| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K991216 |
08/05/1999 |
HOFFMAN IVF-1 |
(ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION |
FRANK STRZEMPEK |
| K991569 |
08/03/1999 |
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 |
02 MARKETING GROUP, INC. |
LESTER FORD |
| K991961 |
08/09/1999 |
3M LVR SYSTEM |
3M COMPANY |
LAEL J PICKETT |
| DEN990005 |
08/20/1999 |
THE 3PM EGG MACHINE |
3PM CO., INC. |
DANIEL J MANELLI |
| K991866 |
08/02/1999 |
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991665 |
08/10/1999 |
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991867 |
08/02/1999 |
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991664 |
08/19/1999 |
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K984569 |
08/12/1999 |
AB2 MED-FLO SOLUTION SET |
AB2 MEDICAL PRODUCTS, LLP |
ARTHUR CHANDLER,III |
| K992140 |
08/26/1999 |
PICCOLO METLYTE 7 REAGENT DISC |
ABAXIS, INC. |
LISA MCGRATH |
| K991839 |
08/11/1999 |
ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER |
ABX DIAGNOSTICS |
PAT AMTOWER |
| K992032 |
08/19/1999 |
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 |
ACRYMED, INC. |
BRUCE GIBBINS |
| K991805 |
08/02/1999 |
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION |
ACUSON CORP. |
WILLIAM WELCH |
| K992470 |
08/23/1999 |
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
TERRENCE J SWEENEY |
| K984085 |
08/05/1999 |
RITEFLO SPACER |
AEROMAX TECHNOLOGIES, INC. |
ALLAN M WACHTER |
| K992283 |
08/27/1999 |
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY |
AIRSEP CORP. |
GREG DZIOMBA |
| K983719 |
08/25/1999 |
BIOSHIELD EXPRESS STERILIZATION WRAP |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K992514 |
08/12/1999 |
CONVERTORS BREATHABLE SURGICAL GOWNS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K991981 |
08/05/1999 |
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA HOOI KOON |
| K992663 |
08/24/1999 |
ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
CHRIS BOHL |
| K990037 |
08/24/1999 |
NEPTUNE WASTE MANAGEMENT SYSTEM |
AMERICAN IMMUNO TECH |
ESTHER SALTZ |
| K983395 |
08/12/1999 |
FETALGARD 3000 FETAL MONITOR |
ANALOGIC CORP. |
STEVEN CLARKE |
| K991847 |
08/26/1999 |
THERMOFLEX SYSTEM |
ARGOMED, INC. |
RICHARD B KLEIN |
| K983577 |
08/13/1999 |
ARTHREX MENISCAL DART SYSTEM |
ARTHREX, INC. |
SCOTT M DURLACHER |
| K992443 |
08/20/1999 |
ADVANTA GRAFT |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K992441 |
08/20/1999 |
ADVANTA GRAFT |
ATRIUM MEDICAL CORP. |
KAREN HALL |
| K991570 |
08/20/1999 |
JOBST READY-TO-WEAR ARM SLEEVES |
BEIERSDORF-JOBT, INC. |
ANGELO R PEREIRA |
| K992672 |
08/24/1999 |
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) |
BELMONT INSTRUMENT CORP. |
URAIWAN LABADINI |
| K990777 |
08/25/1999 |
MED-RX EXTENSION SETS |
BENLAN, INC. |
BILL C.K. LIM |
| K991642 |
08/03/1999 |
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX |
BERTEC CORP. |
DOUG MORR |
| K991726 |
08/27/1999 |
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI |
BINAX, INC. |
PAMELA S ANGELL |
| K992550 |
08/11/1999 |
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 |
BIO-RAD |
ELIZABETH PLATT |
| K990230 |
08/19/1999 |
ELECTRO-NERVE STIMULATOR TENS, MODEL LX |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K991585 |
08/18/1999 |
BIPOLAR SHOULDER PROSTHESIS |
BIOMET, INC. |
FRED MCCLURE |
| K992158 |
08/20/1999 |
LACTOSORB SHEETS |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K991753 |
08/17/1999 |
MAXIM REMOVABLE MOLDED POLY TIBIA |
BIOMET, INC. |
FRED MCCLURE |
| K992567 |
08/27/1999 |
ANATOMICAL BANKART TACK, MODEL 523520A |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K991828 |
08/19/1999 |
STREP B OIA |
BIOSTAR, INC. |
ROGER C BRIDEN |
| K992248 |
08/25/1999 |
POST CEMENT HI-X |
BISCO, INC. |
KATHRYN B PATTERSON |
| K992123 |
08/23/1999 |
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS |
BOSTON SCIENTIFIC SCIMED, INC. |
MELANIE RASKA |
| K983364 |
08/11/1999 |
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 |
BUFFALO FILTER CO., INC. |
CLINTON R HOLLAND JR. |
| K983298 |
08/16/1999 |
