CAIRD TECHNOLOGY |
JAMES H BROWN |
| K983026 |
12/02/1998 |
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
| K983653 |
12/22/1998 |
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D |
CARDIAC PATHWAYS CORP. |
ERIN DIGNAN |
| K983789 |
12/17/1998 |
CARESIDE CALCIUM, ORIGINAL |
CARESIDE, INC. |
KENNETH B ASARCH PHARM |
| K983182 |
12/10/1998 |
ALOE THERAPY ORAL RINSE |
CARRINGTON LABORATORIES, INC. |
E.J. Smith |
| K984042 |
12/04/1998 |
QUADRANT CORE LC |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K984044 |
12/16/1998 |
QUADRANT POSTERIOR DENSE |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K984043 |
12/04/1998 |
QUADRANT TOTAL ETCH |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K984041 |
12/04/1998 |
QUADRANT UNIVERSAL LC |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
| K981746 |
12/07/1998 |
CELL ROBOTICS' LASETTE |
CELL ROBOTICS, INC. |
CONNIE WHITE |
| K981972 |
12/07/1998 |
GREEN-OR DENTIN DESENSITIZER |
CENTRIX, INC. |
JOHN DISCKO |
| K983685 |
12/04/1998 |
BONE BAND |
CHAPEL AND ASSOC. |
JAMES F CHAPEL |
| K983432 |
12/17/1998 |
SUPREME II CONTROL SOLUTIONS |
CHRONIMED, INC. |
JEFFREY P HEATON |
| K983463 |
12/11/1998 |
SURECAUT DIAMOND LASER KNIFE |
CLINICON CORP. |
GERALD S PALECKI |
| K983921 |
12/28/1998 |
AUTOSTAT II ENA SCREEN ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K983714 |
12/23/1998 |
SOLARTEC SOURCE 270, MODEL # 90123 |
COGENT LIGHT TECHNOLOGIES, INC. |
DON KNAEPPLE |
| K983173 |
12/16/1998 |
BIATAIN FOAM ADHESIVE DRESSING |
COLOPLAST CORP. |
M. SYDNEY LILLY |
| K983163 |
12/16/1998 |
BIATAIN FOAM DRESSING |
COLOPLAST CORP. |
M. SYDNEY LILLY |
| K983519 |
12/30/1998 |
COMFEEL SEASORB DRESSING |
COLOPLAST CORP. |
M.SYDNEY LILLY |
| K983553 |
12/07/1998 |
ANTI-TG IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983605 |
12/16/1998 |
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K983606 |
12/16/1998 |
IS BORRELIA BURGDORFERI IGM TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
| K980378 |
12/09/1998 |
MELODIE INFUSION PUMP |
COMPAGNIE DE DEVELOPPEMENT AGUETTANT |
DIANE MCCOLL |
| K983568 |
12/21/1998 |
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER |
CONTRACT LATEX DIPPERS SDN BHD |
VINAYAGAN RAMALINGAM |
| K983415 |
12/01/1998 |
DELIVERY SHEATH |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K983116 |
12/03/1998 |
ELECTROSURGICAL INFLATABLE BASKET ELECTRODES |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K983609 |
12/16/1998 |
COOK TEST TUBE HEATER |
COOK OB/GYN |
BRENDA DAVIS |
| K983594 |
12/21/1998 |
EMBRYO TRANSFER CATHETERS/SETS |
COOK OB/GYN |
DEBBIE SCHMITT |
| K983590 |
12/21/1998 |
GIFT CATHETER SET/S |
COOK OB/GYN |
BRENDA DAVIS |
| K983587 |
12/16/1998 |
HYSTEROSCOPIC GIFT CATHETER SETS |
COOK OB/GYN |
BRENDA DAVIS |
| K983591 |
12/21/1998 |
INTRATUBAL TRANSFER SETS |
COOK OB/GYN |
DEBBIE SCHMITT |
| K984500 |
12/23/1998 |
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
CORDIS CORP. |
ARIEL MACTAVISH |
| K980823 |
12/18/1998 |
CORDIS NITINOL STENT AND DELIVERY SYSTEM |
CORDIS CORP. |
JOAN MARTIN |
| K982434 |
12/22/1998 |
REAADS IGA ANTI-B2GP 1 TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K982391 |
12/07/1998 |
REAADS IGG ANTI-B2GPI TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K982433 |
12/07/1998 |
REAADS IGM ANTI-B2GP1 TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K983914 |
12/22/1998 |
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K982651 |
12/11/1998 |
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER |
COROMETRICS MEDICAL SYSTEMS, INC. |
RICHARD CEHOVSKY |
| K983277 |
12/16/1998 |
