| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K991588 |
05/07/1999 |
EMS SWISS ORTHOCLAST |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
SHEILA HAMEON-HEYER |
| K991569 |
05/05/1999 |
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 |
02 MARKETING GROUP, INC. |
LESTER FORD |
| K991541 |
05/03/1999 |
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 |
A-MED SYSTEMS, INC. |
ROBERTA THOMPSON |
| K991762 |
05/24/1999 |
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991663 |
05/14/1999 |
AST/SGOT |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991665 |
05/14/1999 |
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991664 |
05/14/1999 |
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991761 |
05/24/1999 |
MAGNESIUM PRODUCT NO'S, 112-01, 112-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991666 |
05/14/1999 |
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991605 |
05/10/1999 |
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION |
ABBOTT LABORATORIES |
MICHELLE B ROEDING |
| K991839 |
05/28/1999 |
ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER |
ABX DIAGNOSTICS |
PAT AMTOWER |
| K991818 |
05/27/1999 |
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 |
ACRYMED, INC. |
BRUCE GIBBINS |
| K991805 |
05/26/1999 |
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION |
ACUSON CORP. |
WILLIAM WELCH |
| K991607 |
05/10/1999 |
VANTAGE 2.5 |
ADAC LABORATORIES |
DENNIS W HENKELMAN |
| K991630 |
05/11/1999 |
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET |
ADVANCED MEDICAL SOLUTIONS GROUP PLC |
CHRIS OAKES |
| K991784 |
05/25/1999 |
RENEW LEAD EXTENSION |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
| K991675 |
05/17/1999 |
MODIFICATION OF: STERRAD BI TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K991671 |
05/17/1999 |
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
TERRENCE J SWEENEY |
| K991546 |
05/03/1999 |
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD |
AKTINA MEDICAL PHYSICS CORP. |
JOAN ZACHAROPOULOS |
| K991709 |
05/19/1999 |
BROWNE CIDEX OPA INDICATOR |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K991589 |
05/07/1999 |
FLEXIBLE VASCULAR CLAMP, VERSION 2 |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K991571 |
05/05/1999 |
10 CURIE IRDIUM 192, CSN00100-192 |
ALPHA-OMEGA SERVICES, INC. |
J. HARVEY KNAUSS |
| K991798 |
05/26/1999 |
ACME MEDICAL AESTHETIC ND:YAG LASER |
ALTUS MEDICAL |
MICHAEL LEVERNIER |
| K991626 |
05/11/1999 |
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION |
ANALOGIC CORP. |
GARET VAN GENNEP |
| K991680 |
05/17/1999 |
SOFTINJECT |
ANDROSYSTEMS SRL |
ERMANNO GRECO |
| K991793 |
05/26/1999 |
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K991540 |
05/03/1999 |
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K991847 |
05/28/1999 |
THERMOFLEX SYSTEM |
ARGOMED, INC. |
RICHARD B KLEIN |
| K991686 |
05/17/1999 |
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K991813 |
05/27/1999 |
UNI-GRAFT K DV VASCULAR GRAFT |
ATRIUM MEDICAL CORP. |
JOE DE PAOLO |
| K991576 |
05/06/1999 |
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K991817 |
05/27/1999 |
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
GABRIEL J MURACA JR. |
| K991551 |
05/03/1999 |
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
JAMES W HAYNES |
| K991707 |
05/19/1999 |
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 |
BECKMAN |
ANGELA BYLAND |
| K991702 |
05/19/1999 |
MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 |
