FDA 510(k) Applications Received During September, 2006

FDA 510(k) Number Submission Date Device Name Applicant Contact
K062668 09/08/2006 AUDIT MICROCV IMMUNOASSAY LINEARITY SET AALTO SCIENTIFIC LTD. ALAN VEKICH
K062770 09/15/2006 COPILOT HEALTH MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. MARY ROSE
K062855 09/25/2006 CALCIUM ABBOTT LABORATORIES LINDA MORRIS
K062843 09/22/2006 FOX SV PTA CATHETER ABBOTT LABORATORIES KATHRYN MARCHEL
K062795 09/18/2006 MUGARD MUCOADHESIVE ORAL WOUND RINSE ACCESS PHARMACEUTICALS, INC DAVID NOWOTNIK, PH.D.
K062967 09/29/2006 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY, INC. ANNE SCHLAGENHAFT
K062979 09/29/2006 THYROSAMPLER ACD MEDICAL INNOVATION CORP. Kevin Walls
K062961 09/29/2006 MICROLUX TRANSILLUMINATOR ADDENT, INC. JOSHUA FRIEDMAN
K062878 09/26/2006 EZPACS, VERSION 3.0 ADVANCED IMAGING SOLUTIONS, LLC RAY HASHEMI
K062686 09/08/2006 UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM ADVANCED SPINE TECHNOLOGY, INC. J.D. WEBB
K062684 09/08/2006 EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD AESCULAP, INC. KATHY A RACOSKY
K062694 09/11/2006 MAMMAPRINT AGENDIA BV GUILDO BRINK
K062742 09/14/2006 CR 85-X AGFA CORPORATION JUDITH HARBOUR
K062932 09/28/2006 AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER AHLSTROM MOUNT HOLLY SPRINGS LLC HEATHER MOWERS
K062703 09/11/2006 ONE STEP HCG PREGNANCY TEST AI DE DIAGNOSTIC CO., LTD. LIN WANG
K062951 09/29/2006 TAP III ANTI-SNORING DEVICE AIRWAY MANAGEMENT INC. DARREN HENDERSON
K062971 09/29/2006 BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS Akers Biosciences, Inc. BARBARA A BAGBY
K062624 09/05/2006 NEXT GENERATION LASER ALCON LABORATORIES TERRY J DAGNON
K062865 09/25/2006 SMALL VOLUME SYRINGE ALCON LABORATORIES SEAN P GRIFFIN
K062930 09/28/2006 LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM ALCON RESEARCH, LTD. JANET G JOHNSON
K062826 09/20/2006 AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS ALPHA-OMEGA SERVICES, INC. BOB A BOBNETT
K062823 09/20/2006 AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES ALPHA-OMEGA SERVICES, INC. BOB A ROBNETT
K062825 09/20/2006 AOS MARKER SEEDS ALPHA-OMEGA SERVICES, INC. BOB A ROBNETT
K062824 09/20/2006 AOS UNIVERSAL CONECTING GUIDE TUBE ALPHA-OMEGA SERVICES, INC. BOB A ROBNETT
K062794 09/18/2006 PRN THERMALCARE, MODEL 3000 AMERICAN HEALTHCARE PRODUCTS, INC. KENT D ELLIS
K062609 09/05/2006 MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K062799 09/19/2006 GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. BRUCE A MACFARLANE
K062664 09/07/2006 HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 APEX MEDICAL CORP. ALAN CHANG
K062907 09/27/2006 ALEXIS WOUND RETRACTOR APPLIED MEDICAL RESOURCES CHERYL BLAKE
K062679 09/08/2006 ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES ARTHREX, INC. NANCY HOFT
K062747 09/14/2006 ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM ARTHREX, INC. ANN WATERHOUSE
K062885 09/26/2006 STRIDE MICROCATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K062861 09/25/2006 ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM ASCENSION ORTHOPEDICS, INC. GLEN NEALLY
K062692 09/11/2006 BIS BILATERAL SENSOR ASPECT MEDICAL SYSTEMS, INC. RENEE GOULD
K062613 09/05/2006 BIS EEG MONITOR VIEW ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K062736 09/13/2006 SIASCOPE V ASTRON CLINICA LIMITED E.J. Smith
K062641 09/06/2006 BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 AVAZZIA, INC. CATHERINE TONE
