| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K982893 |
10/26/1998 |
3M TEGASORB HYDROCOLLOID DRESSING |
3M COMPANY |
ANNA E MCRIGHT |
| K982892 |
10/26/1998 |
3M TEGASORB THIN HYDROCOLLOID DRESSING |
3M COMPANY |
ANNA E MCRIGHT |
| K983027 |
10/02/1998 |
TRIMETHOPRIM/SULPHAMETHOXAZOLE |
AB BIODISK |
ANNE BOLMSTROM |
| K981791 |
10/23/1998 |
MG |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981295 |
10/01/1998 |
UPRO |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K982786 |
10/16/1998 |
TRACCELL 2000 SLIDE MAPPING SYSTEM |
ACCUMED INTL., INC. |
NORMAN J PRESSMAN |
| K980485 |
10/21/1998 |
ISOLA SPINAL SYSTEM |
ACROMED CORP. |
WILLIAM CHRISTIANSON |
| K974892 |
10/13/1998 |
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 |
ACUTEK ADHESIVE SPECIALTIES, INC. |
GREG HOLLAND |
| K974891 |
10/21/1998 |
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 |
ACUTEK ADHESIVE SPECIALTIES, INC. |
GREG HOLLAND |
| K974890 |
10/13/1998 |
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 |
ACUTEK ADHESIVE SPECIALTIES, INC. |
GREG HOLLAND |
| K982793 |
10/28/1998 |
PIEZO TRONIC |
ADVANCED MEDICAL DEVICES, INC. |
GREG HOLLAND |
| K982890 |
10/26/1998 |
ADVANCED UROSCIENCE INJECTION NEEDLE |
ADVANCED UROSCIENCE, INC. |
KAREN E PETERSON |
| K980484 |
10/02/1998 |
AESCULAP SPINE SYSTEM EVOLUTION |
AESCULAP, INC. |
LIA SPASARO |
| K982914 |
10/02/1998 |
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS |
AESCULAP, INC. |
LIA S JONES |
| K980186 |
10/07/1998 |
ZYMED TELEMETRY SYSTEM |
AGILENT TECHNOLOGIES |
DUDLEY HARRIS |
| K974248 |
10/07/1998 |
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM |
AIR-SHIELDS, INC. |
MARCI L GOLDFINGER |
| K983002 |
10/16/1998 |
MYSTIQUE ULTRASONIC NEBULIZER |
AIRSEP CORP. |
EDWARD VRANA |
| K983053 |
10/21/1998 |
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) |
ALDEN OPTICAL LABS., INC. |
MARTIN DALSING |
| K982896 |
10/21/1998 |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K982131 |
10/29/1998 |
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE |
ANSELL EDMONT INDUSTRIAL, INC. |
MIKE W HAGANS |
| K982862 |
10/21/1998 |
RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE |
APPLICARE MEDICAL IMAGING, B.V. |
T. WHIT ATHEY |
| K982785 |
10/15/1998 |
FILM DIGITIZER MODEL 2905 |
ARRAY CORP. |
TAKASHI INAMI |
| K980907 |
10/16/1998 |
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY |
AXIS BIOCHEMICALS, ASA |
RONALD G LEONARDI |
| K980812 |
10/01/1998 |
IMX HOMOCYSTEINE |
AXIS BIOCHEMICALS, ASA |
RONALD G LEONARDI, PH.D. |
| K983406 |
10/19/1998 |
SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR |
BANTA HEALTHCARE GROUP, LTD. |
RICHARD PEPPARD |
| K982566 |
10/21/1998 |
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) |
BAR - ADVANCED CONTROL SYSTEMS LTD. |
AHAVA STEIN |
| K982690 |
10/06/1998 |
BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE |
BARCO NV |
FRANK FERGUSON |
| K982820 |
10/08/1998 |
BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM |
BARCO NV DISPLAY SYSTEMS |
FRANK FERGUSON |
| K983321 |
10/06/1998 |
MICROFUSE DUAL RATE INFUSER |
BAXA CORP. |
WILLIAM E MCKAY |
| K982714 |
10/22/1998 |
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY |
BAYER CORP. |
GABRIEL J MURACA, JR. |
| K983709 |
10/28/1998 |
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K982935 |
10/14/1998 |
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K982541 |
10/28/1998 |
VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 |
BECTON DICKINSON VACUTAINER SYSTEMS |
ANDREA HRONCICH |
| K983081 |
