FDA 510(k) Applications Received During December, 2006

FDA 510(k) Number Submission Date Device Name Applicant Contact
K063817 12/22/2006 MANDOMETER III AB MANDO KIM BLOOM
K063723 12/15/2006 IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM ABIOMED, INC. ROBERT T KUNG
K063782 12/26/2006 ACCIN UNI-KNEE SYSTEM ACCIN CORPORATION MICHAEL KVITNITSKY
K063753 12/19/2006 GFX NERVE ABLATION SYSTEM ACI, INC. CLAY ANSELMO
K063728 12/19/2006 TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM ALFA TECH MEDICAL SYSTEMS, LTD. SUSAN D GOLDSTEIN-FALK
K063769 12/20/2006 ALPHA BIO BONE FIXATION SCREW SYSTEM ALPHA-BIO TEC LTD DANIEL J MANELLI
K063770 12/20/2006 ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM ALPHA-BIO TEC LTD DANIEL J MANELLI
K063668 12/11/2006 ROC LUMBAR SYSTEM ALPHATEC SPINE, INC. PAULA MORGAN
K063829 12/26/2006 THERMOGARD THERMAL REGULATION SYSTEM ALSIUS CORP. KENNETH A COLLINS
K063713 12/14/2006 AMS SMART SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. BRAD ONSTAD
K063674 12/11/2006 EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE ANIMAS CORP. AMY SMITH
K063658 12/08/2006 INTRAVASCULAR INTRODUCER SYSTEM APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K063771 12/21/2006 GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY USA, INC. TOM SPEIKERS
K063719 12/15/2006 ARTHREX CROSSPIN, MODEL AR-1964P ARTHREX, INC. ANN WATERHOUSE
K063819 12/27/2006 ASAHI PTCA GUIDE WIRE, FIELDER FC ASAHI INTECC CO., LTD. YOSHI TERAI
K063788 12/21/2006 REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K063779 12/21/2006 OSSEOSPEED 4.0S-6MM, MODEL 24619 ASTRA TECH, INC. FLOYD G LARSON
K063734 12/18/2006 ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE ATLANTIS COMPONENTS, INC. BETSY A BROWN
K063630 12/06/2006 ATRICURE ABLATION SYSTEM ATRICURE, INC. ELSA C ABRUZZO
K063694 12/13/2006 AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 BAUSCH & LOMB, INC. NANETTE CANEPA
K063696 12/13/2006 COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 BAXTERHEALTHCARE, INC. JEME WALLACE
K063845 12/27/2006 ADVIA CHEMISTRY TOTAL BILIRUBIN_2 BAYER HEALTHCARE, LLC PHILIP LIU
K063689 12/12/2006 BD DIRECTIGEN EZ FLU A+B TEST BECTON DICKINSON & CO. DAINELLE N CLARK
K063824 12/26/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K063811 12/22/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K063704 12/13/2006 BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 BEKS INCORPORATED JILL CREASY
K063866 12/29/2006 BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES DAVID BHEND
K063643 12/07/2006 MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI JACKIE BUCKLEY
K063666 12/11/2006 SHARPS CONTAINER, MODEL 039-413 BIODEX MEDICAL SYSTEMS, INC. CLYDE SCHLEIN
K063597 12/04/2006 VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOLYN TENLLADO
K063623 12/06/2006 VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. JOLYN TENLLADO
K063614 12/05/2006 ALTRA FX HIP SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K063732 12/18/2006 MICROPLASTY TIBIAL TRAYS BIOMET MANUFACTURING CORP. BECKY EARL
K063780 12/26/2006 ACE BOND SE BISCO, INC. BENJAMIN LICHTENWALNER
K063874 12/29/2006 DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC MICHELE VOVOLKA
K063776 12/21/2006 ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES BRIGHT ELEMENT SDN BHD SEOW LAW AUDIE
K063777 12/22/2006 ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE BRIGHT ELEMENT SDN BHD SEOW LAW AUDIE
K063839 12/26/2006 POSITIONER C-RAD POSITIONING AB BENGT ERIC ROSTH
