FDA 510(k) Decisions During December, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K093199 12/04/2009 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK 3M COMPANY JIZHONG JIN
K093600 12/04/2009 OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM ACCELERATED CARE PLUS PATRICK PARKER
K092371 12/23/2009 SWIFT-LOCK ANCHOR, MODEL 1192 ADVANCED NEUROMODULATION SYSTEMS PENNY HOUSTON
K092236 12/16/2009 E.COLI/P. AERUGINOSA PNA FISH ADVANDX, INC. PAULA E BULGER
K081092 12/11/2009 MODIFICATION TO MAMMAPRINT AGENDIA GUIDO BRINK
K091711 12/11/2009 S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K082965 12/07/2009 DS-A BLOOD GLUCOSE MONITORING SYSTEM ALLIANCE INTERNATIONAL CO., LTD. KE-MIN JEN
K091198 12/07/2009 LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING ALLIED HILL ENTERPRISES, LTD. PAUL A WARE
K093077 12/23/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K092936 12/04/2009 AMIGO ESCORT 7.5, MODEL 760001 PHS AMIGO MOBILITY INTL., INC. MIKE LABRAKE
K093452 12/23/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 ANDON HEALTH CO.,LTD LIU YI
K093528 12/04/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 ANDON HEALTH CO.,LTD LIU YI
K092588 12/29/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 ANDON HEALTH CO.,LTD LIU YI
K092510 12/23/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 ANDON HEALTH CO.,LTD LIU YI
K093166 12/07/2009 WITTMANN PATCH APERTA LLC DIETMAR H WITTMANN
K091884 12/09/2009 ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K093098 12/23/2009 AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM ARKRAY, INC. KENNETH L BLOCK
K092943 12/11/2009 ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE ARNOLD TUBER INDUSTRIES MICHAEL TUBER
K093259 12/17/2009 ARP RX100 ARP MANUFACTURING, INC LEWIS WARD
K093050 12/18/2009 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 ARROW INTL., INC. CHRISTINE FORD
K093165 12/04/2009 ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K090940 12/14/2009 SPOTCHECK BLOOD SPOT CONTROL, ASSAYED ASTORIA-PACIFIC,INC. CHARLES A PETERSON
K093483 12/22/2009 ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT ASTRA TECH INC. BETSY A BROWN
K092807 12/10/2009 HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 AUGUSTINE BIOMEDICAL & DESIGN, LLC JAMES ECKLEIN
K092958 12/02/2009 AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES AVITA CORPORATION JENNIFER REICH
K090628 12/04/2009 DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 BAYER HEALTHCARE, LLC SUSAN BROCCHI
K093346 12/15/2009 BD GENEOHM MRSA ACP ASSAY BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) RAYMOND BOULE
K092505 12/11/2009 BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 BECKMAN COULTER, INC. CATRIONA NEILAN
K093458 12/04/2009 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 BECKMAN COULTER, INC. MARINE BOYAJIAN
K090921 12/18/2009 ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 BEIERSDORF, INC. PETER STRATTON
K092620 12/04/2009 MD300C318 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K092214 12/15/2009 CHIROPRO L SYSTEM BIEN-AIR DENTAL, SA CYNTHIA J NOLTE
K090964 12/16/2009 BINAXNOX STAPHYLOCOCCUS AUREUS TEST BINAX, INC. SUZANNE M VOGEL
K092791 12/30/2009 KNEEHAB XP CONTROLLER, MODEL 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K092793 12/07/2009 MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K091746 12/07/2009 WATERLASE MD, MODEL 7100102 BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K093549 12/16/2009 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM BIOMET MANUFACTURING CORP. BECKY EARL
K093455 12/04/2009 CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES BIOSENSE WEBSTER, INC. BALAKA DAS
K091352 12/04/2009 SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 BIOSENSE WEBSTER, INC. BALAKA DAS
K091045 12/18/2009 SMART TENS, MODEL: D-BC05T BODY CLOCK HEALTH CARE LTD RASHELLE PRESTON
K093691 12/11/2009 ACCUMAX BOSTON SCIENTIFIC CORP. NICHOLE RIEK
K093636 12/23/2009 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX BOSTON SCIENTIFIC CORP. SHANNON PETTIT
K093720 12/23/2009 STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO BOSTON SCIENTIFIC CORP. MARK MURPHY