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF |
BUFFALO FILTER CO., INC. |
CLINTON R HOLLAND JR. |
| K983333 |
08/11/1999 |
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 |
BUFFALO FILTER CO., INC. |
CLINTON R HOLLAND JR |
| K992500 |
08/18/1999 |
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS |
CANTOR & SILVER LTD. |
MARTIN DALSING |
| K990478 |
08/31/1999 |
CARD GUARD, MODEL CG-6550 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
| K992164 |
08/30/1999 |
TELEMEDICINE 2000 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K991371 |
08/03/1999 |
CARESIDE AMMONIA |
CARESIDE, INC. |
KENNETH B ASSARCH, PHARM |
| K991717 |
08/10/1999 |
CARESIDE MG |
CARESIDE, INC. |
KENNETH B ASARCH |
| K992397 |
08/26/1999 |
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE |
CENOGENICS CORP. |
NITZA KATZ |
| K990310 |
08/30/1999 |
CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) |
CHARTER MEDICAL, LTD. |
DAVID HEAGLE |
| K992252 |
08/10/1999 |
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 |
CHEMICON INTL., INC. |
CINDY PENNY |
| K992157 |
08/05/1999 |
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K992446 |
08/18/1999 |
DAILIES (NELFILCON A) ONE-DAY |
CIBA VISION JOHNS CREEK MFG. |
ALICIA M PLESNARSKI |
| K992126 |
08/03/1999 |
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM |
CIRCON CORP. |
RONALD J EHMSEN |
| K992152 |
08/17/1999 |
GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
J. WILLIAM JONES |
| K991890 |
08/09/1999 |
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K991942 |
08/24/1999 |
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K992339 |
08/16/1999 |
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS |
COLORSOFT LABORATORIES CORP. |
MARTIN DALSING |
| K990724 |
08/13/1999 |
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K991985 |
08/20/1999 |
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET |
COOK, INC. |
APRIL LAVENDER |
| K992198 |
08/27/1999 |
URETHANE PICC LINE MODEL UPICS- |
COOK, INC. |
LISA WEBB |
| K991028 |
08/04/1999 |
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES |
CORDIS CORP. |
CHARLES J RYAN |
| K991674 |
08/12/1999 |
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS |
CORDIS CORP. |
CHARLES J RYAN |
| K984214 |
08/10/1999 |
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER |
CORDIS NEUROVASCULAR, INC. |
ALINA CARABALLO |
| K991157 |
08/02/1999 |
N LATEX STFR REAGENT |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
| K992181 |
08/24/1999 |
TRIP TONOMETRY CATHETER, 8F |
DATEX-OHMEDA, INC. |
JOEL KENT |
| K991909 |
08/20/1999 |
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K992516 |
08/27/1999 |
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K991920 |
08/12/1999 |
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING |
DERMAPHYLYX, INC. |
ANDREW M REED |
| K983886 |
08/19/1999 |
POCKIT HSV 2 RAPID TEST |
DIAGNOLOGY LTD. |
ROBERT SCHIFF |
| K991427 |
08/13/1999 |
PARAMED PARAFFIN WARMER |
DIVI INTL. CO. |
MIKE VIDAL |
| K992608 |
08/24/1999 |
ATC OPTION FOR EVITA 2 DURA AND EVITA 4 |
DRAGER, INC. |
HARALD KNEUER |
| K992327 |
08/18/1999 |
DUTECK DIGITAL CLINICAL THERMOMETER |
DUTECK INDUSTRIAL CO., LTD. |
ALLEN REICH |
| K991721 |
08/13/1999 |
EBI OMEGA 21 SYSTEM |
EBI ELECTRO BIOLOGY |
JONAS WILF |
| K992515 |
08/17/1999 |
EBI XFIX DFS OPTIROM ELBOW FIXATOR |
EBI, L.P. |
JONAS WILF |
| K991921 |
08/13/1999 |
INTERMITTENT COMPRESSION BOOT FOR OTC |
EISCHOCO, INC. |
CLEM EISCHEN |
| K992120 |
08/13/1999 |
DYNAWELL OR DYNAWELL |
EKEROTH QUALITY AB |
NILS EKEROTH |
| K992029 |
08/12/1999 |
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K991941 |
08/19/1999 |
EBI XFIX DFS RAIL SYSTEM |
ELECTRO-BIOLOGY, INC. |
JONAS WILF |
| K992109 |
08/12/1999 |
ENCORE FULLY COATED HIP |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991790 |
08/06/1999 |
ULTIMAX ANKLE FUSION ROD SYSTEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991889 |
08/12/1999 |
ULTIMAX HAIG II NAIL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991794 |
08/13/1999 |
ENDOSCOPIC SPINAL ACCESS SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K990271 |
