FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K981060 |
04/29/1998 |
ABBOTT AXSYM 3RD GENERATION TSH ASSAY |
ABBOTT LABORATORIES |
APRIL VEOUKAS |
K980614 |
04/24/1998 |
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS |
ABBOTT LABORATORIES |
JANICE E BROWN |
K980367 |
04/01/1998 |
AEROSET SYSTEM |
ABBOTT LABORATORIES |
ANDREW JOHNSON |
K981225 |
04/23/1998 |
ASPARTATE AMINOTRANSFERASE (AST) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981221 |
04/23/1998 |
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K981222 |
04/24/1998 |
DIRECT BILIRUBIN (DBIL) |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K974382 |
04/21/1998 |
ACKERMANN SURGICAL INSTRUMENTS |
ACKERMANN INSTRUMENTE GMBH |
FRANK FERGUSON |
K980736 |
04/16/1998 |
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST |
ACON LABORATORIES CO. |
PATRICIA E BONNESS |
K981274 |
04/29/1998 |
ACROMED TIMX PLATE BASED LOW BACK SYSTEM |
ACROMED CORP. |
MARY LEWIS |
K980228 |
04/14/1998 |
UNIVERSITY PLATE ANTERIOR SYSTEM |
ACROMED CORP. |
WILLIAM CHRISTIANSON |
K980361 |
04/21/1998 |
DERMABLATE ER: YAG LASER SYSTEM |
AESCULAP-MEDITEC NORTH AMERICA |
WILLIAM T KELLEY |
K973697 |
04/08/1998 |
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY |
AIRPERM, INC. |
NICK STOYAN |
K980554 |
04/07/1998 |
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) |
ALDEN OPTICAL LABS., INC. |
MARTIN J DALSING |
K980224 |
04/02/1998 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
K980507 |
04/23/1998 |
PROSPECT SHIGA TOXIN MICROPLATE ASSAY |
ALEXON - TREND, INC. |
BARBARA A CHIPONIS, MT (ASCP) |
K980589 |
04/14/1998 |
AR SAFE NITRILE EXAMINATION GLOVES |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA H KOON |
K980471 |
04/09/1998 |
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE |
AMERICAN INSTITUTE OF KORYO HAND THERAPY |
GEORGE SU |
K980472 |
04/09/1998 |
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE |
AMERICAN INSTITUTE OF KORYO HAND THERAPY |
GEORGE SU |
K980470 |
04/06/1998 |
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE |
AMERICAN INSTITUTE OF KORYO HAND THERAPY |
GEORGE SU |
K980469 |
04/03/1998 |
KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE |
AMERICAN INSTITUTE OF KORYO HAND THERAPY |
GEORGE SU |
K980168 |
04/02/1998 |
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE |
ANALOGIC CORP. |
RONALD LUICH |
K980305 |
04/16/1998 |
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE |
APPLIED MEDICAL TECHNOLOGY, INC. |
THOMAS W PARKINSON |
K980145 |
04/10/1998 |
AMT DECOMPRESSION TUBES |
APPLIED MEDICAL TECHNOLOGY, INC. |
THOMAS W PARKINSON |
K980634 |
04/22/1998 |
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
ASPECT VISION CARE, LTD. |
MARTIN S KNOPF |
K981220 |
04/21/1998 |
SYSTEM 7500 ABC ELECTROSURGICAL UNIT |
ASPEN LABORATORIES, INC. |
CHARLES (MIKE) M HART |
K972996 |
04/28/1998 |
EASY ECG PC BASED ELECTROCARDIOGRAPH |
ATES MEDICAL S.R.L. |
MICHAEL DAVIDSON |
K980860 |
04/02/1998 |
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM |
ATLANTIS DIAGNOSTICS INTL., INC. |
TERRENCE J SWEENEY |
K973741 |
04/30/1998 |
BAIR HUGGER BLOOD/FLUID WARMER |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGUSTINE |
K980147 |
04/13/1998 |
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION |
AUTOMATIC LIQUID PACKAGING, INC. |
JOHN SZABOCSIK |
K980982 |
04/16/1998 |
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 |
AVOCET MEDICAL, INC. |
Judith Blunt |
K980541 |
04/09/1998 |
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY |
BARCO NV DISPLAY SYSTEMS |
FRANK FERGUSON |
K971402 |
04/15/1998 |
BARD BTA TRAK TEST |
BARD DIAGNOSTIC SCIENCES,INC. |
GLEN P FREIBERG |
K981318 |
04/22/1998 |
DUAL LUER LOCK CAP |
BAXTER HEALTHCARE CORP. |
MARY ELLEN SNYDER |
K980521 |
04/02/1998 |
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS |
BAYER CORP. |
GABRIEL J MURACA, JR. |
K980376 |
04/23/1998 |
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR. |