BECTON DICKINSON VACUTAINER SYSTEMS |
ANDREA HRONCICCH |
| K991570 |
05/05/1999 |
JOBST READY-TO-WEAR ARM SLEEVES |
BEIERSDORF-JOBT, INC. |
ANGELO R PEREIRA |
| K991527 |
05/03/1999 |
CHROMOPHARE D500, D530, D650 |
BERCHTOLD HOLDING GMBH |
WOLFRAM K HILL |
| K991840 |
05/28/1999 |
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER |
BERNARD B. FRESCO |
BERNARD B FRESCO |
| K991642 |
05/13/1999 |
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX |
BERTEC CORP. |
DOUG MORR |
| K991726 |
05/20/1999 |
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI |
BINAX, INC. |
PAMELA S ANGELL |
| K991756 |
05/24/1999 |
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE |
BIO-RESEARCH ASSOCIATES, INC. |
LONNIE WITHAM |
| K991741 |
05/21/1999 |
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K991604 |
05/10/1999 |
EPI-FOAM SILICONE SHEETING |
BIODERMIS CORP. |
JEFF S SCHLEUNING |
| K991585 |
05/07/1999 |
BIPOLAR SHOULDER PROSTHESIS |
BIOMET, INC. |
FRED MCCLURE |
| K991763 |
05/24/1999 |
LACTOSORB HAND SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K991753 |
05/24/1999 |
MAXIM REMOVABLE MOLDED POLY TIBIA |
BIOMET, INC. |
FRED MCCLURE |
| K991807 |
05/26/1999 |
TITANIUM LOW PROFILE SCREWS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K991708 |
05/19/1999 |
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS |
BIOMET, INC. |
DALENE HUFZIGER BINKLEY |
| K991591 |
05/07/1999 |
BIOTHANE PATIENT RESTRAINT |
BIOPLASTICS |
CLAIRE BORON |
| K991549 |
05/03/1999 |
EMBOSPHERE MICROSPHERES |
BIOSPHERE MEDICAL |
SHEILA HEMEON-HEYER |
| K991829 |
05/28/1999 |
CDTOX A OIA |
BIOSTAR, INC. |
ROGER C BRIDEN |
| K991828 |
05/28/1999 |
STREP B OIA |
BIOSTAR, INC. |
ROGER C BRIDEN |
| K991650 |
05/13/1999 |
CMV BRITE TURBO KIT |
BIOTEST DIAGNOSTICS CORP. |
PATRICIA E BONNESS |
| K991831 |
05/28/1999 |
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 |
BOSTON MEDICAL TECHNOLOGIES, INC. |
DONALD BROKS |
| K991687 |
05/17/1999 |
MODIFICATION TO LINER II: SOFT RELINE LIQUID |
BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K991750 |
05/24/1999 |
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN |
BRIGHTSWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K991752 |
05/24/1999 |
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
BRIGHTSWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K991667 |
05/14/1999 |
BROADLINE OR TOWELS |
BROADLINE MEDICAL INDUSTRIES |
ANNA M RAMZA |
| K991844 |
05/28/1999 |
PRO-GLASS |
CAD CAM VENTURES |
RON FISHELL |
| K991783 |
05/25/1999 |
AB-180 XC SYSTEM, MODEL AB-180XC |
CARDIAC ASSIST, INC. |
RICHARD G CONFER |
| K991717 |
05/20/1999 |
CARESIDE MG |
CARESIDE, INC. |
KENNETH B ASARCH |
| K991582 |
05/07/1999 |
CHIRON DIAGNOSTICS ACS: 180 FOLATE |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K991692 |
05/18/1999 |
CHIRON DIAGNOSTICS ACS: 180 FT3 |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K991834 |
05/28/1999 |
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 |
CHOLESTECH CORP. |
THOMAS E WORTHY |
| K991578 |
05/06/1999 |
SMARTSPOT 2000 |
CMT MEDICAL TECHNOLOGIES, LTD. |
YESHAYAHU RAZ |
| K991734 |
05/21/1999 |
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
| K991635 |
05/12/1999 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
| K991529 |
05/03/1999 |
CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 |
CONWAY STUART MEDICAL, INC. |
DAVID A TUCKER |
| K991811 |
05/27/1999 |
CORDIS MAXI DS PTA BALLOON CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K991674 |