K063712 12/14/2006 AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. BARD, INC. JOHN C KNORPP
K063848 12/28/2006 POWERGROSHONG PICC CATHETER C.R. BARD, INC. LYNN M KIRCHOFF
K063632 12/08/2006 X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. TERRI MORRIS
K063646 12/26/2006 OPTI CAMSIGHT CO., INC. JAY CHOI
K063800 12/22/2006 CANDELA FLUORESCENT PULSED LIGHT SYSTEM CANDELA CORP. JEFFREY ROBERTS
K063717 12/14/2006 CF-1 CANON, INC. SHEILA DRISCOLL
K063644 12/14/2006 CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. TIFFINI LALUDE
K063872 12/29/2006 KINESIA CLEVELAND MEDICAL DEVICES, INC. JOSEPH GIUFFRIDA
K063698 12/13/2006 CO2 LASER SYSTEM, MODEL C-LAS CLINICON CORP. KIM BLOOM
K063774 12/22/2006 MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K063742 12/18/2006 RESONANCE METALLIC URETERAL STENT COOK IRELAND LTD SINEAD BURKE
K063619 12/05/2006 FLIPPER DETACHABLE EMBOLIZATION COILS COOK, INC. LISA WEBB
K063791 12/26/2006 CORIN UNIPOLAR MODULAR HEAD CORIN USA KATHY K TRIER
K063626 12/06/2006 DURAFLEX COSMETIC DENTAL MATERIALS INC ROBERT BOWERS
K063133 12/28/2006 CRANIAL SOLUTION ORTHOSIS CRANIAL SOLUTIONS KIRK A LUCYK
K063867 12/29/2006 CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC. CONNIE HOY
K063621 12/05/2006 3 SERIES PHOTOTHERAPY CABINET DAAVLIN CO. TARA MANSUR
K063754 12/19/2006 DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 DADE BEHRING, INC. PAMELA A JURGA
K063610 12/04/2006 DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063608 12/04/2006 DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063756 12/19/2006 DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE M PLUMMER
K063663 12/08/2006 DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063655 12/08/2006 DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH DADE BEHRING, INC. KATHLEEN DRAY-LYONS
K063564 12/08/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K063633 12/06/2006 DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES DEPUY ORTHOPAEDICS, INC. STEVEN J WENTWORTH
K063686 12/12/2006 DEPUY LPS DISTAL FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. REBECCA LENNARD
K063652 12/08/2006 GLOBAL AP POROUS COATED HUMERAL STEM DEPUY ORTHOPAEDICS, INC. REBECCA LENNARD
K063741 12/18/2006 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K063675 12/11/2006 DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT DIAGNOSTIC HYBRIDS, INC. GAIL GOODRUM
K063798 12/22/2006 DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 DIAGNOSTIC HYBRIDS, INC. GAIL GOODRUM
K063828 12/26/2006 DIOMED DELTA 25 DIOMED, LTD. TIM PHIPPS
K063645 12/07/2006 FREQUENCER, MODEL 1001 DYMEDSO INC. JEAN BIGONEY
K063846 12/27/2006 EIGEN DSA 2000 EIGEN NATALIE J KENNEL
K063620 12/08/2006 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K063797 12/29/2006 GEODESIC EEG SYSTEM 300 ELECTRICAL GEODESICS, INCORPORATED LINDA J BOVARD
K063856 12/28/2006 EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM ESSENTIAL DENTAL SYSTEMS, INC. SUSAN D GOLDSTEIN-FALK
K063785 12/21/2006 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC DAVID WORRELL
K063685 12/12/2006 OPTECURE; OPTECURE + CCC EXACTECH, INC. MARITZA ELIAS
K063642 12/07/2006 FD EMS, MODEL # D-FJ30E FUJI DYNAMICS LIMITED IRENE CHEUNG
K063847 12/27/2006 FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 FUJINON, INC. JOSEPH AZARY
K063628 12/06/2006 CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY GE HEALTHCARE INTEGRATED IT SOLUTIONS KAREN M LUNDE
K063664 12/08/2006 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 GEN-PROBE, INC. E. JOSEPH MCMULLEN