K981280 |
04/30/1998 |
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS |
BAYER CORP., AGFA DIV. |
MICHAEL SULLIVAN |
K980755 |
04/02/1998 |
B-D E ML PEN |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
PETER ZURLO |
K981142 |
04/22/1998 |
MAICO MA53 |
BERNAFON-MAICO, INC. |
SCOTT SAVRE |
K980939 |
04/03/1998 |
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
K980941 |
04/03/1998 |
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
K980940 |
04/03/1998 |
SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
K980871 |
04/06/1998 |
LYPHOCHEK WHOLE BLOOD CONTROL |
BIO-RAD |
ELIZABETH PLATT |
K971726 |
04/10/1998 |
CV PERI-GUARD - CARDIOVASCULAR PATCH |
BIO-VASCULAR, INC. |
BARBARA ATZENHOEFER |
K980819 |
04/03/1998 |
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS |
BIOCIRCUITS CORP. |
SHEILA J RAMERMAN |
K974408 |
04/16/1998 |
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS |
BIOCOMPATIBLES EYEWEAR, INC. |
LISA HAHN |
K980451 |
04/09/1998 |
BIODERM CALCIUM ALGINATE DRESSING |
BIODERM, INC. |
GEORGE WORTHLEY |
K980102 |
04/03/1998 |
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM |
BIODYNAMIC TECHNOLOGIES, INC. |
DANNY HODGEMAN |
K973704 |
04/03/1998 |
PROFUSION BONE VOID FILLER |
BIOGENERATION |
BERNARD F GRISONI |
K980370 |
04/14/1998 |
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR |
BIOMET, INC. |
PATRICIA S BERES |
K980679 |
04/03/1998 |
ENDOBON |
BIOMET, INC. |
MARY L VERSTYNEN |
K973775 |
04/16/1998 |
HARPOON SUTURE ANCHORS |
BIOMET, INC. |
MARY VERSTYNEN |
K972783 |
04/14/1998 |
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR |
BIONX IMPLANTS, INC. |
JONATHAN S KAHAN |
K980314 |
04/08/1998 |
FETAL D TECTION KIT |
BIOPOOL INTL., INC. |
PETER L MINETTI |
K973563 |
04/01/1998 |
BIPORE BALLOON DILATATION CATHETER |
BIPORE, INC. |
DURMUS KOCH |
K974097 |
04/09/1998 |
PERIACRYL |
BLACKLOCK MEDICAL PRODUCTS, INC. |
DON BLACKLOCK |
K980853 |
04/21/1998 |
CEDIA DAU MULTI-DRUG CALIBRATORS |
BOEHRINGER MANNHEIM CORP. |
BETSY SOARES-MADDOX |
K980851 |
04/22/1998 |
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 |
BOSTON SCIENTIFIC CORP. |
DENNIS L WONG |
K980795 |
04/22/1998 |
UROLOGICAL BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
LINDA S POLLITZ |
K980113 |
04/03/1998 |
WALLSTENT ENTERAL ENDOPROSTHESIS |
BOSTON SCIENTIFIC SCIMED, INC. |
Kathy Jo Fahey |
K970768 |
04/09/1998 |
HUMAN LYME IGM WESTERN BLOT KIT |
CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
SILE MACMAHON |
K970761 |
04/09/1998 |
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) |
CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
SILE MACMAHON |
K980356 |
04/16/1998 |
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 |
CANADIAN MEDICAL BRUSH, INC. |
STEPHEN JEMUOVIE |
K980402 |
04/24/1998 |
CAPINTEC MODEL 292 ELECTROMETER |
CAPINTEC, INC. |
MARY ANNE DELL |
K981178 |
04/27/1998 |
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS |
CARDIOVASCULAR DIAGNOSTICS, INC. |
CYNTHIA PRITCHARD |
K973334 |
04/03/1998 |
OZ POWER SYRINGE |
CARDIOVASCULAR INNOVATIONS |
AZAM ANWAR |
K981436 |
04/24/1998 |
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 |
CASCO STANDARDS |
CHRISTINE V BEACH |
K980568 |
04/30/1998 |
JUMBO GLASS IONOMER CEMENT |
CENTRIX, INC. |
JOHN DISCKO |
K964205 |
04/08/1998 |
BETTER-TUBING |
CIRCULATORY TECHNOLOGY, INC. |
YEHUDA TAMARI |
K980336 |
04/06/1998 |
IV STANDS |
CLINTON INDUSTRIES, INC. |
JAMES COLLIE |
K974371 |
04/21/1998 |
CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE |
CLK INTL., INC. |
GEORGE Q KUO |
K980159 |
04/09/1998 |
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 |
CLOSURE MEDICAL CORP. |
JOE B BAREFOOT |
K974424 |
04/23/1998 |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
CHEE YONG FOO |
K981339 |
04/21/1998 |
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 |
CONSOLIDATED TECHNOLOGIES, INC. |
WILLIAM CONE |
K980720 |
04/15/1998 |
