| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K982142 |
06/17/1998 |
MOUNTABLE ENDOSCOPIC KNIFE |
A.M. SURGICAL, INC. |
EUGENE T KING |
| K982094 |
06/15/1998 |
VERABOND 2 |
AALBA DENT, INC. |
VINCENT BENETTI |
| K982159 |
06/19/1998 |
ABBOTT PLUM A+ INFUSION PUMP |
ABBOTT LABORATORIES |
DAVID T GUZEK |
| K981920 |
06/01/1998 |
AMM |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981943 |
06/03/1998 |
DBIL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K982041 |
06/10/1998 |
UIBC |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K981918 |
06/01/1998 |
UREA |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981905 |
06/01/1998 |
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 |
ACU-PAK |
CAROL THOMPSON |
| K981936 |
06/02/1998 |
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION |
ADVANCED BIOMEDICAL DEVICES, INC. |
R. EDWARD WINTERS |
| K981999 |
06/08/1998 |
ALBATECH PERSONAL MONITOR |
ALBATECH, INC. |
SHERYL S NATELSON |
| K982269 |
06/29/1998 |
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA |
ALLEGIANCE HEALTHCARE CORP. |
ZARINA B ILGRAMI |
| K982051 |
06/11/1998 |
KELOCATE SHEETING |
ALLIED BIOMEDICAL CORP. |
CATHERINE RIPLE |
| K982063 |
06/12/1998 |
ALM PRISMALIX (PRX) SURGICAL LIGHT |
ALM SURGICAL EQUIPMENT, INC. |
SUSAN NIELSEN |
| K982218 |
06/24/1998 |
NITRILE POWDER-FREE UNISEAL GLOVES |
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD |
TARANI DEVI |
| K981979 |
06/05/1998 |
UNISEAL GLOVES LOW PROTEIN POWDERED |
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD |
TARANI DEVI |
| K982221 |
06/24/1998 |
PREMIER AP |
AMERICAN IMEX |
JOE FONG |
| K982029 |
06/09/1998 |
SHARPS COLLECTION CONTAINER - SAF-T-SHELL |
AMERICAN MEDICAL MFG., INC. |
MIKE HOFTMAN |
| K982076 |
06/12/1998 |
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM |
AMIRA MEDICAL, INC. |
DAVID A HASKER |
| K982073 |
06/12/1998 |
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM |
ANCHOR PRODUCTS CO. |
ROBERT H THRUM |
| K982131 |
06/17/1998 |
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE |
ANSELL EDMONT INDUSTRIAL, INC. |
MIKE W HAGANS |
| K982239 |
06/23/1998 |
CIRCUIT GUARD |
ARC MEDICAL, INC. |
HAROLD B NORRIS |
| K982141 |
06/17/1998 |
ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K981967 |
06/04/1998 |
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE |
ARTHROTEK/BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K982274 |
06/29/1998 |
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE |
ASIA PACIFIC LATEX SDN BHD |
LEE SOON HONG |
| K982287 |
06/30/1998 |
ASLAN SENSOR MODULAR INSTRUMENT |
ASLAN MEDICAL TECHNOLOGIES, LTD. |
THOMAS J HOOGEBOOM |
| K982288 |
06/30/1998 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K982268 |
06/29/1998 |
ULNAR HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K981909 |
06/01/1998 |
BAXTER HEMOSTASIS VALVE INTRODUCERS |
BAXTER EDWARDS |
SCOTT BEGGINS |
| K982102 |
06/15/1998 |
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 |
| K982219 |
06/24/1998 |
MICROALBUSTIX REAGENT STRIPS |
BAYER CORP. |
ROSANNE M SAVOL |
| K981939 |
06/02/1998 |
AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR |
BCI INTL., INC. |
DONALD J ALEXANDER |
| K982279 |
06/30/1998 |
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 |
BCI INTL., INC. |
DONALD J ALEXANDER |
| K981985 |
06/05/1998 |
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 |
BECKMAN COULTER, INC. |
ELLEN M VOSS |
| K982022 |
06/09/1998 |
VIGIL HEMOGLOBIN (HBALC) CONTROLS |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K982224 |
06/24/1998 |
VIGIL PROTEIN CONTROL |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
| K982250 |
06/26/1998 |
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
BECKMAN INSTRUMENTS, INC. |
