FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K991262 |
09/09/1999 |
SINGLE LUMEN NEEDLE |
INTL., INC. |
MICHAEL D CECCHI |
K991020 |
09/09/1999 |
DOUBLE LUMEN NEEDLE |
INTL., INC. |
MICHAEL D CECCHI |
K991266 |
09/09/1999 |
EMBRYO TRANSFER CATHETER CC GLIDER |
INTL., INC. |
MICHAEL D CECCHI |
K991264 |
09/09/1999 |
SINGLE LUMEN SIDEPORT NEEDLE |
INTL., INC. |
MICHAEL D CECCHI |
K991022 |
09/09/1999 |
SPERM WASHING MEDIA |
INTL., INC. |
MICHAEL D CECCHI |
K992011 |
09/10/1999 |
SYNEA-HS HIGH SPEED-HANDPIECE |
A-DEC, INC. |
PATRICK RIDENOUR |
K991762 |
09/02/1999 |
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
K991761 |
09/02/1999 |
MAGNESIUM PRODUCT NO'S, 112-01, 112-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
K992808 |
09/01/1999 |
A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE |
A&D MEDICAL DIV. |
JERRY WANG |
K991974 |
09/17/1999 |
FUTURA GLASS IONOMER SILVER REINFORCED |
AB ARDENT |
CLYDE E INGERSOLL |
K992444 |
09/24/1999 |
MODIFICATION OF: CELL-DYN 1200 SYSTEM |
ABBOTT LABORATORIES |
JANICE E BROWN |
K990241 |
09/23/1999 |
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP |
ACCUIMAGE DIAGNOSTICS CORP. |
GARY J ALLSEBROOK |
K992194 |
09/13/1999 |
CORTICAL MAPPING UNIT, MODEL CMU |
AD-TECH MEDICAL INSTRUMENT CORP. |
JOHN F ZIOBRO |
K992078 |
09/01/1999 |
VANTAGE EXSPECT II |
ADAC LABORATORIES |
GENINE M GRANT |
K990867 |
09/02/1999 |
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
SANDRA SUNDELL |
K992946 |
09/24/1999 |
RENEW RECEIVER |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
K991883 |
09/15/1999 |
REDI-TEST OPIATES |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
K983717 |
09/16/1999 |
BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
GEORGE MYERS |
K984573 |
09/16/1999 |
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP |
ALCON LABORATORIES |
RALPH H LARSEN |
K992171 |
09/14/1999 |
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
K992951 |
09/22/1999 |
CONVERTORS SURGICAL GOWNS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
K992350 |
09/22/1999 |
PYLON INTRAMEDULLAARY NAIL SYSTEM |
ALPHATEC MFG., INC. |
JASON BLAIN |
K992594 |
09/24/1999 |
A-15 HEMODIALYZER |
ALTHIN MEDICAL AB |
LARS-OLOF SANDBERG |
K992565 |
09/23/1999 |
A-18 HEMODIALYZER |
ALTHIN MEDICAL AB |
LARS-OLOF SANDBERG |
K990253 |
09/24/1999 |
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 |
AMBA MEDICAL LTD. |
MIKE CAUDWELL |
K990873 |
09/01/1999 |
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE |
AMERITEK, INC. |
K.C. YEE |
K992370 |
09/20/1999 |
AMPLAID A724 AND A728 |
AMPLIFON S.P.A. |
DANIEL KAMM |
K991540 |
09/29/1999 |
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
K992137 |
09/03/1999 |
UROLOGICAL CATHETER |
APOGEE, INC. |
BRENT D ROBLING |
K984101 |
09/03/1999 |
FLEXIBLADE |
ARCO MEDIC LTD. |
SHOSHANA FRIEDMAN |
K984210 |
09/24/1999 |
SILVERLON WOUND PACKING STRIPS |
ARGENTUM INTERNATIONAL LLC. |
A. BART FLICK |
K992972 |
09/24/1999 |
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000 |
ARTHROCARE CORP. |
BETTY M JOHNSON |
K992124 |
09/20/1999 |
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI |
AVANTI POLAR LIPIDS, INC. |
ROWENA SHAW |
K992405 |
09/22/1999 |
AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
K992399 |
09/15/1999 |
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
GABRIEL J MURACAA JR |
K992849 |
09/23/1999 |
QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
MONICA E GIGUERE |
K991551 |
09/23/1999 |
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
JAMES W HAYNES |
K992788 |
09/16/1999 |
BEAR CUB 750 PSV |
BEAR MEDICAL SYSTEMS, INC. |
DARRYL SHELBY |
K992170 |
09/07/1999 |
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE |
BEST MANUFACTURING COMPANY |
DAVID C YOUNG |
K992807 |
09/14/1999 |
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
K992091 |
09/09/1999 |
PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 |
