FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K982481 |
09/25/1998 |
A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
K981570 |
09/14/1998 |
AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD |
AARON MEDICAL INDUSTRIES |
ROB SARON |
K982868 |
09/30/1998 |
ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE |
AB BIODISK |
ANNE BOLMSTROM |
K981639 |
09/03/1998 |
SYSTEM U3 FOR CIPROFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
K983131 |
09/28/1998 |
AST |
ABBOTT LABORATORIES |
LINDA MORRIS |
K983134 |
09/23/1998 |
NBIL |
ABBOTT LABORATORIES |
LINDA MORRIS |
K983133 |
09/16/1998 |
TBIL |
ABBOTT LABORATORIES |
LINDA MORRIS |
K981682 |
09/21/1998 |
UPRO |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
K982539 |
09/15/1998 |
HDLC PRECIPITATING REAGENT |
AC BIOCHEMICALS, INC. |
C. C ALLAIN |
K981661 |
09/15/1998 |
HEMAPROMPT |
AERSCHER DIAGNOSTICS |
ROBERT SCHREIBER |
K980686 |
09/02/1998 |
AESCULAP HILAN MOTOR SYSTEM |
AESCULAP, INC. |
MARY ELLEN HOLDEN |
K982623 |
09/30/1998 |
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM |
AESCULAP, INC. |
LIA S JONES |
K981564 |
09/24/1998 |
AIR TECHNIQUES' AIRDENT II |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
K972309 |
09/22/1998 |
JM-102 JAUNDICE METER |
AIR-SHIELDS, INC. |
T. WHIT ATHEY |
K981999 |
09/04/1998 |
ALBATECH PERSONAL MONITOR |
ALBATECH, INC. |
SHERYL S NATELSON |
K982709 |
09/03/1998 |
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY |
ALEXON - TREND, INC. |
KEN HOOD |
K981095 |
09/08/1998 |
ALIGN SYSTEM |
ALIGN TECHNOLOGY |
CAROL PATTERSON |
K982501 |
09/01/1998 |
ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 |
ALKO DIAGNOSTIC CORP. |
JANET A MCGRATH |
K981168 |
09/01/1998 |
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS |
ALLERGAN, INC. |
PAUL J NOWACKI |
K982063 |
09/22/1998 |
ALM PRISMALIX (PRX) SURGICAL LIGHT |
ALM SURGICAL EQUIPMENT, INC. |
SUSAN NIELSEN |
K982446 |
09/29/1998 |
DYNAMIC SHIELDING RADIATION TABLE |
AMERICAN BIOPHYSICS, INC. |
PAUL E DRYDEN |
K982221 |
09/22/1998 |
PREMIER AP |
AMERICAN IMEX |
JOE FONG |
K982073 |
09/22/1998 |
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM |
ANCHOR PRODUCTS CO. |
ROBERT H THRUM |
K982397 |
09/10/1998 |
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM |
ANGIOLAZ, INC. |
JOHN D PLUMADORE |
K981144 |
09/15/1998 |
CLEAN SOURCE I, MODEL CS1000 |
AQUARIUS TECHNOLOGIES, INC. |
WILLIAM JEFFERS |
K981299 |
09/25/1998 |
SILVERLON CONTACT WOUND DRESSING |
ARGENTUM INTERNATIONAL LLC. |
A BART FLICK |
K972382 |
09/14/1998 |
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL |
ARROWS CO., LTD. |
YOSHIMASA OGOSHI |
K982445 |
09/08/1998 |
MODULAP |
ATC MEDICAL TECHNOLOGY, INC. |
MARIAN HARDING COCHRAN |
K982865 |
09/08/1998 |
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT |
ATRIX LABORATORIES, INC. |
ELYSE WOLFF |
K982288 |
09/08/1998 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
K980839 |
09/30/1998 |
AVOCET PT |
AVOCET MEDICAL, INC. |
Judith Blunt |
K971924 |
09/25/1998 |
BLUNT SYRINGE CANNULA |
B. BRAUN MEDICAL, INC. |
MARK S ALSBERGE |
K982894 |
09/11/1998 |
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT |
BALLARD MEDICAL PRODUCTS |
E. MARTIN CHAMBERLAIN |
K982557 |
09/10/1998 |
BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES |
BARD INTERVENTIONAL PRODUCTS DIV. |
MARION GORDON |
K982672 |
09/04/1998 |
COLLEAGUE PUMP SYRINGE ADAPTER SET |
BAXTER HEALTHCARE CORP. |
LINDA COLEMAN |
K982822 |
09/30/1998 |
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 |
BAXTER HEALTHCARE CORP. |
MARY ELLEN SNYDER |
K982102 |
09/04/1998 |
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY |
BAXTER HEALTHCARE CORP. |