K093025 12/22/2009 BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES BOVIE MEDICAL CORPORATION RICHARD KOZLOFF
K083372 12/08/2009 ARROWBONE-A, ARROWBONE-B BRAINBASE CORPORATION H. NEAL DUNNING
K093117 12/11/2009 DIGITAL LIGHTBOX BRAINLAB AG RAINER BIRKENBACH
K093665 12/15/2009 ENDO SMARTCAP BYRNE MEDICAL INC. DON BYRNE
K092483 12/18/2009 BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 C.R. BARD, INC. KEVIN STEVENS
K093663 12/23/2009 RADIONUCLIDE BRACHYTHERAPY SOURCE C.R. BARD, INC. JULIE BASSETT
K092017 12/01/2009 PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) CAPTIVA SPINE, INC MIKE ENSIGN
K083174 12/17/2009 HEALTHEPOD CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K092803 12/23/2009 CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT CARDO MEDICAL CORP. DENISE DUCHENE
K093616 12/23/2009 V. MUELLER CAMERA CONTROLLER WITH STORAGE CART CAREFUSION 2200 GINA RAJTEROWSKI
K090598 12/15/2009 CARIESCAN PRO CARIESCAN LTD. NIKOLA SKELLY
K092782 12/07/2009 INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, CARMEL PHARMA AB. KJELL ANDREASSON
K092953 12/17/2009 XPERT VANA ASSAY CEPHEID RUSSEL K ENNS
K091926 12/22/2009 CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM CHOICE SPINE, LP KAREN WARDEN
K092829 12/02/2009 INSERTEASE CHRISTCOT MEDICAL COMPANY JENNIFER D ENSIGN
K093139 12/30/2009 BANTAM,48XXXXXX, 50XXXXXX CLEAR STREAM TECHNOLOGIES, LTD. FIONA NI MHULLAIN
K093557 12/18/2009 SMARTWAND-DTX CLEARCOUNT MEDICAL SOLUTIONS JEFF WOLFGONG
K093051 12/07/2009 HYLATOPIC PLUS EMOLLIENT FOAM COLLEGIUM PHARMACEUTICAL INCORPORATED RONALD M GURGE
K093513 12/16/2009 IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. AMITA SHAH, RAC
K091034 12/16/2009 AQUACEL AG SURGICAL CONVATEC PATRICIA KEARINS
K093052 12/08/2009 CROSSCATH SUPPORT CATHTER COOK, INC. MOLLY BUSENBARK
K091762 12/22/2009 DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE COVIDIEN MR. WING NG
K093372 12/03/2009 SILS PORT MODEL SILSPT15 COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR ANGELA VAN ARSDALE
K092850 12/15/2009 ENDOFLIP CROSPON, LTD. PAUL DRYDEN
K092904 12/22/2009 PATHWAY IVB/VBR CUSTOM SPINE, INC. SAAD ATTIYAH
K092788 12/18/2009 PERIOPHIL BIPHASIC CYTOPHIL INC VICTOR M BOWERS
K090959 12/24/2009 LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI) JOSEPH P D'ANTONIO
K092912 12/16/2009 STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 DANVILLE MATERIALS, INC. LINDSAY TILTON
K092032 12/08/2009 BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 DAVOL INC., SUB. C.R. BARD, INC. GAIL DOW
K093332 12/09/2009 DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9) DELPHI MEDICAL SYSTEMS GILBERT ROQUE JR.
K093072 12/28/2009 STARCARE HANDPIECE MAINTENANCE UNIT DENTALEZ, INC. KAY ENGLE
K092614 12/02/2009 X-SMART EASY DENTSPLY INTERNTIONAL HELEN LEWIS
K093646 12/17/2009 DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. RHONDA MEYER
K090986 12/30/2009 STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) DFINE, INC. SANDEEP SABOO
K093415 12/23/2009 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K093233 12/04/2009 D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K093167 12/22/2009 STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K092170 12/22/2009 STA LIATEST FREE PS DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K093001 12/18/2009 STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER DIAGNOSTICA STAGO, INCORPORATED UMBERTO V PARROTTA
K093498 12/14/2009 LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DIASORIN, INC. CAROL A DEPOUW
K082588 12/11/2009 GAMMALOC SYSTEM, MODEL 03-00001 DILON TECHNOLOGIES LLC ELAINE DUNCAN
K092417 12/11/2009 INSIGHT ULTRASONIC INSERTS DISCUS DENTAL, LLC WINKIE WONG
K092928 12/16/2009 DOSE VOLUME HISTOGRAM (DVH) EVALUATOR DIVERSILABS, LLC THOMAS KROENKE
K092488 12/18/2009 DYNAREX STERILE LUBRICATING JELLY DYNAREX CORPORATION DANIEL CONSAGA
K090526 12/02/2009 MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR E-WOO TECHNOLOGY VINCENT LEE
K093057 12/01/2009 BIOMET VISION FOOTRING SYSTEM EBI, L.P. MARGARET F CROWE
K092727 12/03/2009 H100B PULSE OXIMETER EDAN INSTRUMENTS, INC. LI FU