BIO-PLEXUS, INC. |
PAUL A TENTHOREY |
K992172 |
09/02/1999 |
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 |
BIO-RAD |
ELIZABETH PLATT |
K992517 |
09/24/1999 |
BIOCHECK FERRITIN ELISA MODEL BC-1025 |
BIOCHECK, INC. |
ROBIN HELLEN |
K992528 |
09/21/1999 |
BIOCHECK IGE ELISA, MODEL BC-1035 |
BIOCHECK, INC. |
ROBIN J HELLEN |
K991994 |
09/10/1999 |
TWILIGHT |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
K992144 |
09/22/1999 |
BIOPRO RIMMED ACETABULAR COMPOMENT |
BIOLOGICALLY ORIENTED PROSTHESES |
ANGENA PAREKH |
K992301 |
09/01/1999 |
REUNITE SCREWS |
BIOMET MANUFACTURING, INC. |
MICHELLE L MCKINLEY |
K992119 |
09/13/1999 |
BIO-MODULAR SHOULDER SYSTEM |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
K992903 |
09/17/1999 |
COLOR BUFFED CEMENTED FEMORAL |
BIOMET, INC. |
DALENE HUFZIGER BINKLEY |
K991990 |
09/10/1999 |
TRI-POLAR SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
K992947 |
09/21/1999 |
CANNULATED SMARTSCREW MODELS 224540C, 224570C |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
K992358 |
09/10/1999 |
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE) |
BIOPRO (M) SDN BHD |
JIM LALE |
K992968 |
09/29/1999 |
CARTO EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
SANDRA WILLIAMSON |
K990494 |
09/03/1999 |
MODIFICATION OF NOGA |
BIOSENSE, INC. |
MARCIA LEATHAM |
K983410 |
09/17/1999 |
@ TARGET |
BRAINLAB, AG |
|
K991667 |
09/27/1999 |
BROADLINE OR TOWELS |
BROADLINE MEDICAL INDUSTRIES |
ANNA M RAMZA |
K991375 |
09/10/1999 |
BARD BALLOON INFLATION SYSTEM |
C.R. BARD, INC. |
MARION GORDON |
K990641 |
09/17/1999 |
CALTAG FETAL HEMOGLOBIN TEST |
CALTAG LABORATORIES, INC. |
DAVID C BISHOP |
K992259 |
09/08/1999 |
ECHOCARDIOGRAPHY SYSTEM SERIES 95000 |
CAMTRONICS, LTD. |
ROBERT KRIEDERMANN |
K992475 |
09/15/1999 |
CARESIDE CO2, TOTAL |
CARESIDE, INC. |
KENNETH B ASARCH |
K992773 |
09/01/1999 |
CERALAS D10 810NM DIODE LASER |
CERAMOPTEC, INC. |
CAROL J MORELLO |
K991834 |
09/09/1999 |
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 |
CHOLESTECH CORP. |
THOMAS E WORTHY |
K992472 |
09/08/1999 |
SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM |
CLINICON CORP. |
GERALD S PALECKI |
K991923 |
09/02/1999 |
SOOTHE-N-SEAL CANKER SORE RELIEF |
CLOSURE MEDICAL CORP. |
W. THOMAS STEPHENS |
K991986 |
09/09/1999 |
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
K992440 |
09/21/1999 |
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
K992743 |
09/13/1999 |
COLLINS CPL |
COLLINS MEDICAL, INC. |
DALE F HUBBARD |
K981047 |
09/16/1999 |
FRESH AIR |
COLORADO MEDTECH, INC. |
LOCKETT E WOOD |
K990462 |
09/03/1999 |
IS H. PYLORI IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
K991274 |
09/03/1999 |
MUMPS IGG ELISA TEST SYSTEM |
COLUMBIA BIOSCIENCE, INC. |
NORMAN JENKINS |
K992576 |
09/03/1999 |
URINE CHEMISTRY CONTROL, LEVEL 1 |
CONSOLIDATED TECHNOLOGIES, INC. |
RUSTY SEWELL |
K992578 |
09/03/1999 |
URINE CHEMISTRY CONTROL, LEVEL 2 |
CONSOLIDATED TECHNOLOGIES, INC. |
RUSTY SEWELL |
K992013 |
09/08/1999 |
DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER |
CONTINUUM BIOMEDICAL, INC. |
LAURIE A RIDENER |
K991529 |
09/14/1999 |
CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 |
CONWAY STUART MEDICAL, INC. |
DAVID A TUCKER |
K992159 |
09/23/1999 |
SURGISIS SLING |
COOK BIOTECH, INC. |
NEAL E FEARNOT |
K992825 |
09/15/1999 |
CORDIS EXTREME PTA BALLOON CATHETER |
CORDIS CORP. |
KAREN WILK |
K991646 |
09/23/1999 |
AGILITY STEERABLE GUIDEWIRE |
CORDIS NEUROVASCULAR, INC. |
MARITZA CELAYA |
K992755 |
09/15/1999 |
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE |
CORDIS, A JOHNSON & JOHNSON CO. |
CHARLES J RYAN |
K992250 |
09/24/1999 |
CORE AUDIBLE TROCAR II |
CORE DYNAMICS, INC. |
THOMAS M MCINTOSH |
K992190 |
09/01/1999 |
CORE POUCH |
CORE DYNAMICS, INC. |
THOMAS M MCINTOSH |
K972708 |
09/13/1999 |
ENDO-SPOR PLUS / HYPROCIDE |
COTTRELL, LTD. |
JACK SCOVILLE |
K992814 |
09/15/1999 |
CYNOSURE ACCOLADE LASER |
