FDA 510(k) Decisions During January, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K080513 01/30/2009 QLASER SYSTEM 2035, INC. KEVIN WALLS
K093169 11/12/2009 SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) A PLUS INTERNATIONAL, INC. SOLOMON CHEN
K092687 11/23/2009 VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER A PLUS MEDICAL THOMAS LOESCHER
K082716 01/15/2009 A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 A-DEC, INC. THOMAS H LOUISELL
K082827 01/07/2009 A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT A-DEC, INC. THOMAS H LOUISELL
K082534 11/02/2009 ETEST VORICONAZOLE 0.002-32 UG/ML AB BIOMERIEUX ANETTE ENGELHARDT
K083574 01/29/2009 RELIEVA STRATUS MICROFLOW SPACER ACCLARENT, INC. KERI YEN
K090730 11/13/2009 AKITA JET ACTIVAERO AMERICA, INC. PAUL DRYDEN
K082668 01/23/2009 BIO-SCREEN ADDENT, INC. JOSHUA FRIEDMAN
K082887 01/16/2009 PM-1000F+PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLIAN
K083915 01/29/2009 ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC ADVANCED TECHNOLOGY LASER CO., LTD. DIANA HONG
K092503 11/19/2009 RADAR VASCULAR COMPRESSION DEVICES ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K092166 11/23/2009 S. AUREUS/CNS PNA FISH, MODEL KT005 ADVANDX, INC. PAULA E BULGER
K083495 01/15/2009 MODIFICATION TO: METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K083730 01/09/2009 ISOLAZ AESTHERA CORPORATION PAMELA M BUCKMAN
K083279 01/28/2009 CALTRIX RESORBABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K092669 11/06/2009 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. JEFFERY A JEDLICKA
K090061 01/23/2009 AIRSTRIP OB AIRSTRIP TECHNOLOGIES, LP
K083040 01/30/2009 S-TEST C-REACTIVE PROTEIN (CRP) ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DENNIS TASCHEK
K083826 01/22/2009 LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K082622 01/12/2009 ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE ALMA LASERS LTD. ANNE WORDEN
K093488 11/20/2009 ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K082857 01/06/2009 RENEGADE WHEELCHAIR ALPHA ONE PATSY J TRISLER
K083496 01/30/2009 CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS ALTATEC GMBH LINDA K SCHULZ
K092568 11/17/2009 SPARTAN S3 FACET SYSTEM AMENDIA, INC. RICHARD JANSEN
K092826 11/12/2009 ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL AMERICAN BIOTECH LABS MIRIAM PROVOST
K092735 11/09/2009 GREENLIGHT XPS LASER SYSTEM AMERICAN MEDICAL SYSTEMS, INC. DARLENE-CROCKET BILLIG
K081767 01/09/2009 AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 AMNISURE INTERNATIONAL, LLC MICHAEL FRIEDMAN
K083246 01/29/2009 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 ANDON HEALTH CO.,LTD LIU YI
K083248 01/29/2009 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 ANDON HEALTH CO.,LTD LIU YI
K083247 01/29/2009 FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 ANDON HEALTH CO.,LTD LIU YI
K093387 11/27/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 ANDON HEALTH CO.,LTD LIU YI
K083317 01/29/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 ANDON HEALTH CO.,LTD LIU YI
K083318 01/29/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 ANDON HEALTH CO.,LTD LIU YI
K083319 01/29/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 ANDON HEALTH CO.,LTD LIU YI
K083617 01/27/2009 APIERON INSIGHT ENO SYSTEM APIERON, INC. NINA PELED
K082968 01/02/2009 APNEICARE CONNECTION CENTER/INTERNET ANALYSIS APNEICARE, LLC PAUL DRYDEN