K062700 09/11/2006 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B. BRAUN MEDICAL, INC. SCOTT PEASE
K062699 09/11/2006 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B. BRAUN MEDICAL, INC. SCOTT PEASE
K062715 09/11/2006 SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW BAODING GUANZHONG GLOVE CO., LTD. MARY A DOUCETTE
K062714 09/11/2006 SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW BAODING GUANZHONG GLOVE CO., LTD. MARY A DOUCETTE
K062621 09/05/2006 NIO 5MP-21 AND MDNG-5121 CB BARCOVIEW LIEVEN DE WANDEL
K062905 09/27/2006 NIO FUSION 4MP; MDNC 4130 BARCOVIEW LIEVEN DE WANDEL
K062887 09/26/2006 MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F BARD PERIPHERAL VASCULAR GENEVIEVE BALUTOWSKI
K062723 09/12/2006 HALO90 COAGULATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K062909 09/27/2006 REPEATER PUMP II TUBE SETS BAXA CORP. KIMBERLY ZIZIK
K062711 09/11/2006 ULTRA LOW PROFILE RONGEUR BAXANO, INC. SHARON ROCKWELL
K062937 09/28/2006 TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K062944 09/28/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K062945 09/28/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062680 09/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML BECTON, DICKINSON & CO. VICKI L KENNEDY
K062687 09/08/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K062797 09/19/2006 POWDERED LATEX SURGICAL GLOVE BEIJING REAGENT LATEX PRODUCTS CO., LTD. RYAN BARR
K062774 09/18/2006 BELMONT BUDDY PLUS FLUID WARMER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K062854 09/25/2006 BENZ-G 4X HIOXIFILCON D BENZ RESEARCH AND DEVELOPMENT CORP. ARTHUR J WARD
K062730 09/13/2006 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS BIOGREEN MEDICAL SDN. BHD. SRI MAHENDRA SATHIACAMA
K062756 09/14/2006 PATHIAM IMAGING SOFTWARE FOR HER2/NEU BIOIMAGENE, INC. ANNA LONGWELL
K062830 09/20/2006 BIOLUCENT APPLICATOR KIT BIOLUCENT, INC. DAVE CAMPBELL
K062819 09/20/2006 BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. JESUS T FARINAS
K062980 09/29/2006 ACTIVASCREW BIORETEC LTD MARI RUOTSALAINEN
K062840 09/22/2006 TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED FIL V BUENVIAJE
K062603 09/01/2006 BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 BIOSPACE CORPORATION LIMITED DANIEL KAMM
K062981 09/29/2006 I-CHROMA CRP TEST BODITECH DIAGNOSTICS, INC. Gary Lehnus
K062820 09/20/2006 UNITY ALPHA SYSTEM BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K062750 09/14/2006 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 BOSTON SCIENTIFIC CORP. ALLYSON BARFORD
K062594 09/01/2006 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation SARAH PETERSON
K062832 09/21/2006 VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 C.R. BARD, INC. GLENN NORTON
K062886 09/26/2006 ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 CAO GROUP, INC. ROBERT K LARSEN
K062619 09/05/2006 DENLASER 800 PLUS CAO GROUP, INC. ROBERT K LARSEN
K062808 09/19/2006 LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT CATCH INCORPORATED Cindy Green
K062897 09/27/2006 C-U2 CEFLA S.C.R.L. Claude Berthoin
K062948 09/28/2006 SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B CEPHEID RUSSEL K ENNS
K062922 09/28/2006 MODIFICATION TO AQUADEX FLEXFLOW SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
K062952 09/29/2006 C300 SERIES AIR NEBULIZER COMPRESSOR CHOICE SMART HEALTH CARE CO. LTD. JANICE MA