LIGHTSOURCE OR ILLUMINATOR MODEL I-100 |
CUDA PRODUCTS CO. |
KIM REED |
| K984193 |
12/14/1998 |
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K984191 |
12/10/1998 |
MYOGLOBIN FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K984093 |
12/14/1998 |
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K984065 |
12/14/1998 |
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K983392 |
12/15/1998 |
DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR |
DATA RAY |
GREG ROBERTS |
| K982091 |
12/22/1998 |
CS/3 COMPACT AIRWAY MODULE, M-COVX |
DATEX-ENGSTROM, INC. |
JOEL C KENT |
| K983366 |
12/23/1998 |
TRIP TONOMETRY CATHETER, 16F |
DATEX-ENGSTROM, INC. |
JOEL KENT |
| K981680 |
12/31/1998 |
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS |
DAYTON WATER SYSTEMS |
CINDY HELTON |
| K984458 |
12/31/1998 |
DEPUY ACE SPIDER PLATE |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K983853 |
12/22/1998 |
DEPUY ACE TIMAX META PLATE |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K983491 |
12/02/1998 |
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K983906 |
12/18/1998 |
DEPUY ORTHOTECH SPIKED WASHER |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K983583 |
12/03/1998 |
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS |
DEPUY, INC. |
LYNETTE WHITAKER |
| K984378 |
12/30/1998 |
DEPUY ACROMED MOSS SPINAL SYSTEM |
DEPUY, INC. |
LYNNETTE WHITAKER |
| K972788 |
12/22/1998 |
CROSSLAPS ELISA |
DEVICES AND DIAGNOSTICS CONSULTING GROUP |
TOM TSAKARIS |
| K983954 |
12/17/1998 |
ALASTAT MICROPLATE MIXED ALLERGEN PANELS |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983263 |
12/07/1998 |
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K982078 |
12/11/1998 |
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983972 |
12/07/1998 |
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983880 |
12/18/1998 |
TRANSFERRIN SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
JUDITH J SMITH |
| K982650 |
12/16/1998 |
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) |
DIDECO S.P.A. |
ROSINA ROBINSON |
| K981881 |
12/02/1998 |
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K983219 |
12/07/1998 |
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 |
DRAGER, INC. |
HARALD KNEUER |
| K984023 |
12/08/1998 |
MAXVIEW DIAGNOSTIC WORKSTATION |
DYNAMIC HEALTHCARE TECHNOLOGIES, INC. |
KAREN W WHITE |
| K983348 |
12/11/1998 |
DYNAREX TRACHEOSTOMY SPONGE |
DYNAREX CORP. |
JOHN G MOULDEN |
| K974259 |
12/01/1998 |
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
R D HIBBERT |
| K983313 |
12/11/1998 |
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY |
ELSCINT, INC. |
STEVEN M KAY |
| K983473 |
12/17/1998 |
FERTILMARQ TEST KIT |
EMBRYOTECH LABORATORIES, INC. |
ANN D MCGONIGLE |
| K982832 |
12/23/1998 |
PROGUARD, RR-1, RR-2 |
EMERSON & CO. S.R.L. |
STEFANO COSTIGLTOLO |
| K983484 |
12/28/1998 |
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE |
EMPI |
CAROLYN M STEELE HUSTEN |
| K974617 |
12/01/1998 |
PERIPHERAL VASCULAR DILATOR |
ENDOVASCULAR INSTRUMENTS, INC. |
JACK SPEER |
| K983414 |
12/16/1998 |
EVERBOND |
ESPE DENTAL AG |
A. PETERMANN |
| K983536 |
12/18/1998 |
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS |
ETHICON ENDO-SURGERY, INC. |
EDWIN O BILLIPS |
| K983199 |
12/14/1998 |
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL |
FIBRA SONICS, INC. |
ROBERT BROHM |
| K983561 |
12/16/1998 |
FUJINON EVL-F VIDEO LAPROSCOPE |
FUJINON, INC. |
GARY A ADLER |
| K983256 |
12/15/1998 |
ADVANTAGE WINDOWS (AW) FUSION |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K982712 |
12/18/1998 |
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