VICKI L DREWS |
K982802 |
09/22/1998 |
BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA |
K982279 |
09/25/1998 |
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 |
BCI INTL., INC. |
DONALD J ALEXANDER |
K981985 |
09/24/1998 |
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 |
BECKMAN COULTER, INC. |
ELLEN M VOSS |
K973448 |
09/17/1998 |
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 |
BECKMAN INSTRUMENTS, INC. |
MICHELE BURTNESS |
K982922 |
09/22/1998 |
VACUTAINER BRAND BLOOD COLLECTION SYRINGE |
BECTON DICKINSON VACUTAINER SYSTEMS |
KEITH M SMITH |
K981563 |
09/15/1998 |
BIOPAK MEASUREMENT SYSTEM |
BIO-RESEARCH ASSOCIATES, INC. |
|
K982954 |
09/24/1998 |
FREE T4 MICROWELL EIA, MODEL #7019 |
BIOMERICA, INC. |
JAY SINGH |
K982869 |
09/22/1998 |
ASCENT SYSTEM |
BIOMET, INC. |
KARA MEZGER |
K982139 |
09/15/1998 |
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM |
BIONX IMPLANTS, INC. |
JOHNATHAN S KAHAN |
K982111 |
09/15/1998 |
VARIOUS DENTAL IMPLANTS |
BIOTECH MEDICAL INSTRUMENTS CORP. |
WILLIAM SIMMONS |
K980869 |
09/10/1998 |
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 |
BIOTRONIK, INC. |
DAVID MAKANANI |
K982645 |
09/02/1998 |
PYRAMID |
BISCO, INC. |
KATHY JOUNG |
K982729 |
09/15/1998 |
RENEW |
BISCO, INC. |
KATHY JOUNG |
K982089 |
09/03/1998 |
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
K982002 |
09/02/1998 |
ACCU-CHEK COMFORT CURVE TEST STRIP |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
K983166 |
09/22/1998 |
ELECSYS CALCHECK MYOGLOBIN |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
K983176 |
09/24/1998 |
ELECSYS MYOGLOBIN STAT ASSAY |
BOEHRINGER MANNHEIM CORP. |
PRISCILLA A HAMILL |
K981981 |
09/03/1998 |
ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19 |
BOSTON SCIENTIFIC CORP. |
STEVE JWANOUSKOS |
K980566 |
09/14/1998 |
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER |
BOSTON SCIENTIFIC CORP. |
WANDA M CARPINELLA |
K982005 |
09/02/1998 |
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS |
BOSTON SCIENTIFIC SCIMED, INC. |
RONALD W BENNETT |
K982216 |
09/11/1998 |
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
K981394 |
09/28/1998 |
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 |
BRAEMAR CORP. |
DAVID NORBERG |
K982403 |
09/22/1998 |
BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
BRENNEN MEDICAL, INC. |
KENNETH B HERLAND |
K981994 |
09/03/1998 |
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER |
C.R. BARD, INC. |
PEGGY KEIFFER |
K982891 |
09/30/1998 |
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
K982702 |
09/10/1998 |
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD |
CAMINO NEUROCARE, INC. |
JODY J FLEMING |
K982345 |
09/01/1998 |
VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM |
CARDIAC MARINERS, INC. |
E. BRUCE FLOYD |
K982565 |
09/22/1998 |
EASY TRANS TIP |
CARL SCHUH |
CARL SCHUH |
K982135 |
09/15/1998 |
OSCILLOMATE EMS NIBP MONITOR MODEL 9001 |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K981970 |
09/02/1998 |
ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI |
CAVEX HOLLAND B.V. |
BERNARD VAN DUIJN |
K982648 |
09/30/1998 |
JOAN II |
CELANESE ACETATE CO. |
WILLIAM C THOMAS |
K982230 |
09/24/1998 |
LASETTE LASER SKIN PERFORATOR |
CELL ROBOTICS, INC. |
RONALD K LOHRDING |
K982665 |
09/08/1998 |
JUMBO SILVER-REINFORCED GLASS IONOMER |
CENTRIX, INC. |
JOHN DISCKO |
K974572 |
09/24/1998 |
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 |
CHUGAI PHARMACEUTICALS CO., LTD. |
GERALD H SCHELL |
K982774 |
09/02/1998 |
SOFT (HYDROPHILIC) CONTACT LENSES |
CL-TINTERS |
MARTIN S KROPF |
K981260 |
09/22/1998 |
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M |
CLINICAL INNOVATIONS, INC. |