K082504 01/27/2009 APOLLO ANTERIOR CERVICAL PLATE SYSTEM APOLLO SPINE, INC. PAMELA PAPINEAU, RAC
K093296 11/05/2009 ALEXIS LAPAROSCOPIC SYSTEM APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K091653 11/02/2009 ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K092104 11/24/2009 ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY USA, INC. HAMID IDRISSI
K082810 01/23/2009 ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW ARTHREX, INC. NANCY HOFT
K092133 11/05/2009 ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N ARTHROCARE CORP. VALERIE DEFIESTA-NG
K083240 01/12/2009 OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES ARTHROCARE CORP. LAURA N KASPEROWICZ
K083145 01/12/2009 ASAHI GUIDE WIRE EXTENSION, MODEL AG149000 ASAHI INTECC CO., LTD. YOSHI TERAI
K083904 01/29/2009 ASAHI SUOH PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K092440 11/05/2009 ASCENSION CANNULATED SCREW SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K082231 01/12/2009 ASCENSION SILICONE PIP ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K092597 11/12/2009 CENTROS CHRONIC HEMODIALYSIS CATHETER SET ASH ACCESS TECHNOLOGY, INC. ROLAND WINGER
K082748 01/14/2009 ATRIUM PROLITE S MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K093187 11/05/2009 MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. ELAINE APLAON
K092959 11/27/2009 AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 AVITA CORPORATION JENNIFER REICH
K092313 11/04/2009 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B. BRAUN MEDICAL, INC. SUSAN OLINGER
K082704 01/09/2009 BIRTHTRACK (A.K.A. CLM) BARNEV, LTD. AHAVA STEIN
K092487 11/10/2009 HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K082473 01/05/2009 BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM BAUSCH & LOMB, INC. NED L LUCE
K083757 11/18/2009 BPZ02 MULTIPURPOSE SOLUTION BAUSCH & LOMB, INC. GLENN A DAVIES, O.D.
K090096 01/30/2009 ALL-IN-ONE CONTAINER BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K092877 11/17/2009 INDISCAL ASPIRATION DEVICE AND ACCESSORIES BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K083718 01/26/2009 BEAU RX SCAR CARE GEL BEAU RX SOLUTIONS, LLC. THOMAS L MCGRAW
K081822 01/21/2009 COULTER 6C CELL CONTROL, MODELS 628027 & A59925 BECKMAN COULTER, INC. LOURDES COBA
K081641 01/16/2009 COULTER LIN-X LINEARITY CONTROL BECKMAN COULTER, INC. NANCY NADLER
K091724 11/13/2009 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON DICKINSON & CO. SABA MODJARRAD
K082852 01/29/2009 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K091730 11/13/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SABA MODJARRAD
K082787 01/12/2009 VITAL SIGNS MONITOR, MODEL: MD500B BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K091272 11/10/2009 BESMED JET NEBULIZER BOTTLE SET BESMED HEALTH BUSINESS CORP. KE-MIN JEN
K083303 01/26/2009 LANDLEX, MODEL: 402X BESTEAM TECHNOLOGY INC. JUNNATA CHANG
K092549 11/16/2009 OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P BIO MEDICAL TECHNOLOGIES CO., LTD CATHRYN CAMBRIA
K091248 11/30/2009 MAXEMS, MODELS 1000 AND 2000 BIO PROTECH, INC. JUDY BURTON
K092732 11/25/2009 PROPENCIL ESU PENCIL BIO PROTECH, INC. KEVIN HAN
K092761 11/24/2009 PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C BIO PROTECH, INC. JUDY BURTON
K081499 01/16/2009 HEALTH MANAGER, VERSION 1.1 BIOCOMFORT DIAGNOSTICS GMBH & CO. KG MARION OTTO
K083274 01/08/2009 WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER BIOCOMPATIBLES, INC. WAYNE RICHARDSON