STEPHEN M PAGE |
| K983847 |
12/01/1998 |
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT |
GERMIPHENE CORP. |
LESLIE DRAKE |
| K984218 |
12/17/1998 |
OASIS |
GLIMEX CORP. |
JEFF HACKETT |
| K983952 |
12/28/1998 |
GREINER VACUETTE BLOOD COLLECTION TUBE |
GREINER MEDITECH, INC. |
DOUG HARRIS |
| K983055 |
12/30/1998 |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 |
GUIDANT CORP. |
SUSAN SILAVIN |
| K982337 |
12/29/1998 |
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER |
HAIDYLENA MEDICAL EGYPT |
SAMEH TAMIM |
| K983535 |
12/29/1998 |
THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 |
HANS HERMANN GMBH |
DAGMAR S MASER |
| K983752 |
12/10/1998 |
ALUMINA-ZINC OXIDE POWDERS F AND R |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K982426 |
12/17/1998 |
SPIFE ALKALINE HEMOGLOBIN |
HELENA LABORATORIES |
PAT FRANKS |
| K984286 |
12/17/1998 |
HEARTSTREAM ELECTRODE ADAPTER |
HEWLETT-PACKARD CO. |
WILLIAM D JORDAN |
| K981781 |
12/04/1998 |
ELECTROSURGICAL UNIT |
HILL-MED, INC. |
ERNESTO ACKERMAN |
| K984278 |
12/11/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
| K984272 |
12/11/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
JAMES JOCHEN ROGERS |
| K980926 |
12/16/1998 |
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K980626 |
12/11/1998 |
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K980632 |
12/11/1998 |
DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K980925 |
12/16/1998 |
DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K983528 |
12/23/1998 |
MICRO DYNAMIC MESH |
HOWMEDICA CORP. |
VIVIAN KELLY |
| K983404 |
12/22/1998 |
TYPE 3 FEMORAL COMPONENTS |
HOWMEDICA CORP. |
FRANK MAAS |
| K983559 |
12/24/1998 |
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR |
ICU MEDICAL, INC. |
SHERYL SAENZ |
| K983924 |
12/18/1998 |
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K980637 |
12/16/1998 |
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT |
IMPLEX CORP. |
ROBERT POGGIE, PH.D. |
| K983128 |
12/03/1998 |
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY |
IMPLEX CORP. |
JOHN SCHALAGO |
| K983769 |
12/15/1998 |
DISTAFLO BYPASS GRAFT |
IMPRA, INC. |
KRISTI M KISTNER |
| K982804 |
12/16/1998 |
SPYROGEL HYDROGEL WOUND AND BURN DRESSING |
INNOVATIVE TECHNOLOGIES (US), INC. |
JULIE CHAFFEE |
| K983303 |
12/09/1998 |
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS |
INNOVATIVE TECHNOLOGIES LTD. |
CHRISTOPHER OAKES |
| K983073 |
12/16/1998 |
I.V. EXTENSION SET OR I.V. ADMINISTRATION SET |
INTEGRA BIOTECHNICAL LLC. |
WILLIAM BERGELIN |
| K982562 |
12/28/1998 |
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER |
INTEGRATED ORBITAL IMPLANTS, INC. |
JEANNE DUNHAM |
| K973328 |
12/10/1998 |
INTERSOURCE |
INTERNATIONAL BRACHYTHERAPY, SA |
VINCENT E CONIGLIONE |
| K981253 |
12/11/1998 |
ULTRACON ULTRAFILTRATOR |
INTERPORE INTL. |
LYNN M RODARTI |
| K982311 |
12/14/1998 |
BARTELS CINAKIT CMV ANTIGENEMIA |
INTRACEL CORP. |
FEDORA DAYE CONTRERAS |
| K983777 |
12/18/1998 |
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM |
INVACARE CORP. |
EDWARD A KROLL |
| K982612 |
12/14/1998 |
ESP7 VENOUS IMAGE |
IRONMASTER, INC. |
FRED DAWSON |
| K984164 |
12/29/1998 |
JELBOND NP |
JELENKO CO. |
TRIDIB DASGUPTA |
| K983362 |
12/16/1998 |
NU-GEL * WOUND DRESSING |
JOHNSON & JOHNSON MEDICAL, INC. |
TERRY J DAGNON |
| K982812 |
12/04/1998 |
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
MARY E GRAY |
| K982379 |
12/18/1998 |
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JANET G JOHNSON |
| K983142 |
12/07/1998 |
KSEA C-MOUNT ARTHROSCOPES |
KARL STORZ ENDOSCOPY |
KEVIN KENNAN |