WM D WALLACE |
K982254 |
09/10/1998 |
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
K973637 |
09/25/1998 |
PRESS-MATE ADVANTAGE |
COLIN MEDICAL INSTRUMENTS CORP. |
MARK RISON |
K982962 |
09/23/1998 |
XENON LIGHT SOURCE, MODELS LS6180, LS6035 |
CONTEC MEDICAL VISION, LTD. |
ALBERT E AUSTIN |
K982116 |
09/08/1998 |
AQUACEL HYDROFIBER WOUND DRESSING |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
AMEER ALLY |
K983003 |
09/17/1998 |
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS |
CORDIS NEUROVASCULAR, INC. |
MARTINE D SCHNEIDER |
K982172 |
09/24/1998 |
CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL |
COULTER CORP. |
MARION S GIDE |
K980883 |
09/03/1998 |
N-ASSAY GLU-UL |
CRESTAT DIAGNOSTICS, INC. |
COLIN GETTY |
K982055 |
09/08/1998 |
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHART |
K983017 |
09/22/1998 |
MODIFICATION TO SYSTEM 83 PLUS |
CUSTOM ULTRASONICS |
FRANK J WEBER |
K983034 |
09/10/1998 |
CYNOSURE CO3 ER:YAG LASER |
CYNOSURE, INC. |
GEORGE CHO |
K981711 |
09/30/1998 |
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
K982187 |
09/16/1998 |
FAST-CATH INTRA-CARDIAC INTRODUCER |
DAIG CORP. |
DEAN BRUHN-DING |
K981226 |
09/28/1998 |
IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 |
DAKO DIAGNOSTICS LTD. |
RON NEWSTEAD |
K981734 |
09/22/1998 |
VTEC-RPLA SEIKEN |
DENKA SEIKEN'S |
KEVIN MANGAN |
K982480 |
09/15/1998 |
PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. |
DENTALVIEW, INC. |
WENDELL EBLING |
K982394 |
09/21/1998 |
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM |
DENTSPLY INTL. |
P.JEFFERY LEHN |
K982318 |
09/15/1998 |
SPECTRUM 800 CURING UNIT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K982483 |
09/14/1998 |
DEPUY MOTECH PEAK FIXATION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
K982320 |
09/14/1998 |
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
DEPUY, INC. |
LYNETTE WHITAKER |
K982511 |
09/14/1998 |
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS |
DEPUY, INC. |
SALLY FOUST |
K982330 |
09/25/1998 |
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
DEPUY, INC. |
CHERYL K HASTINGS |
K981940 |
09/25/1998 |
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES |
DEXIDE, INC. |
LYNETTE CALDWELL |
K980662 |
09/14/1998 |
LICHEN, BACTERIAL IN LINE BREATHING FILTER |
DHD HEALTHCARE CORP. |
JEAN WALLACE |
K983019 |
09/14/1998 |
CARBON DIOXIDE-SL ASSAY, CAT # 253-01 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
K981297 |
09/18/1998 |
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K981163 |
09/21/1998 |
DIAMEDIX IS-CMV IGG TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K981306 |
09/29/1998 |
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K981867 |
09/28/1998 |
IS-VZU IGG TEST SYSTEM |
DIAMEDIX CORP. |
LYNN STIRLING |
K974901 |
09/29/1998 |
HYBRID CAPTURE SYSTEM CMV DNA ASSAY |
DIGENE CORP. |
CONSTANCE A FINCH |
K982546 |
09/22/1998 |
PHASER-2000 |
DIOMEDICS, INC. |
|
K982169 |
09/14/1998 |
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
K982629 |
09/14/1998 |
DORNIER MEDILAS D |
DORNIER SURGICAL PRODUCTS, INC. |
CAROL WERNECKE |
K980642 |
09/04/1998 |
EVITA 4 (8411900) |
DRAGER, INC. |
HARALD KNEUER |
K982422 |
09/30/1998 |
EAGLESOFT CHAIRSIDE |
EAGLESOFT, A PATTERSON CO. |
CRAIG W KABBES |
K982800 |
09/22/1998 |
ECTON LYNX ULTRASOUND SYSTEM |
ECTON, INC. |
CHRISTOPHER B KNELL |
K982842 |
09/25/1998 |
HUMAPEN AND HUMAPEN ERGO |
ELI LILLY AND CO. |
LEEANN CHAMBERS |
K982060 |
09/02/1998 |
VOLUMAX CT IMAGING SYSTEM |
ELSCINT, INC. |
STEVEN M KAY |
K980457 |
09/08/1998 |
ENDO ABSORBABLE INTERFERENCE SCREW |
ENDO SURGICAL CONCEPTS, INC. |
ALAN A SMALL |
K982827 |
09/14/1998 |
