FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K010142 |
01/17/2001 |
OCO DENTAL IMPLANT |
"O" CO., INC. |
DAVID D DALISE |
K013841 |
11/20/2001 |
3DFIS, MODEL IES-FL-101 |
3DSHARP, INC. |
DONALD KRIEGER |
K010183 |
01/19/2001 |
GLOBAL BY BLASTOCYST MEDIA |
INTL., INC. |
MICHAEL D CECCHI |
K010056 |
01/08/2001 |
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 |
A & A MEDICAL, INC. |
JIHAD MANSOUR |
K010127 |
01/03/2001 |
W & H ASSISTINA |
A-DEC, INC. |
LOVENA STANDRIDGE |
K013683 |
11/07/2001 |
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE |
ABBOTT VASCULAR INC. |
PATTY HEVEY |
K010011 |
01/02/2001 |
TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM |
ACCELERATED REHAB DESIGNS, INC. |
RANDALL POTTER |
K010238 |
01/25/2001 |
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ |
ACTHERM, INC. |
RICHARD HSIEH |
K013616 |
11/05/2001 |
POLARUS CAP SCREW |
ACUMED, INC. |
SHARI JEFFERS |
K013886 |
11/23/2001 |
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) |
ADVANCED DIAGNOSTICS, INC. |
STEVE HESSLER |
K010245 |
01/25/2001 |
ACTIVHEAL SCAR MANAGEMENT DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
CHRIS OAKES |
K013778 |
11/13/2001 |
PEACE OF MIND HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
K013946 |
11/29/2001 |
FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM |
AFX, INC. |
NANCY NORRIS |
K010275 |
01/30/2001 |
DRYSTAR 4500 PRINTER, MODEL 4500 |
AGFA MEDICAL IMAGING |
KIRSTEN PAULSON |
K010048 |
01/05/2001 |
M2376A DEVICELINK SYSTEM |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
K013893 |
11/23/2001 |
SCANX |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
K010131 |
01/16/2001 |
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB |
AKSYS, LTD. |
JAN L ZORN |
K013713 |
11/08/2001 |
ARM AUTOMATIC REPROCESSING MACHINE |
ALCAVIS INTERNATIONAL INCORPORATED |
LUDOVICO GIAVOTTO |
K010015 |
01/02/2001 |
INSTANT-VIEW METHADONE URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010014 |
01/02/2001 |
INSTANT-VIEW METHADONE URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010080 |
01/10/2001 |
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010079 |
01/10/2001 |
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010047 |
01/05/2001 |
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010045 |
01/05/2001 |
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST |
ALFA SCIENTIFIC DESIGNS, INC. |
NAISHU WANG |
K010211 |
01/23/2001 |
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
K010223 |
01/24/2001 |
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) |
AMERICAN CONTACT LENS, INC. |
MARTIN DALSING |
K013637 |
11/05/2001 |
ACTICHROME HEPARIN (ANTI-FIIA) |
AMERICAN DIAGNOSTICA, INC. |
JOHN BERRYMAN |
K010046 |
01/05/2001 |
NUVOLASE 532 MEDICAL LASER SYSTEM |
AMERICAN LASER CORP. |
DANIEL HOEFER |
K010277 |
01/30/2001 |
AMS FASCIAL-ANCHORING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA LINKE |
K010192 |
01/22/2001 |
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION |
ANTYLLOS MEDIZINTECHNIK GMBH |
HARALD JUNG |
K013813 |
11/16/2001 |
MODIFICATION TO:APEX MEDICAL IF-4100 |
APEX MEDICAL CORP. |
ALAN CHANGE |
K010182 |
01/19/2001 |
VCF PERSONAL LUBRICANT |
APOTHECUS PHARMACEUTICAL CORP. |
GARY L YINGLING |
K010006 |
01/02/2001 |
DRAINAGE CATHETER OR FOLEY CATHETER |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
K013756 |
11/13/2001 |
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) |
ARGUS BIOMEDICAL PTY LTD |
BARBARA S FANT |
K013614 |
11/05/2001 |
TROJAN CRYSTAL CLEAR LIQUID |
ARMKEL LLC |
STEPHEN C KOLAKOWSKY |
K010063 |
01/08/2001 |
COUCH FOR TOTAL BODY RADIATION |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K010065 |
01/08/2001 |
CRANIAL STEREOTACTIC EQUIPMENT |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K010172 |
01/18/2001 |
LEAD BLOCKS |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K010062 |
01/08/2001 |
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
K010174 |
01/18/2001 |
TRAY ADAPTERS, MULTIPLE |
ARPLAY MEDICAL S.A. |
RICHARD BORJ |
K010124 |
01/16/2001 |
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS |
ARTHREX, INC. |
VERNON BROWN |
K013940 |
11/29/2001 |
LASER SYSTEM YELLOWSTAR |
ASCLEPION-MEDITEC AG |
WILLIAM KELLEY |
K013643 |
11/05/2001 |
AUSAM TOTAL ALBUMIN ASSAY |
AUSAM BIOTECTHNOLOGIES INC |
LYNN ROLAND |
K013818 |
11/16/2001 |
AUTOGENESIS AUTOMATOR, MODEL M1000 |
AUTOGENESIS, INC. |
JAMES EDWARDS |
K013629 |
11/05/2001 |
FINGER JOINT PROSTHESIS |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
K010029 |
01/03/2001 |
HOME HEALTH MONITORING SYSTEM |
AVID CARE CORP. |
WILLIAM GENTHE |
K010292 |
01/31/2001 |
DRX 2000 |
AXIOM WORLDWIDE, INC. |
JIM GIBSON |
K013672 |
11/06/2001 |
BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM |
AZARY TECHNOLOGIES LLC. |
JOSEPH M AZARY |
K013610 |
11/05/2001 |
PERIFIX SAFETY EPIDURAL NEEDLES |
B. BRAUN MEDICAL, INC. |
SHERI L MUSGNUNG |
K013635 |
11/05/2001 |
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) |
BACCHUS VASCULAR, INC. |
GREG MATHISON |
K013892 |
11/23/2001 |
LUTZ NEEDLE |
BALLARD MEDICAL PRODUCTS |
SYDNEE F MCMILLAN |
K013922 |
11/27/2001 |
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM |
BARCO NV |
FRANK FERGUSON |
K013682 |
11/07/2001 |
MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
K013762 |
11/13/2001 |
RIGID GAS PERMEABLE CONTACT LENS |
BAUSCH & LOMB INCORPORATED |
DEBRA L.B. KETCHUM |
K010260 |
01/29/2001 |
HANSATOME MICROKERATOME |
BAUSCH & LOMB, INC. |
PAUL S KRAMSKY |
K010201 |
01/22/2001 |
BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
FREDICK CLERIE |
K013750 |
11/13/2001 |
ADVIA 1650 CHOLINESTERASE ASSAY |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K010050 |
01/05/2001 |
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY |
BAYER DIAGNOSTICS CORP. |
THOMAS F FLYNN |
K013959 |
11/30/2001 |
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K010265 |
01/26/2001 |
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K013904 |
11/26/2001 |
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K013919 |
11/27/2001 |
TORFLEX TRANSSEPTAL GUIDING SHEATH |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K013862 |
11/21/2001 |
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM |
BCI, INC. |
DONALD ALEXANDER |
K010188 |
01/22/2001 |
BD ECLIPSE HYPODERMIC NEEDLE |
BD MEDICAL SYSTEMS |
GREG W MORGAN |
K013719 |
11/08/2001 |
BECKER BAND CRANIAL REMOLDING ORTHOSIS |
BECKER ORTHOPEDIC APPLIANCE CO. |