K083681 01/16/2009 BIOLAND BLOOD PRESSURE MONITOR BIOLAND TECHNOLOGY LTD. DAVID LEE
K083682 01/09/2009 180W CERELAS D 980NM DIODE LASER, MODEL D180 BIOLITEC, INC. JONATHAN S KAHAN
K093224 11/09/2009 DENSICHECK PLUS BIOMERIEUX, INC. JOLYN TENLLADO
K082941 01/07/2009 BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 BIOMERIX CORPORATION CHRISTINA L KICHULA
K092341 11/30/2009 LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION BIOMET 3I, INC. JOSE E CABRERA
K082996 01/15/2009 BIOLOX DELTA OPTION CERAMIC HEADS BIOMET, INC. PATRICIA SANDBORN BERES
K091914 11/06/2009 OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION BIONOSTICS, INC. MINNA RANNIKKO
K081787 01/27/2009 CAMLAB CRANIAL ORTHOSIS HELMET BIOSCULPTOR CORPORATION MARK MAZLOFF
K081258 01/06/2009 VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 BIOSENSE WEBSTER, INC. NATALIE BENNINGTON
K093032 11/13/2009 TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET BIOSITE INCORPORATED MARA CALER
K091815 11/16/2009 SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 BIOTEST MEDICAL CORP. DIANE MANDELL HORWITZ
K093303 11/20/2009 SCOUTPRO 7F LONG CATHETERS BIOTRONIK, INC. JON BRUMBAUGH
K092009 11/06/2009 MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 BOSTON SCIENTIFIC CORPORATION JENNIFER KIMBALL
K093423 11/17/2009 LUNGPOINT PROCEDURE PLANNING BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K092191 11/25/2009 EXILIS, MODEL 5000 BTL INDUSTRIES LTD RICHARD VINCINS
K092090 11/30/2009 ERBELIFT HAND PUMP AND FLEXIBLE PROBE BYRNE MEDICAL INC. CHRIS HIERHOLZER
K092429 11/19/2009 ENDOGATOR BYRNE MEDICAL, INC. DON BYRNE
K083417 01/13/2009 INTRATEMP SOLUTION WARMER C CHANGE SURGICAL LLC PATRICK KAMMER
K092607 11/20/2009 AJUST ADJUSTABLE SINGLE INCISION SLING C.R. BARD, INC. JOHN C KNORPP
K083839 01/15/2009 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. BARD, INC. TERRI MORRIS
K090739 11/10/2009 BARD SACROCOLPOPEXY GRAFT C.R. BARD, INC. TERRI MORRIS
K082396 01/02/2009 DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 C.R. BARD, INC. STEPHANIE BAKER
K093068 11/10/2009 FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US C.R. BARD, INC. CINDY MOSS
K081924 01/07/2009 CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE CALHEALTH INC KE-MIN JEN
K083273 11/19/2009 MICRODOT XTRA CAMBRIDGE SENSORS LIMITED WARREN REEVES
K082521 01/16/2009 EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K090915 11/18/2009 STERILE WATER FOR INHALATION FLEX BAG, USP CARDINAL HEALTH, INC. KIMBERLY SOUTHWELL
K093521 11/25/2009 GDXPRO CARL ZEISS MEDITEC INC JUDY A BRIMACOMBE
K090584 11/24/2009 INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS CARL ZEISS SURGICAL GMBH MARK W SHEEHAN
K082518 01/16/2009 DUAL NEEDLE SUTURE PASSER SYSTEM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K092868 11/20/2009 CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CELLAVISION AB CONSTANCE G BUNDY
K092384 11/04/2009 LIQUICORD CENTRIX, INC. ROGER MASTRONY
K093134 11/27/2009 CERNER CAREAWARE IBUS CERNER CORP. SHELLEY S LOOBY
K080921 01/21/2009 SPIRO-MASTER PC-10 SPIROMETRY SYSTEM CHEST M.I., INC. FUMIAKI KANAI
K091531 11/02/2009 CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER CHOICE SPINE, LLP G.TODD HAWKINS
K080459 11/17/2009 CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH CATHY CAMBRIA
K092362 11/02/2009 SLEEPWEAVER NASAL CPAP MASK CIRCADIANCE LLC DAVID GROLL
K092619 11/13/2009 ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER CIVCO JAMES LEONG