05/17/1999 |
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS |
CORDIS CORP. |
CHARLES J RYAN |
| K991673 |
05/17/1999 |
CORDIS TEMPO ANGIOGRAPHY CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K991646 |
05/13/1999 |
AGILITY STEERABLE GUIDEWIRE |
CORDIS NEUROVASCULAR, INC. |
MARITZA CELAYA |
| K991531 |
05/03/1999 |
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 |
CORDIS WEBSTER, INC. |
MARY ADAMS |
| K991787 |
05/25/1999 |
N LATEX IGE MONO REAGENT |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K991705 |
05/19/1999 |
N PROTEIN STANDARD UY |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K991704 |
05/19/1999 |
N/T PROTEIN CONTROL LC |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K991528 |
05/03/1999 |
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR |
DANEK MEDICAL, INC. |
RICHARD W TREHARNE |
| K991637 |
05/12/1999 |
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 |
DAVOL, INC., SUB. C.R. BARD, INC. |
RINI GEORGEKUTTY |
| K991799 |
05/26/1999 |
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO |
DAVOL, INC., SUB. C.R. BARD, INC. |
LUCINDA L FOX |
| K991649 |
05/13/1999 |
DEPUY ROCKWOOD CLAVICLE PIN |
DEPUY, INC. |
SALLY FOUST |
| K991608 |
05/10/1999 |
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING |
DERMAPHYLYX, INC. |
ANDREW M REED |
| K991609 |
05/10/1999 |
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING |
DERMAPHYLYX, INC. |
ANDREW M REED |
| K991525 |
05/03/1999 |
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF |
DEROYAL INDUSTRIES, INC. |
LOIS MARSH |
| K991814 |
05/27/1999 |
MULTACHOICE INSTRUMENTS |
DEXIDE, INC. |
JOHN CORZINE |
| K991561 |
05/04/1999 |
ROADRUNNER, PEP THERAPY DEVICE |
DHD HEALTHCARE CORP. |
LARRY WEINSTEIN |
| K991797 |
05/26/1999 |
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K991796 |
05/26/1999 |
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K991795 |
05/26/1999 |
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K991660 |
05/14/1999 |
COPALIS MULTIPLEX EBV ANTIBODY ASSAY |
DIASORIN, INC. |
JUDITH J SMITH |
| K991737 |
05/21/1999 |
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K991714 |
05/20/1999 |
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K991822 |
05/27/1999 |
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH |
DR. IHDE DENTAL AG SWITZERLAND |
MOURAD BARAKET |
| K991694 |
05/18/1999 |
DYNAREX DRAIN SPONGE |
DYNAREX CORP. |
JOHN G MOULDEN |
| K991695 |
05/18/1999 |
DYNAREX NON-WOVEN SPONGE |
DYNAREX CORP. |
JOHN G MOULDEN |
| K991721 |
05/20/1999 |
EBI OMEGA 21 SYSTEM |
EBI ELECTRO BIOLOGY |
JONAS WILF |
| K991789 |
05/25/1999 |
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
| K991636 |
05/12/1999 |
ELEKTA STEREOTACTIC GUIDE |
ELEKTA INSTRUMENT AB |
CAROL PATTERSON |
| K991603 |
05/10/1999 |
GRIT BLASTED HUMERAL STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991790 |
05/26/1999 |
ULTIMAX ANKLE FUSION ROD SYSTEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991794 |
05/26/1999 |
ENDOSCOPIC SPINAL ACCESS SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K991601 |
05/10/1999 |
DUAL LUMEN CATHETER, MODEL DL-35-90 |
ENDOLOGIX, INC. |
KAREN U SALINAS |
| K991628 |
05/11/1999 |
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA |
ESC MEDICAL SYSTEMS, INC. |
ZVI LADIN |
| K991729 |
05/20/1999 |
FERRIS POLYOSTOMY STERILE WOUND DRESSING |
FERRIS MFG. CORP. |
THEODORE THORSEN |
| K991522 |
05/03/1999 |
MICROTARGETING ELECTRODE |
FHC, INC. |
FREDERICK HAER |
| K991560 |
05/04/1999 |
