FDA 510(k) Applications Received During December, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K093828 12/14/2009 KYPH X HV-R BONE CEMENT MEDTRONIC INC. MARY ROSE
K093721 12/02/2009 COSP2 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K094007 12/28/2009 UNICEM 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K094064 12/31/2009 ILUMA VISION MODEL VERSION 2.2 3M IMTEC GINGER CANTOR, RAC
K093716 12/02/2009 BABI PLUS INFANT NASAL CANNULA SYSTEM A PLUS MEDICAL TOM LOESCHER
K093801 12/10/2009 IMPELLA CONTROLLER ABIOMED, INC. ROBERT STEWART
K093879 12/18/2009 MISSION SALIVA ALCOHOL TEST STRIP ACON LABORATORIES, INC. RICHARD LENART
K093795 12/10/2009 ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 ACTHERM, INC. RICHARD HSIEH
K093710 12/02/2009 THE MOSES APPLIANCE ALLEN J. MOSES, DDS, LTD. ALLEN J MOSES
K093821 12/14/2009 FS ALIGNER ALLESEE ORTHODONTIC APPLIANCES WENDY GARMAN
K094041 12/30/2009 ALPHA ORTHOPAEDICS AT3 SYSTEM ALPHA ORTHOPAEDICS GINA TO
K093825 12/14/2009 AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE AMBU A/S SANJAY PARIKH
K093773 12/08/2009 AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS AMSINO INTERNATIONAL, INC. JESUS FARINAS
K093755 12/07/2009 AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. YI LIU
K093894 12/18/2009 ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE ANTHOGYR BRAYETTE SABINE
K094043 12/31/2009 LIGAMENTOTAXOR AREX USA ELLEN HOKANSON
K093819 12/14/2009 ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) ARKRAY FACTORY USA, INC. TOM SPEIKERS
K093999 12/28/2009 ARP POV SPORT ARP MANUFACTURING, INC LEWIS WARD
K093912 12/22/2009 ARTHREX TIBIAL GRAFTBOLT ARTHREX, INC. DAVID D'ALESSANDRO
K093702 12/01/2009 REPROCESSED ULTRASONIC COAGULATING SHEARS ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON VARTY
K094056 12/31/2009 HOTDOG MULTI FUNCTION CONTROLLER AUGUSTINE BIOMEDICAL & DESIGN, LLC JAMES ECKLEIN
K093717 12/02/2009 C-MOR VISUALIZATION DEVICE AXIS SURGICAL TECHNOLOGIES, INC JAMES FARNWORTH
K093835 12/15/2009 BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN BAM CORP., LTD. MARY MEJAES
K093855 12/16/2009 HALO 360 & SIZING BALLOON, MODEL 3441C BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K093930 12/22/2009 DIDGET WORLD REPORTS BAYER HEALTHCARE LLC SUSAN BROCCHI
K093972 12/24/2009 BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 BECTON DICKINSON & CO. JULIE T WING
K093872 12/17/2009 HANDHELD ECG MONITOR, MODEL MD100 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K093757 12/07/2009 MD300C1 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K093758 12/07/2009 BGM GALECTIN -3 BG MEDICINE, INC. CAROL ADILETTO
K093954 12/23/2009 BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES JUANG WANG
K094018 12/29/2009 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K093852 12/16/2009 EZLASE 3 LASER SYSTEM BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K093803 12/11/2009 BIO-MODULAR REVERSE SHOLDER BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K093761 12/07/2009 OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM BIOMET TRAUMA (AKA EBI, LP) MARGARET CROWE
K093983 12/24/2009 SMPLE PLATE AND SCREWS BIOMET TRAUMA (AKA EBI, LP) MARGARET CROWE
K093764 12/07/2009 SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM BIOTEST MEDICAL CORP. MAGGIE CHU
K093926 12/22/2009 FIREBIRD SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. RUSSELL JOHNSON
K093720 12/02/2009 STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO BOSTON SCIENTIFIC CORP. MARK MURPHY
K093920 12/22/2009 BUSSE EPIDURAL CATHETER KIT BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K093909 12/22/2009 BUSSE SURGICAL DRAPES IV BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K093747 12/04/2009 ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS C.R. BARD, INC. JOHN KNORPP