CYNOSURE, INC. |
GEORGE CHO |
K992765 |
09/08/1999 |
CYNOSURE DIODERM |
CYNOSURE, INC. |
GEORGE CHO |
K992423 |
09/21/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
K992763 |
09/21/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
K992321 |
09/17/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
DADE BEHRING, INC. |
RANDAMES RIESGO |
K992128 |
09/14/1999 |
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS |
DASH MEDICAL GLOVES SDN BHD |
ROBERT J SULLIVAN JR |
K990378 |
09/20/1999 |
STATVIEW SYSTEM |
DATA CRITICAL CORP. |
DREW WEAVER |
K991799 |
09/13/1999 |
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO |
DAVOL, INC., SUB. C.R. BARD, INC. |
LUCINDA L FOX |
K991996 |
09/08/1999 |
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR |
DENPLUS, INC. |
SHUOJIA DONG |
K992896 |
09/03/1999 |
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) |
DENTAL X-RAY SUPPORT SYSTEMS, INC. |
JUM JACOBSON |
K984201 |
09/29/1999 |
DENZIR |
DENTRONIC AB |
ANDERS SUNDH |
K992610 |
09/07/1999 |
GENDEX 765DC, MODEL 110-0154 |
DENTSPLY INTL. |
DANIEL P MURPHY |
K992518 |
09/22/1999 |
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K992168 |
09/23/1999 |
MOSS MIAMI 6.35MM POLYAXIAL SCREW |
DEPUY ACROMED |
FRANK MAAS |
K990148 |
09/03/1999 |
STACKABLE CAGE SYSTEM |
DEPUY MOTECH ACROMED |
WILLIAM CHRISTIANSON |
K992302 |
09/14/1999 |
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS |
DERMAPHYLYX, INC. |
ANDREW M REED |
K990212 |
09/14/1999 |
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
K991090 |
09/24/1999 |
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3) |
DYNAMIC SYSTEMS, INC. |
DAVID R COURT |
K990642 |
09/16/1999 |
ECHOFLOW DOPPLER BLOOD VELOCITY METER |
ECHOCATH, INC. |
GEPRGE MYERS |
K992367 |
09/23/1999 |
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS |
ELECTRO-BIOLOGY, INC. |
JONAS WILF |
K992882 |
09/24/1999 |
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT |
ELEKTA INSTRUMENT AB |
CAROL PATTERSON |
K991991 |
09/10/1999 |
DUPEL IONTOPHORESIS SYSTEM |
EMPI |
KRISTY K MOLLNER |
K992535 |
09/01/1999 |
ENDIUS SUCTION/IRRIGATION INSTRUMENT |
ENDIUS, INC. |
SUSAN FINNERAN |
K992895 |
09/08/1999 |
IMPREGUM F |
ESPE DENTAL AG |
ANDREAS PETERMANN |
K992897 |
09/08/1999 |
IMPREGUM PENTA |
ESPE DENTAL AG |
ANDREAS PETERMANN |
K992645 |
09/22/1999 |
SINFONY |
ESPE DENTAL AG |
ANDREAS PETERMANN |
K990362 |
09/17/1999 |
INSTRUMENT, ULTRASONIC, SCALPEL |
ETHICON ENDO-SURGERY, INC. |
RUTH ANN WOOD |
K992038 |
09/09/1999 |
POCKETSPACER |
FERRARIS MEDICAL, INC. |
JONATHAN S KAHAN |
K992307 |
09/13/1999 |
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER |
FERTILITY TECHNOLOGY RESOURCES, INC. |
|
K992437 |
09/14/1999 |
SCHOELLY RIGID ENDOSCOPES |
FIBER IMAGING TECHNOLOGIES, INC. |
JOSEPH RESS |
K992588 |
09/10/1999 |
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE |
FORMOSA GLOVE INDUSTRIAL CO., LTD. |
TIANG S CHANG |
K982926 |
09/03/1999 |
FRESENIUS BLOOD VOLUME MONITOR |
FRESENIUS MEDICAL CARE NORTH AMERICA |
DONALD A LINCOLN |
K992135 |
09/08/1999 |
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K993069 |
09/22/1999 |
GE DIASONICS GATEWAY AND GATEWAY FX |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
K991905 |
09/01/1999 |
COROMETRICS MODEL 171 AND 172 FETAL MONITOR |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
RICHARD CEHOVSKY |
K992088 |
09/03/1999 |
BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
MARY E GRAY |
K992094 |
09/17/1999 |
GILTECH PLUS HYDROGEL SKIN DRESSING |
GILTECH PLUS, INC. |
WILLIAM J GILIAM |
K992005 |
09/03/1999 |
GILTECH PLUS TRANSPARENT DRESSING |
GILTECH PLUS, INC. |
WILLIAM J GILIAM |
K982910 |
09/14/1999 |
HAMILTON MEDICAL GALILEOVENTILATOR |
HAMILTON MEDICAL, INC. |
J. DAVID THOMPSON |
K992839 |
09/16/1999 |
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR S MAESER |
K992199 |
09/21/1999 |
ACID HEMOGLOBIN KIT |
HELENA LABORATORIES |
PAT FRANKS |