JAMES H CAMPBELL |
K010064 |
01/08/2001 |
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K010066 |
01/08/2001 |
5C-ES CELL CONTROL, MODELS 7547191, 7547192 |
BECKMAN COULTER, INC. |
STAN SUGRUE |
K010236 |
01/25/2001 |
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
K013842 |
11/20/2001 |
IMMUNO-TROL LOW CELLS |
BECKMAN COULTER, INC. |
LOURDES COBA |
K013621 |
11/05/2001 |
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
K013800 |
11/15/2001 |
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
K013668 |
11/06/2001 |
BERCHTOLD ELEKTROTOM 106 HITT |
BERCHTOLD CORP. |
MARIKA ANDERSON |
K010185 |
01/19/2001 |
6.0 X 5.7MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
K013839 |
11/19/2001 |
BIO-RAD PLATELIA TOXO IGG TMB |
BIO-RAD |
CHRISTOPHER BENTSEN |
K013837 |
11/19/2001 |
BIO-RAD PLATELIA TOXO IGM TMB |
BIO-RAD |
CHRISTOPHER BENTSEN |
K013897 |
11/23/2001 |
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW |
BIO-SCAN S.A |
RICHARD M SANO |
K013908 |
11/26/2001 |
WATERLASE MILLENNIUM |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
K013691 |
11/07/2001 |
CERALAS D DIODE LASER SYSTEM, MODEL # D50 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
K010209 |
01/23/2001 |
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
K013790 |
11/14/2001 |
CALCIGEN-S BONE VOID FILER |
BIOMET ORTHOPEDICS, INC. |
PATRICIA S BERES |
K013657 |
11/06/2001 |
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES |
BIOMET ORTHOPEDICS, INC. |
TRACY J BICKEL |
K013923 |
11/27/2001 |
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER |
BIOMET ORTHOPEDICS, INC. |
LONNIE WITHAM |
K010027 |
01/03/2001 |
MAXIM KNEE SYSTEM |
BIOMET, INC. |
DALENE T BINKLEY |
K010212 |
01/23/2001 |
OFFSET TIBIAL TRAY |
BIOMET, INC. |
CAROL LAUSTER |
K010149 |
01/17/2001 |
WUJIN #3 FEMORAL NAIL |
BIOPRO, INC. |
ANGENA PAREKH |
K010266 |
01/29/2001 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
K013803 |
11/15/2001 |
FLOWGUARD DEVICE |
BIOSONIX LTD. |
AHAVA STEIN |
K010057 |
01/08/2001 |
MODIFICATION TO ARTOSCAN M |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
K010026 |
01/03/2001 |
EMBOGOLD MICROSPHERE |
BIOSPHERE MEDICAL, INC. |
JOHN D BONASERA |
K013634 |
11/05/2001 |
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK |
BIOTEQUE CORP. |
JENNIFER REICH |
K010281 |
01/30/2001 |
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP |
BIOTRONIK, INC. |
Jon Brumbaugh |
K013642 |
11/05/2001 |
AVEA |
BIRD PRODUCTS CORP. |
TOM GUTIERREZ |
K010196 |
01/22/2001 |
TOTAL CURE |
BISCO, INC. |
CYNDY ORIS |
K013885 |
11/23/2001 |
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS |
BLACKSTONE MEDICAL, INC. |
ALAN LOMBARDO |
K013866 |
11/21/2001 |
CONVOY ADVANCED DELIVERY SHEATH KIT |
BOSTON SCIENTIFIC |
ANDREA L RUTH |
K013873 |
11/21/2001 |
COBRA CARDIAC ELECTROSURGICAL SYSTEM |
BOSTON SCIENTIFIC CORP. |
ANDREA L RUTH |
K010002 |
01/02/2001 |
CONTOUR POLARIS URETERAL STENT |
BOSTON SCIENTIFIC CORP. |
LINDA J VARROSO |
K013784 |
11/14/2001 |
URETERAL STENT |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
K013789 |
11/14/2001 |
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 |
BOSTON SCIENTIFIC, TARGET |
GEORGE J PRENDERGAST |
K013928 |
11/28/2001 |
PAIN CARE 3200 |
BREG, INC. |
KATHLEEN BARBER |
K013717 |
11/08/2001 |
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
RUOMEI ZHANG |
K013852 |
11/20/2001 |
JOBST READY-TO-WEAR GAUNTLET |
BSN-JOBST, INC. |
ANGELO R PEREIRA |
K010169 |
01/18/2001 |
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
CAROL VIERLING |
K013907 |
11/26/2001 |
INVERNESS MEDICAL EARLY PREGNANCY TEST |
CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
AVRIL MURRAY |
K010038 |
01/05/2001 |
NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE |
CAMBRIDGE MARKETING, INC. |
JOSEPH B DUNN |
K010104 |
01/12/2001 |
CANDELA LONG PULSE ND:YAG |
CANDELA CORP. |
JOAN CLIFFORD |
K013748 |
11/13/2001 |
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) |
CANDELA CORP. |
L NELSON |
K013825 |
11/19/2001 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORRAINE NELSON |
K013855 |
11/20/2001 |
MICROJET CRONO H |
CANE S.R.I. |
DANIEL KAMM |
K013776 |
11/13/2001 |
MICROJET MODEL # CD4 AND CD4/20 |
CANE S.R.I. |
DANIEL KAMM |
K013840 |
11/19/2001 |
MICROJET CRONO PAR AND CRONO APO-GO |
CANE SRL |
DANIEL KAMM |
K013822 |
11/16/2001 |
MICROJET CRONO PCA |
CANE SRL |
DANIEL KAMM, PE |
K013807 |
11/15/2001 |
MICROJET QUARK, MODEL U100 OR U40 |
CANE SRL |
DANIEL KAMM |
K010184 |
01/19/2001 |
CHESS HAND SURGERY SYSTEM |
CANICA DESIGN, INC. |
GEORGETTE ROY |
K013753 |
11/13/2001 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
CANOPUS MEDICAL SUPPLY CO., LTD. |
ELIZABETH DENG |
K013879 |
11/23/2001 |
TM2000, MODEL 1 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K013901 |
11/26/2001 |
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) |
CARDIOFOCUS, INC. |
JOSEPH CURTIS |
K010261 |
01/29/2001 |
CARDIOMEDICS ECP SYSTEM |
CARDIOMEDICS, INC. |
JOHN HUTCHINS |
K010117 |
01/16/2001 |
GUIDANT AXIUS CORONARY SHUNT |
CARDIOTHORACIC SYSTEMS, INC. |
ANNE SCHLAGENHAFT |
K010133 |
01/17/2001 |
VERSALUX |
CENTRIX, INC. |
JOHN DISCKO |
K010191 |
01/22/2001 |
Y2000 POCKET RESCUE |
CHEEN HOUNG ENT. CO. LTD. |
JAY WANG |
K010244 |
01/25/2001 |
SURE CHECK OVULATION PREDICTOR |
Chembio Diagnostic Systems, Inc. |
FRAN WHITE |
K013733 |
11/09/2001 |
SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET |
CHF SOLUTIONS, INC. |
DIANNA THOMSEN |
K010039 |
01/05/2001 |
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION |
CHRONIMED, INC. |
BRUCE A MACFARLANE |
K013949 |
11/30/2001 |
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR |
CHURCHILL MEDICAL SYSTEMS, INC. |
KETIH PALUCH |
K013950 |
11/30/2001 |
VENTED VIAL ACCESS DEVICE |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEITH PALUCH |
K013721 |
11/09/2001 |
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
THERESA LEINEN |
K010126 |
01/16/2001 |
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
CL-TINTERS |
MARTIN S KNOPF |
K013863 |
11/21/2001 |
CRYSTAL MONITOR MODEL 16 |
CLEVELAND MEDICAL DEVICES, INC. |
ROBERT N SCHMIDT |
K013664 |
11/06/2001 |
COALESCENT SURGICAL U-CLIP |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
K013714 |
11/08/2001 |
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP |
CODAN US CORP. |
MARILYN R POURAZAR |
K013877 |
11/23/2001 |
CODMAN SLIM-LOC SYSTEM |
Codman & Shurtleff, Inc. |
KATHRYN WUNDER |
K013804 |