K063739 12/18/2006 SEPRAMESH, MODEL 5959-1214 GENZYME CORPORATION MATTHEW HIBBERT
K063589 12/01/2006 GSO BONE FIXATION FASTENERS GOLD STANDARD ORTHOPAEDICS LLC DAVID BAUGHMAN
K063766 12/20/2006 TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C GOOD BIOTECH CORP. VICTOR CHIOU
K063636 12/08/2006 ZILOS-TK HAMILTON THORNE BIOSCIENCES DOUGLAS HAMILTON
K063612 12/04/2006 MODIFICATION TO HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. ROBIN BUSH
K063616 12/05/2006 TRIDENT II ACETABULAR SYSTEM HOWMEDICA OSTEONICS CORP MANAL MORCOS
K063857 12/28/2006 SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT HOWMEDICA OSTEONICS CORP. TIFFANI ROGERS
K063875 12/29/2006 STRYKER FOOT PLATING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K063834 12/27/2006 REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM HOYA CONBIO, INC DONNA TEMPLEMAN
K063672 12/11/2006 FIBULA PLATE PROLOCK WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K063784 12/21/2006 DYE MANAGEMENT SYSTEM ICU MEDICAL, INC MARTIN MAIER
K063673 12/11/2006 INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE INNOVACON, INC. EDWARD TUNG
K063747 12/19/2006 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A INOVEL LLC WILLIAM WARZYNIAK
K063773 12/21/2006 VOLUMETRIC TOMOGRAPHY INSTRUMENTARIUM DENTAL INC. FRANK KASHINSKI
K063837 12/26/2006 SIGMA M INSTRUMENTARIUM DENTAL, PALODEX GROUP OY JOUNI ONNELA
K063679 12/11/2006 ACL TOP INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K063682 12/11/2006 INTRALASE FUSION LASER INTRALASE CORP. JUDY GORDON
K063715 12/14/2006 JUNIPER COOLING DEVICE XTRA JUNIPER MEDICAL INC. DON JOHNSON
K063585 12/01/2006 KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE CHEN
K063624 12/20/2006 KAVO EVEREST C-TEMP KAVO AMERICA DANIEL KAMM
K063590 12/01/2006 V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423 KCI USA, INC. CHRISTY HUBBARD OVIATT
K063740 12/18/2006 V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 KCI USA, INC. MARGARET MARSH
K063692 12/13/2006 V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 KCI USA, INC. MARGARET MARSH
K063654 12/13/2006 ENDOGUIDE KMS MEDICAL LLC MARIO ARBESU
K063640 12/07/2006 KOWA SL-15 KOWA CO. LTD. SATOHIKO TAKANASHI
K063593 12/11/2006 CLEARFIL MAJESTY FLOW KURARAY AMERICA, INC. KOJI NISHIDA
K063595 12/12/2006 CLEARFIL MAJESTY POSTERIOR KURARAY AMERICA, INC. KOJI NISHIDA
K063631 12/19/2006 POLYPERF / POLYPERF SAFE LABORATOIRES PEROUSE MARIE NOELLE EROUT
K063745 12/20/2006 MEDILASER, MODEL 1000 LASER THERA, LLC SHELLY HENRY
K063794 12/27/2006 MODIFICATION TO EASYSPINE SYSTEM LDR SPINE USA FLOYD G LARSON
K063802 12/22/2006 LENSTEC LC INJECTION SYSTEM LENSTEC, INC. JIMMY CHACKO
K063855 12/28/2006 LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 LIBERTY HEALTHCARE GROUP, INC. JOHN C GORMLEY
K063601 12/04/2006 PILOT SPINAL SYSTEM LIFE SPINE REBECCA M BROOKS
K063795 12/22/2006 GUARDIANCATHETER-URINARY DRAINAGE CATHETER MARIAN MEDICAL, INC. SANDRA WINKLER
K063648 12/07/2006 SURGI-WRAP MAST TENDON SHEET MAST BIOSURGERY USA INC. KENNETH K KLEINHENZ
K063607 12/12/2006 SPINEASSIST SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K063472 12/05/2006 ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 MEDA LTD. EDWARD A KROLL
K063433 12/05/2006 ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 MEDA LTD. EDWARD A KROLL
K063864 12/29/2006 QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS MEDICAL ELECTRONIC SYSTEMS LTD. ERIKA B AMMIRATI
K063700 12/13/2006 SPYGLASS IRRIGATION SYSTEM MEDICAL SCIENTIFIC, INC. PAUL NARDELLA, JR.