K992196 |
09/10/1999 |
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) |
HEMOCLEANSE, INC. |
STEPHEN R ASH |
K992677 |
09/03/1999 |
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W |
HOLOGIC, INC. |
Nandini Murthy |
K992988 |
09/24/1999 |
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
K992063 |
09/03/1999 |
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
K992570 |
09/01/1999 |
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K992810 |
09/27/1999 |
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE |
HWA TEH INDUSTRIAL SDN. BHD. |
K. KARUNAKARAN |
K992730 |
09/14/1999 |
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE |
HWA TEH INDUSTRIAL SDN. BHD. |
K. KARUNAKARAN |
K983276 |
09/14/1999 |
HYDROFERA BACTERISTATIC NASAL DRESSING |
HYDROFERA, LLC. |
HEATHER S BOND |
K992072 |
09/15/1999 |
BOLUS ACCESSORY SET |
I-FLOW CORP. |
ROBERT J BARD |
K992246 |
09/03/1999 |
QCT BONE MINERAL ANALYSIS SOFTWARE |
IMAGE ANALYSIS, INC. |
BEN ARNOLD |
K991063 |
09/21/1999 |
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 |
IMMUNETICS, INC. |
ANDREW E LEVIN |
K991062 |
09/21/1999 |
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 |
IMMUNETICS, INC. |
ANDREW E LEVIN |
K991998 |
09/17/1999 |
GAMMA-B 25-HYDROXY VITAMIN D RIA |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
PAUL PUNTIN |
K991947 |
09/29/1999 |
3I CERAMIC ABUTMENT SYSTEM |
IMPLANT INNOVATIONS, INC. |
WILLIAM G CONETY |
K992687 |
09/24/1999 |
MILLENIUM MICROKERATOME, MODEL IMD-001 |
INDUSTRIAL & MEDICAL DESIGN, INC. |
YEVGENIY KUKLIN |
K992044 |
09/08/1999 |
INFUSION DYNAMICS POWER INFUSER MODEL M100B |
INFUSION DYNAMICS, INC. |
THOMAS BECZE |
K992345 |
09/10/1999 |
CHRISTOUDIAS SLIM TIP ELECTRODE INSERT |
INNERVISION, INC. |
FRANK M LEWIS |
K992385 |
09/28/1999 |
ORTHOPANTOMOGRAPH OP100D |
INSTRUMENTARIUM CORP. |
TOMMI JOKINIEMI |
K992670 |
09/17/1999 |
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 |
INSTRUMENTATION INDUSTRIES, INC. |
TRICIA WOOD |
K992352 |
09/29/1999 |
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 |
INTELERADIOLOGY, INC. |
MICHAEL VINCENT KLEIN |
K992963 |
09/21/1999 |
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 |
INTERNATIONAL ISOTOPES, INC. |
REBECCA ELLIS |
K992622 |
09/29/1999 |
INTRAMAX ITI GUIDE CATHETER |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
K990592 |
09/01/1999 |
INTRASTENT II |
INTRATHERAPEUTICS, INC. |
CATHY YOHNK |
K991419 |
09/14/1999 |
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI |
IRVINE SCIENTIFIC SALES CO., INC. |
ROBERTA L JOHNSON |
K992545 |
09/01/1999 |
TM-300 TRACTION SYSTEM |
ITO CO., LTD. |
T. WHIT ATHEY |
K991901 |
09/07/1999 |
BIO-97 |
JENERIC/PENTRON, INC. |
MURRAY G GAMBERG |
K992630 |
09/10/1999 |
THERMALIGHT 2000 |
JENNIFERMAXX, INC. |
NORMAN ESTRIN |
K992559 |
09/20/1999 |
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 |
JOSTRA BENTLEY |
KATHY JOHNSON |
K992312 |
09/13/1999 |
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K992311 |
09/13/1999 |
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K992027 |
09/09/1999 |
KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
K992609 |
09/22/1999 |
HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 |
KAY SEE DENTAL MFG. CO. |
CLARK SMITH |
K992540 |
09/14/1999 |
XENON LIGHT SOURCE PES 1 |
LASER OPTIK SYSTEME GMBH & CO. KG |
R. HAPPERSBERGER |
K992671 |
09/24/1999 |
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES |
LATEXX PARTNERS BHD. |
CHONG ENG |
K992938 |
09/23/1999 |
ROTORBLADE SUTURE ANCHOR |
LI MEDICAL TECHNOLOGIES, INC. |
RHODEMANN LI |
K984391 |
09/03/1999 |
THE LIBERATOR |
LIBERATOR WHEELCHAIRS, INC. |
BONNIE BROMLEY |
K992308 |
09/13/1999 |
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 |
LIFETEK MEDICAL, INC. |
ELAINE DUNCAN |
K990194 |
09/17/1999 |
BIOBUTTON |
LINVATEC CORP. |
CAROL A WEIDEMAN |
K992280 |
09/03/1999 |
LORAD 1-650 (INTERNATIONAL 650) |
LORAD CORP. |
KELVIN BURROUGHS |