K062635 09/06/2006 MODEL 2200 CLARIMEDEX, INC. JOHN DUNNING
K062916 09/28/2006 CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 CLINIQA CORPORATION CAROL RUGGIERO
K062846 09/22/2006 COLLAGEN DENTAL MEMBRANE III COLLAGEN MATRIX, INC. PEGGY HANSON
K062881 09/26/2006 COLLAGEN DENTAL MENBRANE - CONFORMABLE II COLLAGEN MATRIX, INC. PEGGY HANSEN
K062593 09/01/2006 CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET COMPASS BIOSCIENCE CARTER GRANDJEAN
K062697 09/11/2006 SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT COOK BIOTECH, INC. MARY A FADERAN
K062729 09/13/2006 SURGISIS RVP RECTO-VAGINAL FISTULA PLUG COOK BIOTECH, INC. DANIEL J DILLON
K062696 09/11/2006 SURGISIS, SURGISIS ES COOK BIOTECH, INC. MARY A FADERAN
K062798 09/19/2006 SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB CORDIS CORP. KAREN WILK
K062977 09/29/2006 CRITIVIEW, MODEL CRV3 CRITISENSE LTD. PAUL DRYDEN
K062970 09/29/2006 I-PAD CU MEDICAL SYSTEMS, INC. ELAINE DUNCAN
K062927 09/28/2006 MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) DADE BEHRING, INC. MAY MORISHIMA
K062585 09/01/2006 MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN DADE BEHRING, INC. SHANNON POPSON
K062923 09/28/2006 MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) DADE BEHRING, INC. LIBBY WARRINER
K062777 09/18/2006 MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN DADE BEHRING, INC. MAUREEN MENDE
K062773 09/18/2006 MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN DADE BEHRING, INC. LIBBY WARRINER
K062938 09/28/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML DADE BEHRING, INC. ROBERT EUSEBIO
K062596 09/01/2006 MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID DADE BEHRING, INC. SHANNON POPSON
K062924 09/28/2006 STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK DADE BEHRING, INC. PAMELA A JURGA
K062705 09/11/2006 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID DADE BEHRING, INC. ROBERT EUSEBIO
K062894 09/27/2006 INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 DAILYCARE BIOMEDICAL INC DANIEL J CHANG
K062754 09/14/2006 GAS MODULE SE, MODEL 0998-00-0481-02 DATASCOPE CORP. KATHLEEN KRAMER
K062710 09/11/2006 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K062732 09/13/2006 TOMAS PIN 6 MM DENTAURUM CHARLES R BELL
K062733 09/13/2006 TOMAS PIN SD 6, 8, AND 10 MM DENTAURUM CHARLES R BELL
K062828 09/20/2006 MOUTHGUARD AND ALIGNER MATERIALS DENTSPLY INTL., INC. HELEN LEWIS
K062654 09/07/2006 DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K062748 09/14/2006 MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD DEPUY ORTHOPAEDICS, INC. ANNE M SCHULER
K062814 09/20/2006 PIPELINE II ACCESS SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K062959 09/29/2006 DMS 300-2, 300-3 AND 300-4 DIAGNOSTIC MONITORING SOFTWARE WILLIAM PARSONS
K062674 09/08/2006 MISSION TRINITY B DIAMOND DIAGNOSTICS, INC. RANDOLPH QUINN
K062758 09/15/2006 OWL URF-3AP DIROS TECHNOLOGY, INC. GEORGE DARMOS
K062895 09/27/2006 XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV F CARLETON
K062873 09/25/2006 SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS E.C.I. USA CORPORATION JAMES WANG
K062724 09/12/2006 ACCUPULSE PULSE OXIMETER EAGLE MEDICAL EQUIPMENT CO. JAMES A DUNNING
K062685 09/08/2006 EBI ARAY SPINAL SYSTEM EBI, L.P. DEBRA BING
K062810 09/19/2006 SOLITAIRE ANTERIOR SPINAL SYSTEM EBI, L.P. DEBRA BING
K062716 09/12/2006 ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 ECO-RX, INC. CONSTANCE R BROWN, ESQ.