10/28/1998 |
BEGOPAL 300 |
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO |
|
| K983080 |
10/28/1998 |
AUROLLOYD KF |
BEGO U.S.A. |
WILLIAM OREMUS |
| K983082 |
10/28/1998 |
BEGOCER G |
BEGO U.S.A. |
WILLIAM OREMUS |
| K983078 |
10/23/1998 |
BEGOPAL |
BEGO U.S.A. |
WILLIAM OREMUS |
| K983077 |
10/23/1998 |
BIO PONTOSTAR |
BEGO U.S.A. |
WILLIAM OREMUS |
| K983079 |
10/23/1998 |
PLATINLLOYD 100 |
BEGO U.S.A. |
WILLIAM OREMUS |
| K982538 |
10/02/1998 |
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
| K982441 |
10/09/1998 |
CCA-220 |
BENSON MEDICAL INSTRUMENTS CO. |
DAVID P MAYOU |
| K982723 |
10/28/1998 |
MAICO MA42 |
BERNAFON-MAICO, INC. |
SCOTT SAVRE |
| K981888 |
10/15/1998 |
SMOKE-EVAC |
BIO-MEDICAL DEVICES, INC. |
NICK HERBERT |
| K983162 |
10/09/1998 |
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC |
BIO-VASCULAR, INC. |
DIANNA L GECK |
| K981634 |
10/13/1998 |
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS |
BIOCIRCUITS CORP. |
SHEILA J RAMERMAN |
| K982778 |
10/21/1998 |
BIODERM FOAM WOUND DRESSING |
BIODERM, INC. |
GEORGE WORTHLEY |
| K982939 |
10/13/1998 |
BTF THIN FILM WOUND DRESSING |
BIODERM, INC. |
MARIE B TEIXEIRA |
| K980585 |
10/08/1998 |
MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
ANDREW I KIMMEL |
| K982497 |
10/16/1998 |
ARTHROTEK INTERFERENCE SCREW |
BIOMET, INC. |
MARY VERSTYNEN |
| K982545 |
10/19/1998 |
BMP CABLE SYSTEM |
BIOMET, INC. |
JULIE K RYAN |
| K982982 |
10/13/1998 |
MINI-FIXATOR FOR COLLES FRACTURES |
BIOMET, INC. |
JULIE K RYAN |
| K982953 |
10/21/1998 |
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES |
BIOMET, INC. |
LONNIE WITHAM |
| K982245 |
10/06/1998 |
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K982444 |
10/06/1998 |
7250 ULTRASOUND IMAGING SYSTEM |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K982580 |
10/22/1998 |
BIRD MONITOR INTERFACE |
BIRD PRODUCTS CORP. |
NEIL BATTISTE |
| K983492 |
10/09/1998 |
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K983510 |
10/27/1998 |
CHEMSTRIP 101 URINE ANALYZER |
BOEHRINGER MANNHEIM CORP. |
JENNIFER TRIBBETT |
| K982948 |
10/27/1998 |
ELECSYS PSA, MODEL # ELECSYS 1010 |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K982949 |
10/27/1998 |
ELECSYS PSA, MODEL 2010 |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
| K983416 |
10/21/1998 |
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 |
BOEHRINGER MANNHEIM CORP. |
LUANN OCHS |
| K980724 |
10/16/1998 |
TINAQUANT B 2-MICROGLOBULIN ASSAY |
BOEHRINGER MANNHEIM CORP. |
JULIE LINGENFELTER |
| K982508 |
10/16/1998 |
FLEXIMA |
BOSTON SCIENTIFIC CORP. |
DANIEL DILLON |
| K982888 |
10/20/1998 |
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM |
BOSTON SCIENTIFIC CORP. |
CHRISTINE M HARRIS |
| K981445 |
10/05/1998 |
ULTIMA AIRFLOW SENSOR, 0510 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K981508 |
10/29/1998 |
VECTORVISION SPINE MODULE |
BRAINLAB, AG |
STEFAN VILSMEIER |
| K981660 |
10/16/1998 |
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters |
C.R. BARD, INC. |
SANDRA PERREAND |
| K974713 |
10/14/1998 |
BARD HYDROPHILLIC COATED GUIDE WIRE |
C.R. BARD, INC. |
FRED BOUCHER |
| K981697 |
10/14/1998 |
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN D GREENBAUM |
| K982835 |
10/29/1998 |
ELECTRODE SWITCHBOX, MODEL 11-081002 |
CARDIMA, INC. |
JACK P DOUGLAS |
| K983052 |
10/19/1998 |
PERITRON PERINEOMETER MODEL 9300V OR 9300A |
CARDIO DESIGN PTY. LTD. |
NEVILLE MOTLEY |
| K982487 |
10/14/1998 |
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO |
CARDIOPULMONARY TECHNOLOGIES, INC. |
MARK S STORSVED |
| K983058 |
10/21/1998 |
CERALAS D LASER SYSTEM, MODEL # CERALAS D15 |
CERAMOPTEC, INC. |
JONATHAN S KAHAN |
| K982761 |
10/22/1998 |
JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 |
CHAMCO, INC. |
JIM CUMMINS |
| K982680 |
10/15/1998 |
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K981613 |
10/26/1998 |
COBE SMARXT TUBING AND CONNECTORS |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K982406 |
10/07/1998 |
COBE VACUUM RELIEF CHECK VALVE |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K974774 |
10/16/1998 |
ENVY GUIDING CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K983023 |
10/01/1998 |
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
CORDIS CORP. |
ARIEL MACTAVISH |
| K980799 |
10/28/1998 |
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
| K981709 |
10/13/1998 |
COAGULATION FACTOR V DEFICIENT PLASMA |
DADE BEHRING, INC. |
MARIO A LOWE |
| K982871 |
10/13/1998 |
DRUG CALIBRATOR II |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K983548 |
10/27/1998 |
FERRITIN CALIBRATOR |
DADE BEHRING, INC. |
CATHY P CRAFT |
| K982299 |
10/19/1998 |
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER |
DAIG CORP. |
MICHAEL G SCHULTZ |
| K973985 |
10/30/1998 |
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) |
DATEX-ENGSTROM, INC. |
JOEL KENT |
| K982593 |
10/22/1998 |
LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE |
DENTALEZ GROUP |
KEITH C PEITHMAN |
| K982564 |
10/06/1998 |
DELTON FS DIRECT DELIVERY SYSTEM |
DENTSPLY INTL. |
P.JEFFERY LEHN |
| K983265 |
10/26/1998 |
DEPUY ACE COMPOSITE LOCKING NUT |
DEPUY ACE MEDICAL CO. |
KATHLEEN DRAGOVICH |
| K982585 |
10/05/1998 |
DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K982918 |
10/05/1998 |
DEPUY C-STEM SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K982662 |
10/28/1998 |
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K983391 |
10/15/1998 |
IMMULITE 2000 OM-MA MODEL L2KOP2 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K981084 |
10/07/1998 |
URISCREEN |
DIATECH DIAGNOSTICS,INC. |
FRAN WHITE |
| K982966 |
10/19/1998 |
DISETRONIC PEN |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K982789 |
10/29/1998 |
MEDICAL AIR COMPRESSOR, MODEL # 8413419 |
DRAGER, INC. |
HARALD KNEUER |
| K982484 |
10/08/1998 |
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM |
ELECTRO-BIOLOGY, INC. |
JONAS WILF |
| K982676 |
10/29/1998 |
AIRWATCH II ZONE |
ENACT HEALTH MANAGEMENT SYSTEMS |
JAMES LYON |
| K982675 |
10/29/1998 |
AIRWATCH II ZONELESS |
ENACT HEALTH MANAGEMENT SYSTEMS |
JAMES LYON |
| K983316 |
10/21/1998 |
ULTRACISION 5MM INSTRUMENTS |
ETHICON ENDO-SURGERY, INC. |
CHUCK TABRI |
| K982479 |
10/14/1998 |
EXCEL AMBULATORY EEG |
EXCEL TECH. LTD. |
JOHN R MUMFORD |
| K980828 |
10/22/1998 |
EXMOOR MYRINGOTOMY KIT |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
| K982642 |
10/21/1998 |
ECHO-SCREEN |
FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. |
DAVID G WOOD |
| K982636 |
10/26/1998 |
PATIENT WARMER- MODEL PW810 |
FISHER & PAYKEL HEALTHCARE, LTD. |
CHRIS MANDER |
| K982576 |
10/22/1998 |
FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476 |
FRIATEC AG |
EUGENE GOORCHENKO |
| K982818 |
10/21/1998 |
HOSPAL TIPSTOP |
GAMBRO HEALTHCARE |
JEFFREY R SHIDEMAN |
| K983436 |
10/29/1998 |
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM |
GAMMAMED USA |
JOHN J MUNRO III |
| K982695 |
10/19/1998 |
GC RELINE |
GC AMERICA, INC. |
TERRY L JORITZ |
| K982196 |
10/06/1998 |