NASO-LARYNGO-PHARYNGOSCOPE |
FIBER IMAGING TECHNOLOGIES, INC. |
JOSEPH RESS |
| K991632 |
05/12/1999 |
FOTONA NOVALIS ER: YAG LASER SYSTEM |
FOTONA D.D. |
MOJCA VALIJAVEC |
| K991634 |
05/12/1999 |
FOTONA NOVALIS R RUBY LASER SYSTEM |
FOTONA D.D. |
MOJCA VALIJAVEC |
| K991520 |
05/03/1999 |
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K991757 |
05/24/1999 |
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE |
FURLONG INDUSTRIES |
PETE FURLONG |
| K991780 |
05/25/1999 |
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C |
G.T. LABORATORIES, INC. |
JOHN M SZABOCSIK |
| K991781 |
05/25/1999 |
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS |
G.T. LABORATORIES, INC. |
JOHN M SZABOCSIK |
| K991774 |
05/25/1999 |
ACRON MC MODIFICATION |
GC AMERICA, INC. |
TERRY L JORITZ |
| K991841 |
05/28/1999 |
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
GE MEDICAL SYSTEMS F.I. HAIFA |
DAN LAOR |
| K991629 |
05/11/1999 |
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K991716 |
05/20/1999 |
HISPEED NX/I CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K991842 |
05/28/1999 |
SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING |
GE VINGMED ULTRASOUND |
PAUL FREDRIKSEN |
| K991611 |
05/10/1999 |
GE LOGIQ 500 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K991739 |
05/21/1999 |
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
MARIA VITUG FOUTS |
| K991735 |
05/21/1999 |
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K991786 |
05/25/1999 |
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LAURA L MCCOMIS |
| K991554 |
05/03/1999 |
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
| K991843 |
05/28/1999 |
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE |
GREINER MEDITECH, INC. |
DOUG HARRIS |
| K991631 |
05/11/1999 |
FASTRAY LC |
HARRY J. BOSWORTH CO. |
MILDRED J BOSWORTH |
| K991616 |
05/10/1999 |
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K991587 |
05/07/1999 |
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS |
HELIX MEDICAL, INC. |
CYNTHIA ANDERSON |
| K991563 |
05/05/1999 |
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C |
HENKE SASS WOLF OF AMERICA, INC. |
ELLEN HENKE |
| K991773 |
05/25/1999 |
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K991535 |
05/03/1999 |
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS |
HITACHI MEDICAL CORP. OF AMERICA |
GARY W ENOS |
| K991543 |
05/03/1999 |
INTRAOP CATHETER |
I-FLOW CORP. |
STANLEY E FRY |
| K991526 |
05/03/1999 |
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
CHERYL BLAKE |
| K991723 |
05/20/1999 |
TRANSFX MULTI PIN CLAMP |
IMMEDICA, INC. |
ROY BOGERT |
| K991545 |
05/03/1999 |
WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK |
INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI |
GUENTER GINSBERG |
| K991792 |
05/26/1999 |
CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE |
INFLUENCE, INC. |
JONATHAN S KAHAN |
| K991657 |
05/13/1999 |
QUANTA LITE ANA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K991725 |
05/20/1999 |
SIDESTREAM NEBULIZER |
INSPIRED MEDICAL PRODUCTS LTD. |
PAUL E DRYDEN |
| K991785 |
05/25/1999 |
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR |
INSTRUMENTATION INDUSTRIES, INC. |
TRICIA WOOD |
| K991572 |
05/05/1999 |
ISOLUX SURGICAL HEADLIGHT |
ISOLUX AMERICA |
STUART L MCGHEE |
| K991564 |
05/05/1999 |
JELTEMP |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K991688 |
05/17/1999 |
WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S |
JAWON MEDICAL CO., LTD. |
