FDA 510(k) Applications Received During November, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K013841 11/20/2001 3DFIS, MODEL IES-FL-101 3DSHARP, INC. DONALD KRIEGER
K013683 11/07/2001 MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE ABBOTT VASCULAR INC. PATTY HEVEY
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
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
K013893 11/23/2001 SCANX AIR TECHNIQUES, INC. JOSEPH CAREY
K013713 11/08/2001 ARM AUTOMATIC REPROCESSING MACHINE ALCAVIS INTERNATIONAL INCORPORATED LUDOVICO GIAVOTTO
K013637 11/05/2001 ACTICHROME HEPARIN (ANTI-FIIA) AMERICAN DIAGNOSTICA, INC. JOHN BERRYMAN
K013813 11/16/2001 MODIFICATION TO:APEX MEDICAL IF-4100 APEX MEDICAL CORP. ALAN CHANGE
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
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
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
K013750 11/13/2001 ADVIA 1650 CHOLINESTERASE ASSAY BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K013959 11/30/2001 BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS BAYER DIAGNOSTICS CORP. KENNETH T EDDS
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
K013719 11/08/2001 BECKER BAND CRANIAL REMOLDING ORTHOSIS BECKER ORTHOPEDIC APPLIANCE CO. JAMES H CAMPBELL
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
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
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
K013803 11/15/2001 FLOWGUARD DEVICE BIOSONIX LTD. AHAVA STEIN
K013634 11/05/2001 BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK BIOTEQUE CORP. JENNIFER REICH
K013642 11/05/2001 AVEA BIRD PRODUCTS CORP. TOM GUTIERREZ
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
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
K013907 11/26/2001 INVERNESS MEDICAL EARLY PREGNANCY TEST CAMBRIDGE DIAGNOSTICS IRELAND, LTD. AVRIL MURRAY
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
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
K013733 11/09/2001 SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET CHF SOLUTIONS, INC. DIANNA THOMSEN
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
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
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
K013623 11/05/2001 CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420 CURELIGHT LTD JONATHAN S KAHAN
K013878 11/23/2001 CYBERMED, INC., V-WORKS CYBERMED, INC. GARY J ALLSEBROOK
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
K013880 11/23/2001 DAYLITE XENON LIGHT SOURCES DESIGNS FOR VISION, INC. AMY GRUMET-AVALLONE
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
K013835 11/19/2001 GLOBAL HEALTHCARE VAGINAL SPECULUM DYNASCEND CONSULTING INT'L LLC. ALAM AHMED
K013686 11/07/2001 KODAK DIRECTVIEW TABLETOP CASSETTE EASTMAN KODAK COMPANY JUDITH A WALLACE
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
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
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
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
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
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
K013772 11/13/2001 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K013688 11/07/2001 MODIFICATION TO XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K013676 11/07/2001 TRIDENT HEMISPHERICAL ACETABULAR SHELLS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K013823 11/19/2001 XIA SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
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
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
K013783 11/14/2001 AUTION MAX AX-4280 URINALYSIS SYSTEM INTERNATIONAL REMOTE IMAGING SYSTEMS CYNTHIA J.M NOLTE
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
K013667 11/06/2001 BCC GAMMA CAMERA IS2 RESEARCH, INC. VICTOR WOODBURN
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
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
K013805 11/15/2001 KOWA AUTOMATED TONOMETER KT-500 KOWA OPTIMED, INC. FRANCES K WU
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
K013875 11/23/2001 MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE MED-TEC,INC. DONALD F RIIBE
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
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
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
K013913 11/27/2001 PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM MEDTRONIC PERCUSURGE, INC. MATTHEW J MOON
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
K013695 11/07/2001 MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 MICROLINE PENTAX, INC. JACQUELINE E MASSE
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
K013827 11/19/2001 TST - SUPPRESSOR MODEL #1000 NEUROSIM LIMITED IAN BROWN
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
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
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
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
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
K013845 11/20/2001 MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD. SANFORD BROWN
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
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
K013796 11/15/2001 LIVESURE METHADONE SCREEN TESTS PAN PROBE BIOTECH, INC. ALICE H YU
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
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
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
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
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
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
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
K013872 11/21/2001 RUSCH MEMORY BAG RUSCH INTL. RICK LYKINS
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
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
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
K013927 11/28/2001 MINI SHOPPER SHOPRIDER INTL., INC. CHRIS TINSLEY
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
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
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
K013630 11/05/2001 ISITE RADIOLOGY STENTOR, INC. GARY J ALLSEBROOK
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
K013775 11/13/2001 TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM STRYKER LEIBINGER ROBIN L ROWE
K013935 11/28/2001 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
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
K013774 11/13/2001 CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA SUPERMAX SDN BHD PRISCILLA WEE
K013647 11/05/2001 REVOLUTION FORMULA 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013895 11/23/2001 TEMPFIL SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013806 11/15/2001 SYNTHES METALLIC SPIKED WASHERS SYNTHES (USA) MATTHEW M HULL
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
K013849 11/20/2001 TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS TETRAD CORP. CHARLES F HOTTINGER
K013768 11/13/2001 POWERED MUSCLE STIMULATOR THERATECH, INC. CAROLANN KOTULA
K013639 11/05/2001 THERMAGE THERMACOOL TC SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K013625 11/05/2001 PERMACOL TISSUE SCIENCE LABORATORIES, PLC HOWARD M HOLSTEIN
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
K013633 11/05/2001 SSA-770A, APLIO ULTRASOUND SYSTEM TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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
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
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
K013854 11/20/2001 MARK 5000 QUADRATURE SHOULDER COIL USA INSTRUMENTS, INC. TORI MASIELLA
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
K013884 11/23/2001 BOUSSIGNAC C.P.A.P. DEVICE VYGON S A LAETITIA BERNARD
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
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
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
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


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