K062762 09/15/2006 DERMA YAG EL.EN. ELECTRONIC ENGINEERING SPA ANDREA TOZZI
K062743 09/14/2006 UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) JEFFREY CHERN
K062888 09/26/2006 MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 EMG TECHNOLOGY CO., LTD. Ke-Min Jen
K062875 09/26/2006 ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES ENDOGASTRIC SOLUTIONS, INC. STEVEN J HOFFMAN
K062712 09/11/2006 ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 ERBE USA, INC. JOHN TARTAL
K062792 09/18/2006 ERCHONIA IOTO_240 ERCHONIA MEDICAL, INC. KEVIN WALLS,RAC
K062598 09/01/2006 IMT.LAB SOFTWARE ESAOTE EUROPE B.V. CARRI GRAHAM
K062630 09/05/2006 OSSIPRO BONE SUBSTITUTE MATERIAL ETEX CORP. FRANCES A FLORENCE
K062869 09/25/2006 CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K062892 09/26/2006 EUKARE EUMED BIOTECHNOLOGY CO., LTD. Ke-Min Jen
K062868 09/25/2006 THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 FLOWCARDIA INC Dustin Michaels
K062976 09/29/2006 MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K062675 09/08/2006 GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES GEMORE TECHNOLOGY CO., LTD. TONY C.S. CHANG
K062834 09/21/2006 OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 GENOSS CO., LTD. KLASS BESSELING
K062883 09/26/2006 GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR GEREONICS, INC. GERALD ROST
K062786 09/18/2006 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K062836 09/20/2006 CITADEL ANTERIOR LUMBAR PLATE SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K062672 09/08/2006 GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES Grace Medical, Inc. JEFF COBB
K062721 09/12/2006 GREENTON ECOLITE IPL SYSTEM GREENTON (LONDON) LTD. ROBERT T HANDREN
K062801 09/19/2006 SMARTSUCTION SOLO DEVICE HAEMONETICS CORP. GABRIEL J MURACA
K062604 09/01/2006 RAPIDTEG TEG-ACT TEST HAEMOSCOPE CORP. ELI COHEN
K062950 09/29/2006 POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) HARTALEGA SDN BHD KUAN K HON
K062737 09/13/2006 CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER HORIBA ABX TIM LAWTON
K062845 09/22/2006 MODULAR REPLACEMENT ELBOW SYSTEM HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K062626 09/05/2006 CORTISOL ELISA IBL-HAMBURG GMBH VICTOR HERBST
K062755 09/14/2006 IKONISCOPE ONCOFISH BLADDER TEST SYSTEM IKONISYS INC OSCAR SANCHEZ
K062634 09/06/2006 ORTHOXP IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062586 09/01/2006 XPLORER 1600 PLUS IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062636 09/05/2006 OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K062985 09/29/2006 IVUS ENHANCER INDEC SYSTEMS, INC. CAROL HUBLER
K062891 09/26/2006 PROTON THERAPY SYSTEM INDIANA UNIVERSITY CYCLOTRON FACILITY JONATHAN S KAHAN
K062617 09/05/2006 MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM INION LTD. KATI MARTINEN
K062782 09/18/2006 INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 INION OY KATI MARTTINEN
K062707 09/11/2006 RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE INNOVATIVE ENDOSCOPY COMPONENTS, LLC. GERALD GOIGITZER
K062759 09/15/2006 PARAMOUNT VBR SYSTEM INNOVATIVE SPINAL TECHNOLOGIES INC GINA YEH
K062589 09/01/2006 SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM INOLASE 2002, LTD. GEORGE J HATTUB
K062708 09/11/2006 QUANTA LITE CELIAC DGP SCREEN INOVA DIAGNOSTICS, INC. DONNA L GUSTAFSON
K062665 09/07/2006 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS INOVEL LLC WILLIAM WAWRZYNIAK
DEN060002 09/21/2006 INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM INRANGE SYSTEMS, INC. CHRISTOPHER E BOSSI