K991754 |
09/08/1999 |
GO GLUCOSE MONITORING SYSTEM |
LXN CORP. |
NEDA RASHTI |
K991927 |
09/17/1999 |
MEDI-TEST COMBI 11 |
MACHEREY-NAGEL-DUREN |
EDUARDO MARCH |
K990810 |
09/17/1999 |
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING |
MAERSK MEDICAL, LTD. |
EVAN DICK |
K992892 |
09/16/1999 |
STEPPING KINEMATIC IMAGING PLATFORM (SKIP) |
MAGNETIC MOMENTS, LLC. |
SUSAN D GOLDSTEIN-FALK |
K991577 |
09/22/1999 |
NIC TONE ACRYLIC RESINS |
MANUFACTURERA DENTAL CONTINENTAL |
GARY MOCNIK |
K992661 |
09/14/1999 |
CONTROL III ELITE |
MARIL PRODUCTS, INC. |
ANNE R WHITEHAIR |
K992705 |
09/22/1999 |
CERADIUM NON-PRECIOUS CERAMIC ALLOY |
MATECH, INC. |
PAUL L SAXTON |
K992106 |
09/17/1999 |
MODUS SYSTEM SELF-DRILLING SCREWS |
MEDARTIS AG |
LINDA JALBERT |
K992305 |
09/08/1999 |
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 |
MEDI-STIM A/S |
JON H HOEM |
K992474 |
09/23/1999 |
ARTHROSCOPE / MEDIFIX INC. |
MEDIFIX, INC. |
GEORGE ALBUSECU |
K992480 |
09/23/1999 |
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES |
MEDIFIX, INC. |
GEORGE ALBULESCU |
K992761 |
09/01/1999 |
SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
MOON T KWON |
K991979 |
09/03/1999 |
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 |
MEDTRONIC MINIMED |
DON SELVEY |
K992910 |
09/15/1999 |
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) |
MEDTRONIC VASCULAR |
DEBRA KRIDNER |
K991066 |
09/14/1999 |
MADTRONIC DLP ARTERIAL CANNULAE |
MEDTRONIC VASCULAR |
JAMES BALUN |
K992237 |
09/09/1999 |
MEDTRONIC GT2 FUSION GUIDE WIRES |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
K990931 |
09/24/1999 |
EZ-HBT HELICOBACTER BLOOD TEST |
METABOLIC SOLUTIONS, INC. |
DAVID A WAGNER |
K991532 |
09/17/1999 |
DRX QT. HCG |
METRIKA, INC. |
YA-CHEN HSU |
K974387 |
09/01/1999 |
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE |
MICROWAVE MEDICAL SYSTEMS, INC. |
RICHARD S GRABOWY |
K991045 |
09/21/1999 |
MINI-LOGGER SERIES 2000 |
MINI-MITTER CO., INC. |
JACK E MCKENZIE |
K992640 |
09/08/1999 |
SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS |
MINUMYS SURGICAL, INC. |
NOEL MESSENGER |
K992487 |
09/21/1999 |
MITEK MINI QUICKANCHOR PLUS |
MITEK PRODUCTS |
CHRISTINE KUNTZ-NASSIF |
K992611 |
09/22/1999 |
MITEK ROTATOR CUFF QUICKANCHOR PLUS |
MITEK PRODUCTS |
CHRISTINE KUNTZ-NASSIF |
K992876 |
09/24/1999 |
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM |
MITEK PRODUCTS |
PAULA E BULGER |
K990816 |
09/24/1999 |
AVCORE SYSTEM |
MODULAR CUTTING SYSTEMS, INC. |
ALLEN P SCHLEIN |
K992893 |
09/08/1999 |
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE |
MRLB INTL., INC. |
B.J. HAMMARBACK |
K992868 |
09/07/1999 |
DENTAPURE DP40 CARTRIDGE |
MRLB INTL., INC. |
B.J. HAMMARBACK |
K992694 |
09/10/1999 |
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I |
MYOTRONICS-NOROMED, INC. |
FRAY ADIB |
K972833 |
09/23/1999 |
E100M VENTILATOR (E100M) |
NEWPORT MEDICAL INSTRUMENTS, INC. |
KARON MORELL |
K990900 |
09/24/1999 |
MICROKERATOME, MODEL MK-2000 |
NIDEK, INC. |
JERRY TSUTSUMI |
K991899 |
09/01/1999 |
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
K990660 |
09/23/1999 |
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX |
NMT NEUROSCIENCES IMPLANTS S.A. |
BARBARA RAMSEYER |
K991966 |
09/03/1999 |
THE NOMOS CHANE II |
NOMOS CORP. |
WILLIAM O CHISHKO |
K992161 |
09/22/1999 |
CERANA |
NORDISKA DENTAL AB |
CHRISTINE EMANUEL |
K992023 |
09/03/1999 |
GRAND CERAM |
NORITAKE CO., INC. |
MARSHA C WERTZBERGER |
K992381 |
09/17/1999 |
CO2 GAS WARMER II, MODEL 6-800-00 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
K992015 |
09/10/1999 |
FREEDOM INFUSION SYSTEM |
NOVACON CORP. |
DAVID P LANG |
K992572 |
09/24/1999 |
NTERO RF SLEEVE |
NTERO SURGICAL, INC. |
D. BOMMI BOMMANNAN |
K984358 |
09/17/1999 |
OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
K992141 |
09/29/1999 |
OLYMPUS WORKING ELEMENT FOR PROBES |
OLYMPUS WINTER & IBE GMBH |
LAURA STORMS-TYLER |