08/30/1999 |
ENDOSONICS TRAK BACK DEVICE |
ENDOSONICS CORP. |
RICHARD HEBERT |
| K991628 |
08/09/1999 |
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA |
ESC MEDICAL SYSTEMS, INC. |
ZVI LADIN |
| K992048 |
08/16/1999 |
MODIFICATION OF PROMPT L-POP |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K991980 |
08/17/1999 |
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, |
ETHICON ENDO-SURGERY, INC. |
TAMIMA ITANI |
| K992363 |
08/12/1999 |
SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN |
EUROMED, INC. |
MARY MCNAMARA-CULLINANE |
| K991903 |
08/04/1999 |
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) |
EXCEL TECH. LTD. |
JOHN R MUMFORD |
| K992313 |
08/19/1999 |
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 |
EXCEL TECH. LTD. |
JOHN R MUMFORD |
| K991729 |
08/27/1999 |
FERRIS POLYOSTOMY STERILE WOUND DRESSING |
FERRIS MFG. CORP. |
THEODORE THORSEN |
| K992040 |
08/06/1999 |
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES |
FIBER IMAGING TECHNOLOGIES, INC. |
JOSEPH RESS |
| K991632 |
08/10/1999 |
FOTONA NOVALIS ER: YAG LASER SYSTEM |
FOTONA D.D. |
MOJCA VALIJAVEC |
| K991634 |
08/10/1999 |
FOTONA NOVALIS R RUBY LASER SYSTEM |
FOTONA D.D. |
MOJCA VALIJAVEC |
| K992275 |
08/04/1999 |
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS |
FRESENIUS USA, INC. |
VIRGINIA SINGER |
| K991757 |
08/12/1999 |
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE |
FURLONG INDUSTRIES |
PETE FURLONG |
| K992499 |
08/12/1999 |
GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
| K992132 |
08/20/1999 |
CHOLESITE TEST SYSTEM |
GDS TECHNOLOGY, LLC. |
KEITH CRAWFORD |
| K992506 |
08/19/1999 |
MINI 6800 DIGITAL MOBILE C-ARM |
GE DEC MEDICAL SYSTEMS |
TED L PARROT |
| K992066 |
08/30/1999 |
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K991841 |
08/26/1999 |
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA |
GE MEDICAL SYSTEMS F.I. HAIFA |
DAN LAOR |
| K991896 |
08/23/1999 |
MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAOR DAN |
| K991629 |
08/02/1999 |
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K992149 |
08/19/1999 |
GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 |
GEIGER MEDICAL TECHNOLOGIES, INC. |
JOHN BOTTJER |
| K991739 |
08/19/1999 |
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
MARIA VITUG FOUTS |
| K991735 |
08/19/1999 |
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K992107 |
08/23/1999 |
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES |
GENERAL GLOVES CORP. |
DAVID HU |
| K990440 |
08/12/1999 |
GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE |
GENTELL |
MARK L ITZKOFF |
| K992291 |
08/06/1999 |
H20- TETHERED OPTION |
GRASS-TELEFACTOR PRODUCT GROUP |
JAMES S BRYAN |
| K992222 |
08/26/1999 |
FLUOROPLASTIC VENTILATION TUBES |
GYRUS ENT L.L.C. |
ALICIA E FARAGE |
| K991508 |
08/27/1999 |
ACUMASTER BRAND ACUPUNCTURE NEEDLE |
HELIO MEDICAL SUPPLIES, INC. |
YI-FEN CHANG |
| K991507 |
08/27/1999 |
KANGNIAN BRAND ACUPUNCTURE NEEDLE |
HELIO MEDICAL SUPPLIES, INC. |
YI-FEN CHANG |
| K992241 |
08/30/1999 |
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K992224 |
08/30/1999 |
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K992243 |
08/30/1999 |
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT |
HEMAGEN DIAGNOSTICS, INC. |
JOSEPH M CALIFANO |
| K984546 |
08/13/1999 |
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK |
HEMOCLEANSE, INC. |
STEPHEN R ASH |
| K991871 |
08/05/1999 |
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A |
HEWLETT-PACKARD CO. |
WARREN R WALTERS |
| K992636 |
08/31/1999 |
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A |
HEWLETT-PACKARD CO. |
MIKE HUDON |
| K992346 |
08/12/1999 |
KINEMATIC II ROTATING HINGE KNEE |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K991055 |
08/27/1999 |
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K992462 |
08/13/1999 |
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG |
HOWMEDICA OSTEONICS CORP. |
KATE SUTTON |
| K992025 |
08/13/1999 |
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K992357 |
08/30/1999 |
