| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K994256 |
12/17/1999 |
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
| K994433 |
12/30/1999 |
CONNECT DATA MANAGEMENT SYSTEM |
ABBOTT DIABETES CARE INC. |
EVE A CONNER |
| K994229 |
12/16/1999 |
VERIPATH PERIPHERAL GUIDING CATHETER |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
STACEY SIMON |
| K994227 |
12/15/1999 |
ADVANTAGE HCG TEST (URINE/SERUM) |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
| K994116 |
12/06/1999 |
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) |
AESCULAP-MEDITEC NORTH AMERICA |
WILLIAM KELLEY |
| K994188 |
12/13/1999 |
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 |
AGILENT TECHNOLOGIES, GMBH |
HERBERT VAN DYK |
| K994395 |
12/28/1999 |
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994399 |
12/28/1999 |
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994398 |
12/28/1999 |
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994403 |
12/28/1999 |
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994410 |
12/28/1999 |
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994405 |
12/28/1999 |
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994400 |
12/28/1999 |
INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994406 |
12/28/1999 |
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994404 |
12/28/1999 |
INSTANT-VIEW MORPHINE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994409 |
12/28/1999 |
INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
| K994244 |
12/16/1999 |
CONVERTORS SURGICAL GOWNS, STERILE |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K994162 |
12/09/1999 |
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K994368 |
12/27/1999 |
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K994107 |
12/06/1999 |
AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS. |
AMYLIOR, INC. |
SYLVAIN DUGAS |
| K994072 |
12/02/1999 |
AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM |
AMYLIOR, INC. |
SYLVAIN DUGAS |
| K994362 |
12/27/1999 |
HEADLAMP HL2000. |
ANGIOLAZ, INC. |
ROBERT ALLMAN |
| K994330 |
12/23/1999 |
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE MORGIDA |
| K994319 |
12/22/1999 |
MODULAP |
ATC TECHNOLOGIES, INC. |
MARIAN HARDING COCHRAN |
| K994373 |
12/27/1999 |
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) |
ATL ULTRASOUND, INC. |
TERRANCE J SWEEENEY |
| K994137 |
12/07/1999 |
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE |
ATRIX LABORATORIES, INC. |
AMY TAYLOR |
| K994321 |
12/22/1999 |
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP |
AUTOMATIC LIQUID PACKAGING, INC. |
JOHN BRDA |
| K994313 |
12/22/1999 |
MODIFICATION TO BONE ANCHOR AND KIT (BAK) |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K994375 |
12/27/1999 |
HORIZON LIGHT |
B. BRAUN MEDICAL, INC. |
GARY GULYAS |
| K994111 |
12/06/1999 |
CELSITE, MODELS ST401L, ST405L |
B. BRAUN/MCGAW |
VALERIE LEWIS |
| K994125 |
12/07/1999 |
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES |
BAUSCH & LOMB, INC. |
GLENN A DAVIES |
| K994221 |
12/15/1999 |
BAYER PSA ASSAY |
BAYER CORP. |
WILLIAM J PIGNATO |
| K994439 |
12/23/1999 |
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 |
BECKMAN COULTER, INC. |
MICHELE S GUST |
| K994200 |
12/13/1999 |
ACCESS HYBRITECH PSA QC, MODEL 37209 |
BECKMAN COULTER, INC. |
MICHELE GUST |
| K994278 |
12/20/1999 |
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY |
BECKMAN COULTER, INC. |
JILL KULL |
| K994277 |
12/20/1999 |
ACCESS OSTASE QC |
BECKMAN COULTER, INC. |
MARA CALER |
| K994325 |
12/22/1999 |
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
| K994169 |
12/10/1999 |
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K000331 |
12/22/1999 |
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
| K994168 |
12/10/1999 |
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR |
BECKMAN COULTER, INC. |
LUCINDA STOCKERT |
| K994082 |
12/03/1999 |
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K994149 |
12/08/1999 |
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K994384 |