DIGITAL RADIOGRAPHIC IMAGING SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K982772 |
10/15/1998 |
SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K981360 |
10/15/1998 |
VINYL PATIENT EXAMINATION GLOVE, POWDERED |
GLORMED INTL., INC. |
JANNA TUCKER |
| K974395 |
10/22/1998 |
ATLANT'S |
GRAD-LINE CORP. |
WALTER L WASSERMAN |
| K982999 |
10/16/1998 |
GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE |
GREINER MEDITECH, INC. |
DOUG HARRIS |
| K982998 |
10/21/1998 |
GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE |
GREINER MEDITECH, INC. |
DOUG HARRIS |
| K981861 |
10/01/1998 |
LINER 1:HARD RELINE LIQUID |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K983409 |
10/16/1998 |
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 |
HDC CORP. |
JAMES S ABILLA |
| K983067 |
10/30/1998 |
FINE-JECT |
HENKE SASS WOLF OF AMERICA, INC. |
ELLEN J HENKE |
| K982670 |
10/02/1998 |
CONTEMPORARY ACETABULAR COMPONENT |
HOWMEDICA CORP. |
FRANK MAAS |
| K982531 |
10/16/1998 |
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM |
HOWMEDICA CORP. |
JOHN DICHIARA |
| K982873 |
10/21/1998 |
ZETA MULTIZONE SCN LOCKING NAIL |
HOWMEDICA CORP. |
VIVIAN KELLY |
| K982824 |
10/29/1998 |
X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID |
I.E.D., INC. |
DONALD R REILLY |
| K982492 |
10/15/1998 |
IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES |
IMCOR |
ADRIAN COOPER |
| K982412 |
10/09/1998 |
MODIFICATION OF CRIT-LINE MONITOR III (CLM III) |
IN-LINE DIAGNOSTICS CORP. |
MATTHEW L HAYNIE |
| K982417 |
10/07/1998 |
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP |
INNERDYNE, INC. |
RICK GAYKOWSKI |
| K982428 |
10/09/1998 |
CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) |
INNERVISION, INC. |
FRANK M LEWIS |
| K983056 |
10/13/1998 |
INNOVASIVE TIBIAL FASTENER |
INNOVASIVE DEVICES, INC. |
KATHLEEN MORAHAN |
| K982603 |
10/07/1998 |
QUANTA LITE CHROMATIN ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K981591 |
10/09/1998 |
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT |
INTERNATIONAL REGULATORY CONSULTANTS |
DONALD F GRABARZ |
| K982064 |
10/05/1998 |
ACTION STORM RANGER II, ACTION STORM POWER 9000 |
INVACARE CORP. |
EDWARD A KROLL |
| K974581 |
10/28/1998 |
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT |
INVIVO RESEARCH, INC. |
FRANCIS CASEY |
| K982255 |
10/22/1998 |
MODEL 2000 PULSE OXIMETER |
IVY BIOMEDICAL SYSTEMS, INC. |
DICK LISTRO |
| K981490 |
10/22/1998 |
WILLI GELLER CREATION PORCELAIN |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K980953 |
10/07/1998 |
ACCU-BITE HOME KIT DISCLUDER |
JEROME M. SIMON |
JEROME M SIMON |
| K983014 |
10/27/1998 |
SUMMIT ACETABULAR SYSTEM |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
JANET G JOHNSON |
| K982905 |
10/05/1998 |
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
| K982658 |
10/15/1998 |
KSEA ENDOSCOPES FOR DENTAL PROCEDURES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN A KENNAN |
| K983091 |
10/28/1998 |
ELAN-2 |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K982673 |
10/29/1998 |
JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM |
KEY WEST FRAGRANCE & COSMETIC |
AL WEISENBORN |
| K981345 |
10/01/1998 |
CHOLESTRON PRO II CHOLESTEROL TEST |
LIFESTREAM DIAGNOSTICS, INC. |
Erika B Ammirati |
| K983186 |
10/21/1998 |
BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K982907 |
10/02/1998 |
MAGNATEK 40 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
| K981024 |
10/06/1998 |
QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) |
MARQUETTE MEDICAL SYSTEMS, INC. |
KRISTIN PABST |
| K982624 |