K093965 12/23/2009 ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS C.R. BARD, INC. CANDACE WADE
K093725 12/03/2009 CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C CANADA ENDOSCOPE CORPORATION ROGER LECLERC
K093969 12/23/2009 ACUITY BREAK-AWAY GUIDE CATHETER CARDIAC PACEMAKERS, INC. KATHLEEN VITTUM
K094062 12/31/2009 PERCU-PRO GUIDEWIRE CARDIOSOLUTIONS INC MICHELE LUCEY
K094048 12/31/2009 PERCUPRO MESSENGER BALLOON CATHETER CARDIOSOLUTIONS INC MICHELE LUCEY
K094045 12/31/2009 MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM CARDO MEDICAL CORP. DAVE LAMB
K093787 12/09/2009 IGUIDE CAPPA CAS INNOVATIONS GMBH & CO. KG ANGELIKA SCHERP
K094030 12/30/2009 FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K093977 12/24/2009 ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX CHESTNUT MEDICAL TECHNOLOGIES, INC. DANIEL CHER
K093931 12/22/2009 BLOOD PRESSURE METER, MODEL CH-4532 CITIZEN SYSTEMS JAPAN CO., LTD. NATHAN A BEAVER
K093713 12/01/2009 ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM CIVCO MEDICAL INSTRUMENTS ARTHUR WARD
K093981 12/24/2009 YRNSORTIP OXIMANOMETER CNOGA MEDICAL LTD TALI HAZAN
K093973 12/24/2009 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CODMAN & SHURTLEFF, INC. AMARILYS MACHADO
K093895 12/28/2009 ALLY PLATFORM SYSTEM CONTINUITY HEALTH SOLUTIONS BRIAN POTEET
K094028 12/30/2009 CP-FIBER (ORTHOFIBER) CP MEDICAL BARBARA K HORTON
K094026 12/30/2009 STERI-DENT, STERI-SURE CPAC, INC. JEFFREY CRANE
K093871 12/17/2009 PERIOPHIL B-TCP CYTOPHIL INC VICTOR M BOWERS
K093848 12/16/2009 PT-MULTI-CALIBRATOR, MODEL OPAT07 DADE BEHRING, INC. RADAMES RIESGO
K093888 12/18/2009 COOPDECH ENDOBRONCHIAL BLOCKER TUBE DAIKEN MEDICAL CO, LTD. FUMIAKI KANAI
K093886 12/18/2009 ENGSTROM CARESTATION, ENGSTROM PRO DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C JIM RASKOB
K093915 12/22/2009 DEKA TAC DEVICE DEKA RESEARCH & DEVELOPMENT CORP. ROBERT SWAIN
K093748 12/04/2009 DD BIO Z AND DD BIO Z - TRANSPA DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) GERHARD DE BOER
K094049 12/31/2009 STLASE DIODE LASER DENTAL PHOTONICS, INC MARCY MOORE
K093736 12/08/2009 DEPUY CORAIL HIP SYSTEM, REVISION STEM DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K093168 12/18/2009 MEDIFLASH AND ESTEFLASH DERMEO E.J. SMITH
K093633 12/03/2009 INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K093788 12/09/2009 INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION DRAEGER MEDICAL SYSTEMS, INC. CHARLES MORGANSON
K093632 12/03/2009 INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE DRAGER MEDICAL AG & CO. KGAA JOYCE KILROY
K093779 12/09/2009 CLEARPATH UGI EASYGLIDE LTD. PAUL DRYDEN
K093728 12/03/2009 BE MICRO, TREA EB NEURO, S.P.A. JAMIE AUSTIN
K093880 12/18/2009 PEANUT GROWTH CONTROL PLATING SYSTEM EBI, L.P. MARGARET F CROWE
K093869 12/17/2009 SE-601 SERIES ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. WILLIAM STERN
K093911 12/22/2009 FOGARTY OCCLUSION CATHETER EDWARDS LIFESCIENCES, LLC. PATRICIA A MILBANK
K093730 12/15/2009 PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K093877 12/16/2009 RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 EDWARDS LIFESCIENCES, LLC. JASON K LYON
K093640 12/15/2009 DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA ELECTRON JSCO. TANMAY SHUKLA
K093723 12/03/2009 EMS MINIMASTER LED EMS ELECTRO MEDICAL SYSTEMS SA CYNTHIA J.M. NOLTE
K093901 12/22/2009 SURGICAL FACE MASK EPARD PROTECTIVE PRODUCTS, LTD DARREN REEVES
K093447 12/16/2009 CARRIGEN ETEX CORP. CHRISTOPHER KLACZYK