12/28/1999 |
CLICKER |
BIOJECT, INC. |
NANCY GERTLAR |
| K994170 |
12/10/1999 |
HYLASHIELD CL |
BIOMATRIX, INC. |
NADINE M QASHU |
| K994326 |
12/22/1999 |
ASCENT KNEE SYSTEM |
BIOMET MANUFACTURING, INC. |
TRACY J BICKEL |
| K994184 |
12/10/1999 |
PLR SPLINED REVISION STEM |
BIOMET, INC. |
TRACY J BICKEL |
| K994281 |
12/20/1999 |
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) |
BIOPRO (M) SDN BHD |
JAMES H LALE |
| K994276 |
12/20/1999 |
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) |
BIOPRO (M) SDN BHD |
JAMES H LALE |
| K994369 |
12/27/1999 |
7250 (MEGAS) |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K994240 |
12/16/1999 |
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K994217 |
12/15/1999 |
BLACKSTONE SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
| K994242 |
12/16/1999 |
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT |
BODYSTAT LTD. |
I. J MEEUWSEN |
| K994203 |
12/13/1999 |
ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 |
BONART CO. LTD. |
BANKSON TSAI |
| K994299 |
12/21/1999 |
ART-P3, MODEL P3-1-ART-A1 |
BONART CO. LTD. |
BANKSON TSAI |
| K994252 |
12/17/1999 |
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
ANDREA BOUMIS |
| K994155 |
12/09/1999 |
EXCELSIOR 1018 MICROCATHETER |
BOSTON SCIENTIFIC, TARGET |
ROXANNE K BAXTER |
| K994413 |
12/29/1999 |
BRAINSCAN |
BRAINLAB AG |
STEFAN VILSMEIER |
| K994290 |
12/21/1999 |
BARD ENDOSCOPIC SUTURING SYSTEM |
C.R. BARD, INC. |
BETH A ZIS |
| K994144 |
12/07/1999 |
TOOTHBRUSH WASH |
CAL HUECH, INC. |
CHERYL A LITTLE |
| K994260 |
12/17/1999 |
CANDELA GENTLELASE GL DERMATOLOGICAL LASER |
CANDELA CORP. |
JAY CAPLAN |
| K994320 |
12/22/1999 |
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES |
CANTOR & SILVER LTD. |
MARTIN DALSING |
| K994194 |
12/13/1999 |
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT |
CARDIOVASCULAR DIAGNOSTICS, INC. |
PETER SCOTT |
| K994159 |
12/09/1999 |
HMP CONTROLS (TAS) RAPIDPOINT |
CARDIOVASCULAR DIAGNOSTICS, INC. |
PETER SCOTT |
| K994160 |
12/09/1999 |
COALESCENT SURGICAL SUTURED-CLIP |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
| K994389 |
12/28/1999 |
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K994209 |
12/14/1999 |
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K994338 |
12/23/1999 |
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K994417 |
12/29/1999 |
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K994358 |
12/27/1999 |
ATW MARKER WIRE STEERABLE GUIDEWIRE |
CORDIS CORP. |
DENNIS S GRIFFIN |
| K994156 |
12/09/1999 |
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B |
CORDIS CORP. |
CHARLES J RYAN |
| K994068 |
12/02/1999 |
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
ELENA JUGO |
| K994153 |
12/08/1999 |
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS |
CORIN U.S.A. |
CRAIG CORRANCE |
| K994152 |
12/08/1999 |
THE LIGAMENT ANCHOR SOFT SCREW |
CORIN U.S.A. |
CRAIG CORRANCE |
| K994199 |
12/13/1999 |
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR |
CUSTOM MEDICAL PRODUCTS, INC. |
STEVE WOODY |
| K994427 |
12/30/1999 |
CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL |
CYNOSURE, INC. |
GEORGE CHO |
| K994437 |
12/30/1999 |
CYNOSURE PHOTOGENICA SPIR |
CYNOSURE, INC. |
GEORGE CHO |
| K994296 |
12/21/1999 |
DIMENSION C3 FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K994293 |
12/21/1999 |
DIMENSION C4 FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K994291 |
12/21/1999 |
DIMENSION SPECIAL PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K994114 |
12/06/1999 |
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR |
DADE BEHRING, INC. |
ROBIN O NORRIS |
| K994294 |
12/21/1999 |
DIMENSION TRNF FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K994341 |
12/23/1999 |
FIBRINOGEN CALIBRATOR KIT |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K994115 |
12/06/1999 |
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
ROBIN O NORRIS |
| K994334 |
12/23/1999 |
ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX |
DAIG CORP. |
TODD KORNMANN |
| K994300 |