NONWOVEN PAD |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
AMEER ALLY |
K973170 |
04/30/1998 |
SIS WOUND DRESSING |
COOK BIOTECH, INC. |
NEAL E FEARNOT |
K972647 |
04/10/1998 |
CO2 PNEUMO-DISSECTOR |
COOK UROLOGICAL, INC. |
TAMMY BACON |
K972800 |
04/16/1998 |
PTA BALLOON CATHETER |
COOK, INC. |
APRIL LAVENDER |
K980545 |
04/29/1998 |
THE NUFFIELD TOTAL KNEE SYSTEM |
CORIN U.S.A. |
CRAIG CORRANCE |
K980091 |
04/09/1998 |
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 |
COSMACEUTICAL MARKETING, INC. |
MICHAEL CASWELL |
K981289 |
04/27/1998 |
N-ASSAY L T-BIL |
CRESTAT DIAGNOSTICS, INC. |
COLIN GETTY |
K980166 |
04/01/1998 |
LIGHTSOURCE OR ILLUMINATOR |
CUDA PRODUCTS CO. |
KIM REEK |
K980350 |
04/28/1998 |
VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 |
CUDA PRODUCTS CO. |
KIM REED |
K974674 |
04/29/1998 |
CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM |
CYNOSURE, INC. |
GEORGE CHO |
K981098 |
04/27/1998 |
STRATUS CS CARDIAC TROPONIN I TESTPAK |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
K981097 |
04/16/1998 |
STRATUS CS CKMB CALPAK |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
K981101 |
04/15/1998 |
STRATUS CS MYO CALPAK |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
K981102 |
04/27/1998 |
STRATUS CS MYOGLOBIN (MYO) TESTPAK |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
K981100 |
04/16/1998 |
STRATUS CS TROP CALPAK |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
K974747 |
04/23/1998 |
CS/3 ARRHYTHMIA WORKSTATION |
DATEX-ENGSTROM, INC. |
JOEL KENT |
K980165 |
04/20/1998 |
INFUTEST 2000 INFUSION DEVICE ANALYZER |
DATREND SYSTEMS, INC. |
RON EVANS |
K980474 |
04/13/1998 |
TELICAM |
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. |
GREG HOLLAND |
K974057 |
04/21/1998 |
DENTEK LD 15 LASERSYSTEM |
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. |
ROBERT W BAUER |
K980543 |
04/14/1998 |
DENOPTIX BARRIER ENVELOPE (SIZE 0-4) |
DENTSPLY INTL. |
DANIEL P MURPHY |
K980513 |
04/14/1998 |
ARTICUL/EZE FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
CHERYL K HASTINGS |
K980447 |
04/14/1998 |
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
K980368 |
04/14/1998 |
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM |
DEPUY, INC. |
LYNNETTE WHITAKER |
K980440 |
04/03/1998 |
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW |
DEPUY, INC. |
CHERYL HASTINGS |
K974117 |
04/27/1998 |
PELVX DONUT, PELVX CUBE |
DESCHUTES MEDICAL PRODUCTS, INC. |
MATTHEW W HOSKINS |
K974116 |
04/27/1998 |
PELVX INCONTINENCE RING |
DESCHUTES MEDICAL PRODUCTS, INC. |
MATTHEW W HOSKINS |
K974115 |
04/27/1998 |
PELVX RING, PELVX RING WITH SUPPORT |
DESCHUTES MEDICAL PRODUCTS, INC. |
MATTHEW W HOSKINS |
K974002 |
04/01/1998 |
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
K980770 |
04/21/1998 |
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
K980772 |
04/27/1998 |
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
K974842 |
04/21/1998 |
IMMULITE 2000 3RD GENERATION PSA |
DIAGNOSTIC PRODUCTS CORP. |
ROBERT M DI TULLIO |
K980759 |
04/23/1998 |
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K980855 |
04/21/1998 |
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT |
DPC CIRRUS |
ROBERT M DI TULLIO |
K980791 |
04/29/1998 |
DUMEX PAK-ITS WOVEN RIBBON PACKING |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
SHARMINI ATHERAY |
K980306 |
04/02/1998 |
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP |
ELSCINT, INC. |
STEVEN M KAY |
K980473 |
04/16/1998 |
PRESS-FIT STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
K980110 |
04/10/1998 |
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM |
ENDOCARE, INC. |
VIN CUTARELLI |
K980804 |
04/01/1998 |
SABRE BT BLUNT0TIP SURGICAL TROCAR |
ENDOSCOPIC CONCEPTS, INC. |
PAMELA PAPINEAU |
K971400 |
04/14/1998 |
MUSCLE RESPONSE MONITOR |
ENRICHING YOUR LIFE |
MARY LOU WILSON |
K980164 |
04/16/1998 |
STERICHEK PERACETIC ACID REAGENT STRIPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