DERMA K ER:YAG/CO2 LASER |
ESC MEDICAL SYSTEMS, INC. |
GEORGE J HATTUB |
K982817 |
09/23/1998 |
EWC: ECG CABLE AND LEADWIRE SYSTEMS |
EWC |
TIMOTHY M DAVIS |
K981143 |
09/14/1998 |
DILKES LASER/SUCTION CANNULAE |
EXMOOR PLASTICS LTD. |
MARGARET BLACKMORE |
K980816 |
09/18/1998 |
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES |
FCI OPHTHALMICS, INC. |
ANNE BOHSACK |
K982306 |
09/22/1998 |
POLYTUBE |
FERRIS MFG. CORP. |
THEODORE THORSEN |
K980930 |
09/22/1998 |
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA |
FIBRA SONICS, INC. |
ROBERT BROHM |
K983088 |
09/22/1998 |
INSTACINE D-2000 |
FIDELITY MEDICAL, INC. |
SPENCER J ANGEL |
K973725 |
09/22/1998 |
BIONECT CLEAR HYDROGEL |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
K973722 |
09/22/1998 |
BIONECT HYDROGEL FOAM |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
K973721 |
09/22/1998 |
BIONECT HYDROGEL GAUZE PADS |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINO |
K973724 |
09/22/1998 |
BIONECT HYDROGEL SPRAY |
FIDIA PHARMACEUTICAL CORP. |
ROBERTO FIORENTINI |
K982157 |
09/02/1998 |
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
FIELD EFFECTS |
GREG HURST |
K970700 |
09/15/1998 |
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX |
FRESENIUS USA, INC. |
TOM FOLDEN |
K980630 |
09/04/1998 |
FRIALIT-2 CORABASE |
FRIATEC AG |
EUGENE GOORCHENKO |
K972140 |
09/30/1998 |
A1 ACOUSTIC RHINOMETER |
G.M. INSTRUMENTS LTD. |
E. W GREIG |
K974899 |
09/23/1998 |
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H |
GAMBRO HEALTHCARE |
JEFFREY R SHIDEMAN |
K970321 |
09/15/1998 |
BIO-OSS ANORGANIC BOVINE BONE |
GEISTLICH-PHARMA |
BIRGIT WENZ |
K974399 |
09/16/1998 |
BIO-OSS COLLAGEN |
GEISTLICH-PHARMA |
PETER S REICHERTZ |
K974226 |
09/22/1998 |
IMMUNODOT MONO-G TEST |
GenBio |
Bryan Kiehl |
K974244 |
09/22/1998 |
IMMUNODOT MONO-M TEST |
GenBio |
Bryan Kiehl |
K982083 |
09/11/1998 |
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
GUIDANT CORP. |
LORNA TSUDA |
K982171 |
09/17/1998 |
HAMAMATSU PET SCANNER, MODEL SHR-22000 |
HAMAMATSU PHOTONICS, K.K. |
T. WHIT ATHEY |
K981009 |
09/04/1998 |
HEARTPORT ENDOPULMONARY VENT CATHETER |
HEARTPORT, INC. |
MARIANNE D DRENNAN |
K982025 |
09/04/1998 |
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR |
HEWLETT-PACKARD CO. |
RICHARD J PETERSEN |
K980429 |
09/09/1998 |
HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) |
HEWLETT-PACKARD CO. |
RAY STELTING |
K982929 |
09/09/1998 |
MAXAIR NASAL DILATOR SYSTEM |
HNL TECHNOLOGIES |
HANFORD N LOCKWOOD, JR. |
K982494 |
09/08/1998 |
BWM SPINE SYSTEM |
HOWMEDICA CORP. |
VIVIAN KELLY |
K982602 |
09/14/1998 |
RETROGRADE ROD SYSTEM |
HOWMEDICA CORP. |
VIVIAN KELLY |
K982463 |
09/30/1998 |
EXTRACRANIAL RADIOTHERAPY SYSTEM |
HOWMEDICA, INC. |
VIVIAN KELLY |
K981876 |
09/30/1998 |
SYNTHETIC EXAMINATION GLOVE, POWDERED |
HSING YI PLASTICS PROCESSING CO, LTD. |
JANNA P TUCKER |
K982266 |
09/25/1998 |
HYDROCISION ARTHROJET SYSTEM |
HYDROCISION, INC. |
ERIC BANNON |
K980578 |
09/11/1998 |
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) |
INNERDYNE, INC. |
RICK GAYKOWSKI |
K982234 |
09/08/1998 |
AL-GEN CALCIUM ALGINATE DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
CJ OAKES |
K982023 |
09/04/1998 |
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
K981817 |
09/28/1998 |
COAMATIC PLASMIN INHIBITOR |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K981952 |
09/01/1998 |
COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER |
INSTRUMENTS FOR MEDICINE AND DIAGNOSTICS |
WILLIAM J MCMAHAN |
K981069 |
09/23/1998 |
ULTRA-COVER PU-TRANSDUCER COVER |
INTERNATIONAL MEDICAL PRODUCTS B.V. |
H.G TE SINKEL |
K972866 |
09/30/1998 |