11/15/2001 |
SOCRATES ROBOTIC TELEMONITORING SYSTEM |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
K013690 |
11/07/2001 |
IDENT-A100 INTRAORAL VIDEO CAMERA |
CONFIDENT TECHNOLOGY, INC. |
LEWIS LIN |
K013814 |
11/16/2001 |
ABSORBENT ANTIMICROBIAL WOUND DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
DEMETRIOS KYDONIEUS |
K010055 |
01/08/2001 |
COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
K010128 |
01/16/2001 |
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
K010242 |
01/25/2001 |
COOK ZILVER BILIARY STENT |
COOK, INC. |
LISA HOPKINS |
K010034 |
01/04/2001 |
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- |
COOK, INC. |
LISA WEBB |
K010016 |
01/02/2001 |
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER |
COOK, INC. |
LISA HOPKINS |
K013916 |
11/27/2001 |
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET |
COOK, INC. |
HEIDI MASTEN |
K013865 |
11/21/2001 |
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER |
COOK, INC. |
LISA HOPKINS |
K010083 |
01/11/2001 |
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A |
CORDIS CORP. |
KAREN WILK |
K010243 |
01/25/2001 |
TRI-FIT FEMORAL STEM |
CORIN U.S.A. |
JOEL K BATTS |
K013623 |
11/05/2001 |
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 |
CURELIGHT LTD |
JONATHAN S KAHAN |
K010210 |
01/23/2001 |
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 |
CURON MEDICAL, INC. |
THOMAS C WEHMAN |
K013878 |
11/23/2001 |
CYBERMED, INC., V-WORKS |
CYBERMED, INC. |
GARY J ALLSEBROOK |
K010005 |
01/02/2001 |
CYNOSURE PHOTOGENICA DL |
CYNOSURE, INC. |
GEORGE CHO |
K010061 |
01/08/2001 |
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K010208 |
01/23/2001 |
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K010206 |
01/23/2001 |
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
K010159 |
01/17/2001 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K010037 |
01/04/2001 |
DAUM DOUBLE-SHOOT BISOPSY GUN |
DAUM GMBH |
CHRISTINA SMITH |
K013896 |
11/23/2001 |
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA |
DEFIBTECH, LLC |
GINTARAS VAISNYS |
K013808 |
11/15/2001 |
SLEEPBITE |
DENTAL IMAGINEERS, LLC. |
WILLIAM A BELFER |
K013824 |
11/19/2001 |
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH |
DENTAL MANUFACTURING S.P.A |
Kevin Walls |
K010171 |
01/18/2001 |
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
K010025 |
01/03/2001 |
ELECTRICATOR MODEL 26000 |
DERMATOLOGIC LAB & SUPPLY, INC. |
DEBORAH GRAFELMAN |
K013880 |
11/23/2001 |
DAYLITE XENON LIGHT SOURCES |
DESIGNS FOR VISION, INC. |
AMY GRUMET-AVALLONE |
K010455 |
01/29/2001 |
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN |
DIAGNOSTICA-STAGO |
ANDREW LOC B LE |
K013628 |
11/05/2001 |
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
K013956 |
11/30/2001 |
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN |
DIAMEDIX CORP. |
LYNNE STIRLING |
K013938 |
11/28/2001 |
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE |
DIAMETRICS MEDICAL, INC. |
NANCY RING |
K013850 |
11/20/2001 |
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
K013915 |
11/27/2001 |
D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER |
DIDECO S.P.A. |
SHAWN RIEDEL |
K013782 |
11/14/2001 |
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE |
DISETRONIC MEDICAL SYSTEMS |
DAVID E CHADWICK |
K013674 |
11/07/2001 |
LUXATEMP/LUXATEMP SOLAR/INSTATEMP |
DMG USA, INC. |
PAMELA PAPINEAU |
K013786 |
11/14/2001 |
DRG ORTHOHEX SS BONE SCREW |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
K010093 |
01/11/2001 |
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 |
DRAGER MEDIZINTECHNIK GMBH |
JAMES J BRENNAN |
K010082 |
01/10/2001 |
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
K013835 |
11/19/2001 |
GLOBAL HEALTHCARE VAGINAL SPECULUM |
DYNASCEND CONSULTING INT'L LLC. |
ALAM AHMED |
K010028 |
01/03/2001 |
SHEER THIN AROMAS RED LATEX CONDOM |
EAGLE TWE, INC. |
KEITH HEINTZ |
K013686 |
11/07/2001 |
KODAK DIRECTVIEW TABLETOP CASSETTE |
EASTMAN KODAK COMPANY |
JUDITH A WALLACE |
K010179 |
01/19/2001 |
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K010003 |
01/02/2001 |
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K013739 |
11/13/2001 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K013631 |
11/05/2001 |
EFILM VIDEO |
EFILM MEDICAL, INC. |
JOSEPH A THOMAS |
K013861 |
11/21/2001 |
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE |
ELEKTA INSTRUMENT AB |
CAROL PATTERSON |
K010112 |
01/12/2001 |
BIPOLAR COAGULATION SYSTEM |
ENABLE MEDICAL CORP. |
MARK L FRIEDMAN |
K013680 |
11/07/2001 |
CARBODISSECTING ENDOSCOPE |
ENDO SURGICAL DEVICES, INC. |
DEBBIE IAMPIETRO |
K013728 |
11/09/2001 |
TRACH VOX |
ENGINEERED MEDICAL SYSTEMS |
PAUL DRYDEN |
K013712 |
11/08/2001 |
ENTERYX INJECTOR |
ENTERIC MEDICAL TECHNOLOGIES |
JILL M VISOR |
K013820 |
11/16/2001 |
FINN CHAMBER (R) |
EPITEST LTD. OY |
CLAWSON BOWMAN |
K013749 |
11/13/2001 |
ENDOANCHOR AND OPENANCHOR |
ETHICON ENDO-SURGERY, INC. |
DOUG KENTZ |
K010165 |
01/18/2001 |
ERO SCAN OAE TEST SYSTEM |
ETYMOTIC RESEARCH |
STEVE ISEBERG |
K010081 |
01/10/2001 |
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS |
EXACTECH, INC. |
Lisa Simpson |
K010120 |
01/16/2001 |
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S |
EXACTECH, INC. |
GARY J MILLER |
K010150 |
01/17/2001 |
64 CHANNEL EEG / MODEL NUMBER EX-NW-64 |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010085 |
01/11/2001 |
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010091 |
01/11/2001 |
EEG WITH VIDEO, MODEL EX-NW |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010088 |
01/11/2001 |
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) |
EXCEL TECH. LTD. |
CAMERON MAHON |
K010086 |
01/11/2001 |
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010084 |
01/11/2001 |
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP |
EXCEL TECH. LTD. |
DEBBIE DAVY |
K010089 |
01/11/2001 |
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) |
EXCEL TECH. LTD. |
DEBBIE DAVY |
K010090 |
01/11/2001 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010092 |
01/11/2001 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
K010087 |
01/11/2001 |
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP |
EXCEL TECH. LTD. |
CAMERON MAHON |
K010197 |
01/22/2001 |
EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET |
EXELINT INTERNATIONAL CO. |
ARMAND HAMID |
K010270 |
01/29/2001 |
TREMOROMETER |
FLEXABLE SYSTEMS, INC. |
ROBERT M TRIPP |
K010268 |