10/26/1998 |
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 |
MED-TEC,INC. |
DONALD F RIIBE |
| K983018 |
10/22/1998 |
ZINC PHOSPHATE CEMENT |
MEDENTAL INTL. |
DEBRA OLSON |
| K983109 |
10/06/1998 |
MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K983222 |
10/08/1998 |
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64 |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K973970 |
10/06/1998 |
SPO2 FINGER PROBES |
MEDICAL CABLES, INC. |
CHRISTOPHER J FONTANA |
| K982548 |
10/19/1998 |
MLT 30 LASER |
MEDICAL LASER TECHNOLOGIES LTD. |
WILLIAM KELLEY |
| K983273 |
10/29/1998 |
XCT 2000 L PQCT BONE DENSITOMETER |
MEDICAL SYSTEMS, INC. |
TERRY SCHWALENBERG |
| K973198 |
10/14/1998 |
VGF-7 VASCULAR GRAFT FLOWMETER |
MEDICARD LTD. |
STEVEN A CLARKE |
| K981119 |
10/14/1998 |
CARDIOPAL MODEL NUMBER PM20 |
MEDICOMP, INC. |
JOSEPHUS RIFFE |
| K982659 |
10/07/1998 |
MEDIVISION HYSTEROSCOPE |
MEDIVISION SCOPE SERVICE CENTER, INC. |
WAYNE B STERNER |
| K982693 |
10/28/1998 |
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K982916 |
10/29/1998 |
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC |
MEDRAD, INC. |
JIM FERGUSON, JR. |
| K982814 |
10/09/1998 |
MEDRAD VISTRON CT INJECTOR SYSTEM |
MEDRAD, INC. |
JAN E DOBSCHA |
| K982220 |
10/15/1998 |
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT |
MEDTRONIC VASCULAR |
BRIAN J EDWARDS |
| K982606 |
10/15/1998 |
AUROFLUID CPF |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
| K982013 |
10/21/1998 |
MGB LAPALUX TELESCOPE |
MGB ENDOSKOPISCHE GERATE GMBH |
BOB LEIKER |
| K982984 |
10/21/1998 |
ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
| K983122 |
10/30/1998 |
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT |
MILL-ROSE LABORATORY |
ALAN C POJE |
| K983124 |
10/30/1998 |
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT |
MILL-ROSE LABORATORY |
ALAN C POJE |
| K983184 |
10/28/1998 |
MEPILEX |
MOLNLYCKE HEALTH CARE, INC. |
MIGUEL A NEGRON |
| K981048 |
10/07/1998 |
HYDRAGEL 6 CSF KIT |
MORAX |
BOREK JANIK, PH.D. |
| K974854 |
10/07/1998 |
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 |
MORAX |
BOREK JANIK |
| K982970 |
10/28/1998 |
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER |
MRI MANUFACTURING AND RESEARCH, INC. |
ED RANSON |
| K982082 |
10/28/1998 |
HANDISOL WOUND HEALING |
NATIONAL BIOLOGICAL CORP. |
FRANCIS D LAMM |
| K981958 |
10/19/1998 |
LEISEGANG VIDEO COLPOSCOPE |
NETOPTIX CORP. |
MARY MCNAMARA-CULLINANE |
| K982359 |
10/02/1998 |
NC-STAT |
NEUROMETRIX, INC. |
RENEE J THIBEAULT |
| K982577 |
10/21/1998 |
NEUFINISH RESURFACING CREAM |
NEUTROGENA CORP. |
YOHINI APPA |
| K982866 |
10/16/1998 |
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K982766 |
10/30/1998 |
PASTE OPAQUE EX-3 |
NORITAKE CO., INC. |
MARSHA C WERTZBERGER |
| K982499 |
10/16/1998 |
COSMO PLUS WITH NICO, MODEL 8200 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
ROBERT H SCHIFFMAN |
| K981323 |
10/09/1998 |
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE |
NOVARTIS NUTRITION CORP. |
ROBERT J LANG |
| K983785 |
10/29/1998 |
AUTOVENT 1000 |
O-TWO SYSTEMS INTL., INC. |
KEVIN BOWDEN |
| K983705 |
10/29/1998 |
EMT RESUSCITATOR |
O-TWO SYSTEMS INTL., INC. |
KEVIN BOWDEN |
| K983643 |
10/29/1998 |
GENESIS BLS |
O-TWO SYSTEMS INTL., INC. |
KEVIN BOWDEN |
| K982725 |
10/23/1998 |
OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TAYLOR |
| K982689 |
10/23/1998 |
WINSTATION RETINAL IMAGER |
OPHTHALMIC IMAGING SYSTEMS |
BETH A SOPER |
| K982358 |
10/02/1998 |
HISTOFREEZER DEVICE |