SHELLIE GUST |
| K982284 |
06/30/1998 |
POWDERED GREEN LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K982285 |
06/30/1998 |
POWDERFREE GREEN LATEX EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K982286 |
06/30/1998 |
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K982238 |
06/25/1998 |
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 |
BINAX, INC. |
PAMELA S ANGELL |
| K982036 |
06/10/1998 |
SILON SCAR STRIPS |
BIO MED SCIENCES, INC. |
MARK E DILLON |
| K982282 |
06/30/1998 |
DURA-GUARD - DURAL REPAIR PATCH |
BIO-VASCULAR, INC. |
MARY FRICK |
| K982095 |
06/15/1998 |
LACTOSORB MENISCAL REPAIR DEVICE |
BIOMET, INC. |
MARY L VERSTYNEN |
| K981996 |
06/08/1998 |
TITANIUM FEMORAL COMPONENT |
BIOMET, INC. |
FRED MCCLURE |
| K982139 |
06/17/1998 |
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM |
BIONX IMPLANTS, INC. |
JOHNATHAN S KAHAN |
| K982245 |
06/26/1998 |
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA |
BIOSITE INCORPORATED |
JOHN F BRUNI |
| K982111 |
06/16/1998 |
VARIOUS DENTAL IMPLANTS |
BIOTECH MEDICAL INSTRUMENTS CORP. |
WILLIAM SIMMONS |
| K982272 |
06/29/1998 |
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 |
BIOTRONIK, INC. |
DAVID MAKANANI |
| K981971 |
06/04/1998 |
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 |
BIRD PRODUCTS CORP. |
NEIL BATTISTE |
| K982034 |
06/10/1998 |
E-FAX SYSTEM |
BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS |
J. HARVEY KNAUSS |
| K982132 |
06/17/1998 |
BLEASE 6200 ANAESTHESIA VENTILATOR |
BLEASE MEDICAL EQUIPMENT LTD. |
FRANCIS X CASEY |
| K982137 |
06/17/1998 |
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE |
BLEASE MEDICAL EQUIPMENT LTD. |
FRANCIS X CASEY |
| K982079 |
06/15/1998 |
ACCU-CHECK VOICEMATE |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K982089 |
06/15/1998 |
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K982002 |
06/08/1998 |
ACCU-CHEK COMFORT CURVE TEST STRIP |
BOEHRINGER MANNHEIM CORP. |
MIKE FLIS |
| K981947 |
06/03/1998 |
STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) |
BOSTON MEDICAL CORP. |
TIMOTHY F HAND |
| K981981 |
06/05/1998 |
ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19 |
BOSTON SCIENTIFIC CORP. |
STEVE JWANOUSKOS |
| K982077 |
06/12/1998 |
SELECTOR DIAGNOSTIC CATHETER |
BOSTON SCIENTIFIC SCIMED, INC. |
JANELL A COLLEY |
| K982184 |
06/22/1998 |
WALLSTENT ENDOPROSTHESIS |
BOSTON SCIENTIFIC SCIMED, INC. |
PHILIP B JARVI |
| K982005 |
06/08/1998 |
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS |
BOSTON SCIENTIFIC SCIMED, INC. |
RONALD W BENNETT |
| K981969 |
06/04/1998 |
ULTIMA BODY POSITION SENSOR |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K982216 |
06/23/1998 |
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K982043 |
06/10/1998 |
BRENEB |
BREMED ITALIA, S.R.L. |
MARK HEBENSTREIT |
| K982158 |
06/19/1998 |
SCOUT |
BURKE, INC. |
DUWAYNE E KRAMER |
| K981994 |
06/08/1998 |
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K982243 |
06/25/1998 |
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 |
CANOGEN INTERNATIONAL LTD. |
MELISSA MAHALL |
| K982283 |
06/30/1998 |
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH |
CARADYNE, LTD. |
PAUL E DRYDEN |
| K982174 |
06/17/1998 |
VENTURI VENTILATOR |
CARDIOPULMONARY CORP. |
JAMES W BIONDI |
| K982135 |
06/17/1998 |
OSCILLOMATE EMS NIBP MONITOR MODEL 9001 |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K982151 |
06/18/1998 |
STERITITE PROCESS INDICATOR ACCESSORIES |
CASE MEDICAL, INC. |
MARCIA FRIEZE |
| K981970 |
06/04/1998 |
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 |
| K981972 |
06/04/1998 |
GREEN-OR DENTIN DESENSITIZER |
CENTRIX, INC. |
JOHN DISCKO |
| K981913 |
06/01/1998 |
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY |
Chembio Diagnostic Systems, Inc. |
RAYMOND DATTWYLER |
| K982168 |
06/19/1998 |
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K981989 |
06/05/1998 |
THE WAVE DIGITAL PHACO SYSTEM |
CIRCUIT TREE |
MAURICE IMONTI |
| K982053 |
06/11/1998 |
EEG ELECTRODES MODEL 445 SERIES |
CLASS A ENT. |
JANICE A AUDI |
| K982254 |
06/26/1998 |
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K982116 |
06/16/1998 |
AQUACEL HYDROFIBER WOUND DRESSING |
CONVATEC, A BRISTOL-MYERS SQUIBB CO. |
AMEER ALLY |
| K981906 |
06/01/1998 |
MODIFICATION FOR PTA BALLOON CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K982280 |
06/30/1998 |
CRYOPRO MAXI AND CRYOPRO MINI |
CORTEX TECHNOLOGY APS |
MARSHA WERTZBERGER |
| K982172 |
06/19/1998 |
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 |
| K982167 |
06/19/1998 |
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 |
COULTER CORP. |
MARION S GAIDE |
| K982166 |
06/19/1998 |
CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 |
COULTER CORP. |
MARION S GAIDE |
| K982055 |
06/11/1998 |
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 |
CRYOMEDICAL SCIENCES, INC. |
RICHARD J REINHART |
| K981962 |
06/04/1998 |
CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE |
CUDA PRODUCTS CO. |
JOSEPH CUDA |
| K981990 |
06/08/1998 |
MRS-400, MAXI 400, MRSL-400, MAXI 400L |
D.B.I. AMERICA CORP. |
UBIRACI R FERNANDES |
| K982210 |
06/23/1998 |
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA |
DADE BEHRING, INC. |
PAUL ROGERS |
| K982292 |
06/30/1998 |
PREALBUMIN CALIBRATOR |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K982187 |
06/22/1998 |
FAST-CATH INTRA-CARDIAC INTRODUCER |
DAIG CORP. |
DEAN BRUHN-DING |
| K982154 |
06/19/1998 |
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K982091 |
06/15/1998 |
CS/3 COMPACT AIRWAY MODULE, M-COVX |
DATEX-ENGSTROM, INC. |
JOEL C KENT |
| K981956 |
06/04/1998 |
DEGANIA SILICONE IDENTI LOOPS |
DEGANIA SILICONE, LTD. |
BETTE LUBIN |
| K981934 |
06/02/1998 |
THE BAGNOLI-4 EMG SYSTEM |
DELSYS, INC. |
GIANLUCA DE LUCA |
| K981948 |
06/03/1998 |
APOLLO 95E |
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. |
GREG HOLLAND |
| K981965 |
06/04/1998 |
FLOWABLE COMPOSITE |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K982007 |
06/08/1998 |
TRUBYTE DENTURE BOND DENTURE BONDING AGENT |
DENTSPLY INTL. |
P J LEHN |
| K982011 |
06/08/1998 |
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
| K981941 |
06/02/1998 |
MULTAPORT CANNULA REDUCER AND ACCESSORIES |
DEXIDE, INC. |
LYNETTE CALDWELL |
| K981940 |
06/02/1998 |
MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES |
DEXIDE, INC. |
LYNETTE CALDWELL |
| K982078 |
06/15/1998 |
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K982027 |
06/02/1998 |
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY |
DIASORIN, INC. |
JUDITH J SMITH |
| K982169 |
06/19/1998 |
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K982003 |
06/08/1998 |
DS30 HCY HOMOCYSTEINE ASSAY KIT |
DREW SCIENTIFIC LTD. |
ANDREW KENNEY |
| K981911 |
06/01/1998 |
PROFA |
DUNCAN HYND ASSOCIATES, LTD. |
DIANA UPTON |
| K982241 |
06/25/1998 |
BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX |
DUXBURY SCIENTIFIC INC. |
ROBERT M ENGLER |
| K982134 |
06/17/1998 |
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 |
DYNAMIC TECHNOLOGY CORP. |
YAW C YANG |
| K982060 |
06/11/1998 |
VOLUMAX CT IMAGING SYSTEM |
ELSCINT, INC. |
STEVEN M KAY |
| K981926 |
06/02/1998 |
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS |
EMD CHEMICALS INC. |
ANNA G BENTLEY |
| K982178 |
06/22/1998 |
VAGABOND SOFT RESTRAINT SYSTEM |
EMERGENT INNOVATIONS, LTD. |
DUANE R ELLIOTT |
| K982059 |
06/11/1998 |
ROTECNO 2000 SURGICAL GOWN |
ENCOMPASS GROUP, LLC. |
TIM CUMMINS |
| K982058 |
