FDA 510(k) Applications Received During October, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K052825 10/05/2005 VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG AFFINITY BIOLOGICALS INC. DENISE FOULON
K052918 10/19/2005 REPROCESSED EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K052944 10/20/2005 AMBU WHITE SENSOR CFM, CFL AMBU A/S SANJAY PARIKH
K052901 10/27/2005 ARTHREX TENSIONLOK ARTHREX, INC. ANN WATERHOUSE
K052776 10/03/2005 TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD ARTHREX, INC. SALLY FOUST
K052830 10/07/2005 SPORTMESH ARTIMPLANT AB TERRY SHERIDAN POWELL
K052981 10/24/2005 BIS EEG MONITOR, MODEL BISX4 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K052893 10/14/2005 ATRICURE TRANSPOLAR SYSTEM ATRICURE, INC. ELSA CHI ABRUZZO
K052698 10/12/2005 MODIFICATION TO: AURORA AURORA IMAGING TECHNOLOGY, INC. MICHAEL A DOUGLAS
K052845 10/18/2005 B-CARE POWDERED LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD. KEVIN WALLS
K052773 10/03/2005 B. BRAUN 0.2 MICRON FILTER B. BRAUN MEDICAL, INC. CHRISTINE FORD
K052764 10/03/2005 DIACAP ULTRA DIALYSIS FLUID FILTER B. BRAUN MEDIZINTECHNOLOGIE GMBH SCOTT J PEASE
K052958 10/21/2005 COLOR NIO 2MP, E-2320 C BARCOVIEW LIEVEN DE WANDEL
K052772 10/03/2005 BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K052892 10/18/2005 SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55 BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K052973 10/24/2005 IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K BAXTER HEALTHCARE CORP. JOHN MANARIK
K053020 10/28/2005 TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K052905 10/14/2005 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K052876 10/12/2005 TELITHROMYCIN 15UG BBL SENSI-DISC BECTON DICKINSON & CO. DAINELLE CLARK
K052853 10/11/2005 TIGECYCLINE 15UG BBL SENSI-DISC BECTON DICKINSON & CO. DAINELLE CLARK
K053011 10/26/2005 PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 BIO PROTECH, INC. E.J. SMITH
K052969 10/21/2005 SLENDERTONE GYMBODY, MODEL 512-01 BIO-MEDICAL RESEARCH, LTD. MICHAEL O'SULLIVAN
K052838 10/07/2005 LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 BIO-RAD MARIA ZEBALLOS
K053012 10/26/2005 FIDIS VASCULITIS, MODEL MX007 BIOMEDICAL DIAGNOSTICS (BMD) SA CHRISTELLE COURIVAUD
K053004 10/28/2005 MSAS-VANTAGE BIOMERIDIAN, INT. GENE SWIFT
K052888 10/13/2005 POROUS TITANIUM ACETABULAR AUGMENTS BIOMET MANUFACTURING CORP. ALLISON KOSKEY
K052996 10/25/2005 POROUS TITANIUM ACETABULAR SHELLS BIOMET MANUFACTURING CORP. ALLISON KOSKEY
K052990 10/24/2005 STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM BIOMET, INC. LESTER F PADILLA
K052789 10/31/2005 TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 BIOSITE INCORPORATED RACHAEL S WILLIAMSON
K052799 10/03/2005 MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K052964 10/21/2005 EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN BOSTON SCIENTIFIC CORP. KATIE GERBENSKY
K052783 10/03/2005 MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX BOSTON SCIENTIFIC CORP. DIANE BRINZA
K052966 10/21/2005 CI KNEE, CI MI TKR BRAINLAB, AG RAINER BIRKENBACH
K052779 10/03/2005 BRECOMP BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052781 10/03/2005 BREFORMANCE BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052780 10/03/2005 DENTAPLAST HOT, MODEL 16-XXX BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052898 10/14/2005 IQMARK EZ STRESS BRENTWOOD MEDICAL TECHNOLOGY CORP. RUOMEI ZHANG
K052862 10/11/2005 FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) BRYAN KEROPIAN DDS BRYAN KEROPIAN
K052843 10/24/2005 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K053031 10/27/2005 EXTENDSURE HBFASC CONTROL CANTEBURY SCIENTIFIC LTD. MAURICE OWEN
K052595 10/03/2005 CRC 15ULTRA CAPINTEC, INC. MARY ANNE DELL