ROBERT D WAXHAM |
| K991592 |
05/07/1999 |
KSEA DE LA PLAZA BLEPHAROPLASTY SET |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K991738 |
05/21/1999 |
DIGITAL VIDEO RECORDING SYSTEM |
KAY ELEMETRICS CORP. |
WILLIAM D HARBESON |
| K991625 |
05/11/1999 |
KOMET XK-95 PERFORATOR MOTOR (MI-102) |
KOMET MEDICAL |
COURTNEY S PARADICE |
| K991749 |
05/24/1999 |
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K991748 |
05/24/1999 |
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K993096 |
05/28/1999 |
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR |
LIFESTREAM TECHNOLOGIES, INC. |
JACKSON B CONNOLLY |
| K991644 |
05/13/1999 |
MICROGAS 7650 TRANSCUTANEOUS MONITOR |
LINDE MEDICAL SENSORS AG |
JEAN-PIERRE PALMA |
| K991715 |
05/20/1999 |
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE |
LINVATEC CORP. |
LAURA SENEFF |
| K991830 |
05/28/1999 |
CAPSULAR SHRINKAGE ELECTRODE |
LINVATEC CORP. |
LAURA SENEFF |
| K991677 |
05/17/1999 |
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) |
LONDON INTERNATIONAL GROUP, INC. |
BRADLEY L PUGH |
| K991754 |
05/24/1999 |
GO GLUCOSE MONITORING SYSTEM |
LXN CORP. |
NEDA RASHTI |
| K991640 |
05/12/1999 |
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES |
M.R.G. INDUSTRIES BERHAD |
LIM CHONG |
| K991759 |
05/24/1999 |
MAERSK MEDICAL CONTOUR INFUSION SET |
MAERSK MEDICAL A/S |
DON SELVEY |
| K991819 |
05/27/1999 |
MAGNATEK 30 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
| K991577 |
05/06/1999 |
NIC TONE ACRYLIC RESINS |
MANUFACTURERA DENTAL CONTINENTAL |
GARY MOCNIK |
| K991615 |
05/10/1999 |
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE |
MAXXIM MEDICAL |
JOYCE MOODY |
| K991659 |
05/14/1999 |
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES |
MEDART CORP. |
MARILYN M CHOU |
| K991685 |
05/17/1999 |
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR |
MEDIC-AID LTD. |
PAUL E DRYDEN |
| K991724 |
05/20/1999 |
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K991719 |
05/20/1999 |
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS |
MEDIMEX HOLFELD GMBH & CO. |
DONALD F GRABARZ |
| K991559 |
05/04/1999 |
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K991755 |
05/24/1999 |
MEDLINE TENDER WET WOUND DRESSING |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K991557 |
05/04/1999 |
MEDRAD VISTRON CT INJECTOR SYSTEM |
MEDRAD, INC. |
JAN E DOBSCHA |
| K991775 |
05/25/1999 |
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS |
MENNEN MEDICAL, INC. |
KENNETH RAICHMAN |
| K991619 |
05/11/1999 |
FOUNTAIN INFUSION SYSTEM |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K991532 |
05/03/1999 |
DRX QT. HCG |
METRIKA, INC. |
YA-CHEN HSU |
| K991670 |
05/17/1999 |
SILVERSTEIN MICROWICK |
MICROMEDICS, INC. |
CHARLES GROTE |
| K991539 |
05/03/1999 |
EXCELL 22 |
MWI, INC. |
GREGORY A WITHERSPOON |
| K991656 |
05/13/1999 |
AED ARTHROSCOPE |
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
GAYLE M BUTLER |
| K991823 |
05/28/1999 |
N-395 PULSE OXIMETER, MODEL N-395 |
NELLCOR PURITAN BENNETT, INC. |
DAVID A. C. GREEN |
| K991769 |
05/24/1999 |
CUTANEOUS (BAR) ELECTRODE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991772 |
05/24/1999 |
CUTANEOUS (DISC) ELECTRODE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991770 |
05/24/1999 |
CUTANEOUS (GROUND) ELECTRODE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991771 |
05/24/1999 |
DIGITAL RING ELECTRDE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991566 |
05/05/1999 |