K062599 09/01/2006 MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS INTEGRA LIFESCIENCES CORPORATION DARLENE M WELSH
K062616 09/05/2006 WELLNESSPRO 2010 INTELSOURCE GROUP, INC. E.J. Smith
K062809 09/19/2006 ADMIRAL XTREME PTA CATHETER INVATEC INNOVATIVE TECHNOLOGIES David Worrell
K062735 09/13/2006 TUTU 7, MODEL IV-T22 INVISIBLE TECHNOLOGY CO., LTD. Allison Scott
K062767 09/15/2006 CTL-63 AND CTL-128 SPINE ARRAY COILS INVIVO CORPORATION THOMAS SCHUBERT
K062880 09/26/2006 SUBDERMAL WIRE ELECTRODE, MODEL SWE IVES EEG SOLUTIONS, INC. JOHN R IVES
K062713 09/11/2006 ADHESIVE DC ACTIVATOR IVOCLAR VIVADENT, INC. ANDERJEET S GULATI
K062740 09/13/2006 JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU JINDELL MEDICAL INSTRUMENTS CO., LTD. Ke-Min Jen
K062602 09/01/2006 BAND-AID(R) BRAND LIQUID BANDAGE JOHNSON & JOHNSON CONSUMER COMPANIES, INC. MICHELLE R TURK
K062614 09/05/2006 VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) JOHNSON & JOHNSON VISION CARE, INC. SUSAN MORRIS
K062918 09/28/2006 KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K062671 09/08/2006 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) KENDALL KEITH MARTIN
K062870 09/25/2006 TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 KENSEY NASH CORP. ROBIN M FATZINGER
K062660 09/07/2006 CATALYSY KI MOBILITY LLC DOUGLAS MUNSEY
K062659 09/07/2006 KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K062857 09/25/2006 KLS MARTIN QUICK DISC KLS MARTIN L.P. JENNIFER DAMATO
K062763 09/15/2006 NONCON ROBO PACHY F&A KONAN MEDICAL, INC. GEORGE MYERS
K062965 09/29/2006 CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM KOSSAN LATEX INDUSTRIES (M) SDN. BHD. JAMES F LOGAN
K062764 09/15/2006 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED KOSSAN LATEX INDUSTRIES(M)SDN BHD LIM KWAN HWA
K062682 09/08/2006 CVS PERSONAL LUBRICANT AND MOISTURIZER LAKE CONSUMER PRODUCTS, INC. MARY L WUNDROCK
K062719 09/12/2006 GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES LASERSCOPE PAUL HARDIMAN
K062931 09/28/2006 IMPLUS IMPLANT SYSTEM LEADER ITALIA S.R.L. HENRY J VOGELSTEIN
K062811 09/19/2006 DPILOG, MODEL DPC-512 LIFE OUTCOMES, INC. CHARLES M HART
K062643 09/06/2006 KINETIC ANTERIOR CERVICAL PLATE LIFE SPINE ERIN MALLOY
K062831 09/20/2006 MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE ERIN MALLOY
K062876 09/26/2006 PRIMACONNEX CERAMIC ABUTMENTS LIFECORE BIOMEDICAL, INC. BRIAN SMEKAL
K062991 09/29/2006 GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE LIGHT BIOSCIENCE, LLC JONATHAN S KAHAN
K062871 09/25/2006 LUMACARE LC-122M NON-COHERENT LIGHT SOURCE LYNTON LASERS LIMITED ANDREW J BERRY
K062974 09/29/2006 TESLA NIBP MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN GMBH ROBERT N CLARK
K062793 09/18/2006 SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION MAQUET CRITICAL CARE AB JAMIE YIEH
K062864 09/25/2006 MASTALEX -MRSA, MODEL RST501 MAST GROUP LTD. BARBARA A LEE
K062901 09/27/2006 HEMOCATH II MED-CONDUIT, INC. GERALD G BOUSQUET
K062662 09/07/2006 TELEMEDICINE SYSTEM MODEL VMS-01 MEDIC4ALL (ISRAEL) LTD. JONATHAN S KAHAN
K062780 09/18/2006 CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. OYTIP KUNWUNLOP
K062611 09/05/2006 IGUIDE SYSTEM MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K062639 09/06/2006 MODIFICATION TO HEXAPOD RT COUCH TOP MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA MICHAEL WOLFF
K062746 09/14/2006 FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 MEDICON HELLAS S.A. GEORGE PSICHAS
K062953 09/29/2006 MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE MEDISYSTEMS CORP. FREDRIC SWINDLER