BRUCE G PIEKARSKI |
K970098 |
04/30/1998 |
E100 SERIES SPO2 SENSORS |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
JEFFREY SECUNDA |
K972419 |
04/30/1998 |
TOENNIES NEUROSCREEN SYSTEM |
ERICH JAEGER, INC. |
D. GROTHEER |
K980537 |
04/15/1998 |
ND: YAG ACCESSORY FOR PHOTODERM SYSTEM |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
K980099 |
04/09/1998 |
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) |
ETHICON ENDO-SURGERY, INC. |
LARRY CARRIER |
K980503 |
04/10/1998 |
TEMPORARY CARDIAC PACING WIRE |
ETHICON, INC. |
GREGORY R JONES |
K980660 |
04/27/1998 |
BIOGOLD PLUS DENTAL ALLOY |
EUROPEAN DENTAL IMPORTS, INC. |
GISELA N EVERNGAM |
K980214 |
04/21/1998 |
EXCEL NEURO WORKS |
EXCEL TECH. LTD. |
JOHN R MUMFORD |
K980033 |
04/21/1998 |
FERNO HEALTHCARE RECLINE-A-BATH 2 |
FERNO-WASHINGTON, INC. |
ERIC N BESANKO |
K973613 |
04/14/1998 |
CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER |
FOLEY & LARDNER |
JOSEPH D EDMONDSON JR. |
K980695 |
04/13/1998 |
FUJI I |
GC AMERICA, INC. |
TERRY L JORITZ |
K980682 |
04/03/1998 |
FUJI II |
GC AMERICA, INC. |
TERRY L JORITZ |
K980322 |
04/24/1998 |
ACCENT 16, ACCENT 22 |
GE MEDICAL SYSTEMS |
LARRY A KROGER, PH.D. |
K980169 |
04/13/1998 |
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
K980176 |
04/13/1998 |
HISPEED QX/I CT SCANNER SYSTEM |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
K981165 |
04/16/1998 |
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOR |
K980768 |
04/09/1998 |
VACUETTE HOLDEX |
GREINER MEDITECH, INC. |
DOUGLAS L HARRIS |
K980294 |
04/24/1998 |
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
GUIDANT CORP. |
DAVID KOLESAR |
K980237 |
04/08/1998 |
GYNEX ENDOSPECULUM |
GYNEX CORP. |
DAVID W SCHLERF |
K965034 |
04/09/1998 |
SORBASTACE |
HEMOSTACE LLC. |
DAVID WEST |
K981081 |
04/29/1998 |
BRIGHTSTAR |
HILL-ROM, INC. |
WILLIAM D JORDAN |
K980505 |
04/07/1998 |
HORTMANN AMDIS-OAE OAE ANALYZER |
HORTMANN AG |
BRADFORD MELANCON |
K974598 |
04/22/1998 |
MICROKERATOME OR THE MATE |
HOWARD INSTRUMENTS, INC. |
JACK HOWARD |
K980364 |
04/29/1998 |
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS |
HOWMEDICA CORP. |
SEAN LULAND |
K980239 |
04/16/1998 |
PARTNERSHIP CALCAR FEMORAL COMPONENTS |
HOWMEDICA, INC. |
FRANK MAAA |
K974660 |
04/02/1998 |
LATEX EXAMINATION GLOVE |
IDEAL QUALITY SDN., BHD. |
LIM L BUNG |
K974662 |
04/02/1998 |
POWDER-FREE LATEX EXAMINATION GLOVE |
IDEAL QUALITY SDN., BHD. |
LIM L BUNG |
K973556 |
04/24/1998 |
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 |
IMEX MEDICAL SYSTEMS, INC. |
DAVID W WAGNER |
K973562 |
04/15/1998 |
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 |
IMEX MEDICAL SYSTEMS, INC. |
DAVID W WAGNER |
K980549 |
04/28/1998 |
OSSEOTITE DENTAL IMPLANT SYSTEM |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
K980486 |
04/14/1998 |
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM |
IMPLEX CORP. |
ROBERT POGGIE |
K973874 |
04/24/1998 |
ACL CLIP-IN PLATE |
INNOVASIVE DEVICES, INC. |
ERIC BANNON |
K980334 |
04/27/1998 |
INNOVASIVE 10MM LINX HT LIGAMENT FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN PAGE |
K980681 |
04/29/1998 |
INNOVASIVE DEVICES MENISCAL SCREW |
INNOVASIVE DEVICES, INC. |
ERIC BANNON |
K980491 |
04/29/1998 |
INNOVASIVE LINX TIBIAL LIGAMENT FASTENER |
INNOVASIVE DEVICES, INC. |
STEPHEN PAGE |
K980312 |
04/02/1998 |
NOVA LITE ENDOMYSIAL |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K980587 |
04/17/1998 |
IV DECANTER-FLEXIBLE |
INRAD |
ANNE ARMSTRONG |
K981038 |
04/16/1998 |
COAMATIC FACTOR VIII |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K980499 |
04/02/1998 |
IL TEST ANTITHROMBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K980875 |
04/21/1998 |
IL TEST PROTEIN C |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K980757 |
04/21/1998 |
ILAB 600 CLINICAL CHEMISTRY SYSTEM |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K963703 |
04/08/1998 |