12/21/1999 |
NASOGASTRIC TUBE HOLDER, MODEL 160 |
DALE MEDICAL PRODUCTS, INC. |
JOHN C BREZACK |
| K994122 |
12/07/1999 |
BONE GRAFT WASHER, MODEL 9090114 - 9090118 |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K994157 |
12/09/1999 |
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 |
DATASCOPE CORP. |
WHITNEY TORNING |
| K994211 |
12/14/1999 |
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 |
DENTSPLY INTL. |
WILLIAM T COUSINS |
| K994285 |
12/20/1999 |
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH |
DENTSPLY INTL. |
WILLIAM T COUSINS |
| K994415 |
12/29/1999 |
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS |
DEPUY ORTHOPAEDICS, INC. |
CHERYL HASTINGS |
| K994079 |
12/02/1999 |
REFLEX TREATMENT SYSTEM |
DESCHUTES MEDICAL PRODUCTS, INC. |
DENISE BESTWICK |
| K994356 |
12/23/1999 |
IMMUNOCYT |
DIAGNOCURE, INC. |
BRUCE F MACKLER |
| K994085 |
12/03/1999 |
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K994424 |
12/30/1999 |
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K994110 |
12/06/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN/AMERICAN STANDARD COMPANIES |
JUDITH J SMITH |
| K994197 |
12/13/1999 |
DISENTRONIC PENFINE INJECTION PEN NEEDLE |
DISETRONIC MEDICAL SYSTEMS |
LEE LEICHTER |
| K994186 |
12/10/1999 |
DISETRONIC D-TRON INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS |
LEE LEICHTER |
| K994070 |
12/02/1999 |
REVELATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K994425 |
12/30/1999 |
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K994226 |
12/15/1999 |
STERICHEK TOTAL CHLORINE REAGENT STRIPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
DAVID A MORRIS |
| K994190 |
12/13/1999 |
IMPREGUM GARANT L DUOSOFT |
ESPE DENTAL AG |
ANDRERAS PETERMANN |
| K994193 |
12/13/1999 |
IMPREGUM PENTA DUOSOFT |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K994192 |
12/13/1999 |
IMPREGUM PENTA M MONOSOFT |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K994251 |
12/17/1999 |
KETAC-MOLAR QUICK |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K994280 |
12/20/1999 |
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105 |
ETHICON ENDO-SURGERY, INC. |
RUTH ANN WOOD |
| K994418 |
12/29/1999 |
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) |
ETHICON, INC. |
GREGORY JONES |
| K994228 |
12/15/1999 |
REMOTEIMAGE SYSTEM |
ETRAUMA.COM CORP. |
DAN HODGEMAN |
| K994336 |
12/23/1999 |
BITX PROBES |
EVEREST MEDICAL CORP. |
FREDERICK G MADES |
| K994098 |
12/03/1999 |
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE |
EVERGREEN MEDICAL PRODUTS (JINGXING) CO., LTD. |
DOREEN FENG |
| K994099 |
12/03/1999 |
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED |
EVERGREEN MEDICAL PRODUTS (JINGXING) CO., LTD. |
DOREEN FENG |
| K994416 |
12/29/1999 |
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
FLEXITECH SDN. BHD. |
Y. F HEW |
| K994354 |
12/23/1999 |
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
FLEXITECH SDN. BHD. |
Y. F HEW |
| K994287 |
12/20/1999 |
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER |
FONAR CORP. |
LUCIANO BONANNI |
| K994267 |
12/17/1999 |
FRESENIUS 2008K |
FRESENIUS MEDICAL CARE |
ARTHUR EILINSFELD |
| K994376 |
12/27/1999 |
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA |
FRIADENT GMBH |
CAROL PATTERSON |
| K994174 |
12/10/1999 |
FRIALIT-2 MH-2 ABUTMENT |
FRIADENT GMBH |
CAROL PATTERSON |
| K994298 |
12/21/1999 |
FRIOS MICROSAW |
FRIADENT GMBH |
CAROL PATTERSON |
| K994266 |
12/17/1999 |
FDTENS 2010 |
FUJI DYNAMICS LIMITED |
TORU HORIUCHI |
| K994265 |
12/17/1999 |
MEDISANA DIGITAL TENS |
FUJI DYNAMICS LIMITED |
TORU HORIUCHI |
| K994390 |
12/28/1999 |
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER |
GAMBRO HEALTHCARE |
JEFFREY R SHIDEMAN |
| K994077 |
12/02/1999 |
AROMA FINE (NORMAL AND FAST SET) |
GC AMERICA, INC. |
TERRY L JORITZ |
| K994073 |
12/02/1999 |
HEMOSITE TEST SYSTEM |
GDS TECHNOLOGY, LLC. |
KEITH CRAWFORD |
| K994167 |
12/09/1999 |
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE) |
GE MEDICAL SYSTEMS F.I. HAIFA |
DAN LAOR |
| K994075 |