SOLUSTAPLE |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K991821 |
05/27/1999 |
NITRILE EXAMINATION GLOVE, POWDERED, BLUE |
NING BO YUJIANG RUBBER & PLASTIC CO. |
JANNA P TUCKER |
| K991623 |
05/11/1999 |
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA |
NIPRO MEDICAL CORP. |
KAELYN HADLEY |
| K991727 |
05/20/1999 |
STAT PROFILE M7 ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K991668 |
05/14/1999 |
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) |
NOVARTIS NUTRITION CORP. |
ROBERT J LANG |
| K991548 |
05/03/1999 |
HAL SCOPE HOLDER SYSTEM |
NOVED MEDICAL |
MIKE GRIFFIN |
| K991701 |
05/19/1999 |
MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K991672 |
05/17/1999 |
OLYMPUS NA-10J-KB ASPIRATION NEEDLE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K991846 |
05/28/1999 |
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE |
OMNIGRACE LTD. |
K.C. CHOONG |
| K991845 |
05/28/1999 |
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. |
OMNIGRACE LTD. |
K.C. CHOONG |
| K991593 |
05/07/1999 |
ORIBRUSH - STANDARD - B002 |
ORIFICE MEDICAL AB |
PATRIK NILSSON |
| K991595 |
05/07/1999 |
ORIBRUSH - WITH PROTECTIVE TIP - B001 |
ORIFICE MEDICAL AB |
PATRIC NILSSON |
| K991800 |
05/26/1999 |
HEMOCHEK URINE COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
| K991586 |
05/07/1999 |
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K991643 |
05/13/1999 |
IDS4 V3.2 IMAGE DISPLAY SYSTEM |
OTECH, INC. |
HERMAN OOSTERWIJK |
| K991590 |
05/07/1999 |
C-LEG (3C100) |
OTTO BOCK ORTHOPEDIC INDUSTRY, INC. |
JOHN HENDRICKSON |
| K991815 |
05/27/1999 |
EXPLORER 3D |
OUR SCIENTIFIC INTL., INC. |
MARIO CABALLERO |
| K991732 |
05/21/1999 |
CENTRAFIX EXTERNAL FIXATOR |
OWANDAR MEDICAL LTD |
JOHN RADWELL |
| K991562 |
05/04/1999 |
PASCAL MEDICAL AB MENIETT 20 |
PASCAL MEDICAL AB |
JEFFREY R SIDEMAN |
| K991533 |
05/03/1999 |
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION |
PERIPHERAL AVE |
SUSAN WALTON |
| K991658 |
05/14/1999 |
PERMOBIL POWERED WHEELCHAIR 1280 |
PERMOBIL A.B. |
BENGT PERSSON |
| K991620 |
05/11/1999 |
VISINE FOR CONTACTS |
PFIZER, INC. |
JOHN TOMASZEWSKI |
| K991641 |
05/12/1999 |
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 |
PHAMATECH |
CARL A MONGIOVI |
| K991824 |
05/27/1999 |
AT HOME DRUG TEST, MODEL 9171 |
PHAMATECH |
CARL A MONGIOVI |
| K991765 |
05/24/1999 |
SYNERGY SHOULDER COIL |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K991568 |
05/05/1999 |
MR SPECTROSCOPY PACKAGE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K991826 |
05/28/1999 |
PLANMED SOPHIE AND SOPHIE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
| K991575 |
05/06/1999 |
PRIMUS STEAM STERILIZERS |
PRIMUS STERILIZER CO., INC. |
JEFF REED |
| K991751 |
05/24/1999 |
STATUS CUP ACCUSIGN CUP |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991618 |
05/11/1999 |
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR |
PROPPER MFG. CO., INC. |
JOHN D DYCKMAN |
| K991633 |
05/12/1999 |
QUICKVUE INFLUENZA A/B TEST |
QUIDEL CORP. |
MARY DE ARMOND |
| K991747 |
05/21/1999 |
QUICKVUE ONE-STEP H. PYLORI II TEST |
QUIDEL CORP. |
Robin Weiner |
| K991523 |
05/03/1999 |
TLC PEDIATRIC FRAME, MODEL TLC-SYS |
RADIONICS, INC. |
NANCY C MACDONALD |
| K991698 |
05/18/1999 |
REDI-TEST PCP |
REDWOOD BIOTECH, INC. |
JANIS FREESTONE |
| K991648 |
05/13/1999 |
REUSABLE CONTOUR II NASAL MASK |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K991627 |
05/11/1999 |
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 |
RESPIRONICS, INC. |