K091992 12/09/2009 EIDOSMED, MODEL EDG4.0 EIDOSMED, LLC DANIEL KAMM
K090889 12/04/2009 EMSI GARMENT ELECTRODES EMSI CHERITA JAMES
K093019 12/22/2009 ENAMELITE ACRYSEAL SPRAY SEALANT ENAMELITE LLC DAVID C FURR
K092174 12/30/2009 ENABLER-P CATHETER SYSTEM, MODEL 3000 ENDOCROSS, LTD. JOHN SMITH
K093227 12/10/2009 SILVERSTREAM AND DERMASEPT ENZYSURGE, LTD. KEREN SHTIEGMAN
K092469 12/23/2009 O-SCAN MR SYSTEM ESAOTE S.P.A. ALLISON SCOTT
K093613 12/23/2009 VASCUVIEW TAP ULTRASOUND SYSTEM ESCALON MEDICAL CORP. ROGER EDENS
K091729 12/23/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP. CHRISTOPHER KLACZYK
K093750 12/09/2009 ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA EV3 INC LAURA HEATON
K092548 12/15/2009 EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS EXTREMITY MEDICAL LLC JAMY GANNOE
K093252 12/17/2009 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER FOOTPRINT MEDICAL INC. CLYDE BAKER
K093006 12/30/2009 FONIX ,MODEL 8000 FRYE ELECTRONICS, INC. KRISTINA FRYE
K093514 12/10/2009 DISCOVERY MODEL NM/CT 670 GE MEDICAL SYSTEMS F.I. HAIFA ELI WERNER
K093141 12/29/2009 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOE LUCAS
K092639 12/02/2009 INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP GE MEDICAL SYSTEMS SCS NICOLE LANDREVILLE
K093242 12/23/2009 PATRIOT TRANSCONTINENTAL LLIF SPACER GLOBUS MEDICAL, INC. KELLY J BAKER
K092546 12/18/2009 GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM GMDASZ MANUFACTURING CO., LTD CHARLIE MACK
K091851 12/28/2009 STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD FOO KHON PU
K092682 12/11/2009 GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS GYRUS ACMI, INC. LORRAINE CALZETTA
K092514 12/04/2009 UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K092557 12/17/2009 DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES HARVARD MEDICAL DEVICES LTD. MARTIN MA
K093644 12/18/2009 RESTORATION ADM SYSTEM X3 ACETABULAR HOWMEDICA OSTEONICS CORP. AVITAL MERL MARGULIES
K093639 12/03/2009 SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 HUVITZ CO., LTD. MATEW J WESS
K090794 12/10/2009 OSTEOTAPE IMPLADENT, LTD. MAURICE VALEN
K090405 12/01/2009 LIPIDPRO SYSTEM INFOPIA CO., LTD PRISCILLA JUHEE CHUNG
K093113 12/18/2009 ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT INSTITUT STRAUMANN AG ANDREAS PETERMANN
K091701 12/22/2009 STRAUMANN MODIFIED DENTAL ABUTMENT INSTITUT STRAUMANN AG ELAINE ALAN
K092840 12/03/2009 INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K091111 12/02/2009 RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC INSTRUMENTATION INDUSTRIES, INC. DORIS WALTER
K091302 12/04/2009 INTEGRA MOZAIK AND OS MOLDABLE MORSELS INTEGRA LIFESCIENCES CORPORATION PETER ALLAN
K093163 12/15/2009 INTEGRA TOTAL WRIST FUSION SYSTEM INTEGRA LIFESCIENCES CORPORATION STEPHEN BEIER
K093260 12/16/2009 AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM INTERNATIONAL BIOMEDICAL, LTD. AMY PIEPER
K092883 12/18/2009 LED LAMP OR OTHER INTRAVISTA MEDICAL SYSTEMS INC WEI SU
K090993 12/16/2009 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 INTUITIVE SURGICAL, INC. USHA S KREADEN
K093642 12/11/2009 NEUTRASAL INVADO PHARMACEUTICALS EDWARD D KOBUS
K090785 12/15/2009 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 INVIVO CORP. RUSTY KELLY
K092796 12/22/2009 IBA PROTON THERAPY SYSTEM, PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K092634 12/01/2009 OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO CHEN XI
K093570 12/04/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K092966 12/08/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIN ZHOU CHANG HAO PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K093534 12/16/2009 MODIFICATION TO CASPIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K073214 12/01/2009 DUOWEDGE SYNTHETIC BONE SUBSTITUTE KASIOS J.D. WEBB
K091585 12/29/2009 VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 KCI USA, INC. MARGARET MARSH
K093312 12/08/2009 KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM KIMBERLY-CLARK CORP. LESTER PADILLA
K091749 12/23/2009 U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS KIMBERLY-CLARK CORP. CHERYL SANZARE