ORASURE TECHNOLOGIES, INC. |
R.SAM NIEDBALA |
| K982389 |
10/07/1998 |
ODC B2 BIPOLAR CUP |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
| K982598 |
10/02/1998 |
OTI FEMORAL LOCK TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K982886 |
10/05/1998 |
OTI MODULAR SHOULDER SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K983339 |
10/27/1998 |
OSTEO DYNATROC PROXIMAL FEMORAL NAIL |
OSTEONICS CORP. |
KATE SUTTON |
| K982936 |
10/21/1998 |
OSTEONICS EXTENDED FEMORAL BEARING HEAD |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K980078 |
10/16/1998 |
PENETREASE |
P.T. PANCA PUSAKA DELI |
JANE CAMPBELL |
| K983381 |
10/19/1998 |
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS |
PARAGON TRADE BRANDS, INC. |
ROBERT J STAAB |
| K982691 |
10/09/1998 |
MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
PERUSAHAAN INTAN EMAS SDN. BHD. |
BIEN LONG NIEN |
| K982621 |
10/16/1998 |
QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 |
PHAMATECH |
CARL A MONGIOVI |
| K982533 |
10/22/1998 |
UNICAP GLIADIN IGA ASSAY |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K982701 |
10/22/1998 |
UNICAP GLIADIN IGG ASSAY |
PHARMACIA & UPJOHN CO. |
KAREN E MATTIS |
| K982834 |
10/29/1998 |
RESTGRID PACKAGE/GYROSCAN NT |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K980820 |
10/13/1998 |
PHILIPS EASYGUIDE |
PHILIPS MEDICAL SYSTEMS, INC. |
FRANK GIANELLI |
| K982631 |
10/06/1998 |
PHILIPS TOMOSCAN CS |
PHILIPS MEDICAL SYSTEMS, INC. |
FRANK GIANELLI |
| K982128 |
10/23/1998 |
SHIKANI-FRENCH SPEAKING VALVE |
PILLING WECK SURGICAL |
ELIZABETH LAZARO |
| K982425 |
10/07/1998 |
CODA MPX30 MOTION ANALYSIS SYSTEM |
PINSCO INC. DBA B & L ENGINEERING |
LEE A BARNES |
| K980977 |
10/27/1998 |
PIOLAX HYDROPHILIC GUIDEWIRE |
PIOLAX MEDICAL DEVICES, INC. |
ELIZABETH BIERMAN |
| K983211 |
10/09/1998 |
CENTAURI |
PREMIER LASER SYSTEMS, INC. |
LISA MOJICA |
| K965136 |
10/16/1998 |
UROSURGE UROTHERM FLUID WARMING SYSTEM |
PRINCETON REGULATORY ASSOC. |
THOMAS BECZE |
| K981371 |
10/30/1998 |
LTV 1000 VENTILATOR |
PULMONETIC SYSTEMS, INC. |
DOUGLAS DEVRIES |
| K973138 |
10/28/1998 |
SPIROCARD |
QRS DIAGNOSTIC, LLC. |
KEVIN J DRISCOLL |
| K982281 |
10/16/1998 |
SERAQUEST RUBELLA IGM |
QUEST INTL., INC. |
ROBERT A CORT |
| K981597 |
10/09/1998 |
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY |
RADIONICS, INC. |
LISA MISTERKA BENATI |
| K982489 |
10/05/1998 |
RFG-3C PLUS |
RADIONICS, INC. |
JEFFREY R MANNION |
| K981208 |
10/21/1998 |
TFR |
RAMCO LABORATORIES, INC. |
JEFFREY B GRUBB |
| K983107 |
10/22/1998 |
VFE |
RAMCO LABORATORIES, INC. |
JEFFREY B GRUBB |
| K982563 |
10/06/1998 |
ULTRAPRO MODEL 98 |
RAMSOFT, INC. |
NAGANATHA S RAMANATHAN |
| K982530 |
10/16/1998 |
SULLIVAN MIRAGE FULL FACE MASK |
RESMED LTD. |
SCOTT DUDEVOIR |
| K981841 |
10/13/1998 |
BREATHE EASY, MODELS AD AND CD |
RESPIRAID LTD. |
SHOSHANA FRIEDMAN |
| K982550 |
10/05/1998 |
BROWSER (EVENT SOFTWARE) MODEL # 4500E |
RESPIRONICS, INC. |
BETSY CORTELLONI |
| K982848 |
10/01/1998 |
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K983387 |
10/09/1998 |
ONTRAK TESTCUP AND TESTSTIK CONTROLS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
MARIA FEIJOO |
| K983037 |
10/20/1998 |
ROEKO SEAL |
ROEKO ULM, ROESCHEISEN GMBH & CO. |
JAMES DELANEY |
| K981630 |
10/01/1998 |
VYGON DOUBLE LUMEN UMBILICAL CATHETER |
SCHIFF & CO. |
ANNE M CESARIO |
| K982592 |
10/21/1998 |
DOCKING-EXTENSION WIRE |
SCHNEIDER (EUROPE) GMBH |
THOMAS THALER |
| K982913 |
10/19/1998 |
ZINFOS ZINC PHOSPHATE CEMENT |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K983447 |