12/02/1999 |
GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435 |
GEIGER MEDICAL TECHNOLOGIES, INC. |
JOHN BOTTJER |
| K994430 |
12/29/1999 |
IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K994361 |
12/27/1999 |
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL |
GENESIS INDUSTRIES, INC. |
ANGELA RICHARDSON |
| K994328 |
12/22/1999 |
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX |
GENZYME CORP. |
JOHN A DELUCIA |
| K994314 |
12/22/1999 |
CASTLE SERIES 100HC STEAM STERILIZERS |
GETINGE/CASTLE, INC. |
MARK N SMITH |
| K994064 |
12/01/1999 |
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE |
GLOVE SOURCE, INC. |
EMMY TJOENG |
| K994142 |
12/08/1999 |
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM |
GRASS INSTRUMENT CO. |
STEPHEN E JOHNSON |
| K994118 |
12/06/1999 |
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS |
GUILIN LATEX FACTORY |
PETER WEI |
| K994166 |
12/09/1999 |
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K994340 |
12/23/1999 |
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ |
HAI LABORATORIES, INC. |
RICHARD C LANZILLOTTO |
| K994067 |
12/01/1999 |
HARDY DISK AMPICILLIN/SULBACTAM |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994063 |
12/01/1999 |
HARDYDISK AZTREONAM, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994129 |
12/07/1999 |
HARDYDISK CEFIXIME, 5MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994089 |
12/03/1999 |
HARDYDISK CHLORAMPHENICOL, 30MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994135 |
12/07/1999 |
HARDYDISK ERYTHROMYCIN, 15MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994091 |
12/03/1999 |
HARDYDISK GENTAMICIN, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994132 |
12/07/1999 |
HARDYDISK IMIPENEM, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994212 |
12/14/1999 |
HARDYDISK MEZLOCILLIN 75MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994150 |
12/08/1999 |
HARDYDISK NORFLOXACIN, 10MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994134 |
12/07/1999 |
HARDYDISK OXACILLIN, 1MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K994243 |
12/16/1999 |
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K994378 |
12/27/1999 |
AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS J THISTLETHWAITE |
| K994062 |
12/01/1999 |
HMS NEUROMUSCULAR STIMULATOR |
HOME MEDICAL SERVICES, INC. |
C.A. TEKLINSKI |
| K994065 |
12/01/1999 |
MS-ONE, MODEL MS-1 |
HOME WELLNESS WEST |
RICHARD M HARRIS |
| K994196 |
12/13/1999 |
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM |
HORIZON MEDICAL PRODUCTS, INC. |
JOHN TARTAL |
| K994347 |
12/23/1999 |
CENTAUR SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K994207 |
12/14/1999 |
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K994128 |
12/07/1999 |
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K994366 |
12/27/1999 |
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
| K994352 |
12/23/1999 |
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 |
HUDSON RESPIRATORY CARE, INC. |
JEANNIE DENNING |
| K994432 |
12/30/1999 |
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS) |
HWA TEH INDUSTRIAL SDN. BHD. |
K. KARUNAKARAN |
| K994374 |
12/27/1999 |
SOAKER CATHETER |
I-FLOW CORP. |
STANLEY E FRY |
| K994117 |
12/06/1999 |
MR ENHANCER |
I.Z.I. CORP. |
E. J SMITH |
| K994148 |
12/08/1999 |
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
| K994317 |
12/22/1999 |
I-PLANT, MODEL 3500 |
IMPLANT SCIENCES CORP. |
HOWARD L SCHRAYER |
| K994076 |
12/02/1999 |
IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY |
IMPLEX CORP. |
JOHN SCHALAGO |
| K994109 |
12/06/1999 |
DETRUSAN 500 |
INNOVAMED USA, INC. |
E.H. CZADILEK |
| K994269 |
12/20/1999 |
TITAN RC TACK |
INNOVASIVE DEVICES, INC. |
KATHLEEN MORAHAN |
| K994238 |
12/16/1999 |
IL TEST LIQUID ANTITHROMBIN |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K994254 |
12/17/1999 |
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER |
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI |
DONNA WARD |
| K994289 |
12/21/1999 |
SUTUREGROOVE |