K063843 12/26/2006 APEXNRG XFR MEDICNRG LTD. GEORGE J HATTUB
K063681 12/11/2006 TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE MEDILINE ITALIA S.R.L. PANTALEONI MAURIZIO
K063876 12/29/2006 MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING MEDIVATORS REPROCESSING SYSTEMS LYNN LUEDERS
K063836 12/26/2006 RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K063670 12/11/2006 MODIFICATIONS TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K063733 12/18/2006 RESOLVE BILIARY DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. AMY MCKINNEY
K063653 12/08/2006 MICRUS MICROCOIL SYSTEM, "CASHMERE" MODEL SRC MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K063671 12/11/2006 REBOUND HRD MINNESOTA MEDICAL DEVELOPMENT, INC. ELAINE DUNCAN
K063586 12/01/2006 MOORFLPI FULL-FIELD LASER PERFUSION IMAGER MOOR INSTRUMENTS LTD. XIABING HUANG
K063676 12/11/2006 DBX DEMINERALIZED BONE MATRIX MIX MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ
K063693 12/14/2006 FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST NEW BAY BIORESEARCH CO. LTD. RODRIGO BERLIE
K063820 12/27/2006 LISFRANC PLATE NEWDEAL S.A. JUDITH E O'GRADY
K063831 12/27/2006 BASAL DORSAL PLATES NEWDEAL SAS JUDITH E O'GRADY
K063721 12/15/2006 NIPRO SAFETOUCH II GAMMA NIPRO MEDICAL CORP. JESSICA OSWALD
K063592 12/04/2006 ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 NOBEL BIOCARE AB HERBERT CRANE
K063718 12/14/2006 SFB AND CFB IMPLANTS - 5.0 PLATFORM NOBEL BIOCARE AB HERBERT CRANE
K063752 12/19/2006 LIFESENSE, MODEL LS1-9R NONIN MEDICAL, INC. LORI M ROTH
K063691 12/12/2006 NEUTRON THERAPY SYSTEM NORTHERN ILLINOIS UNIV. OUTREACH JONATHAN S KAHAN
K063821 12/26/2006 NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM NOVA BIOMEDICAL CORP. PAUL W MACDONALD, PHD
K063549 12/04/2006 NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GAISSER
K063596 12/06/2006 PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL NOVABONE PRODUCTS, LLC DAVID M GAISSER
K063699 12/13/2006 IMDX SYSTEMS NOVX SYSTEMS INC. THOMAS TSAKERIS
K063805 12/27/2006 SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 NUCRYST PHARMACEUTICALS, INC. STEVEN J CHARTIER
K063804 12/22/2006 OLYMPUS TRIGLYCERIDE TEST SYSTEM OLYMPUS AMERICA, INC. BEV HARDING
K063786 12/26/2006 ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K063683 12/14/2006 OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K063690 12/12/2006 COLIN PRESS MATE, MODEL BP S510 OMRON HEALTHCARE, INC. RANNDY KELLOGG
K063720 12/15/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS SARAH CV PARSONS
K063591 12/01/2006 VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 ORTHO-CLINICAL DIAGNOSTICS, INC. MICHAEL M BYRNE
K063709 12/14/2006 TS-BONE HIP TOOL ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K063861 12/28/2006 GS SYSTEM OSSTEM IMPLANT CO.,LTD CATHRYN N CAMBRIA
K063792 12/22/2006 OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM OSTEOMED L.P. PIEDAD PENA
