FDA 510(k) Decisions During March, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K092141 03/10/2010 VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH 3M ESPE DENTAL PRODUCTS TAMARA L STANCZAK
K092740 03/05/2010 ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 ABBOTT LABORATORIES DARLA ABANO
K093594 03/03/2010 MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER ACCLARENT, INC. COURTNEY KALOF
K093795 03/12/2010 ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 ACTHERM, INC. RICHARD HSIEH
K092784 03/12/2010 C. ALBICANS/C. GLABRATA PNA FISH ADVANDX, INC. HENRIK STENDER
K083186 03/04/2010 AESCULAP HYDROLIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. MATHEW M HULL
K091688 03/02/2010 A-GRIX RESORBABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K092427 03/16/2010 SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) ALBERT DAVYDOV DDS PC PROFESSIONAL ALBERT DAVYDOV
K093210 03/04/2010 AQUALASE CAPSULE WASH TIP ALCON MANUFACTURING, LTD. MARTIN A KAUFMAN
K092538 03/05/2010 REFINE SUPPORT SYSTEM, MODEL 100.0100 ALURE MEDICAL INC. JOSEPH TAMAYO
K093571 03/12/2010 ZR DENTAL BLOCK AMS CO., LTD CLAUDE YANG
K093773 03/10/2010 AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS AMSINO INTERNATIONAL, INC. JESUS FARINAS
K092905 03/04/2010 AUTOSTART BURETTE ANALYTICA PTY LTD ELAINE DUNCAN
K093406 03/25/2010 MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 ANGIODYNAMICS, INC. JODI LYNN FRASIER
K100303 03/22/2010 ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY ANGIOSCORE, INC. KIMBERLEY KLINE
K090364 03/23/2010 EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE ANGIOSLIDE, LTD ELISA HARVEY
K093523 03/04/2010 MICRO-TOUCH NITRILE ANSELL HEALTHCARE PRODUCTS LLC CYNTHIA A INGRAM
K093894 03/03/2010 ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE ANTHOGYR BRAYETTE SABINE
K100572 03/17/2010 VERSACLOSE, MODEL VC-200-01 ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K100615 03/30/2010 ARSTASIS ACCESS SYSTEM ARSTASIS, INC. SU-MIEN CHONG
K093912 03/18/2010 ARTHREX TIBIAL GRAFTBOLT ARTHREX, INC. DAVID D'ALESSANDRO
K100457 03/19/2010 OPUS SPEEDSCREW SYSTEM ARTHROCARE CORP. LAURA N KASPEROWICZ
K100080 03/19/2010 REPROCESSED TROCARS, MODEL B5LT AND CB5LT ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON-VARTY
K093702 03/04/2010 REPROCESSED ULTRASONIC COAGULATING SHEARS ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON VARTY
K091631 03/18/2010 ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW ASPYRA, INC. MARTIN D SARGENT
K092089 03/10/2010 CLARUJUST AUDIGENCE, INC. CRAIG PAGAN
K100016 03/04/2010 AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 AVITA CORPORATION JENNIFER REICH
K093717 03/02/2010 C-MOR VISUALIZATION DEVICE AXIS SURGICAL TECHNOLOGIES, INC JAMES FARNWORTH
K100402 03/05/2010 SITE-RITE VISION ULTRASOUND SYSTEM BARD ACCESS SYSTEMS, INC. KIMBERLY GEISLER
K093930 03/12/2010 DIDGET WORLD REPORTS BAYER HEALTHCARE LLC SUSAN BROCCHI
K100722 03/29/2010 TELAVANCIN 30 UG, BBL SENSI-DISC Becton, Dickinson and Company JANINE SPAFFORD
K093872 03/31/2010 HANDHELD ECG MONITOR, MODEL MD100 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K093757 03/03/2010 MD300C1 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K092046 03/24/2010 BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K091616 03/29/2010 BIOPLEX 2200 MMRV IGG Bio-Rad Laboratories DAVID BHEND
K093577 03/12/2010 LIQUICHEK OPIATE CONTROL Bio-Rad Laboratories ELIZABETH PLATT
K100162 03/24/2010 MULTIPLE PRIVATE LABEL BIOGREEN YIELDS SDN.BHD TIONG CHIONG KIENG