IOP, INC. |
JASON MALECKA |
| K994359 |
12/27/1999 |
BOND 1 C & B |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K994435 |
12/30/1999 |
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K994348 |
12/23/1999 |
KSEA SCB-RUI |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K994090 |
12/03/1999 |
KARL STORZ AUTOCLAVABLE CAMERA HEAD |
KARL STORZ IMAGING, INC. |
TERRY FERNANDEZ |
| K994323 |
12/22/1999 |
KAWASUMI LABORATORIES PHILEBOTOMY SET |
KAWASUMI LABORATORIES CO., LTD. |
DONALD R STONE |
| K994214 |
12/14/1999 |
GEM KNEE SYSTEM |
KINAMED, INC. |
JOEL SLOMOFF |
| K994154 |
12/09/1999 |
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES |
KLS-MARTIN L.P. |
ARTHUR WARD |
| K994074 |
12/02/1999 |
TRI-BALL |
LEVENTON, S.A. |
JOAQUIM SORIANO |
| K994205 |
12/01/1999 |
MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM |
LIFECORE BIOMEDICAL, INC. |
CAROLYN ANDERSON |
| K994158 |
12/09/1999 |
MACROSORBOS PROTECTIVE SHEET |
MACROPORE BIOSURGERY, INC. |
FLOYD G LARSON |
| K994185 |
12/10/1999 |
MANUAL WHEELCHAIR |
MAJOR MOBILITY PRODUCTS, INC. |
SCOTT SCHWEISS |
| K994124 |
12/07/1999 |
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES |
MAPA PROFESSIONAL |
ALEJANDRO SANCHEZ |
| K994097 |
12/03/1999 |
MEDAMICUS EPIDURAL INTRODUCER |
MEDAMICUS, INC. |
DENNIS MANSON |
| K994232 |
12/16/1999 |
PHALANGEAL FIXATION SYSTEM |
MEDCANICA, INC. |
AL WEISENBORN |
| K994105 |
12/06/1999 |
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K994367 |
12/27/1999 |
UMBILICAL CORD CLAMP |
MEDICAL SALES CO. |
JOHN E LINCOLN |
| K994218 |
12/15/1999 |
EASY CARE AND TUBING SETS |
MEDIONICS INTERNATIONAL, INC. |
MAHESH A GARWAL |
| K994282 |
12/20/1999 |
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K994283 |
12/20/1999 |
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
| K994306 |
12/21/1999 |
REVERSO |
MEDISYSTEMS CORP. |
FREDRIC G SWINDLER |
| K994131 |
12/07/1999 |
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED) |
MEDTAXX PARTNERS |
E. J SMITH |
| K994141 |
12/08/1999 |
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 |
MEDTRONIC AVE, INC. |
SHELLY TRIMM |
| K994171 |
12/10/1999 |
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE |
MEDTRONIC CARDIAC SURGICAL PRODUCTS |
JAMES BALUN |
| K994208 |
12/14/1999 |
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 |
MEDTRONIC PERFUSION SYSTEMS |
MARIE HOLM |
| K994239 |
12/16/1999 |
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K994331 |
12/23/1999 |
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR |
MEDTRONIC VASCULAR |
NORA K HADDING |
| K994253 |
12/17/1999 |
VACLOK SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K994380 |
12/27/1999 |
CEDIA DAU AMPHASSURE ASSAY |
MICROGENICS CORP. |
NEAL BELLET |
| K994241 |
12/15/1999 |
TRX-CG POWER TILT AND RECLINE SYSTEM |
MOTION CONCEPTS |
ALLEN BOYD |
| K994066 |
12/01/1999 |
MTP DISPOSABLE TROCARS |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K994273 |
12/20/1999 |
MODEL 1000 HOLMIUM LASER SYSTEM |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K994140 |
12/08/1999 |
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 |
NICHOLS INSTITUTE DIAGNOSTICS |
JIMMY WONG |
| K994191 |
12/13/1999 |
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T |
NMT MEDICAL, INC. |
RONALD D ARKIN |
| K994308 |
12/21/1999 |
NUVASIVE TOWNLEY FACET SCREW |
NUVASIVE, INC. |
STEVE REITZLER |
| K994106 |
12/06/1999 |
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE |
OLYMPUS AMERICA, INC. |
LAURA STORMS- TYLER |
| K994103 |
12/06/1999 |
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K994069 |
12/02/1999 |
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K994189 |
12/13/1999 |
OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 |
OLYMPUS DIAGNOSTICA GMBH |
LAURA STORMS-TYLER |
| K994246 |
12/16/1999 |
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED |
OMNIGRACE LTD. |
WILLIAM E PATTON |
| K994112 |
12/06/1999 |
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) |
ONCOGENE SCIENCE, INC. |
WALTER P CARNEY |
| K994333 |
12/23/1999 |
ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
| K994343 |
12/23/1999 |
BACT/ALERT SV |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K994370 |
12/27/1999 |
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
| K994145 |
12/08/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS |
ORTHO-CLINICAL DIAGNOSTICS, INC. |
MARLENE A SHULMAN |
| K994288 |
12/20/1999 |
5.0MM SPINAL SCREWS |
ORTHOTEC, L.L.C. |
DAVID W SCHLERF |
| K994337 |
12/23/1999 |
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER |
ORTHOVITA CO. |
ANGIE IDE |
| K994255 |
12/17/1999 |
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE |
P.T. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K994100 |
12/03/1999 |
PACIFIC HEMOSTASIS THROMBOPLASTIN D |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| K994372 |
12/27/1999 |
MODEL 120 |
PALCO LABS, INC. |
RICHELLA GOO |
| K994225 |
12/15/1999 |
PALOMAR SLP 2000 |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
MARCY MOORE |
| K994302 |
12/21/1999 |
RESIN TOOTH BONDING AGENT |
PARKELL, INC. |
NELSON J GENDUSA |
| K994201 |
12/13/1999 |
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
PETER YEW NIENG CHOON |
| K994237 |
12/16/1999 |
AT HOME DRUG TEST, MODEL 9063 |
PHAMATECH |
CARL A MONGIOVI |
| K994233 |
12/16/1999 |
AT HOME DRUG TEST, MODEL 9068 |
PHAMATECH |
CARL A MONGIOVI |
| K994219 |
12/15/1999 |
AT HOME DRUG TEST, MODEL 9073 |
PHAMATECH |
CARL A MONGIOVI |
| K994220 |
12/15/1999 |
AT HOME DRUG TEST, MODEL 9078 |
PHAMATECH |
CARL A MONGIOVI |
| K994234 |
12/16/1999 |
AT HOME DRUG TEST, MODEL 9083 |
PHAMATECH |
CARL A MONGIOVI |
| K994236 |
12/16/1999 |
AT HOME DRUG TEST, MODEL 9133 |
PHAMATECH |
CARL A MONGIOVI |
| K994093 |
12/03/1999 |
AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C |
PHAMATECH |
CARL A MONGIOVI |
| K994210 |
12/14/1999 |
INTURIS SUITE |
PHILIPS MEDICAL SYSTEMS, INC. |
FRANK GIANELLI |
| K994127 |
12/07/1999 |
GLORY |
PILLAR TECHNOLOGY, INC. |
CHRIS TINSLEY |
| K994312 |
12/22/1999 |
MALE LATEX CONDOM 56MM |
PLEASURE LATEX PRODUCTS SDN. BHD. |
LIM KOI YONG |
| K994311 |
12/22/1999 |
MALE LATEX CONDOM WITH VANILLA FLAVOR |
PLEASURE LATEX PRODUCTS SDN. BHD. |
LIM KOI YONG |
| K994146 |
12/08/1999 |
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP |
PLUS ORTHOPEDICS |
DAVID W SCHLERF |
| K994126 |
12/07/1999 |
MODULAR-PLUS REVISION STEM |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K994353 |
12/23/1999 |
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 |
PRECISION DYNAMICS CORP. |
KALYNA SNYLYK |
| K994263 |
12/17/1999 |
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 |
PRECISION DYNAMICS CORP. |
KALYNA SNYLYK |
| K994224 |
12/15/1999 |
PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
| K994272 |
12/20/1999 |
AUTOMATED CORE BIOPSY DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
| K994426 |
12/30/1999 |
GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) |
PT. WRP BUANA MULTICORPORA |
NG POY SIN |
| K994182 |
12/10/1999 |
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE |
PULPDENT CORP. |
KENNETH J BERK |
| K994181 |
12/10/1999 |
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE |
PULPDENT CORP. |
KENNETH J BERK |
| K994180 |
12/10/1999 |
PULPDENT CAVITY PREPARATION III |
PULPDENT CORP. |
KENNETH J BERK |
| K994279 |
12/20/1999 |
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) |
PURE WATER SOLUTIONS, INC. |
DEAN S LEWIS |
| K994420 |
12/29/1999 |
POWDER FREE LATEX EXAMINATION PATIENT GLOVES |
PURNABINA SDN BHD |
LIEW YOON FONG |
| K994419 |
12/29/1999 |
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM |
QUALISYS DIAGNOSTICS, INC. |
VIJAY K MAHANT |
| K994274 |
12/20/1999 |
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) |
QUEST MEDICAL, INC. |
MALCOLM LEWIS |
| K994381 |
12/28/1999 |
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY |
| K994351 |
12/23/1999 |
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM |
RESONANCE TECHNOLOGY, INC. |
MOKHTAR ZIARATI |
| K994071 |
12/02/1999 |
RHIGENE ANA ELISA TEST SYSTEM |
RHIGENE, INC. |
DAVE KOLESAR |