BETSY CORTELLONI |
| K991827 |
05/28/1999 |
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 |
RI MOS. S.R.L. |
ADENA NORA S RIEMER |
| K991906 |
05/21/1999 |
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K991718 |
05/20/1999 |
OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K991598 |
05/10/1999 |
COBAS INTEGRA ACETAMINOPHEN |
ROCHE DIAGNOSTICS CORP. |
LISA GERARD |
| K991597 |
05/10/1999 |
COBAS INTEGRA AMIKACIN MAB |
ROCHE DIAGNOSTICS CORP. |
LISA GERARD |
| K991653 |
05/13/1999 |
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM |
RYMED TECHNOLOGIES, INC. |
AL WEISENBORN |
| K991788 |
05/25/1999 |
SALTER LABS PEP DEVICE |
SALTER LABS |
DUANE KAZAL |
| K991537 |
05/03/1999 |
SAMSUNG RAYPAX SYSTEM |
SAMSUNG SDS CO., LTD |
HERMAN OOSTERWJICK |
| K991594 |
05/07/1999 |
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS |
SANGSTAT MEDICAL CORP. |
EDA S COOK |
| K991733 |
05/21/1999 |
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS |
SCHIAPPARELLI BIOSYSTEMS, INC. |
STEVEN DALESSIO |
| K991778 |
05/25/1999 |
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991777 |
05/25/1999 |
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991779 |
05/25/1999 |
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991776 |
05/25/1999 |
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991567 |
05/05/1999 |
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. |
SHELHIGH, INC. |
SHLOMO GABBAY |
| K991743 |
05/21/1999 |
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K991745 |
05/21/1999 |
ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K991746 |
05/21/1999 |
ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K991744 |
05/21/1999 |
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K991553 |
05/03/1999 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION |
SHIMADZU CORP. |
MICHAEL FISHBACK |
| K991652 |
05/13/1999 |
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM |
SIEMENS CORP. |
KATHLEEN RUTHERFORD |
| K991600 |
05/10/1999 |
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION |
SIEMENS CORP. |
ALICIA BUSTOS-JUERGENSEN |
| K991661 |
05/14/1999 |
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K991764 |
05/24/1999 |
SOMATOM PROJECT 10-CT SCANNERS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA JUERGENSEN |
| K991599 |
05/10/1999 |
CADD ADMINISTRATION SET |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K991624 |
05/11/1999 |
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K991538 |
05/03/1999 |
OPERA CUPFLANGED ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
JANET JOHNSON GREEN |
| K991565 |
05/05/1999 |
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S |
SMV AMERICA |
PHIL VERNON |
| K991791 |
05/25/1999 |
SOUND VASER SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
WILLIAM W CIMINO |
| K991613 |
05/10/1999 |
SW ULTRASOUND, MODELS 331, 311, 333 |
STARBENE |
JUDITH NIZTZSCHMAMN |
| K991622 |
05/11/1999 |
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER |
STELKAST COMPANY |
DONALD A STEVENS |
| K991612 |
05/10/1999 |
STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G |
STERILOGIC WASTE SYSTEMS, INC. |
CALVIN A ODHNER |
| K991835 |
05/28/1999 |
HANG UPS POWER II |
STL INTL., INC. |
ROGER C TEETER |
| K991706 |
05/19/1999 |
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE |
STRYKER CORP. |
NICOLE PETTY |
| K991696 |
05/18/1999 |
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K991703 |
05/19/1999 |
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K991722 |