K093896 12/18/2009 ETHICON ENDO SURGERY SLOTTED ANOSCOPE ETHICON ENDO-SURGERY, INC. GLENDA MARSH
K093899 12/18/2009 MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K093932 12/22/2009 ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH ETHICON GMBH NEELU MEDHEKAR
K093845 12/15/2009 ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 ETHICON, INC. JOSEPH KICEINA
K093908 12/22/2009 CCPOINT EURO-DIAGNOSTICA AB ROBERT SCHIFF
K093750 12/07/2009 ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA EV3 INC LAURA HEATON
K093866 12/17/2009 EVALVE STEERABLE GUIDE CATHETER EVALVE INC SEVRINA CIUCCI
K093978 12/24/2009 EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM EXACTECH, INC. SHING JEN TAI
K093770 12/15/2009 EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K094039 12/30/2009 HYALO GYN FIDIA FARMACEUTICI SPA GIUSI LOCASTRO
K094040 12/30/2009 F&P ICON SERIES CPAP FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K093599 12/10/2009 ARROW ANATOMICAL SHOULDER SYSTEM FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K093902 12/22/2009 MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 FRESENIUS MEDICAL CARE NORTH AMERICA RANDOLPH QUINN
K093957 12/23/2009 ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, FUJIREBIO DIAGNOSTICS, INC STACEY DOLAN
K093749 12/07/2009 GC AADVA IMPLANT SYSTEM GC AMERICA, INC. CARL JENKINS
K093881 12/18/2009 TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR GE HEALTHCARE FINLAND OY TOMMI JOKINIEMI
K093982 12/24/2009 XELERIS 3 PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS F.I. HAIFA ELI WERNER
K093903 12/22/2009 ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC GENESEE BIOMEDICAL, INC. JOHN T.M. WRIGHT
K093904 12/22/2009 GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER GLENVEIGH SURGICAL, LLC PENNY NORTHCUTT
K093751 12/07/2009 CL-DC20, CL-DC21 GOOD DOCTORS CO., LTD. KEVIN WALLS, RAC
K093910 12/22/2009 IMPROVACUTER GEL & CLOT ACTIVATOR TUBE GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. DIANA HONG
K093759 12/07/2009 MULTIPLE NAME MODEL MULTIPLE GX CORPORATION SDN BHD (PLANT 1) CHO SOW FONG
K094009 12/28/2009 HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI HALT MEDICAL INC RUSS DELONZOR
K093807 12/11/2009 HARDYDISK AST TELAVANCIN,30UG HARDY DIAGNOSTICS WENDY PHILIPS
K093824 12/14/2009 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT HEALTH & LIFE CO., LTD. SARAH SU
K093823 12/14/2009 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM HEALTH & LIFE CO., LTD. SARAH SU
K093831 12/14/2009 FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT HEALTH & LIFE CO., LTD. SARAH SU
K093834 12/14/2009 CRIT-LINE ANEMIA MANAGEMENT SOFTWARE HEMA METRICS, LLC TERRY LANIER
K093729 12/03/2009 GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I HEMCON MEDICAL TECHNOLOGIES EUROPE LTD KEVIN HAWKINS
K094003 12/28/2009 REVIVATOR HERSILL, S.L. ANA MARIA ROMERO
K094016 12/29/2009 NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H HINSON AND HALE MEDICAL TECHNOLOGIES, INC JEFFREY O STULL
K093889 12/18/2009 MODIFICATION TO: HG III ULTRA WIDE SYSTEM HIOSSEN INC. PATRICK LIM
K093946 12/23/2009 HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 HOVEROUND CORP. TONY DIGIOVANNI
K093706 12/01/2009 PROXISCAN MODEL 101 HYBRIDYNE IMAGING TECHNOLOGIES, INC BARRY S SALL, RAC
K093868 12/17/2009 I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K093893 12/18/2009 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. DARLENE GARNER
K093813 12/11/2009 OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE IMBIOTECHNOLOGIES ROSINA ROBINSON
K093808 12/11/2009 INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE INCITE INNOVATION LLC JOHN KIRWAN