| K983363 |
12/18/1998 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K980878 |
12/28/1998 |
PULMOTRACK,MODEL 1010 |
KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. |
CHARLES S IRVING |
| K981737 |
12/09/1998 |
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 |
KATECHO, INC. |
LORNE S CHARNBERG |
| K982995 |
12/04/1998 |
ACCUTRAX, MODEL EPF840 |
KORR MEDICAL TECHNOLOGIES, INC. |
SCOTT KOFOED |
| K983723 |
12/07/1998 |
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K983721 |
12/07/1998 |
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K984019 |
12/23/1998 |
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS) |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K984020 |
12/23/1998 |
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
BOB CHAN |
| K983227 |
12/11/1998 |
POWER BLOCK |
KREATIV, INC. |
JOSEPH M FOREHAND |
| K983965 |
12/22/1998 |
CO2 LASER COUPLER |
LASER, INC. |
WILLIAM K PRZBYBLA |
| K984110 |
12/18/1998 |
LASERSCOPE COOLSPOT |
LASERSCOPE |
PAUL H HARDIMAN |
| K972975 |
12/22/1998 |
LIGHT DIAGNOSTICS RABIES DFA REAGENT |
LIGHT DIAGNOSTICS |
CINDY D PENNY |
| K983724 |
12/08/1998 |
ORCA-DX BONE DENSITOMETER |
LUNAR CORP. |
KENNETH D BUROKER |
| K983564 |
12/08/1998 |
PRODIGY TOTAL BODY SOFTWARE |
LUNAR CORP. |
KENNETH D BUROKER |
| K981942 |
12/14/1998 |
LATEX POWDER FREE EXAMINATION GLOVES |
MAIKA RUBBER PRODUCTS SDN BHD |
RAVI ANBIL |
| K984177 |
12/18/1998 |
MODIFICATION TO SKVEKPATCH |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K980845 |
12/14/1998 |
MS-900S, MS-900SPM & MS-900SFM |
MARS MEDICAL PRODUCTS |
E J SMITH |
| K983448 |
12/18/1998 |
ML UNIVERSAL TUBING |
MED-LOGICS, INC. |
BETTY ROSS |
| K981992 |
12/15/1998 |
ELECTRON WEDGE MODEL MT-EW-1000 |
MED-TEC,INC. |
DONALD F RIIBE |
| K984277 |
12/09/1998 |
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT D KINGHORN |
| K983412 |
12/10/1998 |
MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K983601 |
12/15/1998 |
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
| K983459 |
12/08/1998 |
PULSED OXYGEN CONSERVING DEVICE, POCD |
MEDICAL ELECTRONIC DEVICES, INC. |
THOMAS WENZEL |
| K982303 |
12/08/1998 |
PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST |
MEDISENSE, INC. |
MICHAEL HALPIN |
| K982694 |
12/14/1998 |
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K984211 |
12/23/1998 |
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 |
MEDSCAND AB |
TENNY P TSE |
| K983187 |
12/10/1998 |
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE |
MEDSOL CORP. |
ALEC S GOLDENBERG |
| K983297 |
12/18/1998 |
MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE |
MEDTRONIC INSTENT, INC. |
NOEL MESSENGER |
| K983331 |
12/16/1998 |
MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 |
MEDTRONIC PS MEDICAL |
JEFFREY HENDERSON |
| K980973 |
12/10/1998 |
MEDTRONIC ANGIOGRAPHIC CATHETER |
MEDTRONICS INTERVENTIONAL VASCULAR |
MARK CHARTIER |
| K983065 |
12/01/1998 |
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM |
MENTOR CORP. |
DONNA A CRAWFORD |
| K983255 |
12/17/1998 |
MODIFICATION TO: PREMIER PLATINUM HPSA |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K982764 |
12/03/1998 |
PREMIER CRYPTOSPORIDIUM |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K983976 |
12/30/1998 |
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM |
METAGEN, L.L.C. |
WESLEY D JOHNSON |
| K981554 |
12/22/1998 |
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) |
MICRA INSTRUMENTS LTD. |
JOHN A.K. BASKERVILLE |
| K982543 |
12/11/1998 |
SILVERSTREAK HYDROPHILIC GUIDEWIRE |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
| K981922 |