05/20/1999 |
DEVILBISS 5 LITER OXYGEN CONCENTRATOR |
SUNRISE MEDICAL HHG, INC. |
GREG CLITES |
| K991662 |
05/14/1999 |
TITANIUM HARTSHILL SYSTEM |
SURGICRAFT LTD. |
SIMON FITZER |
| K991700 |
05/18/1999 |
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO |
SWEMED LAB INTERNATIONAL AB |
EDWARD C WILSON |
| K991808 |
05/27/1999 |
OPTIBOND SOLO PLUS 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K991552 |
05/03/1999 |
SYNTHES PEDIATRIC ROD SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K991647 |
05/13/1999 |
TFX MEDICAL INTRODUCER KIT |
TFX MEDICAL GROUP |
JULIE A BEAUMONT |
| K991803 |
05/26/1999 |
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K991802 |
05/26/1999 |
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K991801 |
05/26/1999 |
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K991804 |
05/26/1999 |
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K991758 |
05/24/1999 |
MONOJECT INSULIN SYRINGE |
THE KENDAL CO. |
FRANK J FUCILE |
| K991580 |
05/07/1999 |
ILM ENDOTRACHEAL TUBE |
THE LARYNGEAL MASK CO.,LTD. |
ROBERT L SHERIDAN |
| K991583 |
05/07/1999 |
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR |
THE MAGSTIM COMPANY LTD. |
REZA JALINOUS |
| K991684 |
05/17/1999 |
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 |
THERMOGEAR, INC. |
R. WAYNE FIELDS |
| K991711 |
05/19/1999 |
BISTITE II SC |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
| K991766 |
05/24/1999 |
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K991710 |
05/19/1999 |
SSA-370A/POWERVISION 6000 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K991740 |
05/21/1999 |
OPART, MODEL MRT-600 |
TOSHIBA AMERICA MRI, INC. |
HSU CHANG |
| K991810 |
05/27/1999 |
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K991697 |
05/18/1999 |
UNI-GOLD H. PYLORI |
TRINITY BIOTECH, PLC |
Erika B Ammirati |
| K991693 |
05/18/1999 |
TWO RIVERS POWER LIFT/RECLINE CHAIR |
TWO RIVERS, LLC. |
CHRIS WHITAKER |
| K991720 |
05/20/1999 |
KRONUS OPTIQUANT THYROGLOBULIN KIT |
UNCHANGED |
A.P. DOERSCCHUK |
| K991689 |
05/18/1999 |
LATEX EXAMINATION GLOVES (POWDER FREE) |
USG HEALTHGUARD SDN BHD |
TOH CHEE YEONG |
| K991690 |
05/18/1999 |
LATEX EXAMINATION GLOVES (PRE POWDERED) |
USG HEALTHGUARD SDN BHD |
TOH CHEE YEONG |
| K991602 |
05/10/1999 |
EPTFE RINGED GORE-TEX VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
TIMOTHY J RYAN |
| K991683 |
05/17/1999 |
PTFE RINGED GORE-TEX VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
TIMOTHY J RYNN |
| K991669 |
05/14/1999 |
PMS 750 FINGERSWITCH |
WALLACH SURGICAL DEVICES, INC. |
MICHAEL MALIS |
| K991806 |
05/26/1999 |
VHS SUPRACONDYLAR PLATE SYSTEM |
WALTER ABENDSCHEIN, M.D. |
WALTER ABENDSCHEIN |
| K991550 |
05/04/1999 |
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS |
WESLEY JESSEN CORP. |
JOSEPH FOOS |
| K991617 |
05/10/1999 |
FACE-2-FACE CPR PROTECTION SHIELD |
WHITELINE PLASTICS, INC. |
WALLY SIMPSON |
| K991678 |
05/17/1999 |
WHITESIDE BIOMECHANICS SPINAL SYSTEM |
WHITESIDE BIOMECHANICS, INC. |
DEBRA MEYER |
| K991742 |
05/21/1999 |
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
E. J. SMITH |
| K991820 |
05/27/1999 |
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K991610 |
05/10/1999 |
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K991581 |
05/07/1999 |
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO |
ZIMMER, INC. |
STEPHEN MCKELVEY |
| K991556 |
05/04/1999 |
ZOLL M SERIES 12SL ANALYSIS OPTION |
ZOLL MEDICAL CORP. |
PAUL DIAS |