EASY-CURE (CURING AND WHITENING LIGHT) |
ICS OF NORTH AMERICA, INC. |
ALAN A CREAMER |
| K992304 |
08/27/1999 |
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX |
IMAGE-GUIDED NEUROLOGICS, INC. |
MICHAEL J RENNER |
| K990907 |
08/12/1999 |
REMOTE INTRODUCER, MODEL PI-1000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
MICHAEL J RENNER |
| K992438 |
08/02/1999 |
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K991792 |
08/12/1999 |
CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE |
INFLUENCE, INC. |
JONATHAN S KAHAN |
| K981677 |
08/27/1999 |
REPOSE BONE SCREW SYSTEM |
INFLUENCE, INC. |
JONATHAN S KAHAN, ESQ. |
| K990854 |
08/02/1999 |
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE |
INNERDYNE, INC. |
RICK GAYKOWSKI |
| K991877 |
08/06/1999 |
MACMED PAEDIATRIC INTRAMEDULLARY NAIL |
INNERVISION, INC. |
FRANK M LEWIS |
| K991938 |
08/10/1999 |
CAPHOSOL ARTIFICIAL SALIVA |
INPHARMA A.S. |
BRUCE R MANNING |
| K992477 |
08/24/1999 |
ROTOSNARE |
INSCOPE, LLC. |
AL WEISENBORN |
| K991785 |
08/17/1999 |
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR |
INSTRUMENTATION INDUSTRIES, INC. |
TRICIA WOOD |
| K992508 |
08/19/1999 |
TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA |
INSTRUMENTS FOR MEDICINE AND DIAGNOSTICS |
TRACY S BEST |
| K992006 |
08/17/1999 |
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 |
INTEGRA NEUROCARE LLC. |
NANCY A MATHEWSON |
| K991854 |
08/26/1999 |
OSTEOPLAST, MODEL POP200 |
INTERPORE CROSS INTL. |
LYNN RODARTI |
| K991929 |
08/04/1999 |
INTRASTENT |
INTRATHERAPEUTICS, INC. |
CATHY YOHNK |
| K992052 |
08/12/1999 |
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS |
INVACARE CORP. |
EDWARD A KROLL |
| K991119 |
08/19/1999 |
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G |
INVACARE CORP. |
EDWARD A KROLL |
| K990785 |
08/27/1999 |
TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS |
JAKOUBEK MEDIZINTECHNIK GMBH |
DOUGLAS HULFISH |
| K990470 |
08/30/1999 |
JMS A. V. FISTULA NEEDLE SET |
JMS CO., LTD. |
TETSUHARU HIROSE |
| K990510 |
08/30/1999 |
JMS APHERESIS NEEDLE |
JMS CO., LTD. |
TETSUHARU HIROSE |
| K991904 |
08/31/1999 |
MODIFICATION OF JMS NEEDLES AND JMS SYRINGES |
JMS CO., LTD. |
KEISUKE URATOMI |
| K990236 |
08/20/1999 |
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT |
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. |
LINDA G HILL |
| K982208 |
08/27/1999 |
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER |
JOMED IMAGING LTD. |
CAROLINE SHORT |
| K984338 |
08/19/1999 |
JOSTRA HL-20 TWIN PUMP |
JOSTRA BENTLEY |
KATHY JOHNSON |
| K992114 |
08/18/1999 |
KSEA CALCUSPLIT |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
| K992541 |
08/19/1999 |
LAPAROCAM |
KARL STORZ ENDOSCOPY |
KEVIN KENNAN |
| K991007 |
08/23/1999 |
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 |
KATECHO, INC. |
LORNE SCHARNBERG |
| K991738 |
08/13/1999 |
DIGITAL VIDEO RECORDING SYSTEM |
KAY ELEMETRICS CORP. |
WILLIAM D HARBESON |
| K990648 |
08/10/1999 |
KELLER VITAL SIGNS MONITOR, KMS 890+ |
KELLER MEDICAL SPECIALTIES PRODUCTS, INC. |
JEAN WAGNER |
| K992067 |
08/27/1999 |
BELLEGLAZE |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K991958 |
08/13/1999 |
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT |
KIEL LABORATORIES, INC. |
TANYJA PORCHA |
| K991873 |
08/17/1999 |
KMI WRIST FUSION SYSTEM |
KINETIKOS MEDICAL, INC. |
MICHAEL COLLINS |
| K991875 |
08/18/1999 |
K-L-W INTRAORAL DISTRACTOR |
KLS-MARTIN L.P. |
ED RANSOM |
| K990359 |
08/17/1999 |
KONICA DIRECT DIGITIZER, MODEL DD-341 |
KONICA CORP. |
RUSSELL D MUNVES |
| K992496 |
08/25/1999 |
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
LIM KWAN HWA |
| K992497 |
08/25/1999 |
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) |
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. |
LIM KWAN HWA |
| K982724 |
08/12/1999 |
THERADYNE ROVER POWERED WHEELCHAIR |
KURT MFG. CO. |
PHIL SCHLANGEN |
| K990041 |
08/05/1999 |
UROSTYM BIOFEEDBACK AND STIMULATION PROBES |
LABORIE MEDICAL TECH CORP. |
DALE COLEMAN |
| K990883 |
08/10/1999 |
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K991950 |