12/10/1998 |
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
CARL ANGLES |
| K983374 |
12/23/1998 |
AGATHA-A-H2010 |
MIDIAN INTL. |
CHRIS MONTALBANO |
| K983909 |
12/21/1998 |
MIR SPIROBANK SPIROMETER |
MIR MEDICAL INTL. RESEARCH SRL |
SIMON FOWLER |
| K983401 |
12/15/1998 |
FRAMEWAVE WEB |
ML STRATEGIES, INC. |
ALLAN M GREEN |
| K983876 |
12/16/1998 |
MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC |
MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND |
LARRY STEFFIER |
| K982728 |
12/07/1998 |
NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C |
NELLCOR PURITAN BENNETT, INC. |
SHERYLL A MATHEWS |
| K983274 |
12/09/1998 |
STARTRACK INFANT GRAPHICS MONITOR |
NELLCOR PURITAN BENNETT, INC. |
DAVID A.C. GREEN |
| K982535 |
12/21/1998 |
INSIGHT DIAGNOSTIC IMAGING WORKSTATION |
NEO IMAGERY TECHNOLOGIES, INC. |
GARY J ALLSEBROOK |
| K980475 |
12/16/1998 |
UNIPULSE CO2 SURGICAL LASER SYSTEM |
NIDEK, INC. |
KEN KATO |
| K983072 |
12/01/1998 |
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K983470 |
12/22/1998 |
SUPER PORCELAIN STAIN- PURE WHITE |
NORITAKE CO., INC. |
MARSHA C WERTZBERGER |
| K982323 |
12/11/1998 |
OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K984145 |
12/23/1998 |
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT |
OLYMPUS DIAGNOSTICA GMBH |
LAURA STORMS-TYLER |
| K983811 |
12/24/1998 |
UNIPOLAR OPTICAL BIOPSY FORCEPS |
OLYMPUS WINTER & IBE GMBH |
LAURA STORMS-TYLER |
| K983730 |
12/11/1998 |
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE |
OMNIGRACE LTD. |
K.C. CHOONG |
| K983725 |
12/07/1998 |
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE |
OMNIGRACE LTD. |
K.C. CHOONG |
| K981917 |
12/07/1998 |
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
OON CORP. RESOURCES |
CLEMENT K.K OON |
| K984185 |
12/16/1998 |
MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
| K983267 |
12/30/1998 |
DIGORA FOR WINDOWS 2.0 |
ORION CORPORATION SOREDEX |
KAI LANER |
| K983031 |
12/18/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K983990 |
12/29/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K984011 |
12/07/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K983169 |
12/16/1998 |
POLYMER THREADED ANCHOR |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
JEFFRY B SKIBA |
| K983881 |
12/04/1998 |
COBRA EXTERNAL FIXATOR |
ORTHOPAEDIC INNOVATIONS, INC. |
TODD J HEIN |
| K983353 |
12/18/1998 |
SCS SPINAL SYSTEM |
ORTHOTEC, INC. |
DAVID W SCHLERF |
| K983165 |
12/03/1998 |
OSTEO 4.0MM CANNULATED SCREW SYSTEM |
OSTEONICS CORP. |
KATE SUTTON |
| K984353 |
12/16/1998 |
OSTEO 9MM IC TIBIAL NAIL |
OSTEONICS CORP. |
KATE SUTTON |
| K983508 |
12/07/1998 |
OSTEO COMPRESSION CONDYLE SCREW SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K983382 |
12/11/1998 |
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K983870 |
12/02/1998 |
OSTEONICS RESTORATION HA HIP STEMS |
OSTEONICS CORP. |
KATE SUTTON |
| K983502 |
12/16/1998 |
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K984302 |
12/18/1998 |
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS |
OSTEONICS CORP. |
KATE SUTTON |
| K983226 |
12/04/1998 |
OSTEONICS X CEMENTED HIP STEM SERIES |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K983352 |
12/11/1998 |
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK |
OTODYNAMICS, LTD. |
E.J. Smith |
| K983351 |
12/11/1998 |
ILO292 DP ECHOPORT PLUS OAE SYSTEM |
OTODYNAMICS, LTD. |
E.J. Smith |
| K983350 |
12/11/1998 |
ILO292 DP ECHOPORT PLUS OAE SYSTEM |
OTODYNAMICS, LTD. |
E.J. Smith |
| K983974 |
12/21/1998 |
OWEN MUMFORD 3ML AUTOPEN |
Owen Mumford USA, Inc. |
ROBERT SHAW |
| K982275 |