10/29/1998 |
WISE (II) IMAGE MANAGEMENT SYSTEM |
SECTRA-IMTEC AB |
HERMAN OOSTERWIJK |
| K981096 |
10/29/1998 |
SEMPERMED SURGEONS' GLOVES - SUPREME |
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
RICHARD EHRENFELDNER |
| K981366 |
10/30/1998 |
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES |
SENSORMEDICS CORP. |
LARRY MURDOCK |
| K982931 |
10/21/1998 |
THREADED FIXATION PIN |
SGARLATO LABORATORIES, INC. |
THOMAS SGARLATO |
| K982687 |
10/09/1998 |
DISPOSABLE VINYL EXAM GLOVES, POWDERED |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K982810 |
10/28/1998 |
SHELHIGH NO-REACT VASCUPATCH |
SHELHIGH, INC. |
SHLOMO GABBAY |
| K982879 |
10/15/1998 |
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY |
SHIELD DIAGNOSTICS, LTD. |
EILEEN A MCCAFFERTY |
| K983207 |
10/30/1998 |
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K982583 |
10/05/1998 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL |
SHIMADZU CORP. |
MICHAEL FISHBACK |
| K983327 |
10/09/1998 |
ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DURKHANI ROSHAN |
| K982387 |
10/06/1998 |
E.CAM EXTRA HIGH ENERGY COLLIMATOR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ANDREA DISANTI |
| K981528 |
10/28/1998 |
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE C HESLER |
| K982209 |
10/15/1998 |
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 |
SIGMA DIAGNOSTICS, INC. |
WILLIAN R GILBERT |
| K983057 |
10/22/1998 |
ORTHOPHOS 5/PLUS/CD |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA M HEMEON-HEYER |
| K981034 |
10/30/1998 |
SILENT NIGHT II |
SLEEP SOLUTIONS, INC. |
LISA S JONES |
| K982849 |
10/05/1998 |
PANTHER WHEELCHAIR |
SNUG SEAT, INC. |
KIRK MACKENZIE |
| K982490 |
10/05/1998 |
TENOR SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K982990 |
10/21/1998 |
TSRH SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K982671 |
10/19/1998 |
SECURALLOY |
SPECIALITES SEPTODONT |
PETER S REICHERTZ |
| K980410 |
10/22/1998 |
SLE ELECTRODES AND ACCESSORIES |
SPECIALIZED LABORATORY EQUIPMENT, LTD. |
FRANK FERGUSON |
| K981004 |
10/21/1998 |
SLE EMG ELECTRODES AND ACCESSORIES |
SPECIALIZED LABORATORY EQUIPMENT, LTD. |
FRANK FERGUSON |
| K982679 |
10/07/1998 |
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST |
SPECTRAL DIAGNOSTICS, INC. |
JOSEPH LAURINE |
| K982688 |
10/13/1998 |
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK |
SPECTRUM DESIGNS, INC. |
JIM DISHMAN |
| K983258 |
10/21/1998 |
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
TEENA M AUGOSTINO |
| K983260 |
10/21/1998 |
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
TEENA M AUGOSTINO |
| K982225 |
10/28/1998 |
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 |
SPIRACLE TECHNOLOGY |
GUY GANSEL |
| K982099 |
10/05/1998 |
MOMENTUM NO. FS008 WHEELCHAIR |
SRIRAM ENTERPRISES D.B.A. MOMENTUM GROUP |
RON MOSETICH |
| K982547 |
10/08/1998 |
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR |
STERITEC PRODUCTS MFG. CO., INC. |
TOM ROLL |
| K981497 |
10/29/1998 |
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS |
STERITEC PRODUCTS MFG. CO., INC. |
TOM ROLL |
| K982692 |
10/22/1998 |
STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC |
STERNGOLD/IMPLAMED |
PAMELA PAPINEAU |
| K982895 |
10/09/1998 |
STERNOMEGA COMPOMER CEMENT |
STERNGOLD/IMPLAMED |
PAMELA PAPINEAU |
| K982375 |
10/02/1998 |
STRYKER HIP ARTHOROSCOPY SET |
Stryker Endoscopy |
BALTAZAR ACOUSTA |
| K982903 |
10/21/1998 |
SULZER ORTHOPEDICS FLUTED STEMS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K982989 |