01/29/2001 |
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
K013867 |
11/21/2001 |
XIVE DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
K013685 |
11/07/2001 |
PLLA CANNULATED INTERFERENCE SCREW |
FUTURE MEDICAL SYSTEMS, INC. |
PATRICK JANIN |
K010122 |
01/16/2001 |
CONTINUOUS FLOW Y-TUBING |
G.U.-TEK |
ANTHONY SOLAZZO |
K013724 |
11/09/2001 |
BICART |
GAMBRO RENAL PRODUCTS |
FEI LAW |
K013636 |
11/05/2001 |
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K010042 |
01/05/2001 |
CT PERFUSION 2 |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
K010164 |
01/18/2001 |
ICG MODULE |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
K010217 |
01/24/2001 |
4 PORT, 4 WAY STOPCOCK |
GEORGE LOO, MD |
GEORGE LOO |
K013857 |
11/21/2001 |
AIMSTEP PREGNANCY |
GERMAINE LABORATORIES, INC. |
MARTIN O'CONNOER |
K013731 |
11/09/2001 |
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 |
GIMMI GMBH |
DAGMAR S MASER |
K013707 |
11/08/2001 |
SOFTIQUE, MODEL GI 11001 |
GLOBAL TV CONCEPTS, LTD. |
LAURIE BRADEN |
K013828 |
11/19/2001 |
GLOVCO EBONY |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
K013738 |
11/13/2001 |
WEINMANN SOMNOMASK |
GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS |
ECKHARDT ALBERS |
K013833 |
11/19/2001 |
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 |
GUIDANT CORP. |
JENNIFER PAE RIGGS |
K013638 |
11/05/2001 |
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER |
GUIDANT CORP. |
NANCY E RALSTON |
K010054 |
01/08/2001 |
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
K010078 |
01/10/2001 |
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) |
GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD |
SUSAN D GOLDSTEIN-FALK |
K013718 |
11/08/2001 |
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR |
GYNECARE, A DIV. OF ETHICON, INC. |
GREGORY R JONES |
K013692 |
11/07/2001 |
TRAPSYSTEM SET |
H.S. HOSPITAL SERVICE S.R.L. |
LUCIO IMPROTA |
K013615 |
11/05/2001 |
MICRO-INDUCTION 1000 SYSTEM |
HARBINGER MEDICAL, INC. |
HAROLD HOIUM |
K013611 |
11/05/2001 |
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
LYNETTE HOWARD |
K013709 |
11/08/2001 |
HILL-ROM PRIMAVIEW MONITOR SYSTEM |
HILL-ROM, INC. |
TIMOTHY M DAVIS |
K013723 |
11/09/2001 |
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
WALTER WEYBURNE |
K013722 |
11/09/2001 |
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
WALTER WEYBURNE |
K013612 |
11/05/2001 |
INCARE PELVIC FLOOR THERAPY SYSTEM |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
K013653 |
11/06/2001 |
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE |
HOLLISTER, INC. |
CINDY ROBERTS |
K013871 |
11/21/2001 |
LIFEGUARD SAFETY INFUSION SET |
HORIZON MEDICAL PRODUCTS, INC. |
PATRICIA D JONES |
K010189 |
01/22/2001 |
VORTEX ACCESS SYSTEM |
HORIZON MEDICAL PRODUCTS, INC. |
PENNY M NORTHCUTT |
K010075 |
01/09/2001 |
TEKNIQUE |
HOVEROUND CORP. |
TONY DIGIOVANNI |
K013772 |
11/13/2001 |
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
K010100 |
01/11/2001 |
AVON PATELLO-FEMORAL JOINT PROSTHESIS |
HOWMEDICA OSTEONICS CORP. |
ELIZABETH A STAUB |
K013688 |
11/07/2001 |
MODIFICATION TO XIA SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K010115 |
01/16/2001 |
REFLEX ANTERIOR CERVICAL PLATE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K013676 |
11/07/2001 |
TRIDENT HEMISPHERICAL ACETABULAR SHELLS |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K010170 |
01/18/2001 |
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
K013823 |
11/19/2001 |
XIA SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
K010166 |
01/18/2001 |
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
JULIE POWELL |
K013755 |
11/13/2001 |
CONCERT RADIOPAQUE BONE CEMENT |
IMMEDICA, INC. |
RUSSELL PAGANO |
K013732 |
11/09/2001 |
GELZONE |
IMPLANTECH ASSOCIATES, INC. |
STEPHEN MEADE |
K013958 |
11/30/2001 |
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE |
INDUS TEXTILES, INC. |
MICHELE H VOVOLKA |
K013705 |
11/08/2001 |
ACT III VENTRICULAR CATHETER |
INNERSPACE, INC. |
DONALD E BOBO |
K010178 |
01/19/2001 |
SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AU-KAU |
K013889 |
11/23/2001 |
ENDOSCOPIC MULTI-FIRE CLIP APPLIER |
INSCOPE, LLC. |
BRUCE WEBER |
K013798 |
11/15/2001 |
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
K013891 |
11/23/2001 |
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
K010220 |
01/24/2001 |
XTRACTOR, MODEL M143 |
INSTRUMENTS MEDICAUX G.B., INC. |
MARTIN PAQUETTE |
K010219 |
01/24/2001 |
CHALLENGER DIRECT COMPOSITE |
INTERNATIONAL DENTAL RESEARCH |
PAMELA PAPINEAU |
K013783 |
11/14/2001 |
AUTION MAX AX-4280 URINALYSIS SYSTEM |
INTERNATIONAL REMOTE IMAGING SYSTEMS |
CYNTHIA J.M NOLTE |
K010193 |
01/22/2001 |
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS |
INTERNATIONAL TECHNIDYNE CORP. |
JOHN CLAY |
K013651 |
11/06/2001 |
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS |
INTERVASCULAR |
Amy Aulwes |
K013941 |
11/29/2001 |
PULSION FS LASER KERATOME |
INTRALASE CORP. |
CHARLINE GAUTHIER |
K013952 |
11/30/2001 |
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
MICHAEL YRAMATEGUL |
K010135 |
01/17/2001 |
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4 |
INVACARE CORP. |
RAE A FARROW |
K013667 |
11/06/2001 |
BCC GAMMA CAMERA |
IS2 RESEARCH, INC. |
VICTOR WOODBURN |
K010156 |
01/16/2001 |
SLEEP PAT 200 DEVICE |
ITAMAR MEDICAL (C.M.) 1997 LTD. |
GEORGE H MYERS |
K010250 |
01/26/2001 |
TETRIC CERAM HB |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
K013809 |
11/15/2001 |
D.SIGN 59 |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
K013802 |
11/15/2001 |
FRC POSTEC |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K013929 |
11/28/2001 |
HELIOMOLAR HB TRANSLUCENT SHADES |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K013869 |
11/21/2001 |
SR IVOCRON |
IVOCLAR VIVADENT, INC. |
DONNA M HARTNETT |
K013955 |
11/30/2001 |
VERAVIEWEPOCS, MODEL VE |
J. MORITA USA, INC. |
WILLIAM D HARE |
K013698 |
11/07/2001 |
AST (SGOT) |
JAS Diagnostics, Inc. |
David Johnston |
K013912 |
11/27/2001 |
CREATINE KINASE (CK-NAC) |
JAS Diagnostics, Inc. |
David Johnston |
K013876 |
11/23/2001 |
INFRARED EAR THERMOMETER, MODEL DX-707 |
JAWON MEDICAL CO., LTD. |
WON-HEE PARK |
K010044 |
01/05/2001 |
COSMIC |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
K010160 |
01/16/2001 |
WILLI GELLER CREAPEARL |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
K010231 |
01/24/2001 |
JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE |
JK GLOVES SDN. BHD. |
TAI SAI LEONG |
K010114 |
01/16/2001 |
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) |
JOHNSON & JOHNSON VISION CARE, INC. |
SHARON BRIGGS |
K013944 |
11/29/2001 |
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE |
JOSTRA AG |
KATHLEEN JOHNSON |
K013939 |
11/29/2001 |
JOSTRA FLOWPROBE FP-32E |
JOSTRA AG |
KATHLEEN JOHNSON |
K013914 |
11/27/2001 |
POWDERFREE LATEX SURGEON'S GLOVES |
KANAM LATEX INDUSTRIES PVT. LTD. |
RAVI ABRAHAM |
K013838 |
11/19/2001 |
KSEA CLEARVISION LENS IRRIGATION SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
K010101 |
01/11/2001 |
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM |
KINAMED, INC. |
VINEET SARIN |
K010040 |
01/05/2001 |
SLEEVED FILTER |
KING SYSTEMS CORP. |
CHARLES A BURT |
K010139 |
01/17/2001 |
ZURICH DISTRACTION SYSTEM |
KLS-MARTIN L.P. |
ART WARD |
K013805 |
11/15/2001 |
KOWA AUTOMATED TONOMETER KT-500 |
KOWA OPTIMED, INC. |
FRANCES K WU |
K010246 |
01/26/2001 |
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A |
KYPHON, INC. |
KAREN TALMADGE |
K010199 |
01/22/2001 |
PJUR EROS WATER FORMULATION |
L.C.C. PJUR GROUP GERMANY |
RICHARD HARRIS |
K010113 |
01/16/2001 |
LASER MECHANISMS LASER SCANNING SYSTEM |
LASER MECHANISMS, INC. |
JEFFREY HOCKING |
K010284 |
01/31/2001 |
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL H HARDIMAN |
K010202 |
01/22/2001 |
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES |
LESLIE W. ORGAN |
LESLIE W ORGAN |
K010049 |
01/05/2001 |
PULSECO HEMODYNAMIC MONITOR CM71 |
LIDCO LTD. |
GREGORY SPELLER |
K010252 |
01/26/2001 |
MAGNUM |
MAGNUM EQUIPMENT L.L.C. |
MONTE REGAL |
K010296 |
01/31/2001 |
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 |
MARINA MEDICAL INSTRUMENTS, INC. |
JIHAD (JAY) MANSOUR |
K013792 |
11/14/2001 |
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
K010069 |
01/08/2001 |
DURABOND NON-PRECIOUS CERAMIC ALLOY |
MATECH, INC. |
PAUL L SAXTON |
K010225 |
01/24/2001 |
DOSIMETRY CHECK |
MATH RESOLUTIONS, LLC. |
WENDEL D RENNER |
K010297 |
01/31/2001 |
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) |
MAXXIM MEDICAL |
WUNAN HUANG |
K013875 |
11/23/2001 |
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE |
MED-TEC,INC. |
DONALD F RIIBE |
K010074 |
01/09/2001 |
MODEL 455GE PHASED ARRAY WRIST COIL |
MEDICAL ADVANCES, INC. |
MICHAEL LEIGH |
K010111 |
01/12/2001 |
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK |
MEDICAL ANALYSIS SYSTEMS, INC. |
DARWIN RICHARDSON |
K013734 |
11/13/2001 |
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
K010021 |
01/03/2001 |
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S |
MEDICAL COMPONENTS, INC. |
FLORENCE A CAIKOSKI |
K010187 |
01/22/2001 |
KIMAX, MODEL 1024 |
MEDICAL METRICS, INC. |
ANN TUNSTALL |
K010207 |
01/23/2001 |
PORTABLE INSTENSIVE CARE UNIT |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
K010259 |
01/29/2001 |
MEDIFACE PACS |
MEDIFACE CO., LTD. |
CARL PERSON |
K013704 |
11/08/2001 |
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER |
MEDIPLUS LTD. |
ELIZABETH M PAUL |
K013627 |
11/05/2001 |
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
A. ROBERT DEPALMA |
K010279 |
01/30/2001 |
MEDISYSTEMS LUER ACCESS INJECTION SITE |
MEDISYSTEMS CORP. |
KAREN KRSTULICH |
K013725 |
11/09/2001 |
MEDITRON II THESTERTHOSCOPE SYSTEM |
MEDITRON AS |
CHARLES H KYPER |
K013761 |
11/13/2001 |
MEDLINE EXCEL RECLINCER WHEELCHAIR |
MEDLINE INDUSTRIES, INC. |
ANDREA HAFERKAMP |
K013815 |
11/16/2001 |
MEDRAD QWIK-FIT SYRINGE |
MEDRAD, INC. |
FRANK W PELC III |
K013620 |
11/05/2001 |
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION |
MEDSTONE INTL., INC. |
RON BERGESON |
K010138 |
01/17/2001 |
PROFILE II ER |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K010226 |
01/24/2001 |
VERDICT -II METHAMPHETAMINE |
MEDTOX DIAGNOSTICS, INC. |
MICHEAL TURANCHIK |
K010130 |
01/16/2001 |
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
K013913 |
11/27/2001 |
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM |
MEDTRONIC PERCUSURGE, INC. |
MATTHEW J MOON |
K010249 |
01/26/2001 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K010181 |
01/19/2001 |
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K013663 |
11/06/2001 |
CEMENT RESTRICTOR |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K013829 |
11/19/2001 |
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICK W TREHARNE |
K013665 |
11/06/2001 |
PYRAMID ANTERIOR PLATE FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K013788 |
11/14/2001 |
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 |
MERITS HEALTH PRODUCTS CO., LTD. |
WINSTON ANDERSON |
K013779 |
11/13/2001 |
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F |
MESURE TECHNOLOGY |
PHIL ZULUETA |
K013769 |
11/13/2001 |
V-GNATHOS SUPRA |
METALOR TECHNOLOGIES USA |
BRUCE A BARTON |
K010102 |
01/12/2001 |
SONIC MODEL SO-300 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
K010162 |
01/17/2001 |
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
K010004 |
01/02/2001 |
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 |
MICRO THERAPEUTICS, INC. |
EBEN GORDEN |
K010175 |
01/18/2001 |
MICROLIGHT 830 LASER SYSTEM |
MICROLIGHT CORPORATION OF AMERICA |
MICHAEL BARBOUR |
K013695 |
11/07/2001 |
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 |
MICROLINE PENTAX, INC. |
JACQUELINE E MASSE |
K010008 |
01/02/2001 |
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX |
MICRONET MEDICAL, INC. |
CHARLES LEHMAN |
K010295 |
01/31/2001 |
MICROSTIM 100I TENS DEVICE |
MICROSTIM, INC. |
JOEL ROSSEN |
K013888 |
11/23/2001 |
FIXATION (STEINMANN) PINS |
MILTEX, INC. |
RICHARD GORDON |
K013781 |
11/14/2001 |
RIDIDFIX 2.7MM BTB CROSS PIN KIT |
MITEK PRODUCTS |
JENNIFER JOHNSON |
K013752 |
11/13/2001 |
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) |
MORGAN SCIENTIFIC, INC. |
PATRICK MORGAN |
K010140 |
01/17/2001 |
HRH-127 HEAD ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K010096 |
01/11/2001 |
MULTI CARE THERAPEUTIC VIBRATOR |
MULTICEPT A/S |
KLAUS VAMMEN |
K010298 |
01/31/2001 |
MN-4 COARSE MANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K013827 |
11/19/2001 |
TST - SUPPRESSOR MODEL #1000 |
NEUROSIM LIMITED |
IAN BROWN |
K010019 |
01/02/2001 |
STERILE SUBDERMAL NEEDLE ELECTRODES |
NICOLET BIOMEDICAL, INC. |
Gary Syring |
K013760 |
11/13/2001 |
DC-3300 LASER DIODE PHOTOCOAGULATOR |
NIDEK, INC. |
CAROL PATTERSON |
K013864 |
11/21/2001 |
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 |