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT |
INTERNATIONAL TECHNIDYNE CORP. |
ROBERT H MATLAND |
K980817 |
09/25/1998 |
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L |
INTERPORE INTL. |
DAVID P BALDING |
K982031 |
09/08/1998 |
OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE |
IRIDEX CORP. |
DANIEL MARINSIK |
K982044 |
09/02/1998 |
NUCAMMA R+ |
IS2 RESEARCH, INC. |
PETER SCHULTZ |
K982045 |
09/02/1998 |
NUCAMMA RX |
IS2 RESEARCH, INC. |
PETER SCHULTZ |
K982042 |
09/08/1998 |
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 |
ISLAND BIOSURGICAL, INC. |
HUNTER A MCKAY |
K982705 |
09/08/1998 |
MIDAS TOUCH BIPOLAR FORCEPS |
ITI MEDICAL TECHNOLOGIES, INC. |
ROGER WERNE |
K982616 |
09/08/1998 |
IPS EMPRESS 2 |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
K983241 |
09/29/1998 |
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K983130 |
09/29/1998 |
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K982571 |
09/22/1998 |
KSEA FLIPPTACK |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
K980908 |
09/11/1998 |
LACTATE PRO SYSTEM |
KDK CORP. |
KAZUO IKETAKI |
K974188 |
09/10/1998 |
CETYLCIDE-G |
KELLER AND HECKMAN |
JOHN S ELDRED |
K982331 |
09/11/1998 |
KELLER PULSE OXIMETER, MODEL 850+ |
KELLER MEDICAL SPECIALTIES PRODUCTS, INC. |
JEAN KELLER |
K982927 |
09/08/1998 |
QUICK TAP SELF DRILLING SCREW |
KINAMED, INC. |
ROBERT BRUCE |
K982176 |
09/18/1998 |
KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN PRARIO |
K982259 |
09/22/1998 |
CHROMA ZONE COLOR STAIN |
KURARAY AMERICA, INC. |
KOJI FUJITA |
K982904 |
09/01/1998 |
ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS |
LES LABORATOIRES BLANCHARD |
JOHN M SZABOCSIK |
K982983 |
09/29/1998 |
LSVP INTERNATIONAL BIOPSY FORCEPS |
LSVP INTL., INC. |
LEON PESOTCHINSKY |
K983114 |
09/22/1998 |
MAGNATEK80 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
K982405 |
09/17/1998 |
MTEK-1000 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
K982846 |
09/18/1998 |
MTEK-1400 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
K982256 |
09/30/1998 |
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP |
MCKINLEY, INC. |
SUZANNE DENNIS |
K982507 |
09/16/1998 |
MINI POLYURETHANE CATHETER |
MED INSTITUTE, INC. |
NEAL E FEARNOT |
K982191 |
09/14/1998 |
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND |
MEDENTAL INTL. |
DEBRA OLSON |
K982779 |
09/30/1998 |
MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 |
MEDENTAL INTL. |
DEBRA OLSON |
K982496 |
09/18/1998 |
QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
K983127 |
09/14/1998 |
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
MARY THORSNESS |
K982960 |
09/23/1998 |
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K982215 |
09/18/1998 |
MANUAL RESUSCITATOR WITH ACE |
MEDICAL MARKETING CONCEPTS |
E J SMITH |
K981032 |
09/02/1998 |
PIV SYSTEM |
MEDICAL SOLUTIONS, INC. |
E J SMITH |
K974813 |
09/29/1998 |
COMBISON 530D WITH POWER DOPPLER MODE |
MEDISON AMERICA, INC. |
BOB LEIKER |
K982620 |
09/30/1998 |
MEDIVISION CYSTOSCOPE |
MEDIVISION SCOPE SERVICE CENTER, INC. |
WAYNE B STERNER |
K974062 |
09/02/1998 |
MEDSCI 3% GLUTARALDEHYDE |
MEDSCI, INC. |
ROBERT MCINTOSH JR. |
K982883 |
09/04/1998 |
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER |
MEDTRONICS INTERVENTIONAL VASCULAR |
MARK CHARTIER |
K981337 |
09/30/1998 |
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A |
MESURE TECHNOLOGY |
PHIL ZULUETA |
K982020 |
09/30/1998 |
METRON QA-IDS I.V. PUMP TESTER |
METRON U.S., INC. |
E.J. Smith |
K974352 |
09/08/1998 |
CARDIOVIEW 3000 SOFTWARE |
MICROMEDICAL, INC. |
MALCOM CASTLE |
K982462 |
09/14/1998 |
FIBER OPTIC ENDOILLUMINATION PROBE |
MICROVISION, INC. |
LEONARD KASTRILEVICH |