10/05/1998 |
QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
| K983639 |
10/25/1998 |
ZIPPIE GS, MODEL # EIZGS |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
| K982917 |
10/16/1998 |
B-SYSTEM SILICONE |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K982590 |
10/08/1998 |
TEMPBOND CLEAR-2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K983121 |
10/05/1998 |
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 |
SYNTEC SCIENTIFIC CORP. |
TED Y SHI |
| K982732 |
10/08/1998 |
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) |
SYNTHES |
SHERI L MUSGNUNG |
| K982987 |
10/21/1998 |
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM |
SYNTHES SPINE |
JONATHAN M GILBERT |
| K982470 |
10/14/1998 |
ECG ELECTRODES APRON |
TAPUZ MEDICAL TECHNOLOGY LTD. |
SHOSHANA FRIEDMAN |
| K971549 |
10/05/1998 |
VMT SYSTEM |
TARGET HEALTH, INC. |
JULES T MITCHEL |
| K972960 |
10/07/1998 |
HEALTH CHECK URI-TEST PROTEIN IN URINE |
TCPI, INC. |
FRAN WHITE |
| K982683 |
10/06/1998 |
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION |
TELEX COMMUNICATIONS, INC. |
TOM SCHELLER |
| K982872 |
10/15/1998 |
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
TG MEDICAL SDN BHD |
W.C. LIM |
| K982991 |
10/21/1998 |
ANSPACH ACCESS CRANIAL PERFORATOR |
THE ANSPACH EFFORT, INC. |
LISA KREIDER |
| K981209 |
10/22/1998 |
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K982133 |
10/22/1998 |
OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT |
THE OLYMPUS OPTICAL CO. |
RUTH C FORSTADT |
| K982733 |
10/28/1998 |
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TAYLOR |
| K982734 |
10/05/1998 |
OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TAYLOR |
| K982787 |
10/21/1998 |
ASTEION CT SCANNER, TSX-021A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K981522 |
10/08/1998 |
AIA-PACK TGAB ASSAY |
TOSOH MEDICS, INC. |
LORI ROBINSON |
| K981521 |
10/08/1998 |
AIA-PACK TPOAB ASSAY |
TOSOH MEDICS, INC. |
LON ROBINSON |
| K980906 |
10/06/1998 |
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO |
TRANSONIC SYSTEMS, INC. |
CORNELIS J DROST |
| K983175 |
10/13/1998 |
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE |
ULTRAWIN SDN BHD |
SIEW HOE MAH |
| K982699 |
10/20/1998 |
UNIGRAFE |
UNICARE BIOMEDICAL |
STAN YANG |
| K981207 |
10/28/1998 |
CLEARPLAN EASY FERTILITY MONITOR |
UNIPATH LTD. |
Louise Roberts |
| K983197 |
10/26/1998 |
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
SHARON L MURPHY |
| K982783 |
10/05/1998 |
VAIL 1000 ENCLOSED BED |
VAIL PRODUCTS, INC. |
NANCY VAIL |
| K980601 |
10/21/1998 |
VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER |
VARIAN ASSOC., INC. |
LINDA NASH |
| K980590 |
10/22/1998 |
VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
CHARLES H WILL |
| K981645 |
10/13/1998 |
TITANIUM HEMOSTATIC CLIP |
VITALITEC INT'L., INC. |
ELLEN HENKE-KNUPP |
| K973410 |
10/08/1998 |
ULTRACAM |
W. EDWARD JOHANSEN |
W. EDWARD JOHANSEN |
| K981744 |
10/14/1998 |
COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER |
W. KEITH THORNTON, D.D.S. |
W.KEITH THORNTON |
| K981565 |
10/15/1998 |
BIOCLEAR CONCENTRATE |
WAGGONER PRODUCT DEVELOPMENT |
MARK WAGGONER |
| K982604 |
10/23/1998 |
LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K982436 |
10/08/1998 |
RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R |
WOODSIDE BIOMEDICAL, INC. |
CAROL PATTERSON |
| K981880 |
10/20/1998 |
DX-480, ADD ON DIGITAL IMAGER |
WUESTEC MEDICAL, INC. |
DAVID ANDRESS |
| K983224 |
10/21/1998 |
XPS DRILL SYSTEM |
XOMED, INC. |
DAVID TIMLIN |