K053049 10/28/2005 ALARIS SAFETY MALE LUER CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K052790 10/03/2005 SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K052963 10/21/2005 MEDIQ VERSION 1.0 CLARIO MEDICAL IMAGING, INC. PATRICIA A MILBANK
K053014 10/26/2005 POLY SILOXANE IMPRESSION MATERIAL CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. JEANETTE SMITH
K052812 10/04/2005 OSSIMEND (TM) BONE GRAFT MATERIAL COLLAGEN MATRIX, INC. PEGGY C HANSEN
K053040 10/28/2005 PARACEM UNIVERSAL DC COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K052820 10/04/2005 PARAPOST PARACORE AUTOMIX 5ML COLTENE/WHALEDENT AG H. J. VOGELSTEIN
K052992 10/25/2005 CONMED LINVATEC INSTRUMENT STERILIZATION TRAY CONMED LINVATEC ELIZABETH PAUL
K052841 10/07/2005 MIRA-FLEX 18 MICROCATHETER COOK, INC. THALIA BRINE
K052834 10/07/2005 MREYE EMBOLIZATION COIL COOK, INC. LISA M WEBB
K053061 10/31/2005 EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K052788 10/03/2005 N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K052883 10/13/2005 CARDIOSERVER DATRIX LINDA GLUCKMAN
K052957 10/21/2005 IMPLANTIUM PROSTHETICS DENTIUM CO., LTD. CATHRYN N CAMBRIA
K052823 10/04/2005 IMPLANTIUM ABUTMENTS DENTIUM, INC. KLAAS BESSELING
K053010 10/26/2005 VISTADENT AT COMPLETE, MODEL 3.1 DENTSPLY INTL., INC. HELEN LEWIS
K052840 10/07/2005 IGI-SYSTEM DENX ADVANCED DENTAL SYSTEMS RACHEL WEISSBROD
K053002 10/27/2005 DEPUY CMW 1 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K053003 10/27/2005 DEPUY CMW 1, 2 AND 3 BONE CEMENTS DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K052794 10/07/2005 ETI-MAX 3000 DIASORIN, INC. CAROL A DEPOUW
K052800 10/05/2005 PROVISIONAL INLAY/ONLAY KIT DMG USA, INC. PAMELA PAPINEAU
K052743 10/03/2005 DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 DYNAREX CORP. JAMES HURLMAN
K053008 10/26/2005 E-Z-EM ENDOSCOPIC CO2 REGULATOR E-Z-EM, INC. ROBERT WILLIAMS
K053016 10/26/2005 WIRELESS PHYSIOLOGIC MONITORING SYSTEM EDWARDS LIFESCIENCES, LLC. DIANE PETERSON
K052777 10/03/2005 LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D ELLEX MEDICAL PTY. LTD. KEVIN HOWARD
K052938 10/20/2005 CR-PRO ERADLINK, INC. ALBERT KOUBA
K052805 10/04/2005 MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 ESAOTE S.P.A. CARRI GRAHAM
K053056 10/31/2005 HARMONIC SCALPEL BLADES AND SHEARS ETHICON ENDO-SURGERY, INC. ELIZABETH MILLER
K052953 10/20/2005 NUVANCE* FACIAL REJUVENATION SYSTEM ETHICON, INC. JENNIFER M PAINE
K052999 10/25/2005 SEMPERFLO INFUSION SYSTEM ETHICON, INC. JENNIFER M PAINE
K052909 10/17/2005 EVENFLO ELAN BREAST PUMP EVENFLO COMPANY, INC. THOMAS A SPARNO
K052787 10/03/2005 ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) EXACTECH, INC. MARITZA ELIAS
K052849 10/11/2005 INFRARED THERMOMETER, FDIR-V1 FAMIDOC TECHNOLOGY CO., LTD MR. STEELJIN
K052813 10/04/2005 FD TENS 2030, MODEL DFJ24T FUJI DYNAMICS LIMITED ANTHONY AH YIN SHUN
K052889 10/13/2005 VITROS CA 19-9 FUJIREBIO DIAGNOSTICS, INC. DIANA L WOLANIUK
K052995 10/25/2005 ADVANTAGE WORKSTATION 4.3. GE HEALTHCARE LARRY A KROGER
K052839 10/07/2005 CT PERFUSION 4 GE HEALTHCARE LARRY KROGER
K052972 10/24/2005 DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE HEALTHCARE JOEL KENT
K052977 10/24/2005 DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES GE HEALTHCARE JOEL KENT
K052976 10/24/2005 DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES GE HEALTHCARE JOEL KENT
K052880 10/12/2005 DATEX-OHMEDA S/5 INTERFACE MODULE E-INT GE HEALTHCARE JOEL C KENT
K052756 10/03/2005 DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM GE HEALTHCARE JOEL KENT
K052755 10/03/2005 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT GE HEALTHCARE JOEL KENT
K052975 10/24/2005 DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE GE HEALTHCARE JOEL KENT
K052855 10/11/2005 STARSPEED SERIES CT SCANNER SYSTEMS GE HEALTHCARE LEKSHMI NAIR
K053009 10/26/2005 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K052978 10/24/2005 GE 1.5T SIGNA HDE MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K052897 10/14/2005 GE DEFINIUM AMX 700, MODEL AMX 700 GENERAL ELECTRIC MEDICAL SYSTEMS MARK STAUFFER