K090326 11/25/2009 RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS CLARITY MEDICAL SYSTEMS GARY A SEEGER
K083771 01/30/2009 RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP CLARITY MEDICAL SYSTEMS GARY A SEEGER
K081908 01/16/2009 CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 CLINIQA CORPORATION CAROL RUGGIERO
K093184 11/06/2009 ENVOY GUIDING CATHETERS CODMAN & SHURTLEFF, INC. KATHRYN LAROSE
K083770 11/23/2009 COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM COLOPLAST A/S JANELL A COLLEY
K081537 01/22/2009 CFS FLEXIBLE COMFORT AND FLEXIBLE SYSTEMS JAY MANSOUR
K092160 11/27/2009 POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES COMFORT RUBBER GLOVES IND. SDN. BHD. TAN KENG BENG
K093389 11/17/2009 CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK COMPUTERIZED SCREENING, INC. SAM KUMAR
K092298 11/05/2009 MODIFICATION TO MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K083331 01/09/2009 CONFIDANT, MODEL 2.6 CONFIDANT INC. DANIEL R PLONSKI
K092954 11/06/2009 CADSTREAM VERSION 5 CONFIRMA, INC. BRENT LEWIS
K092359 11/02/2009 ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A COOK IRELAND LTD TRACY MORIARTY
K083814 01/13/2009 OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 CORDIS CORP., A JOHNSON & JOHNSON CO. KAREN WILK
K092730 11/20/2009 COSMEDENT BRUSHABLE COMPOSITE COSMEDENT, INC. JAMES L SANDRIK
K092364 11/03/2009 MODEL 220 PATIENT MAGNET CYBERONICS, INC. KAREN STUEBER
K083795 01/21/2009 CYNOSURE SMARTLIPO MPX LASER CYNOSURE, INC. GEORGE CHO
K081816 01/05/2009 VOCALIS AND VOCALIS SM CYTOPHIL INC GREG JOHNSON
K081815 01/05/2009 VOCALIS GEL CYTOPHIL INC GREG JOHNSON
K073593 01/29/2009 I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 DELTEX MEDICAL LIMITED NEIL R ARMSTRONG
K083398 01/26/2009 CERCOM CEMENT DENALI R&D CORPORATION JAN G STANNARD
K083473 01/22/2009 CLEAR BRAVO DENALI R&D CORPORATION JAN STANNARD
K083201 01/26/2009 ZMATCH BLOCK DENTAIM CO., LTD. DAESUCK CHUN
K082973 01/29/2009 STER-MATE STERILE LAVAGE KIT DENTSPLY INTERNTIONAL HELEN LEWIS
K092473 11/25/2009 EXPEDIUM SPINE SYSTEM DEPUY SPINE,INC LISA GILMAN
K092317 11/02/2009 DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM DEROYAL INDUSTRIES, INC. GRACIE GREENWAY
K091309 11/05/2009 REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX DGIMED ORTHO, INC SCOTT YOUNGSTROM
K092113 11/13/2009 STA - FREE PS CALIBRATOR DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K091382 11/16/2009 KRYPTONITE BONE CEMENT DOCTORS RESEARCH GROUP, INC. JUSTIN EGGLETON
K083258 01/30/2009 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE DORNIER MEDTECH AMERICA, INC. THERON GOBER
K083059 01/30/2009 AIR SONIC SCALER DPM USA CORP. GEORGE ECHEVERRI
K092999 11/24/2009 NBP CUFF DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K081877 01/05/2009 ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV GER VIJFVINKEL
K082863 01/09/2009 DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) DYNAREX CORPORATION JAMES HURLMAN
K083769 01/14/2009 MODIFICATION TO URESTA PESSARY EASTMED INC. ROSHANA AHMED
K082406 01/14/2009 EXPANDABLE PEEK-OPTIMA IMPLANT EBI, L.P. VIVIAN KELLY
K092670 11/19/2009 BIODRIVE MICRO SCREW SYSTEM EBI,LLC D/B/A BIOMET TRAUMA SHIKHA GOLA
K092997 11/10/2009 ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 EDAN INSTRUMENTS, INC. WILLIAM STERN
K090682 11/19/2009 EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 EDWARDS LIFESCIENCES SERVICES GMBH NEIL R ARMSTRONG