| K994363 |
12/27/1999 |
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K994223 |
12/15/1999 |
NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K994349 |
12/23/1999 |
COAGUCHEK S SYSTEM, MODEL 2138280 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K994164 |
12/09/1999 |
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K994165 |
12/09/1999 |
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K994327 |
12/22/1999 |
EMBRYON TRANSFER CATHETERS/SETS |
ROCKET MEDICAL PLC |
LES TODD |
| K994344 |
12/22/1999 |
NEUROTHERM RF CANNULA |
ROCKET MEDICAL PLC |
LES TODD |
| K994081 |
12/03/1999 |
SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES |
SAFESKIN CORP. |
EUGENE V GOORCHENKO |
| K994379 |
12/27/1999 |
EU-TTG IGA ELISA |
SCIMEDX CORP. |
GARY LEHNUS |
| K994346 |
12/23/1999 |
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM |
SENDX MEDICAL, INC. |
MARTIN SELLERS |
| K994136 |
12/07/1999 |
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES |
SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. |
JANNA P TUCKER |
| K994222 |
12/15/1999 |
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
GUI-XI LIU |
| K994206 |
12/14/1999 |
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
GUI-XI LIU |
| K994431 |
12/30/1999 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES |
SHIMADZU MEDICAL SYSTEMS |
MICHAEL FISHBACK |
| K994258 |
12/17/1999 |
SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES |
SHINEMOUND ENTERPRISE, INC. |
HUAN-CHUNG LI |
| K994248 |
12/16/1999 |
SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES |
SHINEMOUND ENTERPRISE, INC. |
HUAN-CHUNG LI |
| K994316 |
12/22/1999 |
MAGNETOM OPEN VIVA WITH PERMANENT MAGNET |
SIEMENS MEDICAL CORP. |
JAMIE YIEH |
| K994231 |
12/16/1999 |
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) |
SIEMENS MEDICAL CORP. |
MALGORZATA STANEK |
| K994315 |
12/22/1999 |
CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K994130 |
12/07/1999 |
RECTOSIGHT RS 300-04 |
SIGHTLINE TECHNOLOGIES LTD. |
AHAVA STEIN |
| K994216 |
12/15/1999 |
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM |
SIMS DELTEC, INC. |
LISA STONE |
| K994275 |
12/20/1999 |
SIMS PORTEX ANESTHESIA CATHETER |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
| K994172 |
12/10/1999 |
CEREC 3 |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
| K994202 |
12/13/1999 |
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM |
SMITH & NEPHEW, INC. |
NICHOLAS CONDAKES |
| K994365 |
12/27/1999 |
DYONICS ELECTROBLADE |
SMITH & NEPHEW, INC. |
DEBORAH CONNORS |
| K994350 |
12/23/1999 |
NEER III TOTAL SHOULDER SYSTEM |
SMITH & NEPHEW, INC. |
NEAL DEFIBAUGH |
| K994143 |
12/08/1999 |
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K994084 |
12/03/1999 |
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K994175 |
12/10/1999 |
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE |
SODEM SYSTEMS |
DANIEL BACCINO |
| K994385 |
12/28/1999 |
BABY FACE |
SONORA MEDICAL SYSTEMS |
COLLEEN HITTLE |
| K994096 |
12/03/1999 |
SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K994438 |
12/30/1999 |
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER |
SPECTRX, INC. |
JAMES R VEALE |
| K994083 |
12/03/1999 |
STANNAH POWER CHAIR, MODEL 201 |
STANNAH POWER CHAIRS LTD. |
CHARLES EDGELL |
| K994173 |
12/10/1999 |
STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230 |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
| K994119 |
12/06/1999 |
SYNOCTA ANGLED ABUTMENTS |
STRAUMANN USA |
LINDA JALBERT |
| K994388 |
12/28/1999 |
XE CHECK |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K994436 |
12/30/1999 |
SURGI-VISION ESOPHAGEAL STYLET COIL |
SURGI-VISION, INC. |
NANCY E TAYLOR |
| K994421 |
12/29/1999 |
SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION |
SURGICAL NAVIGATION SPECIALISTS, INC. |
CAROL NAKAGAWA |
| K994355 |
12/23/1999 |
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ANGELIQUE S DESTRUEL |
| K994087 |
12/03/1999 |
SUPERSTITCH |
SUTURA, INC. |
DAVE BARRY |
| K994309 |
12/21/1999 |
SOLO ORTHO 2 |