K982735 |
09/09/1998 |
LIGHT SABER BONE BIOPSY NEEDLE |
MINRAD, INC. |
THOMAS L PARKER |
K982841 |
09/04/1998 |
MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 |
MISONIX, INC. |
SUSAN D GOLDSTEIN-FALK |
K974170 |
09/30/1998 |
DUOSTAR |
MTI CORP./ ELECTROSTAR S.A.-HAITI |
C. T HARDY |
K982482 |
09/30/1998 |
HANDMASTER NMS1 |
N.E.S.S. NUROMUSCULAR ELECTRICAL STIMULATION SYST |
JONATHAN S KAHAN |
K982743 |
09/14/1998 |
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH |
NEW DEANTRONICS TAIWAN, LTD. |
LEWIS WARD |
K982744 |
09/11/1998 |
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH |
NEW DEANTRONICS TAIWAN, LTD. |
LEWIS WARD |
K982742 |
09/14/1998 |
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH |
NEW DEANTRONICS TAIWAN, LTD. |
LEWIS WARD |
K982749 |
09/14/1998 |
MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 |
NEW DEANTRONICS TAIWAN, LTD. |
LEWIS WARD |
K982746 |
09/14/1998 |
MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 |
NEW DEANTRONICS TAIWAN, LTD. |
LEWIS WARD |
K982884 |
09/14/1998 |
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH |
NEW DEANTRONICS, LTD. |
LEWIS WARD |
K972675 |
09/30/1998 |
CO2 GAS WARMING UNIT (6-800-00) |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
K973447 |
09/30/1998 |
OMNIFLATOR 6630(6-630-00) |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
K982244 |
09/23/1998 |
MAYFIELD ACCISS OPTICAL SYSTEM |
OHIO MEDICAL INSTRUMENT CO., INC. |
KENNETH MILLER |
K982613 |
09/02/1998 |
OMNI PRO LATEX SURGICAL GLOVE, POWDERED |
OMNIGRACE (THAILAND) LTD. |
WILLIAM E PATTON |
K980398 |
09/22/1998 |
KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II |
OPTOMEDIC MEDICAL TECHNOLOGIES LTD. |
WHIT ATHEY |
K982088 |
09/04/1998 |
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM |
ORTHO KINETICS CORP. |
STEVEN O LUSE |
K982553 |
09/22/1998 |
OSTEO COMPRESSION HIP SCREW SYSTEM |
OSTEONICS CORP. |
MARYBETH NAUGHTON |
K982601 |
09/14/1998 |
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL |
OSTEONICS CORP. |
KATE SUTTON |
K974685 |
09/22/1998 |
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS |
OSTEONICS CORP. |
DONNA S WILSON |
K983152 |
09/25/1998 |
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS |
OSTEONICS CORP. |
KATE SUTTON |
K982524 |
09/09/1998 |
AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K982520 |
09/09/1998 |
CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K982517 |
09/09/1998 |
CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K982519 |
09/09/1998 |
LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K982528 |
09/09/1998 |
NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K982669 |
09/09/1998 |
OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K982526 |
09/09/1998 |
SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K982523 |
09/09/1998 |
SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
OXOID, LTD. |
ANDY HOLLINGSWORTH |
K980762 |
09/01/1998 |
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE |
PALL CORP. |
ROBERT A DICKSTEIN, PH.D. |
K982578 |
09/02/1998 |
QUANTI-TEST SYSTEM |
PANATREX, INC. |
GREG HOLLAND |
K982050 |
09/02/1998 |
MODEL MS-2 HANDPIECE |
PARKELL, INC. |
NELSON GENDUSA |
K982146 |
09/14/1998 |
PICTOOLS MEDICAL TOOL KIT MODEL 1.0 |
PEGASUS IMAGING CORP. |
ANDREW HUDSON |
K981834 |
09/29/1998 |
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM |
PERCEPTION, INC. |
JORGE MILLAN |
K982105 |
09/16/1998 |
ORAL POTENTIAL METER (OPM) |
PERTEC OF WISCONSIN, INC. |
DOUGLAS L COOK |
K982806 |
09/30/1998 |
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE |
PERUSAHAAN GETAH ASAS SDN BHD |
BOB CHAN |
K982440 |
09/30/1998 |
NITRILE PATIENT EXAMINATION GLOVE |