K991218 |
09/13/1999 |
ORATEC BIPOLAR ABLATION PROBES |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
K991319 |
09/21/1999 |
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS |
ORFIT INDUSTRIES |
CYNTHIA NOLTE |
K992432 |
09/24/1999 |
BACT/ALERT FN |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
K992401 |
09/03/1999 |
BACT/ALERT PF |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
K992400 |
09/03/1999 |
BACTALERT FA |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
K983762 |
09/15/1999 |
NUCLISENS CMV PP67 |
ORGANON TEKNIKA CORP. |
RON SANYAL |
K991800 |
09/24/1999 |
HEMOCHEK URINE COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
K991388 |
09/13/1999 |
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M |
PACIFIC ANDROLOGY, INC. |
GREG HOLLAND |
K991381 |
09/24/1999 |
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA |
PACIFIC ANDROLOGY, INC. |
GREG HOLLAND |
K992130 |
09/03/1999 |
PACIFIC HEMOSTASIS THROMBOSCREEN 400C |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
K992364 |
09/22/1999 |
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
K991969 |
09/09/1999 |
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS) |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
K992117 |
09/27/1999 |
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
K992420 |
09/27/1999 |
MODIFICATION OF PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K992143 |
09/16/1999 |
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN) |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K992108 |
09/03/1999 |
PASCO MIC AND MIC/ID PANELS (CEFEPIME) |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K992077 |
09/03/1999 |
PASCO MIC AND MIC/ID PANELS (OFLOXACIN) |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K992297 |
09/03/1999 |
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K992296 |
09/21/1999 |
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K991963 |
09/01/1999 |
PATTON SPECULUM |
PATTON MEDICAL CORP. |
MICHAEL T PATTON |
K990960 |
09/23/1999 |
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) |
PERIMED, INC. |
JAMES HOWARD |
K991209 |
09/22/1999 |
ORAL SLEEP DISORDER AID |
PERL-RAD SLEEP DISORDER LAB |
ARTHUR PERLIS |
K991620 |
09/24/1999 |
VISINE FOR CONTACTS |
PFIZER, INC. |
JOHN TOMASZEWSKI |
K992129 |
09/17/1999 |
PHAZX VLD-100 |
PHAZX SYSTEMS, INC. |
LEWIS W WARD |
K990335 |
09/09/1999 |
PHILIPS EASYVISION WORKSTATION: |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
K992225 |
09/07/1999 |
QUANTITATIVE FLOW |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
K992577 |
09/23/1999 |
PHOTON RADIOSURGERY SYSTEM (PRS) |
PHOTOELECTRON CORPORATION |
PAUL A PELLETIER |
K991910 |
09/03/1999 |
LIFEPAK 12 BIPHASIC |
PHYSIO-CONTROL CORP. |
MICHAEL D WILLINGHAM |
K990338 |
09/01/1999 |
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM |
PHYSIO-CONTROL CORP. |
BOB ZITO |
K993188 |
09/28/1999 |
ENDOSTEPPER 1 |
PHYTRON- ELEKTRONIK GMBH |
CORNELIUS RIESS |
K992153 |
09/23/1999 |
PE-PLUS ACETABULAR CUP |
PLUS ORTHOPEDICS |
HATMUT LOCH |
K992864 |
09/09/1999 |
RENDER-PLAN 3-D |
PRECISION THERAPY INTL., INC. |
PAUL SUMMER |
K992374 |
09/22/1999 |
AURORA HL |
PREMIER LASER SYSTEMS, INC. |
BETH A ROBERTS |
K992818 |
09/01/1999 |
OPTIMAX/ COMPACT 2 |
PROTEC GMBH & CO. KG |
|
K991633 |
09/24/1999 |
QUICKVUE INFLUENZA A/B TEST |
QUIDEL CORP. |
MARY DE ARMOND |
K992721 |
09/10/1999 |
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE |
RADIONICS, INC. |
KEVIN J O'CONNELL |
K991399 |
09/21/1999 |
RADIONICS MICROELECTRODE KIT |
RADIONICS, INC. |
KEVIN J O'CONNELL |
K992379 |
09/08/1999 |
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER |
RADIONICS, INC. |
KEVIN J O'CONNELL |
K992526 |
09/24/1999 |
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K992693 |
09/10/1999 |
RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 |
RITA MEDICAL SYSTEMS |
ERIN DIGNAN |
K992558 |
09/27/1999 |