K053041 10/31/2005 MED SCULPT GENERAL PROJECT S.R.L. MAUREEN O'CONNELL
K052899 10/18/2005 ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC GENESEE BIOMEDICAL, INC. JOHN T.M. WRIGHT
K053055 10/31/2005 ORTHODONTIC POLYMER COMPOSITE BRACKET GESTENCO INTERNATIONAL AB GORAN STEEN
K052923 10/18/2005 GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES GREAT GLOVE (CHINA), INC. K.M. LEE
K052922 10/18/2005 GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES GREAT GLOVE (CHINA), INC. K.M. LEE
K052956 10/21/2005 NITRILE BLUE POWDER FREE EXAMINATION GLOVE GREAT GLOVE SDN BHD LIM WEE-CHAI
K052955 10/21/2005 NITRILE BLUE POWDERED EXAMINATION GLOVES GREAT GLOVE SDN BHD LIM WEE-CHAI
K053019 10/26/2005 ACUITY STEERABLE STYLET ACCESSORY GUIDANT CORPORATION JENNIFER X TANG
K052965 10/21/2005 EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. GUIDANT CORPORATION LINDA KLEINSASSER
K053000 10/25/2005 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) HAEMONETICS CORP. GABRIEL J MURACA
K052863 10/12/2005 RAPHAEL COLOR HAMILTON MEDICAL AG CURDIN DANUSER
K052925 10/18/2005 SMARTPREP2 CENTRIFUGE SYSTEM HARVEST TECHNOLOGIES, CORP. JOHN D BONASERA
K052891 10/13/2005 HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM HAWKEN INDUSTRIES GEORGE MYERS
K052935 10/19/2005 HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) HEIDELBERG ENGINEERING GERHARD ZINSER
K052828 10/05/2005 DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) HOSPIRA, INC. THOMAS KOZMA
K053038 10/27/2005 HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K052917 10/18/2005 STRYKER COMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K052811 10/04/2005 HSINER JET NEBULIZER, MODEL HS-31100 HSINER CO., LTD. TOM SHANKS
K052865 10/11/2005 HOSPIRA CATH LAB CONVENIENCE KITS ICU MEDICAL, INC. TOM KOZMA
K053046 10/28/2005 ILUMA ORTHOCAT/DENTALCAT IMTEC CORP. J. BRAD VANCE
K052908 10/14/2005 INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 INFRAREDX, INC. NANDINI MURTHY
K052951 10/20/2005 ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. HOWARD HOLSTEIN
K053045 10/31/2005 MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 INTEGRA LIFESCIENCES CORPORATION DONNA WALLACE
K052791 10/05/2005 MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. STEPHANIE ROBINSON
K053017 10/26/2005 MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS INVIVO CORPORATION THOMAS SCHUBERT
K052979 10/24/2005 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE ISOLUX LLC NILCOLAOS ANDREOULAKIS
K052798 10/03/2005 CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C ISOVAC PRODUCTS LLC LISA S JONES
K052587 10/11/2005 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF J. MORITA USA, INC. KEITH A BARRITT
K053030 10/27/2005 J. MORITA AZ ULTRASONIC SYSTEM J. MORITA USA, INC. HOWARD ROWE
K052870 10/13/2005 INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 KIMBERLY-CLARK CORP. TIERNEY NORSTED
K052824 10/05/2005 KIMBERLY-CLARK PROCEDURE GOWN KIMBERLY-CLARK CORP. CHERYL M SANZARE
K053026 10/27/2005 KOWA NONMYD 7, KOWA NONMYD A-D KOWA CO. LTD. SATOHIKO TAKANASHI
K052980 10/24/2005 LIBERTY GLUCOSE CONTROL, MODEL 2120031 LIBERTY HEALTHCARE GROUP, INC. JOJN C GORMLEY
K052954 10/31/2005 CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET LIFE-TECH, INC. JEFF KASOFF
K052929 10/19/2005 PREFTEST PROFESSIONAL SUITE LIMESTONE TECHNOLOGIES INC. NANCY RUTH
K052846 10/11/2005 TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE MAANSHAN MEDICAL INSTRUMENTS CO., LTD. KEVIN WALLS
K052851 10/11/2005 VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) MAKO SURGICAL CORP. WILLIAM F TAPIA
K052802 10/03/2005 MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE MANAN MEDICAL PRODUCTS, INC. NICOHL R WILDING