12/04/1998 |
RAPPORT V.T.D. |
Owen Mumford USA, Inc. |
ROBERT SHAW |
| K983718 |
12/11/1998 |
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
| K982897 |
12/23/1998 |
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
P.T. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K984129 |
12/01/1998 |
COAGULATION CONTROL LEVEL 1 (NORMAL) |
PACIFIC HEMOSTASIS |
MARK ELLIS |
| K984130 |
12/01/1998 |
COAGULATION CONTROL LEVEL 2 (ABNORMAL) |
PACIFIC HEMOSTASIS |
MARK ELLIS |
| K984131 |
12/01/1998 |
COAGULATION CONTROL LEVEL 3 (ABNORMAL) |
PACIFIC HEMOSTASIS |
MARK ELLIS |
| K983731 |
12/21/1998 |
PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE |
PALL MEDICAL |
ROBERT A DICKSTEIN |
| K983413 |
12/21/1998 |
MODEL MS-1 HANDPIECE |
PARKELL, INC. |
NELSON J GENDUSA |
| K983729 |
12/11/1998 |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE |
PERUSAHAAN GETAH ASAS SDN BHD |
BOB CHAN |
| K983877 |
12/21/1998 |
PHILIPS INTEGRIS 3D RA OPTION |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K983821 |
12/11/1998 |
PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K984111 |
12/11/1998 |
FV-RF |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MICHAEL J HAYES |
| K983342 |
12/21/1998 |
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K984401 |
12/30/1998 |
NEUROMAG VECTORVIEW |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K974096 |
12/08/1998 |
CRX DIAMOND VALVE |
PHOENIX BIOMEDICAL CORP. |
DAVID KUNIN |
| K983477 |
12/22/1998 |
SUPER SEAL |
PHOENIX DENTAL, INC. |
ROBERT A CHERBA |
| K983501 |
12/18/1998 |
ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K984379 |
12/10/1998 |
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM |
PURITAN BENNETT CORP. |
ROBBIE WALSH |
| K984535 |
12/28/1998 |
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION |
PURITAN BENNETT CORP. |
ANN-MARIE BUTLER |
| K972991 |
12/03/1998 |
MONITOR ONE NDX |
QMED, INC. |
JOSEPH HANNA |
| K984099 |
12/10/1998 |
QBC CENTRIFUGAL HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K981643 |
12/14/1998 |
RTM DVT PROSOFT CUFF MODEL NUMBER PS100 |
R.T. MEDICAL SERVICES, INC. |
KAREN L DIEHL |
| K982791 |
12/30/1998 |
ROCS TPS |
RADIATION ONCOLOGY COMPUTER SYSTEMS |
CHARLENE NEBLETT |
| K984245 |
12/18/1998 |
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS |
RADIONICS, INC. |
KEVIN J O'CONNELL |
| K982549 |
12/30/1998 |
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC |
RADIONICS, INC. |
DAVID CROMWICK |
| K974064 |
12/07/1998 |
MICRO X RESIDUAL TEST STRIPS |
REPROCESSING PRODUCTS CORP. |
WALTER JANSEN |
| K983236 |
12/04/1998 |
BIPOLAR HF CABLE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983279 |
12/02/1998 |
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983628 |
12/11/1998 |
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K983871 |
12/01/1998 |
RITA MODEL 70 ELECTROSURGICAL PROBE |
RITA MEDICAL SYSTEMS |
DAVID A TUCKER |
| K983555 |
12/15/1998 |
ABUSCREEN ONLINE BENZ 200 CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K983556 |
12/15/1998 |
ABUSCREEN ONLINE BENZ 300 CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K983697 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983699 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983701 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983703 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K983700 |
12/11/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K973718 |
12/15/1998 |
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
ROCHE MOLECULAR SYSTEMS, INC. |
ALEX WESOLOWSKI |
| K981678 |
12/11/1998 |
STRATA, MODEL V.O.95 |
ROSSES MEDICAL SYSTEMS |
RENE SPECTOR |