K093852 03/12/2010 EZLASE 3 LASER SYSTEM BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K093122 03/15/2010 MBCP+ BIOMATLANTE JEANNE CHAMOUSSET-ROMAN
K091025 03/02/2010 CHROMID VRE AGAR, MODEL: REF 43 851 BIOMERIEUX, INC. Nancy Weaver
K100048 03/09/2010 E1 ANTIOXIDANT INFUSED TECHNOLOGY BIOMET MANUFACTURING CORP. BECKY EARL
K093629 03/09/2010 SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K093761 03/05/2010 OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM BIOMET TRAUMA (AKA EBI, LP) MARGARET CROWE
K093983 03/19/2010 SMPLE PLATE AND SCREWS BIOMET TRAUMA (AKA EBI, LP) MARGARET CROWE
K091722 03/12/2010 COAXIAL APPLICATOR SYSTEM BIOMET, INC. ELIZABETH WRAY
K092786 03/10/2010 INBODY, MODELS: 270, R20, R20B BIOSPACE CORPORATION LIMITED DANIEL KAMM
K090050 03/05/2010 STEREOS WORKSTATION BIOSPACE MED JOHN J SMITH
K093764 03/02/2010 SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM Biotest Medical Corp. MAGGIE CHU
K100712 03/30/2010 RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation ASHLEY PYLE
K092149 03/18/2010 BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 BOVIE MEDICAL RICHARD KOZLOFF
K092383 03/10/2010 BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 BOVIE MEDICAL CORPORATION RICHARD KOZLOFF
K093965 03/17/2010 ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS C.R. BARD, INC. CANDACE WADE
K092565 03/18/2010 DIGITAL RETINAL CAMERA CX-1 CANON COMPONENTS, INC. SHEILA DRISCOLL
K093969 03/05/2010 ACUITY BREAK-AWAY GUIDE CATHETER CARDIAC PACEMAKERS, INC. KATHLEEN VITTUM
K093124 03/10/2010 PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 CARDINAL HEALTH 207, INC. MONTHER ABUSHABAN
K100094 03/11/2010 CARESTREAM IMAGE SUITE CARESTREAM HEATLH, INC. JOHN PARDO
K100035 03/17/2010 MODEL VISULAS 532S LASER WITH THE VITE OPTION CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K093213 03/12/2010 GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K100468 03/03/2010 ZEISS INFRARED 800 WITH FLOW 800 OPTION CARL ZEISS SURGICAL GMBH JUDITH BRIMACOMBE
K093787 03/11/2010 IGUIDE CAPPA CAS INNOVATIONS GMBH & CO. KG ANGELIKA SCHERP
K100386 03/01/2010 DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD Diana Hong
K100490 03/16/2010 LITEPAC, MODEL 682 CLEAR STREAM TECHNOLOGIES, LTD. FIONA NI MHULLAIN
K092437 03/25/2010 CODMAN STERILIZATION CONTAINERS Codman & Shurtleff, Inc. PAUL AMARAL
K100351 03/16/2010 NEUROSCOUT STEERABLE GUIDEWIRE Codman & Shurtleff, Inc. JOAN BARTLE
K092414 03/10/2010 CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM CONMED CORPORATION SANDY COVELESKI
K093556 03/12/2010 VCARE DX CONMED CORPORATION SARAH RIZK
K092847 03/11/2010 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. Jean Simon
K094028 03/18/2010 CP-FIBER (ORTHOFIBER) CP MEDICAL BARBARA K HORTON
K093480 03/05/2010 CUATTRO UNOMD CUATTRO, LLC MARK SKEELS
K093888 03/16/2010 COOPDECH ENDOBRONCHIAL BLOCKER TUBE DAIKEN MEDICAL CO, LTD. FUMIAKI KANAI
K092944 03/18/2010 DANA REUSABLE TEST PACK FOR STEAM STERILIZATION DANA PRODUCTS, INC. HARRY BALA
K091732 03/04/2010 VRLXP, MODEL XP DEEP BREEZE LTD. JEFF BAETZ
K100532 03/17/2010 VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K100446 03/05/2010 CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. RUTH WU
K100352 03/11/2010 DIAGNOSOFT HARP MODEL 2.06 DIAGNOSOFT, INC. JEFFREY ROBERTS
K092244 03/01/2010 MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS DIAGNOSTIC GROUP LLC DANIEL EGGAN
K093492 03/19/2010 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K093384 03/10/2010 MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K100020 03/08/2010 DX SERIES FINGER SENSOR DIXTAL MEDICAL INC. ROBERT SCHIFFMAN