K093993 12/24/2009 LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 INFRAREDX, INC. STEVEN J CHARTIER
K093922 12/22/2009 INOMAX DS INO THERAPEUTICS LARRY LEPLEY
K094060 12/31/2009 QUANTA FLASH H-TTG IGA INOVA DIAGNOSTICS, INC. TANA KEIVENS
K093737 12/04/2009 HEMOSIL F11 & FV DNA CONTROL INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K093968 12/23/2009 OSV II LOW FLOW LOW PRO VALVE INTEGRA LIFESCIENCES CORPORATION DONNA MILLISKY
K093842 12/15/2009 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS INVIVO CORPORATION ELIZABETH WHEELER
K093861 12/16/2009 IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE IRIS INTERNATIONAL, INC. ELLEN JOHNSTON
K093744 12/09/2009 EXCITE F AND EXCITE DSC IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K093708 12/02/2009 TELIO CAD IVOCLAR VIVADENT, INC. DONNA MHARTNETT
K094061 12/31/2009 KENSEY NASH ECM SURGICAL PATCH KENSEY NASH CORPORATION LORI A BURNS, MS, RAC
K093810 12/16/2009 BF-NAVI KGT INC. RICHARD VINCINS
K094052 12/31/2009 LENSX 550 LASER SYSTEM. MODEL 550 LENSX LASERS, INC. JUDY GORDON
K093832 12/14/2009 LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES LEVITRONIX LLC. SUSAN K HAMANN
K093745 12/04/2009 ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. LISA MCGRATH
K093857 12/16/2009 C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES LIGHTLAB IMAGING,INC. CHRISTINE BRAUER
K094046 12/31/2009 LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS MASIMO CORPORATION MARGUERITE THOMLINSON
K093753 12/07/2009 MDPO FRAME SYSTEM MDPO, LLC MARIE MARLOW
K093944 12/22/2009 MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S MEDACTA INTERNATIONAL, SA HEATHER NEELY
K093806 12/11/2009 MYKNEE CUTTING BLOCKS MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K093816 12/11/2009 DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 MEDIEN INTERNATIONAL CO., LTD CHARLES MACK
K093849 12/16/2009 ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K093714 12/02/2009 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG AM SHIM
K093726 12/03/2009 MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K093830 12/14/2009 MEDLINE ANGIOGRAPHIC CONTROL SYRINGE MEDLINE INDUSTRIES, INC. MATT CLASEN
K093738 12/04/2009 MRI PATIENT POSITIONING DEVICES MEDTEC, INC. JAMES LEONG
K094025 12/30/2009 CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK JENNIFER HACKNEY
K093820 12/14/2009 SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 MEMOMETAL TECHNOLOGIES GILLES AUDIC
K093766 12/07/2009 VITALOGIK 6000/6500 MENNEN MEDICAL LTD. IFAT OREN SHWARTS
K093913 12/22/2009 MERCURY MEDICAL T-PIECE RESUSCITATOR MERCURY MEDICAL, INC. PAUL DRYDEN
K093947 12/23/2009 ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC MERIT MEDICAL SYSTEMS, INC. CAROL HOLLOWAY, RAC
K094021 12/30/2009 ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I MICROSULIS MEDICAL LIMITED DENISE REXHAUS
K093919 12/22/2009 MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V MICROVENTION, INC. LARAINE PANGELINA
K093815 12/16/2009 LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 MILLIPORE CORPORATION CATHERINE KARAMAN
K094047 12/31/2009 18" STANDARD WHEELCHAIR, MODEL MS005-4, 18" RECLINING WHEELCHAIR , MODEL MS008-1, 14" PEDIATRIC WHEELCHAIR MODERN REHABILITATION SOLUTIONS CO., LTD KEVIN WALLS
K093949 12/28/2009 OLYMPIC BRAINZ MONITOR MODEL OBM70001 NATUS MEDICAL, INC. GOLDY SINGH
K093781 12/09/2009 MODIFIED: NEWDEAL HALLU PLATES NEWDEAL SAS STEPHEN BEIER
K093914 12/22/2009 NEWDEAL COMPRESSION PLATES NEWDEAL SAS STEPHEN BEIER
K093739 12/04/2009 BLOOD PRESSURE MONITOR/ MODELS NINGBO DIAIER ELECTRONIC CO., LTD. LAO XIKUN
K093985 12/24/2009 NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE NIPRO MEDICAL CORP. JESSICA OSWALD