NIDEK, INC. |
CAROL PATTERSON |
K013694 |
11/07/2001 |
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) |
NIDEK, INC. |
CAROL PATTERSON |
K010264 |
01/29/2001 |
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET |
NIPRO MEDICAL CORP. |
RICHARD D BLISS, JR |
K010224 |
01/24/2001 |
NPAC MULTI-USE THERMOMETER, MODEL TD400 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
K010053 |
01/08/2001 |
HUMI-FLOW, MODEL 6-850-00/ 01/02 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
K013729 |
11/09/2001 |
STAT PROFILE PHOX BASIC ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
K013730 |
11/09/2001 |
ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES |
NOVASYS MEDICAL, INC. |
THOMAS C WEHMAN |
K013930 |
11/28/2001 |
NEUROSENSOR |
NOVUS MONITORING LTD |
PETER F GIBSON |
K010032 |
01/03/2001 |
SEED SELECTRON MODEL V. 1.0 |
NUCLETRON CORP. |
RALPH E SHUPING |
K013655 |
11/06/2001 |
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 |
NXSTAGE MEDICAL, INC. |
KAREN ST. ONGE |
K013613 |
11/05/2001 |
SOFT PLUG ABSORBABLE PLUG-SA |
OASIS MEDICAL, INC. |
JAMES CHRISTENSEN |
K010222 |
01/24/2001 |
OHMEDA MEDICAL GIRAFFE INCUBATOR |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
K013617 |
11/05/2001 |
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K013759 |
11/13/2001 |
MSS-28CS-301/701 NEEDLESCOPE |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
K010256 |
01/29/2001 |
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL |
OPTI-CENTRE LABORATORIES |
MARTIN DALSING |
K013882 |
11/23/2001 |
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
K013622 |
11/05/2001 |
NUCLEOTOMY INTRADISCAL CATHETER |
ORATEC INTERVENTIONS, INC. |
LINDA GUTHRIE |
K010107 |
01/12/2001 |
R STENT BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
ROBERT FRECHETTE |
K013845 |
11/20/2001 |
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
K010024 |
01/03/2001 |
O2/CO2 NASAL FILTERLINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
K010235 |
01/25/2001 |
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX |
ORIENTAL SYSTEM TECHNOLOGY, INC. |
SUSAN D GOLDSTEIN-FALK |
K013900 |
11/23/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
MARLENE A SHULMAN |
K013899 |
11/23/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS |
ORTHO-CLINICAL DIAGNOSTICS |
MARLENE A SHULMAN |
K010273 |
01/29/2001 |
CRANIAL MOLDING ORTHOSIS |
ORTHOTIC SOLUTIONS, INC. |
JOSEPH F TERPENNING |
K013764 |
11/13/2001 |
IMMIX BONE GRAFT EXTENDER |
OSTEOGENICS BIOMEDICAL, INC. |
RICHARD A HAMER |
K013618 |
11/05/2001 |
INTRAORAL MANDIBULAR DISTRACTION SYSTEM |
OSTEOMED CORP. |
DAWN T HOLDEMAN |
K010118 |
01/16/2001 |
NORMED MANDIBULAR FIXATION SYSTEM |
OSTEOMEDICS, INC. |
ALBERT ENAYATI |
K010233 |
01/24/2001 |
POWDER FREE NITRILE EXAMINATION GLOVES |
P.T. HEALTHCARE GLOVINDO |
ELLEN HUTAPEA |
K010232 |
01/24/2001 |
PRE-POWDERED NITRILE EXAMINATION GLOVES |
P.T. HEALTHCARE GLOVINDO |
ELLEN HUTAPEA |
K013796 |
11/15/2001 |
LIVESURE METHADONE SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K010001 |
01/02/2001 |
LIVESURE THC SCREEN TEST |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
K010109 |
01/12/2001 |
FLUOROPERM 151-OK, PARAGON HDS 100-OK |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
K010009 |
01/02/2001 |
KOKO PEAK KP; KOKO PEAK KP+ |
PDS HEALTHCARE PRODUCTS, INC. |
CHERYL RAILSBACK |
K013856 |
11/06/2001 |
PMH 1000 HEATED HUMIDIFIER |
PEGASUS RESEARCH CORP. |
KENNETH G MILLER |
K013640 |
11/05/2001 |
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
K013894 |
11/23/2001 |
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN HARMER |
K013858 |
11/21/2001 |
INFINION 0.6T MR IMAGING SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE C PRASCHAN |
K013644 |
11/05/2001 |
ACQPLAN 5.0 |
PHILIPS MEDICAL SYSTEMS, INC. |
ROBERT L TUROCY |
K013624 |
11/05/2001 |
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
DENISE HALEY |
K013656 |
11/06/2001 |
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
K010116 |
01/16/2001 |
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
K013921 |
11/27/2001 |
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X |
PORGES S.A. |
BERNARD ISMAEL |
K013846 |
11/20/2001 |
ULTRAGARD IMPERVIOUS REINFORCED GOWN |
PRECEPT MEDICAL PRODUCTS, INC. |
MARY ANN FAULKNER |
K013708 |
11/08/2001 |
REFERENCE CHECK, CATALOG NUMBER-RCN-10 |
PRECISION BIOLOGIC |
STEPHEN L DUFF |
K013700 |
11/08/2001 |
ORTHOSIS HELMET MOLDING |
PRECISION PROSTHETICS & ORTHOTICS, INC. |
CONNIE FICKLIN |
K013654 |
11/06/2001 |
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER |
PRECISION SYSTEMS, INC. |
BILL HADEN |
K010195 |
01/22/2001 |
PREMIER ULTRASONIC SCALER AND INSERTS |
PREMIER DENTAL PRODUCTS CO. |
WILLIAN FREZEL |
K013787 |
11/14/2001 |
NYCOCARD CRP |
PRIMUS CORP. |
JIMMIE K NOFFSINGER |
K013905 |
11/26/2001 |
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS |
PRO-TECH SERVICES, INC. |
NEIL SHELLER |
K010077 |
01/10/2001 |
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES |
PWA INDUSTRIES SDN. BHD. |
K. KARUNAKARAN |
K013715 |
11/08/2001 |
RE-USABLE STERILIZATION POUCH / BAG |
QUALITY PRODUCTS OF MONTANA |
LARRY LARSON |
K013662 |
11/06/2001 |
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS |
QUANTIMETRIX CORP. |
GEBHARD NEYER |
K013898 |
11/23/2001 |
R&D RET-LINE KIT |
R & D SYSTEMS, INC. |
RALPH E HOGANCAMP |
K013943 |
11/29/2001 |
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 |
RADI MEDICAL SYSTEMS AB |
MATS GRANLUND |
K013660 |
11/06/2001 |
GENETRA |
RADIOMED CORPORATION |
GORDON ROBERTS |
K013661 |
11/06/2001 |
XPLAN 2.2 WITH THE BODY SYSTEM |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
K010194 |
01/22/2001 |
COMFOR-CLINER |
RECLINER CARE, INC. |
MARK D BROWN |
K013711 |
11/07/2001 |
BACTI-SWAB DRY |
REMEL CO. |
ROBERT E BOOTH |
K013843 |
11/20/2001 |
AUTOSET SPIRIT CPAP SYSTEM |
RESMED CORP. |
ROGER KOTTER |
K013909 |
11/26/2001 |
S7 ELITE CP AP SYSTEM |
RESMED CORP. |
ROGER KOTTER |
K010263 |
01/29/2001 |
REMSTAR PLUS CPAP SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
K010052 |
01/08/2001 |
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER |
RESPIRONICS, INC. |
DAVID J VANELLA |
K013859 |
11/21/2001 |
RHODIA BITE REGISTRATION MATERIAL |
RHODIA INC. |
ALAIN MORIN |
K013881 |
11/23/2001 |
RIBBOND - TRIAXIAL |
RIBBOND, INC. |
SHOSHANA RUDO DRIVER |
K013771 |
11/13/2001 |
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE |
RICH-MAR CORP. |