PERUSAHAAN GETAH ASAS SDN BHD |
BOB CHAN |
K982807 |
09/30/1998 |
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE |
PERUSAHAAN GETAH ASAS SDN BHD |
BOB CHAN |
K980997 |
09/28/1998 |
PGK DEVICE (MODIFIED) |
PGK, INC. |
PANOS G KOUTROUVELIS |
K982152 |
09/21/1998 |
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 |
PHAMATECH |
CARL A MONGIOVI |
K982343 |
09/15/1998 |
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
K982706 |
09/02/1998 |
PHILIPS BV300 SERIES RELEASE 2.1 |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
K982993 |
09/29/1998 |
PHILIPS OMNIDIAGNOST |
PHILIPS MEDICAL SYSTEMS, INC. |
PETER ALTMAN |
K974770 |
09/02/1998 |
ACQPLAN |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
K982408 |
09/14/1998 |
AEROTEE, MODEL # 1001 |
PIPER MEDICAL PRODUCTS |
S. DAVID PIPER |
K982040 |
09/08/1998 |
MEDPOR SURGICAL GRANULE IMPLANTS |
POREX SURGICAL, INC. |
HOWARD MERCER |
K983123 |
09/25/1998 |
POC ENT ENDOSCOPE - SINUSCOPE |
PRECISION OPTICS CORP. |
JAMES REILLY |
K983147 |
09/28/1998 |
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
K980798 |
09/22/1998 |
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG, PH.D. |
K982439 |
09/08/1998 |
PROXIDERM, MODELS TN 460, TN 90 460, BK 460 |
PROGRESSIVE SURGICAL PRODUCTS, INC. |
ROBERT ODDSEN |
K982182 |
09/18/1998 |
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K981055 |
09/29/1998 |
XKNIFE-4 |
RADIONICS, INC. |
LISA MISTERKA BENATI |
K982767 |
09/21/1998 |
RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR |
RAICHEM |
MELISSA SANER |
K981973 |
09/03/1998 |
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM |
RAM SCIENTIFIC |
GEOFFREY LEVITT |
K982529 |
09/11/1998 |
RANDOX DIRECT LDL CHOLESTEROL |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
K982401 |
09/08/1998 |
PROSTATE BIOPSY NEEDLE |
REMINGTON MEDICAL, INC. |
STEVE WOODY |
K980721 |
09/01/1998 |
SULLIVAN AUTOSET |
RESMED LTD. |
SCOTT DUDEVOIR |
K981334 |
09/10/1998 |
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K982382 |
09/28/1998 |
COBAS INTEGRA REAGENT CASSETTES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
K982396 |
09/14/1998 |
VISIVOX, MODEL V-2 |
RSQ, LLC. |
DORIS DRUCKER |
K983161 |
09/30/1998 |
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC |
SABRE-K LTD. |
STEVEN BUCKLEY |
K973203 |
09/30/1998 |
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES |
SANGSTAT MEDICAL CORP. |
HANA BERGER MORAN |
K982491 |
09/03/1998 |
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT |
SANGUI BIOTECH, INC. |
JOHN J KIANG |
K982752 |
09/30/1998 |
SEARE BIOMEDICAL CHIN IMPLANTS |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE JR |
K982763 |
09/30/1998 |
SEARE BIOMEDICAL MALAR IMPLANTS |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE, JR. |
K982753 |
09/30/1998 |
SEARE BIOMEDICAL NASAL IMPLANTS |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE JR |
K982762 |
09/30/1998 |
SEARE BIOMEDICAL PECTORALIS IMPLANT |
SEARE BIOMEDICAL CORP. |
WILLIAM JOHN SEARE, JR. |
K983043 |
09/30/1998 |
SEARE BIOMEDICAL SILICONE BLOCK |
SEARE BIOMEDICAL CORP. |
WILLIAM J SEARE, JR |
K983041 |
09/30/1998 |
SEARE BIOMEDICAL SILICONE SHEETING |
SEARE BIOMEDICAL CORP. |
WILLIAM J SEARE, JR |
K982704 |
09/30/1998 |
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
K982589 |
09/10/1998 |
SURGEON'S GLOVE |
SHIVA MEDICARE LTD. |
JAMES F LOGAN |
K982193 |
09/01/1998 |
ESOPHAGEAL STETHOSCOPE |
SHORE MEDICAL, INC. |
MARK RICHARDSON |
K982319 |
09/22/1998 |
CAREGRAPH |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
K982349 |
09/30/1998 |
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA JUERGENSEN |
K982149 |
09/10/1998 |
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