K093643 12/07/2009 MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS NOBELBIOCARE AB HERBERT CRANE
K093853 12/16/2009 SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES NONIN MEDICAL, INC. LORI ROTH
K093971 12/24/2009 DENTAL HANDPIECE NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. DIANA HONG
K094054 12/31/2009 MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE NUVASIVE, INC. SHEILA BRUSCHI
K093804 12/11/2009 NUVASIVE HELIX REVOLUTION ACP SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K093862 12/17/2009 CAREVENT HANDHELD CPAP SYSTEM O-TWO MEDICAL TECHNOLOGIES, INC. DAVID ZHANG
K093951 12/23/2009 OUCHLESS MODEL PN10114 OCCAM DESIGN VAS ABRAMOV
K094017 12/29/2009 TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 OMNI LIFE SCIENCE, INC. ROBERT ZOLETTI
K093923 12/22/2009 CEROX MODEL 3210 OR-NIM MEDICAL LTD. MICHAL BALBERG, PHD
K094012 12/29/2009 CAPNOSTREAM20 WITH MICROMEDICO2 MODULE ORIDION CAPNOGRAPHY, INC. RACHEL WEISSBROD
K093998 12/28/2009 KNEEALIGN SYSTEM WITH REFERENCE SENSOR ORTHALIGN, INC AMY WALTERS
K094037 12/30/2009 TC PLATING SYSTEM ORTHO-PRO LLC J.D. WEBB
K093900 12/18/2009 EDGELOCK ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K093805 12/11/2009 OSCAR 3 ORTHOSONICS, LTD. MICHAEL J.R. YOUNG, PH.D.
K093974 12/23/2009 ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING OSMETECH MOLECULAR DIAGNOSTICS ROBERT S DICHECK
K093719 12/02/2009 PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# OSTEOGENICS BIOMEDICAL, INC. DUSTYN WEBB
K093975 12/24/2009 SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 PAN GLOBAL IMPLANT HAROLD BERGMAN
K093918 12/22/2009 JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) PATHWAY MEDICAL TECHNOLOGIES, INC. BRIT BAIRD
K093970 12/23/2009 PICA CATHETER PENUMBRA, INC. SETH A SCHULMAN
K093916 12/22/2009 NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U PERKINELMER, INC. KAY TAYLOR
K093796 12/11/2009 ASEPT PERITONEAL DRAINAGE SYSTEM PFM MEDICAL, INC SALVADORE PALOMARES
K093925 12/22/2009 LIFENET SYSTEM PHYSIO-CONTROL, INC. TERESA DAVIDSON
K093771 12/08/2009 QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY EMILY DOWNS
K093976 12/24/2009 RAISIN PERSONAL MONITOR PROTEUS BIOMEDICAL, INC. GREGORY MOON
K094038 12/30/2009 COMPACT TOUCH QUANTEL S.A. MIKE JOHNSON
K094020 12/29/2009 GRIND NO MORE GENERATION II RANIR LLC JONATHAN S KAHAN
K093964 12/24/2009 VENOFER PUMP RENAL SOLUTIONS INC. DAVID VANELLA
K093731 12/03/2009 VPAP III ST-A RESMED LTD. DAVID D'CURZ
K093905 12/29/2009 TRILOGY 202 VENTILATOR RESPIRONICS, INC. JOSEPH OLSAVSKY
K093833 12/14/2009 KAPSS SPINAL SYSTEM ROBERT REID INC. KAREN E WARDEN
K093800 12/15/2009 ROBINSON MEDSURG QUICKSCREW RACK ROBINSON MEDSURG LLC RANDOLPH C ROBINSON
K093955 12/23/2009 ANTI-HAV IGM ROCHE DIAGNOSTICS KELLY FRENCH
K094031 12/30/2009 ELECSYS FOLATE III CALCHECK 5 ROCHE DIAGNOSTICS KELLY COLEEN O'MAINE ADAMS
K093836 12/15/2009 ELECSYS TSH CALCHECK 5 ROCHE DIAGNOSTICS KELLY COLLEEN O'MAINE ADAMS
K093989 12/24/2009 ORAL FLUID PHENCYCLIDINE ROCHE DIAGNOSTICS MICHELLE LEE NEFF
K093884 12/18/2009 ROCHE FLUDI METHAMPHETAMINE ROCHE DIAGNOSTICS MICHELLE LEE NEFF
K093700 12/01/2009 ELECSYS HCG STAT CALCHECK 5 ROCHE DIAGNOSTICS CORP. KELLY C O'MAINE ADAMS
K093775 12/08/2009 EVGUIDE TIP LOCATION SYSTEM ROMEDEX INTERNATIONAL SRL SORIN GRUNWALD
K093793 12/10/2009 LS-40 CO2 LASER SYSTEM MODEL LS-40 SANDSTONE MEDICAL TECHNOLOGIES, LLC MARK ROHRER
K093883 12/18/2009 AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- SEPPIM S.A.S. DEBRA K HUTSON
K093711 12/01/2009 RACEGEL SEPTODONT WAYNE MATELSKI, ESQ
K093794 12/10/2009 SMART-READ EZTEST-STEAM SCBI AND TEST PACK SGM BIOTECH, INC. JOHN R GILLIS, PH.D.