06/11/1998 |
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN |
ENCOMPASS GROUP, LLC. |
TIM CUMMINS |
| K982160 |
06/19/1998 |
HINGED KNEE |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K982119 |
06/16/1998 |
DIODE LASER |
ESC MEDICAL SYSTEMS LTD. |
ZVI LADIN |
| K982129 |
06/17/1998 |
ANTAGON PORCELAIN |
EUROPEAN DENTAL IMPORTS, INC. |
MICHAEL H EVERNGAM |
| K982118 |
06/03/1998 |
CARESIDE ANALYZER |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K981899 |
06/01/1998 |
CARESIDE HDL-CHOLESTEROL |
EXIGENT DIAGNOSTICS, INC. |
KENNETH B ASARCH |
| K982157 |
06/19/1998 |
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
FIELD EFFECTS |
GREG HURST |
| K982170 |
06/19/1998 |
FLUIDSENSE FLUID DELIVERY SYSTEM |
FLUIDSENSE CORP. |
ERIC BRENNAN |
| K982201 |
06/22/1998 |
ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) |
FOREMOST DENTAL MFG., INC. |
D T WOLF |
| K981928 |
06/02/1998 |
GALILEO DISPOSABLE ENDOSCOPES |
GALILEO ELECTRO-OPTICS CORP. |
MARY MCNAMARA-CULLINANE |
| K982196 |
06/22/1998 |
DIGITAL RADIOGRAPHIC IMAGING SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K982004 |
06/08/1998 |
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
| K981964 |
06/04/1998 |
MEDI-TRACE 4103 NEONATAL ELECTRODE |
GRAPHIC CONTROLS CORP. |
SUSAN KRASNY |
| K981919 |
06/01/1998 |
BISSINGER CABLES, CAT. NO. 801000XX |
GUENTER BISSINGER MEDIZINTECHNIK GMBH |
DAGMAR S MASER |
| K982083 |
06/15/1998 |
ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
GUIDANT CORP. |
LORNA TSUDA |
| K982057 |
06/11/1998 |
BC 900 SLIT LAMP |
HAAG-STREIT AG |
JUERG H SCHNETZER |
| K982171 |
06/19/1998 |
HAMAMATSU PET SCANNER, MODEL SHR-22000 |
HAMAMATSU PHOTONICS, K.K. |
T. WHIT ATHEY |
| K981954 |
06/04/1998 |
VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS |
HEALTHLINE IMPLANTS, INC. |
WILLIAM SIMMONS |
| K981995 |
06/08/1998 |
QUICKDRAW VENOUS CANNULA |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K982025 |
06/09/1998 |
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR |
HEWLETT-PACKARD CO. |
RICHARD J PETERSEN |
| K982068 |
06/12/1998 |
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM |
HOWMEDICA CORP. |
SEAN LULAND |
| K982248 |
06/26/1998 |
HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A |
HOWMEDICA, INC. |
FRANK MAAS |
| K982266 |
06/29/1998 |
HYDROCISION ARTHROJET SYSTEM |
HYDROCISION, INC. |
ERIC BANNON |
| K982071 |
06/12/1998 |
I-STAT LACTATE TEST |
I-STAT CORP. |
PAUL VANDRWERF |
| K982249 |
06/26/1998 |
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
DONNA WARD |
| K982155 |
06/18/1998 |
SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM |
INFLUENCE, INC. |
JONATHAN S KAHAN |
| K982234 |
06/25/1998 |
AL-GEN CALCIUM ALGINATE DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
CJ OAKES |
| K982023 |
06/09/1998 |
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K981952 |
06/03/1998 |
COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER |
INSTRUMENTS FOR MEDICINE AND DIAGNOSTICS |
WILLIAM J MCMAHAN |
| K982180 |
06/22/1998 |
DURAGEN DURAL GRAFT MATRIX |
INTEGRA LIFESCIENCES CORP. |
JUDITH E O'GRADY |
| K982064 |
06/12/1998 |
ACTION STORM RANGER II, ACTION STORM POWER 9000 |
INVACARE CORP. |
EDWARD A KROLL |
| K982242 |
06/25/1998 |
INVACARE CPAP |
INVACARE CORP. |
EDWARD A KROLL |
| K982031 |
06/10/1998 |
OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE |
IRIDEX CORP. |
DANIEL MARINSIK |
| K982232 |
06/25/1998 |
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM |
IRVINE BIOMEDICAL, INC. |
ROGER TU |
| K982044 |
06/10/1998 |
NUCAMMA R+ |
IS2 RESEARCH, INC. |
PETER SCHULTZ |
| K982045 |
06/10/1998 |
NUCAMMA RX |
IS2 RESEARCH, INC. |
PETER SCHULTZ |
| K982042 |
06/10/1998 |
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 |