K100062 03/26/2010 INFILTRATION KIT DMG USA, INC. PAMELA PAPINEAU
K100510 03/25/2010 CERAMIR CROWN & BRIDGE DOXA AB MARGARETH JORVID
K093633 03/30/2010 INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K093788 03/08/2010 INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION Draeger Medical Systems, Inc. CHARLES MORGANSON
K093779 03/09/2010 CLEARPATH UGI EASYGLIDE LTD. PAUL DRYDEN
K092428 03/18/2010 BIO-OSS COLLAGEN ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER REICHERTZ
K092613 03/03/2010 COLOR LCD MONITOR, MODEL RADIFORCE RS210 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K100115 03/10/2010 XVI R4.5 ELEKTA LTD. ANDREW HEDGES
K093324 03/05/2010 EMPI CONTINUUM EMPI JO P CHIU
K092331 03/03/2010 DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; ENCORE MEDICAL, L.P. TEFFANY HUTTO
K093003 03/24/2010 BONASTENT BILIARY ENDOCHOICE, INC. SHOSHANA FRIEDMAN
K092849 03/30/2010 BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER EPOCAL, INC. ROY LAYER
K093896 03/25/2010 ETHICON ENDO SURGERY SLOTTED ANOSCOPE ETHICON ENDO-SURGERY, INC. GLENDA MARSH
K100280 03/24/2010 GYNCARE MORCELLEX TISSUE MORCELLATOR ETHICON, INC. BRYAN LISA
K100485 03/16/2010 GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, INC. SUSAN LIN
K093957 03/18/2010 ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, FUJIREBIO DIAGNOSTICS, INC STACEY DOLAN
K093881 03/12/2010 TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR GE HEALTHCARE FINLAND OY TOMMI JOKINIEMI
K092061 03/26/2010 FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 GENEXEL MEDICAL INSTRUMENT INC JAY MANSOUR
K092493 03/29/2010 GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM GPC MEDICAL LTD VIKAS NARANG
K093232 03/15/2010 OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER Greatbatch Medical SHANNON SPRINGER
K100202 03/19/2010 SLIT LAMP BO 900, BQ 900, BP900 HAAG-STREIT AG OSCAR BANZ
K092148 03/04/2010 HAMILTON-C2 HAMILTON MEDICAL AG JOERG SCHNEIDER
K092558 03/17/2010 WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES HARVARD MEDICAL DEVICES LTD. MARTIN MA
K093831 03/25/2010 FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT HEALTH & LIFE CO., LTD. SARAH SU
K091890 03/24/2010 EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT HEALTHPOINT, LTD. AMY CAMPBELL
K100327 03/22/2010 HEARTWAY POWER CHAIR, P23 HEARTWAY MEDICAL PRODUCTS CO., LTD. Ke-Min Jen
K093258 03/03/2010 BLOM-SINGER INDWELLING TEP OCCLUDER HELIX MEDICAL, LLC CYNTHIA ANDERSON
K093575 03/05/2010 GLUMA DESENSITIZER POWER GEL HERAEUS KULZER, LLC CHERYL V ZIMMERMAN
K093044 03/16/2010 OASIS MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K092448 03/30/2010 HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 HIVOX BIOTEK, INC. Ke-Min Jen
K093126 03/02/2010 ANAPNOGUARD ENDOTRACHEAL TUBE HOSPITECH RESPIRATION LTD. YORAM LEVY
K093946 03/22/2010 HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 HOVEROUND CORP. TONY DIGIOVANNI
K100350 03/22/2010 HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT HOVEROUND CORP. TONY GIOVANNI
K100527 03/26/2010 HOVEROUND TEKNIQUE, MODEL HD-6 HOVEROUND CORP. TONY DIGIOVANNI
K100401 03/30/2010 SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM HU-FRIEDY MFG. CO., INC MARIA VRABIE
K091520 03/10/2010 IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K093808 03/24/2010 INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE INCITE INNOVATION LLC JOHN KIRWAN
K092842 03/01/2010 ECHOPLAQUE INDEC SYSTEMS, INC. CAROL HUBLER