DAVID RICHARDS |
K013770 |
11/13/2001 |
MODIFICATION TO: WINNER ST-2 STIMULATOR |
RICH-MAR CORP. |
DAVID RICHARDS |
K010033 |
01/04/2001 |
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K010060 |
01/08/2001 |
RITA STARBURST XLI ELECTROSURGICAL DEVICE |
RITA MEDICAL SYSTEMS |
ERIN MAZZONE |
K010255 |
01/29/2001 |
CAVITY VARNISH |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
K010240 |
01/25/2001 |
POLYCARBOXYLATE (PCA) CEMENT |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
K010237 |
01/25/2001 |
ELECSYS HCG+B CALCHECK |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
K013757 |
11/13/2001 |
ROCHE ACETAMINOPHEN |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
K013646 |
11/05/2001 |
ROSE K POST GRAFT LENS |
ROSE K INTERNATIONAL LTD. |
IAN JENNINGS |
K010190 |
01/22/2001 |
WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43 |
ROSSMAX INTERNATIONL LTD. |
MICHAEL YEH |
K013872 |
11/21/2001 |
RUSCH MEMORY BAG |
RUSCH INTL. |
RICK LYKINS |
K010068 |
01/08/2001 |
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM |
RUSCH INTL. |
KARENANN J BROZOWSKI |
K010012 |
01/02/2001 |
LC PROVIFILL |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
K010203 |
01/22/2001 |
ACCU-PULSE TENS UNIT |
SADLER ELECTRONICS |
C A SADLER |
K013801 |
11/15/2001 |
ULTRASAFE DENTAL INJECTION SYSTEM |
SAFETY SYRINGES, INC. |
THOMAS L HALL |
K013951 |
11/30/2001 |
SANDHILL SCIENTIFIC PEDIATEC PH PROBE |
SANDHILL SCIENTIFIC, INC. |
LEWIS WARD |
K013703 |
11/08/2001 |
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M |
SANYO NORTH AMERICA CORP. |
SACHI KATAOKA |
K013649 |
11/05/2001 |
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS |
SAUFLON PHARMACEUTICALS, LTD. |
LIGIA DELACRUZ |
K010289 |
01/31/2001 |
SCIMEDX PHASE II MPO IGG ANTIBODY EIA |
SCIMEDX CORP. |
Gary Lehnus |
K010287 |
01/31/2001 |
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA |
SCIMEDX CORP. |
Gary Lehnus |
K010285 |
01/31/2001 |
CONTOUR PROFILE LASER |
SCITON, INC. |
PETER N ALLEN |
K013812 |
11/15/2001 |
SPIROLAB II, MODEL 29 |
SDI DIAGNOSTICS, INC. |
MICHAEL J BOYLE |
K013641 |
11/05/2001 |
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS |
SENORX, INC. |
AMY BOUCLY |
K013931 |
11/28/2001 |
OMNI OXYGEN SYSTEM, MODEL 1000 |
SEQUAL TECHNOLOGIES, INC. |
PAM JACKSON |
K010095 |
01/11/2001 |
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR |
SGMP CO., LTD. |
JANNA P TUCKER |
K010247 |
01/26/2001 |
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES |
SHANGHAI CHINASTAR CORP. |
LEE HUNG TE CHIH |
K013793 |
11/14/2001 |
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K013794 |
11/14/2001 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K013795 |
11/14/2001 |
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K010097 |
01/11/2001 |
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K010110 |
01/12/2001 |
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE |
SHEN WEI (USA), INC. |
BELLE L CHOU |
K013927 |
11/28/2001 |
MINI SHOPPER |
SHOPRIDER INTL., INC. |
CHRIS TINSLEY |
K010137 |
01/17/2001 |
ORBITER II CCI/SPECT ORBITER II CCI/SPECT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
RONALD NOLTE |
K013826 |
11/19/2001 |
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) |
SIEMENS MEDICAL SYSTEMS, INC. |
SANDRA ROBINSON |
K013819 |
11/16/2001 |
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM |
SIERRA DIAGNOSTIC, L.L.C. |
DONALD R STONE |
K010158 |
01/17/2001 |
THROMBOMAX-HS WITH CALCIUM, MODEL T6540 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
K013751 |
11/13/2001 |
HANDHELD GAMMA FINDER (HGF) |
SILICON INSTRUMENTS GMHB |
THOMAS GOEBEL |
K013696 |
11/07/2001 |
SILMED NASAL SEPTAL BUTTON |
SILMED, INC. |
RAMA GUNDLAPALLI |
K013936 |
11/28/2001 |
SILVERLEAF CONTACT WOUND DRESSING |
SILVERLEAF TECHNOLOGIES INC |
ALAN THOMPSON |
K013659 |
11/06/2001 |
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
K013650 |
11/06/2001 |
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA M HEMEON-HEYER |
K013727 |
11/09/2001 |
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G |
SMART GLOVE CORP. SDN BHD |
NG YEW SOON |
K013658 |
11/06/2001 |
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K013870 |
11/21/2001 |
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
K010132 |
01/16/2001 |
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 |
SOADCO, S.L. |
MERCEDES ROLDAN |
K013817 |
11/16/2001 |
GLO-SPEC |
SOL WEISS MD INC |
SOL WEISS |
K013701 |
11/08/2001 |
ENDO-GLIDE |
SONOTECH, INC. |
MARGARET J LARSON |
K013887 |
11/23/2001 |
BACFIX SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
DAVID M HOPPER |
K013773 |
11/13/2001 |
SAFE |
SSN MEDICAL PRODUCTS SDN. BHD. |
ANG TECK LEONG |
K010282 |
01/30/2001 |
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM |
STELKAST COMPANY |
DONALD A STEVENS |
K010241 |
01/25/2001 |
PROTRACT PRESS FIT HIP STEM-HA COATED |
STELKAST COMPANY |
DONALD A STEVENS |
K013630 |
11/05/2001 |
ISITE RADIOLOGY |
STENTOR, INC. |
GARY J ALLSEBROOK |
K010176 |
01/18/2001 |
CALEX CONDITIONER |
STEPHEN M. KORAL, D.M.D. |
STEPHEN M KORAL |
K013767 |
11/13/2001 |
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
K013687 |
11/07/2001 |
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER |
STEVEN K. SUE |
STEVEN K SUE |
K010291 |
01/31/2001 |
ITI DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
LINDA JALBERT |
K010204 |
01/23/2001 |
STRYKER NAVIGATION SYSTEM-KNEE MODULE |
STRYKER CORP. |
NICOLE PETTY |
K013775 |
11/13/2001 |
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM |
STRYKER LEIBINGER |
ROBIN L ROWE |
K010073 |
01/09/2001 |
SPLINE DENTAL IMPLANT SYSTEM |
SULZER CALCITEK, INC. |
FOSTER BOOP |
K013935 |
11/28/2001 |
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
K010177 |
01/18/2001 |
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K013689 |
11/06/2001 |
RE-ENTRANT CHAMBER |
SUN NUCLEAR CORP. |
JIM MIXON |
K013953 |
11/30/2001 |
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
K010198 |
01/22/2001 |
STERILE POWDERED LATEX SURGEON GLOVES |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
K013774 |
11/13/2001 |
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA |
SUPERMAX SDN BHD |
PRISCILLA WEE |
K010041 |
01/05/2001 |
SLT DIFFUSER FIBER |
SURGICAL LASER TECHNOLOGIES, INC. |
DAVIS WOODWARD |
K010214 |
01/23/2001 |
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 |
SURVIVALINK CORP. |
Sew-Wah Tay |
K013647 |
11/05/2001 |