ISLAND BIOSURGICAL, INC. |
HUNTER A MCKAY |
| K982255 |
06/26/1998 |
MODEL 2000 PULSE OXIMETER |
IVY BIOMEDICAL SYSTEMS, INC. |
DICK LISTRO |
| K982208 |
06/23/1998 |
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER |
JOMED IMAGING LTD. |
CAROLINE SHORT |
| K982176 |
06/22/1998 |
KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR |
KIRWAN SURGICAL PRODUCTS, INC. |
KEVIN PRARIO |
| K982259 |
06/26/1998 |
CHROMA ZONE COLOR STAIN |
KURARAY AMERICA, INC. |
KOJI FUJITA |
| K982164 |
06/19/1998 |
ESTENIA |
KURARAY AMERICA, INC. |
KOJI FUJITA |
| K981955 |
06/04/1998 |
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS |
LS RUBBER SDN BHD |
RAJIL VOHRA |
| K982267 |
06/29/1998 |
DPX-RX BONE DENSITOMETER |
LUNAR CORP. |
KENNETH D BUROKER |
| K982114 |
06/16/1998 |
LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES |
M/S MIDLAND LATEX PRODUCTS LTD. |
ANIL SEGAT |
| K981898 |
06/01/1998 |
ORTHOVU-1000 |
MAGNEVU |
BOB ROSE |
| K981942 |
06/02/1998 |
LATEX POWDER FREE EXAMINATION GLOVES |
MAIKA RUBBER PRODUCTS SDN BHD |
RAVI ANBIL |
| K982260 |
06/26/1998 |
MARKWELL GAUZE SPONGE |
MARKWELL INTL., INC. |
SEAN WANG |
| K982256 |
06/26/1998 |
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP |
MCKINLEY, INC. |
SUZANNE DENNIS |
| K981992 |
06/08/1998 |
ELECTRON WEDGE MODEL MT-EW-1000 |
MED-TEC,INC. |
DONALD F RIIBE |
| K982191 |
06/22/1998 |
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND |
MEDENTAL INTL. |
DEBRA OLSON |
| K982123 |
06/16/1998 |
CONTRAST CONTROL DEVICE |
MEDEX, INC. |
CINDY CHENETSKI |
| K982024 |
06/09/1998 |
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT KINGHORN |
| K981933 |
06/02/1998 |
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 |
MEDICAL ANALYSIS SYSTEMS, INC. |
|
| K982104 |
06/15/1998 |
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 |
MEDICAL DATA ELECTRONICS |
DAVID M TRUEBLOOD |
| K982085 |
06/15/1998 |
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K982215 |
06/23/1998 |
MANUAL RESUSCITATOR WITH ACE |
MEDICAL MARKETING CONCEPTS |
E J SMITH |
| K982047 |
06/10/1998 |
MPS HUBER NEEDLE EXTENSION SET |
MEDICAL PRODUCT SPECIALISTS |
DAN HYUN |
| K982048 |
06/10/1998 |
MPS RESERVOIR BAG |
MEDICAL PRODUCT SPECIALISTS |
DAN HYUN |
| K982211 |
06/23/1998 |
PROFILE-II MODEL 600582 |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
| K982755 |
06/29/1998 |
MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) |
MEDTRONIC BLOOD MANAGEMENT |
STEPHEN MCKELVEY |
| K982220 |
06/24/1998 |
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT |
MEDTRONIC VASCULAR |
BRIAN J EDWARDS |
| K982145 |
06/17/1998 |
MEGA 3 |
MEGA MOTION, INC. |
PAUL GRONKA |
| K982144 |
06/17/1998 |
MEGA 4 |
MEGA MOTION, INC. |
PAUL GRONKA |
| K982066 |
06/11/1998 |
MP-3 POWER BASE CHAIR |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K982020 |
06/09/1998 |
METRON QA-IDS I.V. PUMP TESTER |
METRON U.S., INC. |
E.J. Smith |
| K982013 |
06/08/1998 |
MGB LAPALUX TELESCOPE |
MGB ENDOSKOPISCHE GERATE GMBH |
BOB LEIKER |
| K981966 |
06/04/1998 |
NOSEBLEED NOSECLIP |
MICHAEL M. KNOTT, M.D. |
MICHAEL M KNOTT |
| K982006 |
06/08/1998 |
MICOMED - HALM ZIELKE INSTRUMENTATION |
MICOMED GMBH |
CHARMAINE HENDERSON |
| K982278 |
06/29/1998 |
MICRINS MICRO ANASTOMOSIS CLAMP |
MICRINS SURGICAL, INC. |
BERNHARD TEITZ |
| K981922 |
06/01/1998 |
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
CARL ANGLES |
| K981976 |
06/01/1998 |
ACUTRON MENTOR MODEL 961 |
MICROCURRENT RESEARCH, INC. |
PAUL DAVIS |
| K982276 |
06/29/1998 |
BAHO AUTOCLAVABLE LAPAROSCOPE |
MICROPTIX INT'L, LLC. |
GEORGE N HALLACK |
| K982018 |
06/08/1998 |
LIGHT SABER ASPIRATION NEEDLE |
MINRAD, INC. |
JOHN MCNEIRNEY |
| K982420 |
06/15/1998 |
MITEK MICRO ANCHOR |
MITEK PRODUCTS |