08/12/1999 |
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K991949 |
08/12/1999 |
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K992019 |
08/05/1999 |
LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K991481 |
08/11/1999 |
PARAGON |
LANCER ORTHODONTICS, INC. |
DOUGLAS D MILLER |
| K990903 |
08/27/1999 |
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL HARDIMAN |
| K992490 |
08/19/1999 |
B2C HIP SYSTEM |
LEPINE GROUPE SPA. |
DOUGLAS W STUART |
| K991312 |
08/20/1999 |
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING |
LIBRARY MEDICAL, INC. |
RICHARD A HARTMAN |
| K991892 |
08/19/1999 |
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR |
LINE ONE LABORATORIES |
ROBERT GRUBER |
| K991715 |
08/06/1999 |
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE |
LINVATEC CORP. |
LAURA SENEFF |
| K991830 |
08/20/1999 |
CAPSULAR SHRINKAGE ELECTRODE |
LINVATEC CORP. |
LAURA SENEFF |
| K992102 |
08/31/1999 |
LUMA LIGHT 2000 CURE LIGHT |
LUMA LITE, INC, |
JOSEPH FOREHAND |
| K990942 |
08/02/1999 |
DUET II GLUCOSE CONTROL MONITORING SYSTEM |
LXN CORP. |
NEDA RASHTI |
| K992236 |
08/27/1999 |
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA |
LYSTA A/S |
GREGERS LYSTAGER |
| K991819 |
08/19/1999 |
MAGNATEK 30 |
MAGNA ADVANCED TECHNOLOGIES, INC. |
ANNIE VELEZ |
| K991426 |
08/05/1999 |
MAHE INSTRUMENTS |
MAHE INTL., INC. |
WINIFRIED REICH |
| K992035 |
08/12/1999 |
MANUAL WHEELCHAIR |
MAJOR MOBILITY PRODUCTS, INC. |
SCOTT SCHWEISS |
| K991685 |
08/13/1999 |
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR |
MEDIC-AID LTD. |
PAUL E DRYDEN |
| K991724 |
08/02/1999 |
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K992430 |
08/30/1999 |
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT D KINGHORN |
| K992413 |
08/19/1999 |
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR |
MEDICAL DATA ELECTRONICS |
DAVID M TRUEBLOOD |
| K992411 |
08/18/1999 |
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR |
MEDICAL DATA ELECTRONICS |
DAVID M TRUEBLOOD |
| K992483 |
08/30/1999 |
MEDIFIX INC. |
MEDIFIX, INC. |
GEORGE ALBULESCU |
| K991719 |
08/18/1999 |
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS |
MEDIMEX HOLFELD GMBH & CO. |
DONALD F GRABARZ |
| K991559 |
08/23/1999 |
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K992318 |
08/02/1999 |
MEDTRONIC AVE BRIDGE STENT |
MEDTRONIC AVE, INC. |
SUSAN WALTON |
| K992569 |
08/31/1999 |
MEDTRONIC AVE BRIDGE STENT |
MEDTRONIC AVE, INC. |
SUSAN WALTON |
| K990263 |
08/09/1999 |
IMMUNOCARD STAT! E. COLI O157:H7 |
MERIDIAN DIAGNOSTICS, INC. |
ALLEN D NICKOL |
| K984530 |
08/10/1999 |
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE |
METRIKA, INC. |
Erika B Ammirati |
| K992337 |
08/17/1999 |
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA |
MEXPO INTL., INC. |
TIM THAI |
| K991283 |
08/18/1999 |
DYNA TORQ TORQUE WRENCH, TORQUE WRENCH |
MICRO MOTORS, INC. |
KAREN U SALINAS |
| K990487 |
08/31/1999 |
EQUINOX OCCLUSION BALLOON SYSTEM |
MICRO THERAPEUTICS, INC. |
TOM DAUGHTERS |
| K991516 |
08/05/1999 |
MICRO-STRIP FOR MARIJUANA METABOLITES |
MICRODIAGNOSTICS, INC. |
ROY CHUNG |
| K991505 |
08/05/1999 |
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES |
MICRODIAGNOSTICS, INC. |
ROY CHUNG |
| K992138 |
08/09/1999 |
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES |
MICROMEDICS, INC. |
CHARLES GROTE |
| K991670 |
08/26/1999 |
SILVERSTEIN MICROWICK |
MICROMEDICS, INC. |
CHARLES GROTE |
| K991851 |
08/30/1999 |
RENACLEAR DIALYZER CLEANING SYSTEM |
MINNTECH CORP. |
RICHARD M ORMSBEE |
| K991989 |
08/27/1999 |
MITAKA POINT SETTER |
MITAKA USA, INC. |
MAX STURGIS |
| K992406 |
08/06/1999 |
VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM |
MITEK PRODUCTS |
PAULA E BULGER |
| K992439 |
08/13/1999 |
NORODYN 8000 SEMG SYSTEM, ND-8000 |
MYOTRONICS-NOROMED, INC. |
FRAY ADIB |
| K984029 |
08/05/1999 |
SILGEL STC-S |
NAGOR LTD. |
J.A. EVANS |
| K991823 |
08/25/1999 |
N-395 PULSE OXIMETER, MODEL N-395 |
NELLCOR PURITAN BENNETT, INC. |
DAVID A. C. GREEN |
| K990565 |
08/18/1999 |
SUZANNE |
NELLCOR PURITAN BENNETT, INC. |