K063697 12/13/2006 SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K063736 12/22/2006 FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 PDG PRODUCT DESIGN GROUP, INC. EDWARD A KROLL
K063775 12/21/2006 ELIA GLIADIN IGA, IGG AND CELIAC CONTROL PHADIA US INC. MARTIN R MANN
K063781 12/21/2006 PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K063783 12/21/2006 PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A PHILIPS MEDICAL SYSTEMS, INC. TAPAN D SHAH
K063725 12/15/2006 MP5 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K063578 12/04/2006 PROMOS MODULAR SHOULDER SYSTEM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K063746 12/18/2006 POWER EXTENDERS MODEL# PEC200, PES200,PES200S POWER MEDICAL INTERVENTIONS, INC. BARBARA WHITMAN
K063735 12/19/2006 PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 PRESYM, INC. TAMIM HAMID
K063494 12/28/2006 DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS PRO-MED INSTRUMENTS GMBH EDGAR SCHUELE
K063581 12/11/2006 SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE PT MAHAKARYA INTI BUANA V. NADARAJAN
K063650 12/08/2006 VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 PURITAN BENNETT CORP. PATRICK GARVEY
K063584 12/01/2006 STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 REGENERATION TECHNOLOGIES, INC. LISA SIMPSON
K063750 12/19/2006 XCEL 255 SLIT LAMP REICHERT INC. SANDRA BROWN
K063637 12/15/2006 RELIANCE VBS SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K063808 12/27/2006 FRAXEL IV SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. HEATHER TANNER MACFALLS
K063661 12/08/2006 RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 RENU MEDICAL, INC. BRUCE PIERSON
K063830 12/26/2006 REMSTAR AFLEX CPAP SYSTEM RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K063662 12/08/2006 RAMP NT-PROBNP ASSAY RESPONSE BIOMEDICAL CORP. KEN PILGRIM
K063744 12/18/2006 COBAS INTEGRA C 111 ROCHDIAG CORINA HARPER
K063823 12/26/2006 COAGUCHEK XS PT CONTROLS ROCHE DIAGNOSTICS CORP. THERESA AMBROSE BUSH
K063684 12/12/2006 COBAS LITHIUM ROCHE DIAGNOSTICS CORP. THERESA AMBROSE BUSH
K063814 12/22/2006 BP-200 PLUS SCHILLER AG RETO KUETTEL
K063634 12/06/2006 RTR SYRINGE SEPTODONT WAYNE H MATELSKI
K063757 12/19/2006 MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES SHANGHAI MOTEX HEALTHCARE CO., LTD. KE-MIN JEN
K063641 12/15/2006 PC-60, NON-INVASIVEPULSE OXIMETER SHENZHEN CREATIVE INDUSTRY CO., LTD MACK CHARLES
K063609 12/04/2006 RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER SHL TELEMEDICINE INTERNATIONAL LTD. GEORGE J HATTUB
K063743 12/20/2006 RHYTHM TOUCH Q 2-WAY SHOCKIM ENTERPRISES, LTD. NICOLAAS C BESSELING
K063762 12/20/2006 SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY SIEMENS AG, MEDICAL SOLUTIONS KRISTIN FROWEIN
K063761 12/20/2006 ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. MICHAELA MAHL
K063826 12/26/2006 SYNGO MI APPLICATIONS 2007A SIEMENS MEDICAL SOLUTIONS USA, INC. FRANK POKROP