K093822 12/14/2009 DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY SHEPHERD SCIENTIFIC INC PAUL TEIRSTEIN
K093703 12/01/2009 3DI SHINA SYSTEMS LTD. DAN LAOR
K093785 12/09/2009 MODULAR ENDOSCOPE SIALO TECHNOLOGY, LTD. AHAVA STEIN/ EYAL OZERI
K093732 12/04/2009 ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 SIEMENS HEALTHCARE DIAGNOSTICS KIRA GORDON
K093939 12/22/2009 ADVIA CHEMISTRY SALICYLATE REAGENT SIEMENS HEALTHCARE DIAGNOSTICS KIRA GORDON
K093987 12/24/2009 IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 SIEMENS HEALTHCARE DIAGNOSTICS INC. DONNA VELASQUEZ
K093812 12/11/2009 ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K093963 12/23/2009 QUASAR BLUE LIGHT THERAPY SYSTEM SILVER BAY, LLC PETER NESBITT
K093790 12/10/2009 SIMONDR DRP SIMONDR, INC. VALERIE LOHR
K093943 12/22/2009 BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM SMITH & NEPHEW INC., ENDOSCOPY DIV. JULIE ACKER
K093897 12/18/2009 SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIV. CHRISTINA FLORES
K093991 12/24/2009 SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS SMITH & NEPHEW, INC. SHEREEN MYERS
K093935 12/22/2009 SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR SMITH & NEPHEW, INC. CHRISTINA FLORES
K093844 12/15/2009 SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR SMITH & NEPHEW, INC. CHRISTINA FLORES
K093746 12/04/2009 VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM SMITH & NEPHEW, INC. JASON SELLS
K093882 12/18/2009 SORIN C5 SYSTEM MODEL 58-00-00 SORIN GROUP DEUTSCHLAND GMBH ROSINA ROBINSON, RN, MED, RAC
K093986 12/24/2009 AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS SORIN GROUP ITALIA S.R.L. BARRY SALL
K094002 12/28/2009 SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM SPARTEK MEDICAL, INC. HENRY KLYCE
K094036 12/30/2009 TURBO-TANDEM SYSTEM MODEL 472-110 SPECTRANETICS CORP. MICHAEL K HANDLEY
K093936 12/22/2009 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART FRANCK PENNESI
K093776 12/08/2009 INDUS ANTERIOR CERVICAL PLATE SYSTEM SPINEFRONTIER, INC. JOHN SULLIVAN
K093942 12/22/2009 ENSITE VELOCITY SYSTEM V1.3 ST. JUDE MEDICAL DONNA LUNAK
K093858 12/16/2009 PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI BEENA FLYNN
K094035 12/30/2009 EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM STELKAST COMPANY DONALD A STEVENS
K093864 12/17/2009 AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX STRYKER CORP. KIMBERLY S LANE
K093704 12/01/2009 AVS PL PEEK SPACERS STRYKER CORP. KIMBERLY LANE
K093792 12/10/2009 LED LIGHT SOURCE SUNOPTIC TECHNOLOGIES, LLC JANICE G LEE
K093798 12/10/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVE SUPERMAX PLASTIC PRODUCTS CO., LTD. JIE LIU
K093797 12/10/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE) SUPERMAX PLASTIC PRODUCTS CO., LTD. JIE LIU
K093789 12/09/2009 INTOUCH DIABETES SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC RAE ANN DELAY
K093772 12/08/2009 SYNTHES STERNAL FIXATION SYSTEM SYNTHES ANDREA M TASKER
K093928 12/22/2009 SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES SYNTHES (USA) KARL J NITTINGER
K093762 12/07/2009 SYNTHES ZERO-P SYNTHES SPINE AMNON TALMOR
K093940 12/22/2009 ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 TAIDOC TECHNOLOGY CORPORATION DEBRA LIANG