DARIN BUSCH |
| K991769 |
08/18/1999 |
CUTANEOUS (BAR) ELECTRODE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991772 |
08/18/1999 |
CUTANEOUS (DISC) ELECTRODE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991770 |
08/18/1999 |
CUTANEOUS (GROUND) ELECTRODE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991771 |
08/18/1999 |
DIGITAL RING ELECTRDE |
NEURO SUPPLIES, INC. |
RONALD LUICH |
| K991566 |
08/03/1999 |
SOLUSTAPLE |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K991284 |
08/06/1999 |
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM |
NIDEK, INC. |
JERRY TSUTSUMI |
| K991623 |
08/09/1999 |
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA |
NIPRO MEDICAL CORP. |
KAELYN HADLEY |
| K982969 |
08/12/1999 |
NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 |
NONIN MEDICAL, INC. |
RICHARD P BENNETT |
| K992024 |
08/27/1999 |
SUPER PORCELAIN TI-22 |
NORITAKE CO., INC. |
MARSHA C WERTZBERGER |
| K990180 |
08/13/1999 |
BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING |
NORTRADE MEDICAL, INC. |
JAY W TAYLOR |
| K990179 |
08/13/1999 |
BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD |
NORTRADE MEDICAL, INC. |
JAY W TAYLOR |
| K990178 |
08/13/1999 |
BURNFREE PAIN RELIEVING GEL, MODEL 4B |
NORTRADE MEDICAL, INC. |
JAY W TAYLOR |
| K991701 |
08/10/1999 |
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 |
| K992086 |
08/19/1999 |
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K991846 |
08/05/1999 |
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE |
OMNIGRACE LTD. |
K.C. CHOONG |
| K991845 |
08/05/1999 |
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. |
OMNIGRACE LTD. |
K.C. CHOONG |
| K992589 |
08/26/1999 |
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY |
OPTI-CENTRE LABORATORIES |
MARTIN DALSING |
| K992473 |
08/12/1999 |
EXPRESSEYE |
OPTOMOTOR LABORATORIES |
BURKHART FISCHER |
| K992596 |
08/30/1999 |
TOF-WATCH S |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K992598 |
08/30/1999 |
TOF-WATCH SX |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K992349 |
08/24/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A SHULMAN |
| K991083 |
08/20/1999 |
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY |
OTSUKA PHARMACEUTICAL CO., LTD. |
JAMES W HARRIS |
| K991815 |
08/13/1999 |
EXPLORER 3D |
OUR SCIENTIFIC INTL., INC. |
MARIO CABALLERO |
| K992278 |
08/26/1999 |
HEPARIN CONTROL PLASMA LEVEL 1 |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| K992279 |
08/26/1999 |
HEPARIN CONTROL PLASMA LEVEL 2 |
PACIFIC HEMOSTASIS |
LAURA A WORFOLK |
| K992361 |
08/20/1999 |
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 |
PALL MEDICAL |
LEONARD S BERMAN |
| K992165 |
08/25/1999 |
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K992223 |
08/30/1999 |
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K992299 |
08/23/1999 |
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
| K991893 |
08/13/1999 |
PARALLAX TRACER RADIOPAQUE PARTICLES |
PARALLAX MEDICAL, INC. |
SUSAN G MARQUES |
| K990766 |
08/27/1999 |
CERSR ELECTROMYOGRAPHY SYSTEM |
PARASPINAL DIAGNOSTIC CORP. |
JOEL S FADEN |
| K992059 |
08/30/1999 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K991925 |
08/26/1999 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K992076 |
08/30/1999 |
PASCO MIC AND MIC/ID PANELS (CEFUROXIME) |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K992324 |
08/19/1999 |
FUNNEL TROCAR |
PATTON MEDICAL CORP. |
MICHAEL T PATTON |
| K990536 |
08/31/1999 |
O.B. TAMPON |
PERSONAL PRODUCTS CO. |
RALPH PETRONE |
| K991765 |
08/02/1999 |
SYNERGY SHOULDER COIL |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K992412 |
08/17/1999 |
IPASS BOLUS TRACKING |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K991943 |
08/23/1999 |
MRGP OPTICAL TRACKING UNIT |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K991826 |
08/10/1999 |
PLANMED SOPHIE AND SOPHIE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
| K990261 |
08/27/1999 |
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) |
PLUS ORTHOPEDICS |
HARTMUT LOCH |
| K992002 |
08/05/1999 |