K062984 09/29/2006 MEDLINE HYPODERMIC NEEDLES MEDLINE INDUSTRIES, INC. LARA N SIMMONS
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K062947 09/28/2006 HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES PENG LIM ENTERPRISE CO., LTD. Ke-Min Jen
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K062787 09/18/2006 ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 PHADIA US INC. MARTIN R MANN
K062583 09/01/2006 ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 PHADIA US INC. MARTIN R MANN
K062650 09/07/2006 EP NAVIGATOR SOFTWARE PHILIPS MEDICAL SYSTEMS LYNN HARMER
K062605 09/05/2006 PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T PHILIPS MEDICAL SYSTEMS RICH MCCLEARY
K062683 09/08/2006 ENAMEL PRO VARNISH PREMIER DENTAL PRODUCTS CO. VINCE D'ALESSANDRO
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K062955 09/29/2006 POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE PT. HALONI JANE EMMY TJOENG
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K062817 09/20/2006 PTW DAVID IMRT QC VERIFICATION SYSTEM PTW-NEW YORK CORP. RICHARD D BARKER
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K062942 09/28/2006 QUANTIMETRIX NICOSURE COTININE URINE CONTROL QUANTIMETRIX CORP. BERNICE NAVARRO
K062929 09/28/2006 QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA QUEST DIAGNOSTICS, INC. LIUMING YU
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K062769 09/15/2006 PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 RADI MEDICAL SYSTEMS AB MATS GRANLUND
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K062612 09/05/2006 RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 RAYNER SURGICAL INC MARK MULLANEY
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K062642 09/06/2006 RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A RF SURGICAL SYSTEMS, INC. KEVIN COSENS
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K062912 09/27/2006 SCIENT'X SPINAL SYSTEM SCIENT'X J.D. WEBB
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K062784 09/18/2006 SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. PAUL WARE
K062966 09/29/2006 QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS SERADYN INC. JACK ROGERS
K062893 09/27/2006 KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LTD. ZHAO J YU
K062676 09/08/2006 RUIKE, MODEL 3331 SHANGHAI RUIKE SPORTS GOODS CO., LTD. JUNNATA CHANG
K062646 09/04/2006 RUIKE, MODEL 3411 SHANGHAI RUIKE SPORTS GOODS CO., LTD. JUNNATA CHANG
K062645 09/06/2006 RUIKE, MODEL 3431 SHANGHAI RUIKE SPORTS GOODS CO., LTD. JUNNATA CHANG
K062919 09/28/2006 TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) SHEN WEI (USA), INC. CYNTHIA LIU
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K062673 09/08/2006 MODIFICATION TO SYNGO INSPACE 4D SIEMENS AG, MEDICAL SOLUTIONS RUDIGER KOMER
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K062903 09/27/2006 SBI CARPAL FUSION PLATE SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K062898 09/27/2006 SBI LATERAL RHEAD IMPLANT SMALL BONE INNOVATIONS INC. ROBERT HOEHN
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K062849 09/25/2006 SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM SMITH & NEPHEW, INC. KATHLEEN BURNS
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K062701 09/11/2006 QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR SUNRISE MEDICAL, INC. JOSEPH E OLSAVSKY
K062884 09/26/2006 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) SUQIAN GREEN GLOVE CO., LTD. CHU XIAOAN
K062882 09/26/2006 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) SUQIAN GREEN GLOVE CO., LTD. CHU XIAOAN