SYBRON DENTAL SPECIALTIES, INC. |
WENDY URTEL |
| K994121 |
12/06/1999 |
SMALL STATURE USS |
SYNTHES (USA) |
JONATHAN M GILBERT |
| K994161 |
12/09/1999 |
SYNTHES BIORESORBABLE SUTURE ANCHOR |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K994364 |
12/27/1999 |
SYNTHES BUTTON PLATE |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K994187 |
12/13/1999 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K994101 |
12/06/1999 |
E. HISTOLYTICA II |
TECHLAB, INC. |
DAVID M LYERLY |
| K994250 |
12/16/1999 |
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
TEKMEDIC (M) SDN BHD |
KOK-KEE HON |
| K994329 |
12/22/1999 |
IIVS INTEGRATED IMAGE VIEWING STATION |
TERARECON, INC. |
DAVID W SCHLERF |
| K994095 |
12/03/1999 |
LATEX CONDOM |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
ELI J CARTER |
| K994339 |
12/23/1999 |
HYCURE ORAL / HYCURE ORAL SMART GEL |
THE HYMED GROUP CORP. |
ANITA M PETITO |
| K994383 |
12/28/1999 |
DOGBONE ACFS |
THEKEN SURGICAL |
LUKAS EISERMANN |
| K994382 |
12/28/1999 |
NONLINEAR TAPER LAG SCREW |
THEKEN SURGICAL |
LUKAS EISERMANN |
| K994357 |
12/27/1999 |
BITEM LOCK, MODELS SW006, SW012 |
THERMOELASTIC TECHNOLOGIES, INC. |
ART WARD |
| K994198 |
12/13/1999 |
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L |
TORAY INDUSTRIES (AMERICA), INC. |
LISA S JONES |
| K994392 |
12/28/1999 |
AEQUALIS SHOULDER FRACTURE SYSTEM |
TORNIER |
DAVID W SCHLERF |
| K994393 |
12/28/1999 |
AEQUALIS UNIVERSAL SHOULDER GLENOID |
TORNIER |
DAVID W SCHLERF |
| K994230 |
12/16/1999 |
ULTICARE DISPOSABLE SYRINGE |
ULTIMED, INC. |
CHARLES W ERICKSON |
| K994261 |
12/17/1999 |
ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT |
ULTRADENT PRODUCTS, INC. |
SCOTT E MOORE |
| K994078 |
12/02/1999 |
U1 HIP SYSTEM |
UNITED ORTHOPEDIC CORP. |
MELLEN LIU |
| K994345 |
12/23/1999 |
MAGNA 5000 PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
RONY THOMAS |
| K994428 |
12/30/1999 |
E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE |
VALLEYLAB, INC. |
ROBERT C MOORE JR |
| K994429 |
12/30/1999 |
VENUSA, LTD. EXTENSION SET WITH FILTER |
VENUSA LTD. |
ROSS MAGLADRY |
| K994176 |
12/10/1999 |
SUTRALON NYLON SUTURES |
VISIONARY MEDICAL SUPPLIES, INC. |
JONATHAN GREEN |
| K994177 |
12/10/1999 |
SUTRASILK SILK SUTURE |
VISIONARY MEDICAL SUPPLIES, INC. |
JONATHAN GREEN |
| K994324 |
12/22/1999 |
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
SHARON BRIGGS |
| K994318 |
12/22/1999 |
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
SHARON BRIGGS |
| K994270 |
12/20/1999 |
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 |
VISUALIZATION TECHNOLOGY, INC. |
NORMA LEMAY |
| K994304 |
12/21/1999 |
ARABESK FLOW |
VOCO GMBH |
EVAN DICK |
| K994268 |
12/17/1999 |
ARABESK TOP |
VOCO GMBH |
EVAN DICK |
| K994423 |
12/29/1999 |
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 |
VSM MEDTECH LTD. |
HOWARD M HOLSTEIN |
| DEN990008 |
12/20/1999 |
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 |
WALLAC, INC. |
CARROLL L MARTIN |
| K994292 |
12/21/1999 |
WATER PURIFICATION SYSTEM |
WATER & POWER TECHNOLOGIES, INC. |
BARRY PEARCE |
| K994335 |
12/23/1999 |
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS |
WESLEY JESSEN CORP. |
JOSEPH F FOOS |
| K994387 |
12/28/1999 |
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL |
WOODSIDE BIOMEDICAL, INC. |
CAROL PATTERSON |
| K994139 |
12/07/1999 |
FIRST CHECK HOME DRUG TEST PANEL 2 |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
| K994138 |
12/07/1999 |
FIRST CHECK HOME DRUG TEST PANEL 3 |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
| K994061 |
12/01/1999 |
LOCON-T DISTAL RADIAL PLATE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K994151 |
12/09/1999 |
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES |
XIMED/PROSURE/INJECTX |
LEE BUI |
| K994262 |
12/17/1999 |
FRONTAL SINUS TREPHINATION CANNULA |
XOMED, INC. |
MARTIN D SARGENT |
| K994257 |
12/16/1999 |
LOCATOR IMPLANT ANCHOR |
ZEST ANCHORS, INC. |
PAUL ZUEST |
| K994286 |
12/20/1999 |
ZMR HIP SYSTEM-POROUS REVISION |
ZIMMER, INC. |
KAREN CAIN |