EDWARD F KENT |
| K982173 |
06/19/1998 |
BUZBEE |
MWR ELECTRONICS INDUSTRIAL CO. |
MANFRED W ROSCHER |
| K982098 |
06/15/1998 |
TUTODROP 1 AND TUTODROP 2 |
MYCO MEDICAL SUPPLIES, INC. |
SANJIV KUMAR |
| K982082 |
06/15/1998 |
HANDISOL WOUND HEALING |
NATIONAL BIOLOGICAL CORP. |
FRANCIS D LAMM |
| K981958 |
06/04/1998 |
LEISEGANG VIDEO COLPOSCOPE |
NETOPTIX CORP. |
MARY MCNAMARA-CULLINANE |
| K982130 |
06/17/1998 |
RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 |
NEW DEANTRONICS, LTD. |
LEWIS WARD |
| K981910 |
06/01/1998 |
SUCTION CATHETER |
NI-MED, INC. |
MICHAEL GIBLIN |
| K982277 |
06/29/1998 |
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K981949 |
06/03/1998 |
NUMOBAG |
NUMOTECH, INC. |
W. PATRICK NOONAN |
| K981963 |
06/04/1998 |
SENSITEX EXAMINATION GLOVE |
OAK CAROLINA, INC. |
DARRELL ALFORD |
| K982244 |
06/25/1998 |
MAYFIELD ACCISS OPTICAL SYSTEM |
OHIO MEDICAL INSTRUMENT CO., INC. |
KENNETH MILLER |
| K982289 |
06/30/1998 |
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K982035 |
06/10/1998 |
OLYMPUS CALCIUM ARSENAZO III REAGENT |
OLYMPUS DIAGNOSTICA GMBH |
LAURA STORMS-TYLER |
| K981917 |
06/01/1998 |
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
OON CORP. RESOURCES |
CLEMENT K.K OON |
| K982110 |
06/16/1998 |
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR |
OPTECH, INC. |
JAMES A BROOKS |
| K982061 |
06/04/1998 |
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) |
ORASURE TECHNOLOGIES, INC. |
SAM R NIEDBALA |
| K982263 |
06/29/1998 |
MB/BACT BLOOD CULTURE BOTTLE |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K982088 |
06/15/1998 |
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM |
ORTHO KINETICS CORP. |
STEVEN O LUSE |
| K982032 |
06/10/1998 |
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS |
OSTEONICS CORP. |
KATE SUTTON |
| K982275 |
06/29/1998 |
RAPPORT V.T.D. |
Owen Mumford USA, Inc. |
ROBERT SHAW |
| K982090 |
06/15/1998 |
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM |
PACEART, INC. |
GEORGE MYERS |
| K981953 |
06/03/1998 |
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS |
PARAGON TRADE BRANDS, INC. |
ROBERT J STAAB |
| K982050 |
06/11/1998 |
MODEL MS-2 HANDPIECE |
PARKELL, INC. |
NELSON GENDUSA |
| K982235 |
06/25/1998 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA DILLON |
| K982156 |
06/18/1998 |
PASCO MIC AND MIC/ID PANELS/ CEFDINIR |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K982146 |
06/17/1998 |
PICTOOLS MEDICAL TOOL KIT MODEL 1.0 |
PEGASUS IMAGING CORP. |
ANDREW HUDSON |
| K981907 |
06/01/1998 |
V.F.I.-VISCOUS FLUID INFUSION TUBING SET |
PEREGRINE SURGICAL LTD. |
TODD RICHMOND |
| K982105 |
06/16/1998 |
ORAL POTENTIAL METER (OPM) |
PERTEC OF WISCONSIN, INC. |
DOUGLAS L COOK |
| K982152 |
06/18/1998 |
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 |
PHAMATECH |
CARL A MONGIOVI |
| K982010 |
06/08/1998 |
FACTS |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K981959 |
06/04/1998 |
OUTLOOK LARGE PHASED ARRAY NECK COIL |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K982203 |
06/22/1998 |
CAAS II LVA BIPLANE OPTION |
PIE MEDICAL EQUIPMENT B.V. |
FRANK ANIBA |
| K982128 |
06/17/1998 |
SHIKANI-FRENCH SPEAKING VALVE |
PILLING WECK SURGICAL |
ELIZABETH LAZARO |
| K981978 |
06/05/1998 |
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS, JR. |
| K982040 |
06/10/1998 |
MEDPOR SURGICAL GRANULE IMPLANTS |
POREX SURGICAL, INC. |
HOWARD MERCER |
| K982127 |
06/17/1998 |
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER |
POROUS MEDIA CORP. |
KEITH A ROBERTS |
| K982062 |
06/15/1998 |
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 |
PRECISION BIOLOGICALS, INC. |
SANDY MORRISON |
| K982281 |
06/30/1998 |
SERAQUEST RUBELLA IGM |
QUEST INTL., INC. |
ROBERT A CORT |