K093375 12/02/2009 KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) KOON SENG SDN.BHD JIGAR SHAH
K092344 12/17/2009 LAC-MAC INNERBLOC LR SURGICAL GOWNS LAC MAC, LTD. JEFFREY O STULL
K093285 12/10/2009 MODIFICATION TO LANX SPINAL FIXATION SYSTEM LANX, LLC ANDREW LAMBORNE
K093144 12/16/2009 LOUSEBUSTER LARADA SCIENCES PHIL TRIOLO
K092647 12/11/2009 LENSX 550 LASER SYSTEM LENSX LASERS, INC. JUDY GORDON
K091301 12/15/2009 LIFE SPINE STAND-ALONE SPACER SYSTEM LIFE SPINE MICHAEL S BUTLER
K092550 12/15/2009 TIGRT IVS LINATECH, LLC JONATHAN YAO
K092998 12/23/2009 CONMED LINVATEC INTERCEPT IMPLANT LINVATEC CORP. DIONNE SANDERS
K093067 12/29/2009 LIPOSE DISPOSABLE CANNULA LIPOSE CORP. CHRISTINE EMANUEL
K083845 12/11/2009 XTAG CF60 KIT V2 LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K090533 12/18/2009 HLM TUBING SET WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG INGRID RICHTER
K090555 12/23/2009 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K093522 12/07/2009 QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K090518 12/18/2009 QUART ARTERIAL FILTER WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG INGRID RICHTER
K090515 12/18/2009 ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K090534 12/23/2009 VENOUS HARDSHELL CARDIOTOMY RESERVIORS MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K090690 12/23/2009 VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K092903 12/01/2009 "BORA UP 2080", BORA UP 2080 OP" AND "BORA UP 2080 MOUNTING" MAQUET GMBH AND CO. KG ANNETTE JAKOB
K092951 12/07/2009 STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS MECTRON S.P.A. ROGER GRAY
K091875 12/07/2009 E-PULSE MEDEVICE CORPORATION TZVI MILSHTEIN
K093714 12/10/2009 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG AM SHIM
K092914 12/09/2009 WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES MEDSHAPE SOLUTIONS JACK GRIFFIS
K093247 12/02/2009 MEDSYNAPSE PACS SOFTWARE MEDSYNAPTIC PRIVATE, LTD. DANIEL KAMM
K093434 12/02/2009 VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MELISA L WEISMAN
K092087 12/30/2009 MEDTRONIC DENTAL TCP MEDTRONIC SOFAMOR DANEK USA, INC. PAMELA EDWARDS
K092325 12/15/2009 MODIFICATION TO:CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K091582 12/04/2009 GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 MEDTRONIC VASCULAR COLLEEN MULLINS
K082249 12/31/2009 MORPHEUS MEIBACH TECH LTDA STUART L FRIEDEL
K092749 12/03/2009 MAS AND MINI-TROL PTH CONTROL MICROGENICS CORPORATION LISA CHARTER
K093397 12/17/2009 TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE MICROVENTION, INC. NAOMI GONG
K092855 12/29/2009 MILTEX MEMBRANE TACK KIT MILTEX, INC. JENNIFER BOSLEY
K092663 12/14/2009 ELI 350 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHARLES MORREALE
K083371 12/08/2009 NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) NATUS MEDICAL, INC. NICOHL R WILDING
K093392 12/31/2009 MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS NAVILYST MEDICAL, INC. WANDA CARPINELLA
K092964 12/11/2009 COOLTOUCH VARIA ND:YAG LASER SYSTEM NEW STAR LASERS, INC. NATALIE R VOLLRATH
K091118 12/16/2009 FOOT AND HAND MOTION SYSTEM NEWCLIP TECHNICS J.D. WEBB
K091457 12/08/2009 NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM NEXSTIM OY CYNTHIA J NOLTE
K091579 12/23/2009 FORESEE HOME NOTAL VISION LTD. JUDY GORDON
K091838 12/04/2009 OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK OBP MEDICAL KEITH LARSON
K091364 12/11/2009 DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 OEHM UND REHBEIN GMBH ALAN SCHWARTZ
K090819 12/23/2009 ONTEX TAMPON (UNSCENTED) ONTEX INTERNATIONAL NV NEAL KOBER
K092837 12/23/2009 OTI-SCAN 3000 OPKO INSTRUMENTATION, INC MARIO ARBESU
K091996 12/15/2009 ORTHOCOR KNEE SYSTEM BASIC ORTHOCOR MEDICAL INES BURGOS
K092044 12/18/2009 ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE ORTHOCOR MEDICAL INES BURGOS
K092674 12/28/2009 SIMPLER TOADSTOOL MINI IMPLANT PAN GLOBAL IMPLANT HAROLD BERGMAN
K093456 12/01/2009 JETSTREAM G3 SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. CYNDY ADAMS
K092710 12/02/2009 PENTAX ED-3490TK, VIDEO DUODENOSCOPE PENTAX MEDICAL COMPANY LISA LANCIA
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