| K982614 |
12/04/1998 |
RUSCH POLYFLEX STENT KIT |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K983403 |
12/17/1998 |
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER |
SALTER LABS |
DUANE KAZAL |
| K982661 |
12/11/1998 |
CDR - PAN MODEL 4700 |
SCHICK TECHNOLOGIES, INC. |
ENRICO RENZI |
| K983305 |
12/17/1998 |
SCI-PHARM DESENSITIZING VARNISH |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K983630 |
12/11/1998 |
SEARE BIOMEDICAL SILICONE RODS |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE, JR. |
| K983792 |
12/11/1998 |
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE JR |
| K983468 |
12/17/1998 |
FASTTAKE ADAPTER, MODEL # P/N 020-072-01 |
SELFCARE, INC. |
BETTY LANE |
| K982885 |
12/04/1998 |
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE |
SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. |
DON MORRIS |
| K983645 |
12/04/1998 |
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K982316 |
12/16/1998 |
LASEAWAY ALEXANDRITE LASER SYSTEM |
SILVER CREEK, INC. |
LORNA K LINVILLE |
| K983242 |
12/11/1998 |
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HAMEON-HEYER |
| K983964 |
12/09/1998 |
BATCH #6060 CONDUCTIVE GEL |
SKYLARK DEVICE CO., LTD. |
GEORGE CHEN |
| K981449 |
12/11/1998 |
SD-956 ULTRASOUND THERAPY |
SKYLARK DEVICE CO., LTD. |
GEORGE K C CHEN |
| K983210 |
12/10/1998 |
ALGISITE M |
SMITH & NEPHEW, INC. |
JIM G IRVIN |
| K983942 |
12/04/1998 |
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP |
SMITH & NEPHEW, INC. |
|
| K980184 |
12/18/1998 |
CD SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K983672 |
12/16/1998 |
DYNA-LOK SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K984196 |
12/11/1998 |
MODIFICATION TO PROWESS PRO-SIM |
SSGI PROWESS SYSTEMS |
ROBERT J MORTON |
| K983129 |
12/04/1998 |
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) |
STAAR SURGICAL CO. |
STEVEN L ZIEMBA |
| K983947 |
12/04/1998 |
AMERSE 2 |
STERIS Corporation |
MICHAEL G SARLI |
| K983557 |
12/18/1998 |
STRYKER WEDGE SUTURE ANCHOR |
Stryker Endoscopy |
TODD MILLER |
| K983153 |
12/04/1998 |
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS |
SULZER ORTHOPEDICS, INC. |
DENISE CUCHENE |
| K983733 |
12/18/1998 |
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K980675 |
12/22/1998 |
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME |
SUMMIT TECHNOLOGY, INC. |
Eric Ankerud |
| K983320 |
12/11/1998 |
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS |
SURETEX PROPHYLACTICS (INDIA) LTD. |
V.V. RAMANA RAO |
| K983397 |
12/04/1998 |
STEALTHSTATION TREATMENT GUIDANCE PLAFFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K982212 |
12/02/1998 |
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 |
SYNERGETICS, INC. |
KURT GAMPP |
| K983495 |
12/16/1998 |
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 |
SYNTEC SCIENTIFIC CORP. |
TED Y SHI |
| K983873 |
12/30/1998 |
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM |
SYNTEC SCIENTIFIC CORP. |
TED Y SHI |
| K983757 |
12/04/1998 |
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 |
SYNTEC SCIENTIFIC CORP. |
TED Y SHI |
| K983485 |
12/21/1998 |
SYNTHES 1.3 MM SELF-DRILLING SCREW |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K983530 |
12/16/1998 |
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM |
SYNTHES (USA) |
JONATHAN M GILBERT |
| K983766 |
12/18/1998 |
SYNTHES SYNMESH |
SYNTHES (USA) |
JAMES MCCRACKEN |
| K971981 |
12/22/1998 |
LS SERIES 200 FLOVISION SYSTEM |
SYSTAM |
ED RANSOM |
| K981363 |
12/22/1998 |
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST |
TCPI, INC. |
JEFFREY BOLTS |
| K981912 |