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) |
INTERNATIONAL BIOPHYSICS CORP. |
H. DAVID SHOCKLEY, JR. |
K974060 |
04/09/1998 |
MINISTRIP/ SERUM AND URINE COMBO HCG TEST |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
BENNY WANG |
K974059 |
04/09/1998 |
ONE STEP MIDSTREAM HCG PREGNANCY TEST |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
BENNY WANG |
K980783 |
04/21/1998 |
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 |
IRT MANAGEMENT CORP. |
NICHOLAS G LEVANDOSKI, PH.D. |
K961486 |
04/17/1998 |
IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT |
IVAC MEDICAL SYSTEMS |
RENEE L FLUET |
K980922 |
04/30/1998 |
PROTEC CEM. |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
K973639 |
04/20/1998 |
ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. |
J-LLOYD MEDICAL, INC. |
JAMES L SKAGGS |
K971504 |
04/20/1998 |
HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER |
J-LLOYD MEDICAL, INC. |
JAMES L SKAGGS |
K971407 |
04/20/1998 |
JTECH COMMANDER AND ALGOMETER |
J-TECH MEDICAL, INC. |
E. J SMITH |
K980493 |
04/28/1998 |
I.V. CATHETER SYSTEM |
JOHNSON & JOHNSON MEDICAL, INC. |
LINDA G HILL |
K980081 |
04/09/1998 |
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
MARY E GRAY |
K980286 |
04/03/1998 |
ULTIMA ACETABULAR ROOF REINFORCEMENT RING |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JANET G JOHNSON |
K980134 |
04/15/1998 |
KSEA N2O ENDOFLATOR |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
K980235 |
04/09/1998 |
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) |
KCI NEW TECHNOLOGIES, INC. |
JUDITH A HARBOUR |
K973064 |
04/07/1998 |
KEELER TEARSCOPE-PLUS |
KEELER INSTRUMENTS, INC. |
EUGENE R VAN ARSDALE |
K980395 |
04/16/1998 |
GLADRAGS COTTON MENSTRUAL PAD |
KEEPERS!, INC. |
BRENDA MALLORY |
K980412 |
04/08/1998 |
COLOURED POWDWR-FREE SURGICAL GLOVES |
KENWELL INTERNATIONAL LTD. |
SUSAN D GOLDSTEIN-FALK |
K980803 |
04/03/1998 |
STERILE POWDER-FREE LATEX EXAMINATION GLOVES |
KENWELL INTERNATIONAL LTD. |
SUSAN D GOLDSTEIN-FALK |
K980616 |
04/30/1998 |
PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) |
KOHLER MEDIZINTECHNIK GMBH & CO. KG |
DAGMAR S MASER |
K980357 |
04/24/1998 |
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER |
KONAN, INC. |
GEORGE H MYERS |
K980142 |
04/03/1998 |
FEATHERLITE DIODE LASER |
LASERLITE, LLC. |
DAVID F MULLER |
K981090 |
04/21/1998 |
LASERLITE DIODE SURGICAL LASER |
LASERLITE, LLC. |
MAUREEN O'CONNELL |
K974302 |
04/08/1998 |
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B |
LIGHT DIAGNOSTICS |
CINDY PENNY |
K980516 |
04/23/1998 |
REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE |
LONDON INTERNATIONAL GROUP, INC. |
NEIL ANDERSON, RAC |
K980204 |
04/17/1998 |
DUREX LATEX CONDOMS |
LONDON INTL. LLC. |
NEIL ANDERSON |
K980079 |
04/09/1998 |
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES |
LUMENIS, INC. |
ANNE WORDEN |
K980299 |
04/24/1998 |
APEX OXIMETER |
MARQUETTE MEDICAL SYSTEMS, INC. |
DAVID WAHLIG |
K980525 |
04/15/1998 |
UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD |
MARUKIN SHOYU CO., LTD. |
GREG HOLLAND |
K973986 |
04/24/1998 |
MECTEST |
MECO INDUSTRIES |
EUGENE A ESGNERRA |
K964001 |
04/17/1998 |
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM |
MED INSTITUTE, INC. |
NEAL E FEARNOT, PH.D., E.E. |
K974743 |
04/06/1998 |
MANAN |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K980227 |
04/23/1998 |
MANAN GALACTOGRAPHY KIT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K974745 |
04/06/1998 |
MANAN GWI GUIDE WIRE INTRODUCER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K981258 |
04/22/1998 |
MANAN MALECOT BASKET DRAINAGE CATHETER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K981229 |
04/22/1998 |
MANAN MANTA CATHETER FIXATION DISK |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K974742 |
04/06/1998 |
MANAN POTTS-COURNAND NEEDLE |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K980372 |
04/27/1998 |