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE |
RIVERSTONE RESOURCES SDN. BHD. |
C.M. CHONG |
K992772 |
09/17/1999 |
CARDIOPHONICS 1000 MEMORY MONITOR |
RLT MEDICAL ASSOC., INC. |
RICHARD L TRADER |
K992981 |
09/24/1999 |
ELECSYS ESTRADIOL CALSET II |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
K992680 |
09/28/1999 |
ELECSYS PARATHYROID HORMONE TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
K990992 |
09/30/1999 |
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
K984415 |
09/29/1999 |
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F |
S.S. WHITE TECHNOLOGIES, INC. |
DAVE TAYLOR |
K992210 |
09/10/1999 |
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES |
SAFESKIN CORP. |
EUGENE V GOORCHENKO |
K991378 |
09/24/1999 |
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED |
SAGE BIOPHARMA |
GREG HOLLAND |
K991112 |
09/02/1999 |
SAGE CONTRAST MANAGEMENT SYSTEM |
SAGE LABORATORIES, INC. |
DAVID CHEN |
K992986 |
09/24/1999 |
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER |
SALTER LABS |
DUANE KAZAL |
K992306 |
09/22/1999 |
SAMSUNG RAYPAX DISPLAY WORKSTATION |
SAMSUNG SDS CO., LTD |
CARL ALLETTO |
K992112 |
09/09/1999 |
SAMSUNG RAYPAX FILM DIGITIZER |
SAMSUNG SDS CO., LTD |
CARL ALLETTO |
K992131 |
09/13/1999 |
SAMSUNG RAYPAX LONG TERM ARCHIVE |
SAMSUNG SDS CO., LTD |
CARL ALLETTO |
K991125 |
09/14/1999 |
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES |
SAUFLON PHARMACEUTICALS, LTD. |
JOHN M SZABOCSIK |
K991480 |
09/17/1999 |
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP |
SELFCARE, INC. |
Carol Adiletto |
K992686 |
09/24/1999 |
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR |
SHEEN MORE ENT. CO., LTD. |
KEN HUANG |
K992419 |
09/13/1999 |
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E.J. Smith |
K992418 |
09/13/1999 |
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E.J. Smith |
K992417 |
09/13/1999 |
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E.J. Smith |
K992464 |
09/14/1999 |
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG DILLY PLASTICS PRODUCTS CO., LTD. |
XINGLAI ZHOU |
K992860 |
09/24/1999 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
GUI-XI LIU |
K980024 |
09/03/1999 |
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER |
SHINING WORLD HEALTH CARE CO., LTD. |
CAROLANN KOTULA |
K992073 |
09/09/1999 |
AX WORKSTATION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ROBERT W CALLAHAN |
K991922 |
09/01/1999 |
DIGITAL IMAGING SYSTEM (BSR) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ROBERT W CALLAHAN |
K973971 |
09/13/1999 |
KION ANESTHESIA SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DAVID SIMARD |
K992801 |
09/28/1999 |
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K992800 |
09/28/1999 |
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K992803 |
09/13/1999 |
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K992798 |
09/28/1999 |
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
K992057 |
09/13/1999 |
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
K992090 |
09/08/1999 |
MILLENNIUM GOLD |
SKYTRON, DIV. THE KMW GROUP, INC. |
KARI OGREEN |
K991948 |
09/02/1999 |
DR. B'S MOUTHPIECE, MODEL 32129-10002 |
SNORE - EZZER |
ROBERT A GALL |
K992110 |
09/14/1999 |
PREMIER ANTERIOR CERVICAL PLATE SYSTEM |
SOFAMOR DANEK USA |
RICHARD W TREHARNE |
K992928 |
09/21/1999 |
CD HORIZON SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
BAILEY LIPSCOMB |
K991036 |
09/14/1999 |
DANEK PLATE AND SCREW SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD TREHARNE |
K992026 |
09/23/1999 |
SORING GMBH, SONOCA 300 |
SORING GMBH MEDIZINTECHNIK |
CARL ALLETTO |
K992728 |
09/29/1999 |
SPRING POWERLITE 2000 |
SPRING HEALTH PRODUCTS, INC. |
NATHANIEL H LIEB |
K990979 |
09/03/1999 |
STECO-TITANMAGNETICS |
STECO-SYSTEM-TECHNIK GMBH & COKG |
JORN PROBST |
K992270 |
09/23/1999 |
MIRACLEBREATH TONGUE CLEANER |
STELLAR LABS, INC. |
HARLAN POMEROY III |