K062753 09/14/2006 FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC SURGIMED, INC. FERNANDO LAVOI
K062949 09/29/2006 ENSEAL PTC TISSUE SEATING SEALING DEVICE SURGRX INC LINDA OLESON
K062781 09/18/2006 MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY SYMTIUM CORPORATION SEAN COMER
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K062872 09/26/2006 SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K062789 09/18/2006 SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM SYNTHES (USA) JEFFREY DOW
K062933 09/28/2006 SYNTHES ORACLE SPACER SYNTHES SPINE CO.LP BONNIE J SMITH
K062818 09/20/2006 FLEXITOUCH SYSTEM TACTILE SYSTEMS TECHNOLOGY INC PHILLIP R ROSE
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K062691 09/11/2006 COMPORUS TAKIRON CO., LTD KENSHI OKAZAKI
K062652 09/07/2006 INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR TANITA CORPORATION OF AMERICA BETH MACKEY
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K062608 09/05/2006 29G AND 30G K-PACK II NEEDLE TERUMO EUROPE N.V. M.J. AERTS
K062858 09/25/2006 MODIFICATION TO GLIDESHEATH TERUMO MEDICAL CORP. MARK UNTERREINER
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K062702 09/11/2006 ULTICARE DISPOSABLE SYRINGES AND NEEDLES ULTIMED, INC. CAROLE STAMP
K062791 09/18/2006 USI DENTAL SCALER, 25XXX SERIES ULTRASONIC SERVICES INC. JAMES FEINE
K062788 09/18/2006 COLLIMATOR, MODEL M-38 UMI INTERNATIONAL KWANG C JUNG
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K062850 09/25/2006 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC FRANK GIANELLI
K062785 09/18/2006 LTD POLYAXIAL FIXATION SYSTEM US SPINE RICHARD JANSEN
K062734 09/13/2006 ADJUST-RIGHT FIXATION DEVICES VALPO ORTHOPEDIC TECHNOLOGY, INC. RON CLARK
K062618 09/05/2006 TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K062627 09/05/2006 INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 VASCULAR SOLUTIONS, INC. PATRICE STROMBERG
K062877 09/26/2006 TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 VASCULAR SOLUTIONS, INC. JULIE TAPPER
K062822 09/20/2006 VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 VASCULAR SOLUTIONS, INC. PATRICE STROMBERG
K062670 09/07/2006 VERTIFLEX SPINAL SCREW SYSTEM VERTIFLEX (TM), INCORPORATED STEVE REITZLER
K062956 09/29/2006 EZ-MIO, EZ-IO DISTAL TIBIA VIDACARE CORPORATION GRACE HOLLAND
K062833 09/21/2006 POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM VIDACARE CORPORATION GRACE HOLLAND
K062615 09/05/2006 VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 VISION BIOSYSTEMS INC. RONALD F LAGERQUIST
K062940 09/28/2006 BONE INJECTION GUN (B.I.G.) WAISMED LTD. JONATHAN S KAHAN
K062842 09/22/2006 TWIST DRILL WALTER LORENZ SURGICAL, INC. KIM REED
K062917 09/28/2006 STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 WEAR SAFE MALAYSIA SDN. BHD. TK LOH
K062778 09/18/2006 STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED WEAR SAFE MALAYSIA SDN. BHD. LIM L BUNG
K062704 09/11/2006 STERILIZATION POUCH WITH INDICATORS WINNER INDUSTRIES (SHENZHEN) CO., LTD. MING XIE
K062960 09/29/2006 CONSERVE FEMORAL RESURFACING COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K062693 09/11/2006 GLADIATOR BIPOLAR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. MATT PAUL
K062790 09/18/2006 WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E WU'S TECH CO., LTD. Ke-Min Jen
K062757 09/14/2006 XERON PACS XERON HEALTHCARE CORP. MELISSA MAHALL
K062768 09/15/2006 NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL ZIMMER, INC. ANTHONY FRANCALANCIA


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