MANAN VS ACCESS NEEDLE/SET |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K980187 |
04/03/1998 |
MLT R694 RUBY LASER SYSTEM |
MEDICAL LASER TECHNOLOGIES LTD. |
DAVID HAMILTON |
K974438 |
04/30/1998 |
MEDRAD ATD-T INTERFACE DEVICE |
MEDRAD, INC. |
MARY ANNE GREENWALT |
K973237 |
04/27/1998 |
CSS-CARDIOPLEGIA SAFETY SYSTEM |
MEDTRONIC BIO-MEDICUS, INC. |
THOMAS K JOHNSON |
K972894 |
04/27/1998 |
AUTOTRANSFUSION APPARTUS (AUTOLOG) |
MEDTRONIC BLOOD MANAGEMENT |
JOYCE THOMAS |
K974510 |
04/14/1998 |
ENVOY PATIENT MONITOR |
MENNEN MEDICAL, INC. |
KENNETH RAICHMAN |
K980483 |
04/30/1998 |
MENTOR SUSPEND SLING |
MENTOR CORP. |
DONNA A CRAWFORD |
K980077 |
04/02/1998 |
PARA-PAK SPINCON |
MERIDIAN DIAGNOSTICS, INC. |
ALLAN D NICKOL |
K980020 |
04/03/1998 |
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM |
METAGEN, L.L.C. |
FLOYD G LARSON |
K981023 |
04/30/1998 |
KLEENASEPTIC |
METREX RESEARCH CORP. |
WENDY A URTEL |
K980104 |
04/10/1998 |
FLOW RIDER FLOW DIRECTED MICRO CATHETER |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
K970211 |
04/30/1998 |
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR |
MICRO WEISS ELECTRONICS |
SUSAN D GOLDSTEIN-FALK |
K970139 |
04/30/1998 |
MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO |
MICRO WEISS ELECTRONICS |
SUSAN D GOLDSTEIN-FALK |
K974351 |
04/01/1998 |
BIOLOG 3000 ELECTROCARDIOGRAPH |
MICROMEDICAL, INC. |
MALCOM CASTLE |
K974341 |
04/16/1998 |
MITEK BTB ABSORBABLE (PLA) CROSS PIN |
MITEK PRODUCTS |
Robert Zoletti |
K980383 |
04/30/1998 |
MOOORLDI LASER DOPPLER IMAGER |
MOOR INSTRUMENTS LTD. |
DAVID BOGGETT |
K980623 |
04/30/1998 |
N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE |
N-TECH ENDOSCOPY, INC. |
NICK SURU |
K980599 |
04/15/1998 |
NTECH ARTHROSCOPE |
N-TECH ENDOSCOPY, INC. |
NICK SURU |
K980592 |
04/28/1998 |
NTECH CYSTOSCOPES |
N-TECH ENDOSCOPY, INC. |
NICK SURO |
K980441 |
04/30/1998 |
SPIROMETER MODEL NPB-500 |
NELLCOR PURITAN BENNETT, INC. |
DAVID GREEN |
K980607 |
04/03/1998 |
DERMATHERM 100 |
NEW STAR LASERS, INC. |
NINA DAVIS |
K980657 |
04/20/1998 |
AHMED GLAUCOMA VALVE, MODEL S3 |
NEW WORLD MEDICAL, INC. |
A.M. AHMED |
K980716 |
04/03/1998 |
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY |
NICHOLS INSTITUTE DIAGNOSTICS |
DAVE SMITH |
K980991 |
04/15/1998 |
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K980437 |
04/30/1998 |
SILICONE PUNCTAL PLUG |
OASIS MEDICAL, INC. |
NORMAN DELGADO |
K973896 |
04/21/1998 |
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM |
OHMEDA MEDICAL |
CHARLES MORREALE |
K980296 |
04/17/1998 |
OLDELFT DIGIDELCA |
OLDELFT CORP. OF AMERICA |
ERNEST KING |
K980465 |
04/21/1998 |
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TAYLER |
K974776 |
04/16/1998 |
MDA D-DIMER |
ORGANON TEKNIKA CORP. |
RON SANYAL |
K980324 |
04/16/1998 |
MICROSTREAM FILLERLINE OR/EMS |
ORIDION MEDICAL LTD. |
SANFORD BROWN |
K980327 |
04/16/1998 |
MICROSTREAM FILTERLINE ICU |
ORIDION MEDICAL LTD. |
SANFORD BROWN |
K980325 |
04/16/1998 |
MICROSTREAM NASAL CANNULA FILTERLINE |
ORIDION MEDICAL LTD. |
SANFORD BROWN |
K980363 |
04/16/1998 |
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) |
OROFACIAL DYNAMICS |
RONALD E TURA |
K980436 |
04/27/1998 |
CLASS III REVERSE PULL FACEMASK |
ORTHO KINETICS CORP. |
STEVEN O LUSE |
K980245 |
04/21/1998 |
NITOM LOCKING FACEBOW |
ORTHO KINETICS CORP. |
STEVEN O LUSE |
K980864 |
04/20/1998 |
POWER COINS GLOW IN THE DARK LIGATURES |
ORTHO KINETICS CORP. |
STEVEN O LUSE |
K980151 |
04/06/1998 |
RELEASABLE FORCE MODULE |
ORTHO KINETICS CORP. |
STEVEN O LUSE |
K980774 |
04/29/1998 |
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS |
OSTEONICS CORP. |
KATE SUTTON |
K981164 |
04/23/1998 |
POWDER FREE CHLORINATED GLOVES-(TEXTURED) |
PAN-CENTURY RUBBER PRODUCTS SDN. BHD. |
H.R.K. MURTHY |
K980243 |
04/03/1998 |
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) |
PARAMETER DEVELOPMENTS, INC. |
GARY J ALLSEBROOK |
K973441 |
04/01/1998 |