AUTOHDL CHOLESTEROL REAGENT SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS |
| K992620 |
08/20/1999 |
BLULAZE |
PREMIER LASER SYSTEMS, INC. |
BETH A ROBERTS |
| K992422 |
08/10/1999 |
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991747 |
08/04/1999 |
QUICKVUE ONE-STEP H. PYLORI II TEST |
QUIDEL CORP. |
Robin Weiner |
| K991237 |
08/30/1999 |
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL |
RADIONICS, INC. |
NANCY MACDONALD |
| K992104 |
08/23/1999 |
PARSET, MODEL A10001E |
RD MEDICAL MFG., INC. |
CARLOS A RODRIGUEZ-GARCIA |
| K991698 |
08/25/1999 |
REDI-TEST PCP |
REDWOOD BIOTECH, INC. |
JANIS FREESTONE |
| K990428 |
08/12/1999 |
DRAINAGE BAG |
REMINGTON MEDICAL, INC. |
STEVE WOODY |
| K991261 |
08/05/1999 |
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET |
RESEARCH INSTRUMENTS LTD. |
DAVID C LANSDOWNE |
| K992336 |
08/13/1999 |
MONARCH II MINI MASK |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K991895 |
08/12/1999 |
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) |
RI MOS. S.R.L. |
JAMES DELANEY |
| K991718 |
08/12/1999 |
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 |
| K984304 |
08/12/1999 |
RIWO DRIVE GENERATOR |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K973707 |
08/04/1999 |
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
ROCHE MOLECULAR SYSTEMS, INC. |
ALEX WESOLOWSKI |
| K983618 |
08/05/1999 |
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
JEFFREY R SHIDEMAN |
| K992071 |
08/27/1999 |
TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE |
RON-TECH MEDICAL LTD. |
AHAVA STEIN |
| K992494 |
08/25/1999 |
FLEXIFLO ENTERAL FEEDING TUBE |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
DANIEL HAMILTON |
| K992387 |
08/03/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K992388 |
08/03/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K990619 |
08/03/1999 |
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K990630 |
08/19/1999 |
SAS ADENO TEST |
SA SCIENTIFIC, INC. |
J. WESSLING |
| K990842 |
08/09/1999 |
SAS ROTA TEST |
SA SCIENTIFIC, INC. |
J. WESSLING |
| K992162 |
08/30/1999 |
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM |
SAFESKIN CORP. |
EUGENE V GOORCHENKO |
| K992062 |
08/25/1999 |
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES |
SAFESKIN CORP. |
EUGENE V GOORCHENKO |
| K991788 |
08/06/1999 |
SALTER LABS PEP DEVICE |
SALTER LABS |
DUANE KAZAL |
| K991594 |
08/05/1999 |
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS |
SANGSTAT MEDICAL CORP. |
EDA S COOK |
| K992362 |
08/05/1999 |
FLEXISCOPE IQ 101 |
SCHOELLY FIBEROPTIC, GMBH |
JOSEPH RESS |
| K990545 |
08/11/1999 |
JETSONIC 2000 |
SDS DENTAL, INC. |
CESAR CORAL |
| K992503 |
08/10/1999 |
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES |
SECHRIST INDUSTRIES, INC. |
GREG GODFREY |
| K983800 |
08/27/1999 |
DN ACUPUNTURE NEEDLES |
SEDATELEC |
DAVID W SCHLERF |
| K983798 |
08/27/1999 |
SEDATELEC ASP ACUPUNCTURE NEEDLES |
SEDATELEC |
DAVID W SCHLERF |
| K991778 |
08/31/1999 |
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991777 |
08/31/1999 |
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991779 |
08/11/1999 |
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991776 |
08/11/1999 |
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) |
SELTOM PACIFIC SDN. BHD. |
S. SEGARAN |
| K991972 |
08/13/1999 |
INFANT FLOW SYSTEM |
SENSORMEDICS CORP. |
ALEX STENZLER |
| K992395 |
08/26/1999 |
URINE DRUG SCREENING CONTROL |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K992017 |
08/05/1999 |
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K992200 |
08/17/1999 |
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K992463 |
08/30/1999 |
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG DILLY PLASTICS PRODUCTS CO., LTD. |
XINGLAI ZHOU |
| K991652 |
08/03/1999 |
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM |
SIEMENS CORP. |
KATHLEEN RUTHERFORD |
| K991764 |
08/17/1999 |
SOMATOM PROJECT 10-CT SCANNERS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALICIA JUERGENSEN |
| K992046 |
08/13/1999 |
SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE HESLER |