K093066 03/16/2010 I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 INFIMED, INC. JIGAR SHAH
K093669 03/18/2010 SEC IBF CAGE INNVOTEC SURGICAL, INC. JUSTIN EGGLETON
K092545 03/10/2010 INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS LLC LARRY LEPLEY
K092181 03/11/2010 HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K091975 03/10/2010 INTEGRATED LABORATORY AUTOMATION SOLUTION INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. MARIA F GRIFFIN
K100559 03/30/2010 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM INTERLACE MEDICAL INC. John Vozella
K092409 03/10/2010 HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER INTERSURGICAL, INC. MICHAEL ZALEWSKI
K092352 03/16/2010 SCUBA BILIARY STENT SYSTEM INVATEC S.P.A. STEVE CAMP
K093842 03/05/2010 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS INVIVO CORPORATION ELIZABETH WHEELER
K093273 03/03/2010 VIT KIT - FREEZE AND THAW IRVINE SCIENTIFIC SALES CO., INC. JAYME YAMAGUCHI-OWENS
K093744 03/10/2010 EXCITE F AND EXCITE DSC IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K093708 03/10/2010 TELIO CAD IVOCLAR VIVADENT, INC. DONNA MHARTNETT
K092326 03/05/2010 SMOOTHCOOL JEISYS MEDICAL, INC. Kevin Walls
K093576 03/04/2010 RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR JIANGSU CUREGUARD GLOVE CO., LTD. CHU XIAOAN
K092211 03/05/2010 CHESAPEAKE SPINAL SYSTEM K2M, INC. RICHARD WOODS
K092474 03/11/2010 PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS K2M, INC. RICHARD W WOODS
K093603 03/18/2010 STORM-BASE 2.0 KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K093526 03/10/2010 V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D KCI USA, INC. (KINETIC CONCEPTS, INC.) RANDALL WHEELAND
K100500 03/09/2010 PSL CLASSIC SLIT LAMP KEELER INSTRUMENTS, INC. EUGENE VANARSDALE
K100083 03/19/2010 ESTHETICA KERR CORPORATION Wendy Garman
K093115 03/19/2010 KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 KIMBERLY-CLARK CORP. MARCIA JOHNSON
K100328 03/05/2010 CLEARFIL MAJETY POSTERIOR KURARAY MEDICAL INC. KIYOYUKI ARIKAWA
K100575 03/31/2010 LDR SPINE USA SPINE TUNE TL SPINE SYSTEM LDR SPINE USA NOAH BARTSCH
K093485 03/16/2010 VESISCAN LIFE-TECH, INC. JEFF KASOFF
K093048 03/23/2010 D-STORM 810NM, D-STORM 980NM LIGHT INSTRUMENTS YORAM LEVY
K092494 03/01/2010 GEL FILLED GUM SOOTHER LUV N' CARE, LTD. JOSEPH H HAKIM
K100385 03/24/2010 NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP LUV N' CARE, LTD. JEAN ASQUITH
K100053 03/10/2010 MATTIOLI PULSE TWO/THREE PLUS FAMILY MATTIOLI ENGINEERING CORP. GIANFRANCO BERNABEI
K100314 03/31/2010 IMNS MEDACTA NAVIGATION SYSTEM,33.221000US MEDACTA INTERNATIONAL, SA HEATHER NEELY
K091967 03/02/2010 MEDACTA BIPOLAR HEAD MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K092265 03/12/2010 VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS MEDACTA INTERNATIONAL, SA NATALIE KENNEL
K093336 03/05/2010 INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM MEDICAL NUMERICS, INC. DOUGLAS M TUCKER
K083803 03/10/2010 FIXIT HEADREST CLAMP SYSTEM MEDICON, E.G. JOACHIM SCHMID
K100484 03/16/2010 IMPIX MANTA CERVICAL INTERBODY DEVICE MEDICREA J.D. WEBB
K100297 03/04/2010 PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
K100186 03/24/2010 MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. MARK JOB
K092675 03/03/2010 GRINDCARE MEDOTECH A/S Calley Herzog
K093535 03/22/2010 AUTOLOG AUTOTRANSFUSION SYSTEM MEDTRONIC INC. CARALEE WALTON
K092308 03/16/2010 POLESTAR, MODEL N-30 MEDTRONIC NAVIGATION ISRAEL, LTD. YAIR PENIAS
K082855 03/09/2010 MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES MENICON CO. LTD. BEVERLEY D VENUTI