LEKSELL GAMMAPLAN |
PATTERSON CONSULTING GROUP, INC. |
CAROL PATTERSON |
K973834 |
04/30/1998 |
CS2000 & CS2000 TOMO |
PAUSCH CORP. |
KENNETH TICE |
K980399 |
04/30/1998 |
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
K980400 |
04/30/1998 |
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
K980044 |
04/03/1998 |
XENON 300MX |
PERKINELMER OPTOELECTRONICS |
ANTHONY STATUTO |
K980896 |
04/02/1998 |
QUICKCARD PRO HCG TEST, MODEL 9008 |
PHAMATECH |
CARL A MONGIOVI |
K980865 |
04/01/1998 |
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 |
PHAMATECH |
TUAN PHAM |
K980924 |
04/15/1998 |
PLANCON MICROLAMELLAR KERATOME EVOLUTION |
PLANCON INSTRUMENTS |
ALAIN DUPRAT |
K980581 |
04/17/1998 |
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM |
PLANMECA OY |
LARS MORING |
K980478 |
04/03/1998 |
PLAYTEX TAMPONS #03498 |
PLAYTEX, INC. |
MARK ROSENGARTEN |
K972824 |
04/03/1998 |
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER |
PN MEDICAL |
PEGGY NICHOLSON |
K970158 |
04/28/1998 |
BABYPAC |
PNEUPAC, INC. |
NORMAN GRAY |
K971749 |
04/01/1998 |
EASYGO ASPIRATOR |
PRECISION MEDICAL, INC. |
CONLEY WALLACE |
K980729 |
04/02/1998 |
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) |
PT. EKA WIRA ASIA |
EMMY TJOENG |
K980807 |
04/02/1998 |
NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE) |
PT. EKA WIRA ASIA |
EMMY TJOENG |
K980848 |
04/28/1998 |
HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED |
PT. IRAMA DINAMIKA LATEX |
ANIL TANEJA |
K980605 |
04/14/1998 |
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE) |
PT. SARANA INDOPROTEX |
ELLEN HUTAPEA |
K970460 |
04/30/1998 |
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) |
PURITAN BENNETT CORP. |
ANN-MARIE BUTLER |
K980391 |
04/24/1998 |
SERAQUEST ANTI-DSDNA |
QUEST INTL., INC. |
ROBERT A CORT |
K980059 |
04/23/1998 |
SERAQUEST MUMPS IGG |
QUEST INTL., INC. |
ROBERT A CORT |
K980898 |
04/21/1998 |
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K972793 |
04/24/1998 |
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K974602 |
04/21/1998 |
OPTICAL TRACKING SYSTEM (OTS) |
RADIONICS SOFTWARE APPLICATIONS, INC. |
LISA M BENATI |
K980448 |
04/03/1998 |
MODEL PS-1 PENA MUSCLE STIMULATOR |
RADIONICS, INC. |
NICHOLE RIEK |
K980019 |
04/01/1998 |
HTL MALE CONDOM |
REDDY MEDTECH HEALTH PRODUCTS LTD. |
A.V.K. REDDY |
K974380 |
04/03/1998 |
REJUVENESS |
REJUVENESS PHARAMCEUTICALS, INC. |
RICHARD A PICCOLO |
K970961 |
04/10/1998 |
VAPORIZATION ELECTRODES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K974840 |
04/24/1998 |
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
JAMES W HAYNES |
K981278 |
04/23/1998 |
ELECSYS CALCHECK CA 125II |
ROCHE DIAGNOSTICS GMBH |
Patricia M Klimley |
K981281 |
04/24/1998 |
ELECSYS CALCHECK FERRITIN |
ROCHE DIAGNOSTICS GMBH |
PATRICIA M KLIMELY |
K980179 |
04/13/1998 |
SHARPS PLUS 5 GALLON SHARPS CONTAINER |
ROTONICS MFG., INC. |
ED KRAUSSE |
K972546 |
04/14/1998 |
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET |
RUSCH INTL. |
JAMES R WHITNEY |
K972705 |
04/30/1998 |
RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC |
SAGE PRODUCTS, INC. |
KAREN PINTO |
K980784 |
04/29/1998 |
SURETOUCH |
SAHAR TECHNOLOGIES, INC. |
GARY SHAFFER |
K980360 |
04/29/1998 |
SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES |
SCIMED LIFE SYSTEMS, INC. |
JILL TOWNSEND |
K980611 |
04/02/1998 |
POWDERED LATEX EXAMINATION GLOVES |
SERVICOM SERVICES SDN BHD |
N.S. KUMAR |
K980557 |
04/24/1998 |
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE HESLER |
K980667 |
04/21/1998 |
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K981248 |
04/29/1998 |
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT, PH.D. |
K981254 |
04/29/1998 |
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT, PH.D. |
K981255 |
04/29/1998 |
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT, PH.D. |
K980221 |
04/02/1998 |
SILIMED NASAL RETAINER |
SILIMED, LLC. |
E.J. Smith |
K980583 |