REVOLUTION FORMULA 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K013895 |
11/23/2001 |
TEMPFIL |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K010030 |
01/03/2001 |
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR |
SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV. |
JAMES F GODFREY |
K010108 |
01/12/2001 |
USS-LINE EXTENSION |
SYNTHES |
JONATHAN GILBERT |
K010121 |
01/16/2001 |
STERILE BUTTON PLATE |
SYNTHES (USA) |
THOMAS M MAGUIRE |
K013806 |
11/15/2001 |
SYNTHES METALLIC SPIKED WASHERS |
SYNTHES (USA) |
MATTHEW M HULL |
K010094 |
01/11/2001 |
A & I WHEELCHAIRS |
TAIWAN AN I CO.,LTD. |
ANI HWONG |
K010007 |
01/02/2001 |
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP |
TAUT, INC. |
RONALD KENSETH |
K010239 |
01/25/2001 |
COCAINE DIPSTICK TEST, MODEL D747-A |
TECO DIAGNOSTICS |
DINDO CARRILLO |
K013747 |
11/13/2001 |
TEKNO-MEDICAL OBSTETRICAL FORCEPS |
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. |
MARKUS DENK |
K013737 |
11/13/2001 |
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON |
TELEMED SYSTEMS, INC. |
MICHAEL CARROLL |
K010103 |
01/12/2001 |
SURSHIELD WINGED INFUSION SET |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
K013849 |
11/20/2001 |
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS |
TETRAD CORP. |
CHARLES F HOTTINGER |
K010147 |
01/17/2001 |
ENA EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K010146 |
01/17/2001 |
ENA EIA KIT RANGE |
THE BINDING SITE, LTD. |
JAY H GELLER |
K010148 |
01/17/2001 |
ENA SCREEN EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K010283 |
01/30/2001 |
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 |
THERAGENICS CORP. |
JANET E ZEMAN |
K013768 |
11/13/2001 |
POWERED MUSCLE STIMULATOR |
THERATECH, INC. |
CAROLANN KOTULA |
K013639 |
11/05/2001 |
THERMAGE THERMACOOL TC SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
K010271 |
01/29/2001 |
THINKINGNET |
THINKING SYSTEMS CORP. |
J B WANG |
K013625 |
11/05/2001 |
PERMACOL |
TISSUE SCIENCE LABORATORIES, PLC |
HOWARD M HOLSTEIN |
K010267 |
01/29/2001 |
PALFIQUE ESTELITE LV CLEAR |
TOKUYAMA AMERICA, INC. |
DANIEL J MANELLI |
K013673 |
11/06/2001 |
HI-ART SYSTEM |
TOMO THERAPY INC |
KENNETH D BUROKER |
K013821 |
11/16/2001 |
SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
TOP QUALITY MFG., INC. |
MARC SINKOW |
K013906 |
11/26/2001 |
HLS NOETOS SYSTEM |
TORNIER |
Mireille Lemery |
K010129 |
01/16/2001 |
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K013633 |
11/05/2001 |
SSA-770A, APLIO ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
K010253 |
01/26/2001 |
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
K013925 |
11/14/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K013903 |
11/26/2001 |
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 |
TRIAD MEDICAL, INC. |
RITA GIEBEL |
K013848 |
11/20/2001 |
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 |
U-SYSTEMS, INC. |
SHEILA W PICKERING |
K013902 |
11/26/2001 |
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 |
U-SYSTEMS, INC. |
SHEILA W PICKERING |
K013677 |
11/07/2001 |
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM |
U.S. FILTER/IONPURE, INC. |
DAVID A DENTINO |
K010070 |
01/08/2001 |
ULTRAPAK NEHA |
ULTRADENT PRODUCTS, INC. |
MARKUS R GEE |
K013874 |
11/21/2001 |
CLEARPLANE EASY OVULATION TEST |
UNIPATH LTD. |
STEVEN H ARMSTRONG |
K013860 |
11/21/2001 |
AUTO SUTURE SURGICAL STAPLES |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHESTER MCCOY |
K010035 |
01/04/2001 |
IVS TUNNELLER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHESTER MCCOY |
K013671 |
11/06/2001 |
L-25 ABSORBABLE SURIGCAL SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
ROBERT ZOTT |
K013890 |
11/23/2001 |
SURGICAL DYNAMICS MENISCAL STAPLE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JENNIFER SCHUCK |
K010098 |
01/11/2001 |
MODIFICATION TO CAVERMAP SURGICAL AID |
UROMED CORP. |
FREDERICK TOBIA |
K010213 |
01/23/2001 |
MODIFICATION TO CAVERMAP SURGICAL AID |
UROMED CORP. |
FREDERICK TOBIA |
K013854 |
11/20/2001 |
MARK 5000 QUADRATURE SHOULDER COIL |
USA INSTRUMENTS, INC. |
TORI MASIELLA |
K010013 |
01/02/2001 |
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 |
VALLEYLAB, INC. |
KEVIN RANDALL |
K010010 |
01/02/2001 |
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR |
VALLEYLAB, INC. |
JULIE ROSS |
K013702 |
11/08/2001 |
VICTORCH HCG TEST STRIP |
VICTORCH MEDITEK, INC. |
PIERCE LIU |
K013678 |
11/07/2001 |
VICTORCH MEDITEK'S HCG TEST CARD |
VICTORCH MEDITEK, INC. |
PIERCE LIU |
K010218 |
01/24/2001 |
VISTAKON (HEFILCON C) CONTACT LENSES |
VISTAKON |
MICHAEL J TERSAK |
K013884 |
11/23/2001 |
BOUSSIGNAC C.P.A.P. DEVICE |
VYGON S A |
LAETITIA BERNARD |
K010288 |
01/31/2001 |
ANEUVYSION MULITICOLOR DNA PROBE KIT |
VYSIS |
RUSSEL K ENNS |
K013785 |
11/14/2001 |
UROVYSION BLADDER CANCER RECURRENCE KIT |
VYSIS |
RUSSEL K ENNS |
K013810 |
11/15/2001 |
CARDIOVASCULAR ARRAY |
W.L. GORE & ASSOCIATES,INC |
TRACEY D WOLF |
K010228 |
01/24/2001 |
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES |
W.L. GORE & ASSOCIATES,INC |
R. LARRY PRATT |
K013648 |
11/05/2001 |
VIABAHN ENDOPROSTHESIS |
W.L. GORE & ASSOCIATES,INC |
TIMOTHY J RYNN |
K013954 |
11/30/2001 |
LORENZ SELF DRILLING SCREWS |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
K010186 |
01/22/2001 |
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM |
WELCH ALLYN, INC. |
DAVID A YOUNG II |
K010031 |
01/03/2001 |
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM |
WESCOR, INC. |
WAYNE K BARLOW |
K010059 |
01/08/2001 |
ENGPLUS |
WESTERN SYSTEMS RESEARCH, INC. |
LINDA DAVIS-O'LEARY |
K013652 |
11/06/2001 |
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
K010058 |
01/08/2001 |
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK |
WITT BIOMEDICAL CORPORATION |
LORRAINE R FREDES |
K010072 |
01/09/2001 |
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE W CHOW |
K013942 |
11/29/2001 |
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD H HUSSEIN |
K013763 |
11/13/2001 |
WU'S 4-WHEELED NEO SCOOTER, WT-L4 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
K013926 |
11/28/2001 |
QIZHOU ACUPUNCTURE NEEDLE |
WUJIANG CITY SHENLI MEDICAL AND HEALTH MATERIAL CO |
GONG BO |
K010051 |
01/08/2001 |
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE |
XIROS PLC |
JIM ROWLAND |
K010099 |
01/11/2001 |
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER |
ZCV ,INC. |
JING ZHANG |
K010257 |
01/29/2001 |
ZOLL M SERIES |
ZOLL MEDICAL CORP. |
PAUL DIAS |