K982258 |
09/08/1998 |
MAMMARY SIZER |
SPECIALTY SURGICAL PRODUCTS, INC. |
T JAN VARNER |
K982945 |
09/22/1998 |
DUAL PURPOSE CLOSED CATHETER |
SPIRIT MEDICAL SYSTEMS, INC. |
JEFF SAWYER |
K980696 |
09/11/1998 |
FOAM TIP INJECTOR |
STAAR SURGICAL CO. |
JANICE L FILIPPELLI |
K982400 |
09/23/1998 |
STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT |
STERI-OSS, INC. |
JEFF HAUSHEER |
K982014 |
09/04/1998 |
STOCKERT COMPACT SYSTEM |
STOECKERT INSTRUMENTE |
ROSINA ROBINSON |
K982509 |
09/30/1998 |
ORTHO IMPLANT AND ACCESSORIES |
STRAUMANN USA |
LINDA JALBERT |
K982542 |
09/22/1998 |
STRYKER URETERAL ILLUMINATOR SYSTEM III |
Stryker Endoscopy |
TONY LEE |
K982305 |
09/22/1998 |
SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT |
SULZER CALCITEK, INC. |
FOSTER BOOP |
K981314 |
09/04/1998 |
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K982304 |
09/25/1998 |
DEVILBISS SUCTION UNIT |
SUNRISE MEDICAL HHG, INC. |
MATT SMITH |
K973477 |
09/04/1998 |
BIOSENSORS EMBOLECTOMY CATHETER |
SUNSCOPE INTL., INC. |
JOHN SHULZE |
K982719 |
09/25/1998 |
THE BONE TIE |
SURGICRAFT LTD. |
SIMON FITZER |
K982459 |
09/30/1998 |
TEMPFIL F - 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K982103 |
09/11/1998 |
ULMER (VNG) VIDEO NYSTAGMOGRAPH |
SYNAPSYS, INC. |
VERA BUFFALOE |
K982117 |
09/04/1998 |
FLUID CONTROL |
T.A. COLEMAN ENT. |
KEITH A BARRITT |
K982223 |
09/10/1998 |
CAPIOX SX HARDSHELL RESEVOIR |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
K981644 |
09/03/1998 |
BINDAZYME ANTIGLIADIN IGG |
THE BINDING SITE, LTD. |
JAY H GELLER |
K981929 |
09/03/1998 |
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT |
THE BINDING SITE, LTD. |
JAY GELLER |
K982781 |
09/30/1998 |
DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER |
THERMAL WASTE TECHNOLOGY, INC. |
BILL RANSONE |
K982475 |
09/22/1998 |
SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL |
TISSUE TECHNOLOGIES, INC. |
JESSE KRAMER |
K982300 |
09/25/1998 |
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DONELLE KRAJEWSKI |
K982121 |
09/17/1998 |
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT |
TRACE SCIENTIFIC LTD. |
David Johnston |
K982120 |
09/10/1998 |
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) |
TREX MEDICAL CORP. |
WILLIAM T COUSINS |
K982427 |
09/23/1998 |
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C |
TREX MEDICAL CORP. |
WILLIAM T COUSINS |
K982179 |
09/17/1998 |
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER |
TRUDELL MEDICAL |
DARRYL FISCHER |
K982113 |
09/30/1998 |
UMECO OPTIMA 694 RUBY LASER SYSTEM |
UMECO, INC. |
IAIN D MILLER |
K981573 |
09/15/1998 |
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE |
UNITED BIOTECH, INC. |
SHARON SUN |
K973076 |
09/16/1998 |
EUROMEDICAL HAEMATURIA FOLEY CATHETER |
UNOMEDICAL SDN BHD |
PATRICK J LAMB |
K981344 |
09/10/1998 |
URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING |
URESIL CORP. |
LEV MELINYSHYN |
K982339 |
09/04/1998 |
FLOW 7000 PERIPHERAL VASCULAR COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
K982388 |
09/14/1998 |
SURGI STIM |
VISION QUEST INDUSTRIES, INC. |
ROBERT R THAUER |
K981726 |
09/17/1998 |
PERCUSSIVETECH HF, MODEL 2001 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
GORDON A WONG |
K982271 |
09/22/1998 |
WAKO DIRECT LDL-C |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K981553 |
09/29/1998 |
AUTOMATED MEDICAL REPORT WRITER |
WOODSON AND ASSOCIATES, LLC. |
GRATTAN WOODSON, III |
K982390 |
09/14/1998 |
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
K982595 |
09/04/1998 |
NIM4 |
XOMED, INC. |
DAVID TIMLIN |
K982294 |
09/18/1998 |
XOMED SILICONE PRE-FORM BLOCKS |
XOMED, INC. |
ROY BERENS |