04/27/1998 |
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE |
SIMS DELTEC, INC. |
DAVID H SHORT |
K981035 |
04/21/1998 |
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
K980155 |
04/01/1998 |
ENDOBUTTON CONTINUOUS LOOP |
SMITH & NEPHEW, INC. |
DEMETRIOS TSAKONAS |
K980279 |
04/24/1998 |
SONY DXC-LS1 COLOR VIDEO CAMERA |
SONY MEDICAL ELECTRONICS CO. |
CYNTHIA A SINCLAIR |
K980138 |
04/03/1998 |
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
K981039 |
04/21/1998 |
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) |
SRI JOHANI SDN. BHD. |
LIM L AIK |
K980276 |
04/24/1998 |
STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM |
STELKAST COMPANY |
DONALD A STEVENS |
K965212 |
04/23/1998 |
STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM |
STERITEC PRODUCTS MFG. CO., INC. |
TOM ROLL |
K971157 |
04/15/1998 |
MACRALP(A) ENZYME IMMUNOASSAY KIT |
STRATEGIC DIAGNOSTICS, INC. |
JOSEPH X DAUTLICK |
K972201 |
04/14/1998 |
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE |
SULZER CARBOMEDICS, INC. |
EDWARD E NEWTON |
K972548 |
04/21/1998 |
SLT CL MD CONTACT LASER SYSTEM |
SURGICAL LASER TECHNOLOGIES, INC. |
MONICA FERRANTE |
K980199 |
04/17/1998 |
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS |
SYNTHES (USA) |
SHERI MUSGNUNG |
K980944 |
04/27/1998 |
SYNTHES SCHUHLI IMPLANT SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K980358 |
04/16/1998 |
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM |
SYNTHES (USA) |
BARRY E SANDS |
K964488 |
04/21/1998 |
DETACHABLE SILICONE BALLOON (DSB) |
TARGET THERAPEUTICS |
LYNN K BELL |
K965071 |
04/21/1998 |
DETACHABLE SLICONE BALLOON (DSB) |
TARGET THERAPEUTICS |
LYNN K BELL |
K980776 |
04/29/1998 |
ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST |
TCPI, INC. |
CLEVE W LAIRD |
K981106 |
04/16/1998 |
UREA NITROGEN (BUN) LIQUID REAGENT |
TECO DIAGNOSTICS |
RHODA FILIPINA |
K980796 |
04/02/1998 |
TERUMO ALLERGY SYRINGE |
TERUMO CORP. |
KRISTINE WAGNER |
K980181 |
04/02/1998 |
TERUMO DISPOSABLE HYPODERMC SYRINGE |
TERUMO MEDICAL CORP. |
KRISTINE WAGNER |
K980443 |
04/30/1998 |
PEAK FLOW METER MINIMAX |
THE D&T, INC. |
GEORGE DEBUSH |
K980534 |
04/30/1998 |
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H |
THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG |
JEAN CHAMPION |
K980054 |
04/27/1998 |
PALFIQUE ESTELITE |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K980058 |
04/27/1998 |
TOKUSO MAC BOND II |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K981123 |
04/24/1998 |
UREA |
TRACE SCIENTIFIC LTD. |
|
K980373 |
04/29/1998 |
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE |
ULTRAMIND INTERNATIONAL LTD. |
SHOSHANA FRIEDMAN |
K972911 |
04/25/1998 |
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR CLAVELLI |
K980346 |
04/28/1998 |
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) |
UNIVERSAL TECHNOLOGY SYSTEMS, INC. |
GARY HEINEY |
K980282 |
04/24/1998 |
URESIL DILATOR WITH RADIOPAQUE MARKER |
URESIL CORP. |
LEV MELINYSHYN |
K980889 |
04/08/1998 |
URESIL NEPHRO-URETERAL STENT |
URESIL CORP. |
LEV MELINYSHYN |
K980617 |
04/09/1998 |
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER |
UROHEALTH SYSTEMS, INC. |
JULIE POWELL |
K980627 |
04/07/1998 |
NEVA SYSTEM |
UROMETRICS, INC. |
PHILIP A MESSINA |
K980157 |
04/13/1998 |
PREMIER 7000 CTL SPINE COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K974315 |
04/17/1998 |
VIDAR VXR LS LASER FILM DIGITIZER |
VIDAR SYSTEMS CORP. |
BILLY STAMPER |
K981051 |
04/15/1998 |
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES |
W.L. GORE & ASSOCIATES,INC |
JOHN W NICHOLSON |
K971377 |
04/30/1998 |
GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE |
WILSON GREATBATCH TECHNOLOGIES, INC. |
GARY J SFEIR |
K980496 |
04/14/1998 |
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
K973335 |
04/30/1998 |
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) |
ZENYX SCIENTIFIC LTD. |
PAUL W MCWALTER |