12/04/1998 |
HUMAN IGA SUBCLASS BNII COMBI KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K983622 |
12/30/1998 |
BODYFORM THORACO-LUMBAR FIXATION SYSTEM |
THEKEN SURGICAL,LLC |
LUKAS EISERMANN |
| K981171 |
12/02/1998 |
ERADIC-ALL |
THERATECHNOLOGIES, INC. |
ANDRE DE VILLERS |
| K983917 |
12/04/1998 |
THERATRON ELITE |
THERATRONICS, INC. |
E.S. MARTELL |
| K984384 |
12/23/1998 |
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 |
THERMO BIOANALYSIS CORP. |
JANET A MCGRATH |
| K983825 |
12/04/1998 |
NITRILE LATEX POWDER FREE EXAMINATION GLOVE |
TOP GLOVE SDN. BHD. |
T.S. PUON |
| K983816 |
12/04/1998 |
NITRILE LATEX POWDERED EXAMINATION GLOVE |
TOP GLOVE SDN. BHD. |
T.S. PUON |
| K970829 |
12/22/1998 |
PHUSIS ABSORBABLE INTERFERENCE SCREW |
TORNIER |
DAVID W SCHLERF |
| K983514 |
12/23/1998 |
POSITRON OPTION, MODEL NSCO-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DONNELLE KRAJEWSKI |
| K983516 |
12/23/1998 |
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DONELLE KRAJEWSKI |
| K984359 |
12/23/1998 |
AIA-PACK TROPONIN I ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K984414 |
12/30/1998 |
XRE COLLIMATOR WITH SPECTRAL FILTER |
TREX MEDICAL CORP. |
WAYNE V LOOMER |
| K981946 |
12/10/1998 |
CLEARVIEW IM |
UNIPATH LTD. |
Louise Roberts |
| K984342 |
12/30/1998 |
ANTERIOR CERVICAL PLATING SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
KAREN F JURCZAK |
| K983293 |
12/16/1998 |
AUTO SUTURE LAPAROSCOPES DEVICE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JAMIE YIEH |
| K983904 |
12/22/1998 |
ROGOZINSKI SPINAL ROD SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K983899 |
12/22/1998 |
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K982140 |
12/08/1998 |
CLINICAL ELECTRONIC THERMOMETER |
VALEO CORP. |
PHIL ZULUETA |
| K983529 |
12/31/1998 |
INSTATRAK 3000 |
VISUALIZATION TECHNOLOGY, INC. |
MARY MCNAMARA-CULLINANE |
| K982901 |
12/21/1998 |
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED |
VITALCARE GROUP, INC. |
GINGER TALLEY |
| K983716 |
12/23/1998 |
VITALCARE DISPOSABLE VAGINAL SPECULUM |
VITALCARE GROUP, INC. |
GINGER TALLEY |
| K983525 |
12/10/1998 |
GORE REVOX THYROPLASTY IMPLANT |
W.L. GORE & ASSOCIATES,INC |
JOHN NICHOLSON |
| K983663 |
12/18/1998 |
C.T.M. MOBILITY SCOOTER, MODEL # HS-666 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K983662 |
12/18/1998 |
C.T.M. MOBILITY SCOOTER, MODEL # HS-686 |
WAREPALMY ENTERPRISE LLC (USA) |
ROBERT S MCQUATE |
| K982344 |
12/22/1998 |
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS |
WESLEY JESSEN CORP. |
JOSEPH FOOS |
| K983833 |
12/10/1998 |
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE |
WESTAIM BIOMEDICAL, INC. |
JONATHAN S KAHAN |
| K984157 |
12/08/1998 |
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE |
WILSON-COOK MEDICAL, INC. |
PAULA JOYCE |
| K983765 |
12/11/1998 |
INJECTION NEEDLE PROBE/DEVICE-TUNIS |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
| K983200 |
12/11/1998 |
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX |
XIMED/PROSURE/INJECTX |
ASHVIN DESAI |
| K984173 |
12/22/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K984347 |
12/17/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K984175 |
12/17/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983803 |
12/14/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983804 |
12/08/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K983801 |
12/10/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K984315 |
12/17/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K982981 |
12/17/1998 |
NEW ZIMMER SHOULDER SYSTEM |
ZIMMER, INC. |
LAURA D WILLIAMS |
