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 |
12/21/2006 |
ACCIN UNI-KNEE SYSTEM |
ACCIN CORPORATION |
MICHAEL KVITNITSKY |
K063753 |
12/19/2006 |
GFX NERVE ABLATION SYSTEM |
ACI, INC. |
CLAY ANSELMO |
K063863 |
12/28/2006 |
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER |
ADVANTAGE MEDICAL CABLES, INC. |
KEN KENDRICKS |
K063617 |
12/05/2006 |
EUSOL-C |
AL.CHI.MI.A |
GEORGE MYERS |
K063728 |
12/15/2006 |
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 |
K063716 |
12/14/2006 |
AEROSOL SYSTEM |
AMICI, INC. |
MICHAEL BONO |
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 |
12/26/2006 |
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 |
12/21/2006 |
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 |
12/06/2006 |
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER |
C.R. BARD, INC. |
TERRI MORRIS |
K063646 |
12/07/2006 |
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 |
12/07/2006 |
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 |
12/21/2006 |
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 |
12/22/2006 |
CORIN UNIPOLAR MODULAR HEAD |
CORIN USA |
KATHY K TRIER |
K063626 |
12/06/2006 |
DURAFLEX |
COSMETIC DENTAL MATERIALS INC |
ROBERT BOWERS |
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 |
K063659 |
12/08/2006 |
EASY CURING PEN-STYLE LED CURING LIGHT |
DENT CORP. RESEARCH & DEVELOPMENT |
DAVID ALBELDA |
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 |
K063772 |
12/21/2006 |
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 |
12/05/2006 |
EKOS MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K063797 |
12/22/2006 |
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 |
12/07/2006 |
ZILOS-TK |
HAMILTON THORNE BIOSCIENCES |
DOUGLAS HAMILTON |
K063612 |
12/04/2006 |
MODIFICATION TO HEALTH BUDDY APPLIANCE |
HEALTH HERO NETWORK, INC. |
ROBIN BUSH |
K063852 |
12/28/2006 |
ACCESSA CHOLESTEROL PANEL |
HOME ACCESS HEALTH CORP. |
KAREN L HANSON |
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 |
12/26/2006 |
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 |
K063818 |
12/22/2006 |
QUANTA PLEX CELIAC IGA PROFILE |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
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 |
12/06/2006 |
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 |
12/08/2006 |
ENDOGUIDE |
KMS MEDICAL LLC |
MARIO ARBESU |
K063640 |
12/07/2006 |
KOWA SL-15 |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
K063593 |
12/04/2006 |
CLEARFIL MAJESTY FLOW |
KURARAY AMERICA, INC. |
KOJI NISHIDA |
K063595 |
12/04/2006 |
CLEARFIL MAJESTY POSTERIOR |
KURARAY AMERICA, INC. |
KOJI NISHIDA |
K063631 |
12/06/2006 |
POLYPERF / POLYPERF SAFE |
LABORATOIRES PEROUSE |
MARIE NOELLE EROUT |
K063745 |
12/19/2006 |
MEDILASER, MODEL 1000 |
LASER THERA, LLC |
SHELLY HENRY |
K063794 |
12/22/2006 |
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 |
K063841 |
12/26/2006 |
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS |
LIPOSCIENCE |
MARK A DEL VECCHIO |
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 |
12/04/2006 |
SPINEASSIST SYSTEM |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
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 |
12/13/2006 |
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST |
NEW BAY BIORESEARCH CO. LTD. |
RODRIGO BERLIE |
K063710 |
12/14/2006 |
SATURN 9000 |
NEW MEDICAL CO., LTD. |
YOUNG-HOON SHIN |
K063820 |
12/26/2006 |
LISFRANC PLATE |
NEWDEAL S.A. |
JUDITH E O'GRADY |
K063831 |
12/26/2006 |
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 |
K063596 |
12/04/2006 |
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL |
NovaBone Products, LLC |
DAVID M GAISSER |
K063699 |
12/13/2006 |
IMDX SYSTEMS |
NOVX SYSTEMS INC. |
THOMAS TSAKERIS |
K063805 |
12/22/2006 |
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 |
12/21/2006 |
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K063683 |
12/12/2006 |
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 |
K063842 |
12/26/2006 |
CYRTINA SYSTEM |
ORATIO B.V. |
JEF M VAN DER ZEL |
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 |
12/18/2006 |
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 |
K063746 |
12/18/2006 |
POWER EXTENDERS MODEL# PEC200, PES200,PES200S |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA WHITMAN |
K063735 |
12/18/2006 |
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 |
PRESYM, INC. |
TAMIM HAMID |
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 |
12/07/2006 |
RELIANCE VBS SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
K063808 |
12/22/2006 |
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 |
12/07/2006 |
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 |
12/18/2006 |
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 |
12/06/2006 |
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 |
12/20/2006 |
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 |
12/07/2006 |
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 |
K063680 |
12/11/2006 |
SHARPOINT PDO (POLYDIOXANONE) SUTURES |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
K063859 |
12/28/2006 |
SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA |
SURGIQUEST, INC. |
KOUROSH AZARBARZIN |
K063603 |
12/03/2006 |
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 |
12/13/2006 |
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 |
12/13/2006 |
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 |
K063778 |
12/21/2006 |
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE |
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 |
12/05/2006 |
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
K063695 |
12/13/2006 |
RUNTHROUGH NS |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K063688 |
12/12/2006 |
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE |
THE ANSPACH EFFORT, INC. |
JIM BANIC |
K063622 |
12/05/2006 |
FINECUBE DENTAL CT |
THE YOSHIDA DENTAL MFG. CO., LTD. |
DANIEL KAMM |
K063647 |
12/07/2006 |
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 |
K063873 |
12/29/2006 |
ICARE TONOMETER TA01I |
TIOLAT OY |
NELSON TOBIN |
K063639 |
12/07/2006 |
AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
K063599 |
12/04/2006 |
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 |
K063611 |
12/03/2006 |
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 |
12/22/2006 |
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 |
12/18/2006 |
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 |
12/18/2006 |
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 |
12/04/2006 |
AUTOPULSE RESUSCITATION SYSTEM MODEL100 |
ZOLL CIRCULATION |
MARK PERKINS |