K053025 10/27/2005 JOSTRA HLM TUBING SET MAQUET CARDIOPULMONARY AG KATHLEEN JOHNSON
K053052 10/31/2005 MEDELA SWING BREAST PUMP MEDELA AG WEMER FREI
K052911 10/17/2005 ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. SHIM KYUNG-AM
K052833 10/07/2005 GORE-TEX NON-STERILE SURGICAL GOWNS MEDLINE INDUSTRIES, INC. JENNIFER MASON
K053042 10/28/2005 MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE MEDRAD, INC. LISA A EWING
K052827 10/07/2005 MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS MEDRAD, INC. LISA A EWING
K052797 10/18/2005 LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM MEDTEK DEVICES, INC. ROBERT O DEAN
K052854 10/11/2005 LIFENET EXCHANGE SYSTEM MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. TERESA DAVIDSON
K052860 10/12/2005 CG FUTURE ANNULOPLASTY BAND MEDTRONIC HEART VALVES JULIE SHERMAN
K052970 10/24/2005 SIMPLICI-T ANNULOPLASTY SYSTEM MEDTRONIC HEART VALVES PHIL NEURURER
K052931 10/19/2005 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052919 10/21/2005 MICROSULIS TISSUE ABLATION SYSTEM MICROSULIS AMERICAS, INC. TIMOTHY Y COWART
K053018 10/26/2005 POLY SILOXANE IMPRESSION MATERIAL MILLENNIUM DENTAL INTERNATIONAL, INC. JEANETTE SMITH
K052946 10/20/2005 MPS ACACIA NERVE BLOCK NEEDLE MPS ACACIA FERGIE F FERGUSON
K052874 10/12/2005 SOPRANO HAIR REMOVAL DIODE LASER MSQ (M2) LTD. TATIANA EPSTEIN
K052942 10/20/2005 21.3INCH MONOCHROME LCD MONITOR NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP. SHUICHI KINO
K052930 10/19/2005 NAVIGATOR ENDOSCOPY SYSTEM NEOGUIDE SYSTEMS, INC. MICHAEL A DANIEL
K052878 10/14/2005 NT-1000 NEUROTHERM, INC. WILLIAM RITTMAN
K052885 10/20/2005 ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 NOBEL BIOCARE USA LLC HERBERT CRANE
K052829 10/13/2005 WRISTOX MODEL 3100 PULSE OXIMETER NONIN MEDICAL, INC. LORI ROTH
K052987 10/24/2005 BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC NORAS RONTGEN-UND MEDIZINTECHNIK GMBH CARL ALLETTO
K052804 10/04/2005 BREATHKEY MODEL G10/BREATHKEY MODEL G30X OMEGAPOINT SYSTEMS, LLC BARBARA S FANT
K053044 10/28/2005 OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 OPTO GLOBAL, INC MARK T FUKUHARA
K052819 10/25/2005 VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K052867 10/11/2005 VITROS CHEMISTRY PRODUCTS DTIBC REAGENT ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K052968 10/21/2005 MODIFICATION TO: ORLUS MINI SCREW ORTHOLUTION CO., LTD. CATHRYN CAMBRIA
K052866 10/14/2005 OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER OXYHEAL HEALTH GROUP DAVE HEANY
K052983 10/28/2005 FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES PARAGON VISION SCIENCES WILLIAM E MEYERS
K052793 10/03/2005 IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 PHARMACIA DIAGNOSTICS AB MARTIN R MANN
K052974 10/24/2005 WARMING LIQUID PERSONAL LUBRICANT PHARMAPAC LLC TOM OTTO
K052961 10/21/2005 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN PHILIPS MEDICAL SYSTEMS TAPAN D SHAH
K052801 10/03/2005 INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HAUKE SCHIK
K052795 10/03/2005 PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH MARKUS STACHA
K052988 10/24/2005 CAAS PIE MEDICAL IMAGING B.V. CARLA DE VRIES
K052910 10/17/2005 POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K052941 10/20/2005 I-NEB INSIGHT AAD SYSTEM PROFILE THERAPEUTICS PLC BARBARA CAMPBELL
K052903 10/14/2005 PEDIATRIC FEEDING TUBE PROMEDIC, INC. PAUL DRYDEN
K052858 10/12/2005 SOOTHIES GEL PADS PURONXY, INC. LESLIE SEBASTAIN
K052900 10/14/2005 QUILL NONABSORBABLE NYLON BARBED SUTURE QUILL MEDICAL, INC. LOIS V SMART
K052991 10/25/2005 RADIANCY FACIAL SKINCARE DEVICE RADIANCY (ISRAEL) LTD. MARGARET FOURTE
K052914 10/17/2005 RX IMOLA RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K053047 10/28/2005 FRAXEL SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. HEATHER TANNER
K052844 10/07/2005 KAVS - CATHETER, MODELS 1107100 & 1107060 RICHTER & ROTHE AG JOACHIM RICHTER