K083470 01/23/2009 CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 EDWARDS LIFESCIENCES, LLC. ERICA WALTERS
K092741 11/10/2009 COLOR LCD MONITOR, MODEL RADIFORCE MX241W EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K090045 01/28/2009 COLOR LCD MONITOR, RADIFORCE RX320 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K083061 01/09/2009 ELLEX INNOVATIVE IMAGING EYE CUBED V4 ELLEX, INC. TOM DAVIS
K090796 11/25/2009 MULTI-BITE HOT BIOPSY FORCEPS ENDO-THERAPEUTICS, INC. MARK R WADDELL
K092400 11/06/2009 ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 ENDOGASTRIC SOLUTIONS, INC. STEVE HOFFMAN
K082409 01/21/2009 SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 ENDOPHOTONIX, INC KIRK S HONOUR
K081703 01/08/2009 MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS ENTRA HEALTH SYSTEMS, LTD. CARLOS GONZALEZ
K082750 01/06/2009 ENTACT SEPTAL STAPLER, MODEL 610-00100 ENTRIGUE SURGICAL, INC. GABRIELE G NIEDERAUER
K083099 01/16/2009 EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 EPS BIO TECHNOLOGY CORP. Y. C LEI
K081796 01/23/2009 EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM EPS BIO TECHNOLOGY CORP. Y.C. LEI
K083882 01/30/2009 MYLABFIVE ESAOTE EUROPE B.V. JAMIE AUSTIN
K091607 11/02/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP. CHRISTOPHER KLACZYK
K082955 01/15/2009 ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 ETHICON ENDO-SURGERY, INC. GLENDA C MARSH
K091824 11/27/2009 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 ETHICON ENDO-SURGERY, INC. GLENDA MARSH
K093236 11/10/2009 ETHICON ENDO-SURGERYOPTICAL DILATOR ETHICON ENDO-SURGERY, INC. RENEE ROWE
K080299 01/13/2009 RESPIFIT S, MODEL RS-LR1001004 EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH DAVID LEVINE
K091657 11/19/2009 IMMUNOSCAN CCPLUS EURO-DIAGNOSTICA AB ANNIKA ANDERSSON
K093286 11/13/2009 POWERCROSS .018 OTW PTA DILATION CATHETER EV3 INC SARA BAKKER
K093301 11/06/2009 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM EV3 INC BRENDA JOHNSON
K083151 01/22/2009 EXTREMITY MEDICAL SUTURE ANCHOR EXTREMITY MEDICAL LLC JAMY GANNOE
K082291 01/02/2009 A-LAP SET (A-LAP, EZAXESS, TROCAR) EZSURGICAL KEVIN WALLS
K083358 01/09/2009 LUBRICANO-ULTRASOUND FARCO PHARMA GMBH SETH A MAILHOT
K080964 01/14/2009 FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K092271 11/17/2009 GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 GE HEALTHCARE NICOLE LANDREVILLE
K093348 11/25/2009 3.0T 16 CHANNEL HEAD NECK SPINE COIL GE HEALTHCARE COILS (USA INSTRUMENTS INC.) ELIZABETH MATHEW
K072102 01/16/2009 EPIVISION SL SYSTEM GEBAUER MEDIZINTECHNIK GMBH KIMBERLEY DONEY
K092231 11/24/2009 GEBDI TRIBOS 501 GEBDI DENTAL-PRODUCTS GMBH THOMAS BISKUPSKI
K082488 01/13/2009 DIAZYME LP(A) ASSAY GENERAL ATOMICS ABHIJIT DATTA
K082789 01/07/2009 G1B PULSE OXIMETER GENERAL MEDITECH, INC. DIANA HONG
K080117 01/30/2009 PATIENT ISOLATION UNIT, MODEL G019-1000 GENTEX CORPORATION BARRY SHOPE
K081054 01/15/2009 GISH ARTERIAL FILTER WITH HA COATING GISH BIOMEDICAL, INC. HARVEY KNAUSS
K081881 01/23/2009 GISH TUBING AND CONNECTORS WITH HA COATING GISH BIOMEDICAL, INC. EDWARD F WADDELL
K081838 01/26/2009 GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING GISH BIOMEDICAL, INC. MARTIN SELLERS
K083416 01/09/2009 REVOLVE STABILIZATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K092146 11/16/2009 XTEND ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
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