| K991268 |
08/11/1999 |
GONOSTAT GONOCOCCAL DETECTION KIT |
SIERRA DIAGNOSTICS |
DONALD R STONE |
| K992644 |
08/23/1999 |
SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
| K990666 |
08/06/1999 |
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
| K991565 |
08/02/1999 |
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S |
SMV AMERICA |
PHIL VERNON |
| K991198 |
08/27/1999 |
DYNA-LOK PLUS SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K991995 |
08/27/1999 |
SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS |
SOFTCHROME, INC. |
MARTIN DALSING |
| K991791 |
08/12/1999 |
SOUND VASER SYSTEM |
SOUND SURGICAL TECHNOLOGIES LLC. |
WILLIAM W CIMINO |
| K991888 |
08/25/1999 |
MINIJECT |
SPARTAN ULTRASONICS, INC. |
ALDO EAGLE |
| K991960 |
08/13/1999 |
SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH |
Stryker Endoscopy |
N. MANI PRAKASH |
| K991254 |
08/23/1999 |
QS DELIVERY SYSTEM |
SUB-Q, INC. |
DAN W MILLER |
| K974728 |
08/03/1999 |
INTER-OP METASUL ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K992081 |
08/19/1999 |
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL |
SURETEX PROPHYLACTICS (INDIA) LTD. |
LON D MCILVAIN |
| K992457 |
08/27/1999 |
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION |
SURGICAL NAVIGATION SPECIALISTS, INC. |
CAROL NAKAGAWA |
| K991273 |
08/18/1999 |
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE |
SWEMED LAB INTERNATIONAL AB |
EDWARD C WILSON JR. |
| K992160 |
08/18/1999 |
NEXUS 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K992118 |
08/18/1999 |
PRODIGY 4 TRANSLUCENT SHADES |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K991089 |
08/27/1999 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES SPINE |
JONATHAN GILBERT |
| K992051 |
08/10/1999 |
RADIFOCUS OPTITORQUE |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
| K991932 |
08/20/1999 |
INTRAVASCULAR ADMINISTRATION SET |
THE KIPP GROUP |
GARY WERSCHMIDT |
| K991931 |
08/12/1999 |
CTD MARK I TRACTION DEVICE |
THERASYS, INC. |
EARNIE S PHILPOT |
| K992428 |
08/09/1999 |
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE |
TILLOTSON HEALTHCARE CORP. |
THOMAS N TILLOTSON |
| K980244 |
08/23/1999 |
AEQUALIS SHOULDER PROSTHESIS |
TORNIER |
DAVID W SCHLERF |
| K991766 |
08/10/1999 |
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K991740 |
08/02/1999 |
OPART, MODEL MRT-600 |
TOSHIBA AMERICA MRI, INC. |
HSU CHANG |
| K992365 |
08/10/1999 |
AIA-PACK FOLATE ASSAY |
TOSOH MEDICS, INC. |
JUDITH E LOEBEL |
| K991316 |
08/09/1999 |
TOUCH TEAR IGE MICROASSAY KIT |
TOUCH SCIENTIFIC, INC. |
ALAN J TOUCH |
| K992229 |
08/06/1999 |
MXU-125 OR TMX-125 |
TREX MEDICAL CORP. |
KELVIN BURROUGHS |
| K991693 |
08/17/1999 |
TWO RIVERS POWER LIFT/RECLINE CHAIR |
TWO RIVERS, LLC. |
CHRIS WHITAKER |
| K991720 |
08/09/1999 |
KRONUS OPTIQUANT THYROGLOBULIN KIT |
UNCHANGED |
A.P. DOERSCCHUK |
| K982860 |
08/13/1999 |
UM-L20/ UM-L30 |
UNION MEDICAL ENGENEERING CO., LTD. |
ANNIE VALEZ |
| K990651 |
08/13/1999 |
SKIN 2 FORTE SILICONE SHEETING |
UNITED HOSPITAL TECHNOLOGIES, INC. |
SAMUEL SWETLAND |
| K992391 |
08/18/1999 |
UROSURGE SPIRALFLO URETERAL STENT |
UROSURGE, INC. |
STEVEN J PREISS |
| K992485 |
08/27/1999 |
MONOPOLAR ELECTRODES AND CABLES |
US ENDO, INC. |
JONEL MANCIU |
| K984532 |
08/09/1999 |
CADPLAN HELIOS OPTION 6.0 |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
| K984567 |
08/12/1999 |
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) |
VENTANA, INC. |
JUDITH FREDERICK |
| K992289 |
08/04/1999 |
VINYL POWDERED EXAM GLOVE / CAT.# 15-020 |
VITALCARE GROUP, INC. |
GINGER TALLEY |
| K991669 |
08/12/1999 |
PMS 750 FINGERSWITCH |
WALLACH SURGICAL DEVICES, INC. |
MICHAEL MALIS |
| K991806 |
08/06/1999 |
VHS SUPRACONDYLAR PLATE SYSTEM |
WALTER ABENDSCHEIN, M.D. |
WALTER ABENDSCHEIN |
| K991437 |
08/30/1999 |
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 |
WELLS JOHNSON CO. |
KEN RODENBURG |
| K991678 |
08/12/1999 |
WHITESIDE BIOMECHANICS SPINAL SYSTEM |
WHITESIDE BIOMECHANICS, INC. |
DEBRA MEYER |
| K991820 |
08/12/1999 |
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