K052982 10/24/2005 ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET ROCHE DIAGNOSTICS RANDY JOHNSON
K053059 10/31/2005 ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK ROCHE DIAGNOSTICS RANDY JOHNSON
K053006 10/26/2005 ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II ROSSMAX INTERNATIONL LTD. YOLANDA LIN
K052934 10/24/2005 DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM S.O.R. INTERNACIONAL, S.A. IAN GORDON
K052861 10/11/2005 MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 SANARUS MEDICAL, INC. TRENA DEPEL
K052809 10/04/2005 SAUFLON FLAT COLOURED LENS CASE SAUFLON PHARMACEUTICALS, LTD. AZITTA JADALIZADEH
K052832 10/06/2005 SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES SAUFLON PHARMACEUTICALS, LTD. TANYA FAIR
K052920 10/17/2005 DELTA4 SCANDIDOS AB THOMAS MATZEN
K052810 10/05/2005 SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM SCANDIUS BIOMEDICAL, INC. ERIC BANNON
K052763 10/21/2005 STELLA CERVICAL PLATE SCIENT'X J. D. WEBB
K052904 10/14/2005 VIRTUAL MEDICAL SYSTEMS MODEL VT3000 SCIENTIFIC IMAGING, INC. CHRIS JOHNSON
K052857 10/11/2005 ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 SENORX, INC. AMY BOUCLY
K052815 10/04/2005 QMS AMIKACIN REAGENTS SERADYN INC. JACK ROGERS
K052826 10/05/2005 QMS QUINIDINE. QMS QUINIDINE CALIBRATORS SERADYN INC. JACK ROGERS
K052890 10/13/2005 NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E SIAM SEMPERMED CORP. LTD. WILLIAM E HARRIS
K053024 10/21/2005 SYNGO NEURO DSA CT SIEMENS AG RUEDIGER KOERNER
K052775 10/03/2005 SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) SIEMENS AG, MEDICAL SOLUTIONS SIEGLINDE WEST
K052895 10/14/2005 FOURSIGHT VIEWTOOL IMAGE VIEWER SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICK J LYNCH
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K052962 10/21/2005 OPTIMIZED BARB DESIGN SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
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K053028 10/27/2005 TECHDEVICE GUIDEWIRE TECHDEVICE CORPORATION LEIGH HAYWARD
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K052837 10/06/2005 SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA TERANG NUSA SDN BHD CHIN GUAN LOW
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K052818 10/04/2005 EZ SMART-168 GLUCOSE MONITORING SYSTEM TYSON BIORESEARCH, INC. DAVID ROSEN
K052817 10/19/2005 EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF UNIVERSAL MEDICAL TECHNOLOGIES GLENN HERSKOWITZ
K052916 10/17/2005 USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY USA INSTRUMENTS, INC. ROBERT B SMITH
K052814 10/04/2005 LUMINA 1600, 3300 AND 6600 SYSTEMS USA LASER BIOTECH INC. M. JOYCE HEINRICH
K052836 10/06/2005 BODIHEALTH SYSTEM USA LASER THERAPEUTICS, INC. M. JOYCE HEINRICH
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K053051 10/28/2005 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. TRISH STEPHENS
K052738 10/11/2005 INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 VEINRX INC. GREGORY J MATHISON
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K052806 10/04/2005 BURANE WAVELIGHT LASER TECHNOLOGIE AG ALEXANDER POPP
K052784 10/03/2005 DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 WELCH ALLYN, INC. CHRIS KLACZKY
K053027 10/27/2005 VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) WELCH ALLYN, INC. JOHN E SAWYER
K052785 10/05/2005 OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 WELL-LIFE HEALTHCARE LIMITED GRACE CHANG
K052913 10/17/2005 IGNITE BONE VOID FILLER KIT WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
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K052847 10/07/2005 CAPLESS PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC. FLOYD G LARSON
K052912 10/19/2005 YUSHENG DISPOSABLE VAGINAL SPECULUM ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. PEIFANG XING
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