K063803 12/22/2006 ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI MICHAELA MAHL
K063806 12/22/2006 SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED SLEEPNET CORPORATION PAUL CHIESA
K063635 12/06/2006 SBI FOREFOOT SET SMALL BONE INNOVATIONS, INC. ROBERT HOEHN
K063627 12/08/2006 POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) SMART GLOVE CORP. SDN BHD CHO S FONG
K063726 12/15/2006 PLC SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIV. DEANA BOUSHELL
K063835 12/26/2006 ALLEVYN AG DRESSING SMITH & NEPHEW, INC. TERRY MCMAHON
K063755 12/19/2006 PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K063764 12/22/2006 SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM SOUTHERN SPINE, LLC JULIE STEPHENS
K063606 12/01/2006 MODIFICATION TO STAXX FX SYSTEM SPINE WAVE, INC. RONALD K SMITH
K063799 12/22/2006 STEAMPLUS STEAM INTEGRATOR SPS MEDICAL SUPPLY CORP. GARY J SOCOLA
K063638 12/11/2006 MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 ST. JUDE MEDICAL SHANNON SPRINGER
K063844 12/26/2006 REPROCESSED HEART STABILIZERS AND POSITIONERS STERILMED, INC. DENNIS TOUSSAINT
K063812 12/22/2006 STRAUMANN PREFGEL STRAUMANN USA LISA M QUAGLIA
K063789 12/21/2006 WN SYNOCTA GOLD ABUTMENT STRAUMANN USA ELAINE ALAN
K063822 12/26/2006 MODIFICATION TO HIPSTAR FEMORAL STEM STRYKER ORTHOPAEDICS TIFFANI ROGERS
K063816 12/22/2006 PCA ALUMINA FEMORAL HEADS STRYKER ORTHOPAEDICS PATRICIA SETTI-LAPERCH
K063600 12/04/2006 VISTA AVS SUMMIT DOPPLER SYSTEMS, INC. KEN JARRELL
K063859 12/28/2006 SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA SURGIQUEST, INC. KOUROSH AZARBARZIN
K063603 12/05/2006 SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 SUTURTEK INCORPORATED ART RANKIS
K063832 12/26/2006 SYNTHES (USA) ELBOW HINGE FIXATOR SYNTHES (USA) JENNIFER PERKS
K063790 12/22/2006 THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K063708 12/15/2006 4S SPINAL SYSTEM TAE YEON MEDICAL CO., LTD GIL WOON CHOI
K063722 12/15/2006 SEKURIT SHARPS COLLECTION CONTAINER TECHEN SAFETY, INC. SID MATHUR
K063729 12/15/2006 DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 TECHNOMED EUROPE MAURICE ROOST
K063701 12/14/2006 TECO HOMOCYSTEINE ENZYMATIC ASSAY TECO DIAGNOSTICS JIAN VAECHES
K063758 12/19/2006 CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R TELEFLEX MEDICAL LORI HAYS
K063759 12/19/2006 HEATMARKER TIME TEMPERATURE INDICATOR TEMPTIME CORPORATION RICHARD PHILLIPS
K063618 12/05/2006 TENDERFLOW PERIATRIC ARTERIAL CANNULA TERUMO CARDIOVASCULAR SYSTEMS CORP. CHRISTINA L THOMAS
K063613 12/12/2006 MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP. SANDI HARTKA
K063695 12/13/2006 RUNTHROUGH NS TERUMO MEDICAL CORP. MARK UNTERREINER
K063688 12/20/2006 SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE THE ANSPACH EFFORT, INC. JIM BANIC
K063622 12/20/2006 FINECUBE DENTAL CT THE YOSHIDA DENTAL MFG. CO., LTD. DANIEL KAMM
K063647 12/15/2006 CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH THERMO ELECTRON OY PAIVI SORMUNEN