K093941 12/22/2009 CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 TAIDOC TECHNOLOGY CORPORATION DEBRA LIANG
K093724 12/03/2009 FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION TAIDOC TECHNOLOGY CORPORATION DEBRA LIANG
K094005 12/28/2009 FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION NICKY PAN
K093712 12/02/2009 FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION NICKY PAN
K094044 12/31/2009 SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT TAYSIDE FLOW TECHNOLOGIES LIMITED RUDY MOUNIA
K093937 12/22/2009 LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) TEARSCIENCE, INC. CHRISTY MOENY
K093992 12/24/2009 TERUMO LAUER LOCK ADAPTER TERUMO CARDIOVASCULAR SYSTEMS CORPORATION EILEEN DORSEY
K093705 12/01/2009 FUORECAM THERAPEUTIC TECHNOLOGIES, INC. BART COLLINS
K093847 12/16/2009 DUFLO CATHETER (HEPARIN COATED) THERMOPEUTIX INC. THOMAS SCHROEDER
K093984 12/24/2009 PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 TIME MEDICAL LIMITED DIANA HONG
K094013 12/29/2009 HLS KNEETEC SYSTEM TORNIER SEVERINE BONNETON
K093799 12/10/2009 TORNIER SURGICAL MESH TORNIER, INC. HOWARD L SCHRAYER
K093891 12/18/2009 AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K093960 12/23/2009 ST AIA-PACK CYSTATIN C, MODEL 025217 TOSOH BIOSCIENCE, INC. JUDITH K OGDEN
K093865 12/16/2009 SENSITITRE 18-24HR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CINDY KNAPP
K093741 12/04/2009 SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, LTD. CYNTHIA KNAPP
K094019 12/29/2009 GLIDER PTA BALLOON CATHETER TRIREME MEDICAL INC DENNIS SALZMANN
K093707 12/02/2009 DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 U&I CORP. GYEONG-JE KWON
K094006 12/28/2009 OPAL BOND MV ULTRADENT PRODUCTS, INC. DIANE ROGERS
K093967 12/23/2009 VARIAN TREATMENT VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K093817 12/11/2009 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS VASCUTEK LTD. KAREN KELSO
K093995 12/28/2009 IG 4 IMAGE GUIDED SYSTEM VERAN MEDICAL TECHNOLOGIES, INC. SCOTT WRIGHTSTONE
K093809 12/09/2009 VIDAR DENTAL FILM DIGITIZER VIDAR SYSTEMS CORP. CARRIE L BRANCART
K093688 12/02/2009 CANON, MODEL URS-50RF VIRTUAL IMAGING, INC. DANIEL KAMM
K093934 12/22/2009 GORE HYBRID VASCULAR GRAFT W.L. GORE & ASSOCIATES MICHAEL IVEY
K093791 12/11/2009 GORE DRYSEAL SHEATH W.L. GORE & ASSOCIATES,INC ALICIA HEMPHILL
K093907 12/22/2009 WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE WELCH ALLYN, INC. HUY DOAN
K093950 12/23/2009 BIOFOAM BONE WEDGE MODEL ASSORTED WRIGHT MEDICAL TECHNOLOGY, INC. KELLEN HILLS
K093784 12/09/2009 ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K093837 12/17/2009 ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC. (ZEUS) EWA NADOLCZAK
K093727 12/03/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR ZIBO BOLIN GLOVES CO., LTD CHU XIAOAN
K093846 12/15/2009 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS ZIMMER, INC. BENJAMIN CURSON
K093802 12/11/2009 ULTRAVIEW DM3 MONITOR ZOE MEDICAL, INC. JIM CHICKERING
K093718 12/09/2009 ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 ZUTRON MEDICAL LLC JORDAN HARTONG


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