| K982231 |
06/25/1998 |
STATUSFLOW |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K982182 |
06/22/1998 |
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
| K981973 |
06/05/1998 |
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM |
RAM SCIENTIFIC |
GEOFFREY LEVITT |
| K982341 |
06/22/1998 |
DIRECT HDL-CHOLESTROL LIQUID |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K982096 |
06/15/1998 |
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO |
RAPID MFG. CO. |
CHARITY MARTIN |
| K982056 |
06/09/1998 |
RAICHEM CO2 REAGENT |
REAGENTS APPLICATIONS, INC. |
|
| K982115 |
06/16/1998 |
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY |
RIM-WIDE COMPANIES, INC. |
DANIEL HSU |
| K981897 |
06/01/1998 |
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K982087 |
06/15/1998 |
ROCHE CRP T CONTROL N |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K981931 |
06/02/1998 |
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY |
ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH |
Patricia M Klimley |
| K982217 |
06/24/1998 |
AC/AD LINEARITY VERIFIERS |
SC CALIBRATORS & CONTROLS LLC. |
ROY F SCHALL, JR |
| K982136 |
06/17/1998 |
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 |
SCHIFF & CO. |
ANNE M CESARIO |
| K982101 |
06/15/1998 |
SHELHIGH NO-REACT DURA SHIELD |
SHELHIGH, INC. |
SHLOMO GABBAY |
| K982193 |
06/22/1998 |
ESOPHAGEAL STETHOSCOPE |
SHORE MEDICAL, INC. |
MARK RICHARDSON |
| K981975 |
06/05/1998 |
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED |
SIAM SEMPERMED CORP. LTD. |
DON MORRIS |
| K982028 |
06/09/1998 |
FLUOROSPOT COMPACT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MALGORZATA STANEK |
| K982209 |
06/23/1998 |
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 |
SIGMA DIAGNOSTICS, INC. |
WILLIAN R GILBERT |
| K982236 |
06/25/1998 |
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K982251 |
06/26/1998 |
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT |
SIGMA DIAGNOSTICS, INC. |
|
| K982049 |
06/11/1998 |
BIOPSY M |
SITCO, INC. |
ROBERT H MCCARTHY |
| K982149 |
06/18/1998 |
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE |
SMITH & NEPHEW, INC. |
DEBORAH J CONNORS |
| K982067 |
06/12/1998 |
MAGNETIC PORT SILICONE TISSUE EXPANDER |
SPECIALTY SURGICAL PRODUCTS, INC. |
T. JAN VARNER |
| K982258 |
06/26/1998 |
MAMMARY SIZER |
SPECIALTY SURGICAL PRODUCTS, INC. |
T JAN VARNER |
| K982065 |
06/12/1998 |
STERILE SILICONE EXTERNAL WOUND COVER |
SPECIALTY SURGICAL PRODUCTS, INC. |
T. JAN VARNER |
| K981902 |
06/01/1998 |
SPENCO SILICONE GEL SHEET |
SPENCO MEDICAL CORP. |
BRENDA HUNT |
| K982225 |
06/24/1998 |
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 |
SPIRACLE TECHNOLOGY |
GUY GANSEL |
| K982099 |
06/15/1998 |
MOMENTUM NO. FS008 WHEELCHAIR |
SRIRAM ENTERPRISES D.B.A. MOMENTUM GROUP |
RON MOSETICH |
| K982188 |
06/22/1998 |
STERI-PAK BOWIE DICK TEST PACK |
STERITEC PRODUCTS MFG. CO., INC. |
LON BRUSO |
| K982014 |
06/08/1998 |
STOCKERT COMPACT SYSTEM |
STOECKERT INSTRUMENTE |
ROSINA ROBINSON |
| K982290 |
06/29/1998 |
CHEM-CHEX STAT (NEW) |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K982264 |
06/29/1998 |
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 |
SURVIVALINK CORP. |
Sew-Wah Tay |
| K982148 |
06/18/1998 |
PRODIGY 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K982103 |
06/15/1998 |
ULMER (VNG) VIDEO NYSTAGMOGRAPH |
SYNAPSYS, INC. |
VERA BUFFALOE |
| K982212 |
06/23/1998 |
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 |
SYNERGETICS, INC. |
KURT GAMPP |
| K982222 |
06/24/1998 |
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K981950 |
06/03/1998 |
SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 |
SYSMEX CORP. |
CATHERINE M TRESTER |
| K982117 |
06/16/1998 |