K063838 12/26/2006 LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH THERMO ELECTRON OY PAIVI SORMUNEN
K063705 12/13/2006 LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL THERMO ELECTRON OY PAIVI SORMUNEN
K063748 12/19/2006 THERMOMED 1.8 THERMOSURGERY TECHNOLOGIES, INC. GENE ZISCHKE
K063787 12/21/2006 INPLEX CF MOLECULAR TEST THIRD WAVE TECHNOLOGIES, INC. ANDREW A LUKOWIAK
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K063639 12/08/2006 AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 TISSUELINK MEDICAL, INC. VICKI ANASTASI
K063599 12/05/2006 PORTI 7 PHYSIOLOGICAL AMPLIFIER TMS INTERNATIONAL BV DAVID W WAGNER
K063605 12/04/2006 ST AIA-PACK INTACT PTH ASSAY TOSOH BIOSCIENCE, INC. CHARLES P GILL
K063714 12/14/2006 AXCEL FLOW TRI DENTAL INNOVATORS LINDA NGUYEN
K063711 12/14/2006 TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA TUTTNAUER CO. LTD. MARK YACURA
K063703 12/13/2006 CITRIC ACID 20% SOLUTION, MODEL 329 ULTRADENT PRODUCTS, INC. COREY JASEPH
K063558 12/08/2006 PEAK SE, MODEL 5135 ULTRADENT PRODUCTS, INC. DIANE ROGERS
K063611 12/06/2006 SALINE/ CONTRAST MEDIA INFUSION CATHETER UTAH MEDICAL PRODUCTS, INC. KEVIN L CORNWELL
K063815 12/22/2006 VARIAN ESOPHAGUS BOUGIE APPLICATOR VARIAN MEDICAL SYSTEMS VY TRAN
K063851 12/28/2006 AUTO-FILL SYRINGE KIT, MODEL 7600 VASCULAR SOLUTIONS, INC. PATRICE STROMBERG
K063871 12/29/2006 D-STAT HANDLE, MODEL 8500-053 VASCULAR SOLUTIONS, INC. ALYSSA MALINSKI
K063860 12/28/2006 THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT VASCULAR SOLUTIONS, INC. JAMES CHAPMAN
K063813 12/27/2006 VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA VENTLAB CORP. JAMES A COCHIE
K063768 12/20/2006 TITANIUM SCALLOPED ABUTMENT VIDENT ELIZABETH WOLFSEN
K063604 12/04/2006 TWINKY STAR NF VOCO GMBH MANFRED THOMAS PLAUMANN
K063730 12/19/2006 DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0 VOLUME INTERACTIONS PTE LTD VALERIE FAN
K063868 12/29/2006 MASSTRAK IMMUNOSUPPRESSANTS KIT WATERS CORPORATION FRAN WHITE
K063660 12/08/2006 OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 WELL-LIFE HEALTHCARE LIMITED JENNY HSIEH
K063677 12/11/2006 FUSION QUATTRO EXTRACTION BALLOON XL WILSON-COOK MEDICAL, INC. SCOTTIE FARIOLE
K063840 12/26/2006 XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION WITT BIOMEDICAL CORP JAMES LUKER
K063731 12/19/2006 ADVANCE STATURE FEMORAL COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K063587 12/01/2006 XODUS MEDICAL ANTI-FOG SOLUTION XODUS MEDICAL, INC. BRENDA NIEL
K063657 12/08/2006 VASCUTRAK PTA DILATION CATHETER YMED INC. THOMAS SCHROEDER
K063810 12/22/2006 YULEX LATEX POWDER-FREE EXAM GLOVES YULEX CORPORATION KATRINA CORNISH
K063582 12/01/2006 ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE ZIMMER, INC. CINDY J DICKEY
K063602 12/05/2006 AUTOPULSE RESUSCITATION SYSTEM MODEL100 ZOLL CIRCULATION MARK PERKINS


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