K991946 |
09/03/1999 |
ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L |
STERILEX CORP. |
SHIRA KRAMER |
K991160 |
09/02/1999 |
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE |
STIHLER ELECTRONIC GMBH |
RICHARD C LANZILLOTTO |
K991159 |
09/03/1999 |
PRISMATHERM II, ASTOLINE |
STIHLER ELECTRONIC GMBH |
RICHARD C LANZILLOTTO |
K991398 |
09/22/1999 |
BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT |
STRYKER LEIBINGER |
KRISTYN R KELLEY |
K992193 |
09/03/1999 |
ENDO-ESOPHAGEAL MR COIL |
SURGI-VISION, INC. |
NANCY TAYLOR |
K992348 |
09/23/1999 |
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K992748 |
09/02/1999 |
DRUGCHECK X MULTIDRUG SCREENING DEVICE |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
K992990 |
09/20/1999 |
QUICKPAC II ONE STEP COCAINE TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
K992557 |
09/14/1999 |
QUALATEX POWDERED LATEX EXAMINATION GLOVES |
TAN SIN LIAN INDUSTRIES SDN. BHD. |
TAN TIOW GIN |
K972267 |
09/14/1999 |
HELICA TC |
TENERCO, INC. |
JOHN B WEBB |
K991973 |
09/03/1999 |
CAPIOX SX10 HARDSHELL RESEVOIR |
TERUMO MEDICAL CORP. |
GARRY A COURTNEY |
K992802 |
09/09/1999 |
TERUMO U-100 INSULIN SYRINGE |
TERUMO MEDICAL CORP. |
KRISTINE WAGNER |
K992488 |
09/17/1999 |
TOTAL HAEMOLYTIC COMPLEMENT RID KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K990500 |
09/28/1999 |
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C |
THE KENDAL CO. |
PAUL W EVANS |
K992079 |
09/29/1999 |
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 |
THE KENDALL COMPANY, L.P. |
PAUL W EVANS |
K992268 |
09/15/1999 |
NAC PRN NEEDLELESS ACCESS CONNECTOR |
THE KIPP GROUP |
TIM L TRUITT |
K992659 |
09/03/1999 |
O2N DEMAND-II, VICTOR MODEL OCPR-II |
THERMADYNE HOLINGS CORP. |
DICK LANGFORD |
K992917 |
09/14/1999 |
AEROCHAMBER PLUS VALVED HOLDING CHAMBER |
TRUDELL MEDICAL INT'L |
DARRYL FISCHER |
K983196 |
09/15/1999 |
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) |
TZ MEDICAL, INC. |
BYRON ZAHLER |
K983232 |
09/15/1999 |
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT |
TZ MEDICAL, INC. |
BYRON G ZAHLER |
K992175 |
09/24/1999 |
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED |
ULTRAWIN SDN BHD |
MELANIE LIM |
K983097 |
09/17/1999 |
TENS/FES/NMES ELECTRODES |
UNI-PATCH, INC. |
MANAGER J GEOLAT |
K992753 |
09/03/1999 |
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM |
VARIAN ASSOC., INC. |
LINDA S NASH |
K990412 |
09/01/1999 |
CUFF-ABLE PLUS |
VITAL SIGNS, INC. |
ANTHONY P MARTINO |
K992378 |
09/29/1999 |
DIAGNOSTIC ULTRASOUND, MODEL 1.0 |
VOLUMETRICS MEDICAL IMAGING, INC. |
JIM MUNDELL |
K991683 |
09/08/1999 |
PTFE RINGED GORE-TEX VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
TIMOTHY J RYNN |
K992736 |
09/29/1999 |
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM |
WALLACH SURGICAL DEVICES, INC. |
MICHAEL MALIS |
K992873 |
09/17/1999 |
LORENZ EXTERNAL MANDIBULAR DISTRACTOR |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
K992050 |
09/14/1999 |
LUMENON XENON LIGHT SOURCE |
WALTER LORENZ SURGICAL, INC. |
TREVOR BYRD |
K990662 |
09/24/1999 |
DISPOSABLE HEATING TUBING SET #7642HSES |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
S. GRUNWALD |
K991915 |
09/03/1999 |
MODULAR RADIAL HEAD |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
K992103 |
09/01/1999 |
C-QUEST |
WUESTEC MEDICAL, INC. |
BRENDA DAVIS |
K992282 |
09/23/1999 |
MICRO-FRANCE LIPOSUCTION CANNULAS |
XOMED, INC. |
MARTIN D SARGENT |
K990689 |
09/03/1999 |
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 |
ZCV ,INC. |
PRISCILLA WHITEHEAD COX |
K991180 |
09/03/1999 |
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
K991185 |
09/03/1999 |
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK KOPNITSKY |
K992166 |
09/03/1999 |
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
K990762 |
09/03/1999 |
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) |
ZOLL MEDICAL CORP. |
PAUL DIAS |