FLUID CONTROL |
T.A. COLEMAN ENT. |
KEITH A BARRITT |
| K982257 |
06/26/1998 |
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED |
TAIAN PLASTICS PRODUCTS (JINGXING) CO., LTD. |
CHIN-YU LIN |
| K982015 |
06/08/1998 |
VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE |
TAIAN PLASTICS PRODUCTS (JINGXING) CO., LTD. |
MR.LIN CHIN-YU |
| K981938 |
06/02/1998 |
TAMPA HYPERBARIC MONOPLACE CHAMBER |
TAMPA HYPERBARIC ENT. |
MICHAEL CAPRIA |
| K982223 |
06/24/1998 |
CAPIOX SX HARDSHELL RESEVOIR |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
| K981912 |
06/01/1998 |
HUMAN IGA SUBCLASS BNII COMBI KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K982100 |
06/15/1998 |
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981915 |
06/01/1998 |
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981914 |
06/01/1998 |
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981997 |
06/08/1998 |
POSI-STOP/POSI-TRAC SYSTEM |
THE DENTAL MEDICAL DEVICE CO., L.L.C. |
MARCI BLOOM |
| K982133 |
06/17/1998 |
OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT |
THE OLYMPUS OPTICAL CO. |
RUTH C FORSTADT |
| K981993 |
06/08/1998 |
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K981923 |
06/01/1998 |
THE SNORE PEACE |
THE SNORE PEACE GROUP |
DAVID V SHEEHAN |
| K982150 |
06/18/1998 |
EL-ANA PROFILES: EL-ENA/4 |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K982622 |
06/18/1998 |
EL-ANA PROFILES: EL-ENA/5 |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K982112 |
06/16/1998 |
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM |
THERMATREK, INC. |
DAVID R BALZER |
| K982265 |
06/29/1998 |
AQUILION CT SCANNER, MODEL TSX-101A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K982121 |
06/16/1998 |
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT |
TRACE SCIENTIFIC LTD. |
David Johnston |
| K982120 |
06/16/1998 |
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) |
TREX MEDICAL CORP. |
WILLIAM T COUSINS |
| K982179 |
06/22/1998 |
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER |
TRUDELL MEDICAL |
DARRYL FISCHER |
| K982181 |
06/22/1998 |
TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER |
TRUDELL MEDICAL |
DARRYL FISCHER |
| K982228 |
06/25/1998 |
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 |
TZ MEDICAL, INC. |
BYRON ZAHLER |
| K981908 |
06/01/1998 |
UM-150A |
UMECO UNION MEDICAL ENGINEERING |
ANNIE VELEZ |
| K982113 |
06/16/1998 |
UMECO OPTIMA 694 RUBY LASER SYSTEM |
UMECO, INC. |
IAIN D MILLER |
| K982611 |
06/26/1998 |
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE) |
UNIJECT GLOVES PCL |
SARA JOHNSON |
| K981946 |
06/03/1998 |
CLEARVIEW IM |
UNIPATH LTD. |
Louise Roberts |
| K981935 |
06/02/1998 |
POLYSORB SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JAMIE YIEH |
| K982226 |
06/24/1998 |
UROMED BRACHYTHERAPHY IODINE-125 SOURCES |
UROMED CORP. |
FREDERICK TOBIA |
| K982140 |
06/17/1998 |
CLINICAL ELECTRONIC THERMOMETER |
VALEO CORP. |
PHIL ZULUETA |
| K981916 |
06/01/1998 |
LIGASURE VESSEL SEALING SYSTEM |
VALLEYLAB, INC. |
CHARLES COPPERBERG |
| K981944 |
06/03/1998 |
BREATHERITE |
VENTLAB CORP. |
E.J. Smith |
| K981998 |
06/08/1998 |
PEDIATRIC INSTATRAK SYSTEM |
VISUALIZATION TECHNOLOGY, INC. |
MARY MCNAMARA-CULLINANE |
| K982016 |
06/08/1998 |
PIPER IPPB MODEL 2055 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
GORDON A WONG |
| K982271 |
06/29/1998 |
WAKO DIRECT LDL-C |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K981937 |
06/02/1998 |
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM |
WELCH ALLYN, INC. |
KATHY LOWTHER |
| K982097 |
06/15/1998 |
WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY LAMOUREUX |
| K982294 |
06/30/1998 |
XOMED SILICONE PRE-FORM BLOCKS |
XOMED, INC. |
ROY BERENS |