K092584 03/22/2010 LAPORT MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) PATRICK GAENSICKE
K093194 03/03/2010 MGB DISPOSABLE RETRIEVAL BAG LAPBAG MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) PATRICK GAENSICKE
K093815 03/12/2010 LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 MILLIPORE CORPORATION CATHERINE KARAMAN
K094047 03/22/2010 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR MODERN REHABILITATION SOLUTIONS CO., LTD Kevin Walls
K093380 03/05/2010 MIZZY EXPRESS MYCONE DENTAL SUPPLY CO., INC. NICK PALMER
K091634 03/01/2010 NMI FC NAVILYST MEDICAL, INC. SHILPA PREM
K092908 03/10/2010 NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO NEOMED, INC. PENNY NORTHCUTT
K092699 03/18/2010 NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 NEUROTRONICS, INC. JAMES SCHUBERT
K092930 03/10/2010 NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED NEXUS MEDICAL, LLC HEATHER TURNER
K091978 03/25/2010 DBB-06 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO. LTD. FUMIAKI KANAI
K100520 03/17/2010 NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER NIPRO MEDICAL CORPORATION JESSICA OSWALD
K093306 03/04/2010 SINGLE-PATIENT USE DISPOSABLE SENSOR NONIN MEDICAL, INC. LORI ROTH
K100671 03/30/2010 NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT NovaBone Products, LLC DAVID M GAISSER
K093585 03/08/2010 MICROCYN SKIN AND WOUND HYDROGEL OCULUS INNOVATIVE SCIENCES, INC. ANTOINETTE DOUGLAS
K093507 03/10/2010 OLYMPUS CHF TYPE Y0003 OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K100345 03/22/2010 SYSTEMS INTEGRATION MODEL: ENDOALPHA OLYMPUS MEDICAL SYSTEMS CORPORATION STACY KLUESNER
K100555 03/29/2010 APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK OMNI LIFE SCIENCE, INC. RADHIKA PONDICHERRY
K094017 03/05/2010 TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 OMNI LIFE SCIENCE, INC. Robert Zoletti
K093624 03/05/2010 OPTISCAN MODEL OPTISCAN CEIS OPTISCAN PTY LTD. PETER PAVLICEK
K091656 03/11/2010 SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L ORGAN RECOVERY SYSTEMS, INC. PJ PARDO
K093388 03/04/2010 SMART CAPNOLINE GUARDIAN ORIDION MEDICAL 1987 LTD. RACHEL WEISSBROD
K091564 03/19/2010 NBM-200MP PULSE OXIMETRY DEVICE ORSENSE LTD AHAVA STEIN
K093998 03/22/2010 KNEEALIGN SYSTEM WITH REFERENCE SENSOR ORTHALIGN, INC AMY WALTERS
K094037 03/10/2010 TC PLATING SYSTEM ORTHO-PRO LLC J.D. WEBB
K091208 03/03/2010 GS III SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K093719 03/01/2010 PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# OSTEOGENICS BIOMEDICAL, INC. DUSTYN WEBB
K092817 03/09/2010 POC-AS10 AUTO SAMPLER OTSUKA PHARMACEUTICAL CO., LTD. CYNTHIA A SINCLAIR
K092424 03/05/2010 P-ART, MODEL 001 P-CURE LTD MICHAEL MARASH
K100270 03/29/2010 ARTISAN AESTHETIC SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. SHARON TIMBERLAKE, MSHS, RAC, CC
K092980 03/11/2010 PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 Panpac Medical Corporation Yen-Ming Pan
K093494 03/30/2010 LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM PATHFINDER THERAPEUTICS, INC. CRAIG HENDERSON
K083842 03/23/2010 ROTEM DELTA THROMBOELASTOMETRY SYSTEM PENTAPHARM GMBH VOLKER JOACHIM FRIEMERT
K090123 03/05/2010 NEONATAL BIOTINIDASE KIT, MODEL 3018 PERKINELMER, INC. KAY A TAYLOR
K091120 03/19/2010 MEDPOR CONTAIN IMPLANT POREX SURGICAL, INC. JERRI L MANN
K093976 03/25/2010 RAISIN PERSONAL MONITOR PROTEUS BIOMEDICAL, INC. GREGORY MOON
K092460 03/05/2010 STAR-LITE -LM, MODEL SL8809 PS ADVANCED ENGINEERING WEN YANG
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