FDA 510(k) Applications Received During January, 2001

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
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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


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