FDA 510(k) Decisions During October, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K091910 10/01/2009 PICCOLO MAGNESIUM TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K092986 10/27/2009 ACACIA PISTON SYRINGE ACACIA, INC. FERGIE FERGUSON
K092926 10/28/2009 ACELL MATRISTEM WOUND SHEET ACELL, INC RODNEY W BOSLEY
K091354 10/21/2009 ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING ACRYMED, INC. CHARLES K GRIFFIN
K083626 10/19/2009 DISTRACTABLE WAVE CAGE ADVANCED MEDICAL TECHNOLOGY, INC. J.D. WEBB
K092990 10/23/2009 AMD 6605 TENS/NMES ADVANTAGEOUS MEDICAL DEVICES, LLC JOHN HEROD
K091284 10/28/2009 VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA AFFINITY BIOLOGICALS INC. DENISE FOULON
K091369 10/14/2009 ELECTROFLUIDGRAPH AKERN USA, LLC KEVIN WELLS
K091777 10/20/2009 ALCON ULTRACHOPPER ALCON RESEARCH, LTD. MARTIN A KAUFMAN
K091413 10/26/2009 S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) ALFA WASSERMANN, INC. HYMAN KATZ
K091240 10/23/2009 ALPHAMED SURGICAL SPEAR, MODEL 70-5000 ALPHAMED INC. JAMES GUBACHY
K092824 10/21/2009 N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 ALPHAPROTECH, INC. DAVID KITCHEN
K092225 10/09/2009 AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR AMYLIOR, INC. ERIC DUGAS
K083133 10/30/2009 SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS ANDOVER HEALTHCARE INC. VALERIE GUNN
K092539 10/01/2009 SEAMFREE APEX DENTAL MATERIALS, INC. CHRIS KULTON
K090751 10/23/2009 COMET ANTERIOR CERVICAL PLATE SYSTEM APOLLO SPINE, INC. ANN-MARIE FRANCIS
K090472 10/14/2009 GRIND GUARD ARCHTEK, INC. KRISTA OAKES
K092182 10/09/2009 VOYAGER COMPACT IMAGING SYSTEM ARDENT SOUND, INC. DEBORAH VAN GORDER
K091102 10/23/2009 ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS ARKRAY FACTORY USA, INC. HAMID IDRISSI
K090653 10/09/2009 POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY USA, INC. HAMID IDRISSI
K091196 10/27/2009 GRS GLENOID RESURFACING SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K092425 10/21/2009 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K093183 10/23/2009 BIS QUATRO SENSOR ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K092112 10/06/2009 BTI DENTAL IMPLANT TINY 2.5-3.0 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDO GOMEZ
K092729 10/02/2009 BAXANO NEURO CHECK DEVICE BAXANO, INC. CINDY DOMECUS
K092318 10/30/2009 BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE BAXTER HEALTHCARE CORPORATION VALERIE FOLLOWELL
K092337 10/16/2009 PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K091846 10/16/2009 SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 BECKMAN COULTER, INC. MARINE BOYAJIAN
K091758 10/09/2009 BD SPINAL NEEDLE 27G BECTON DICKSON & CO. PASQUALE AMATO
K090716 10/06/2009 BEGO SEMADOS S-LINE BEGO IMPLANT SYSTEMS GMBH & CO. KG MARTIN ELLERHORST
K092296 10/21/2009 POWDER FREE EXAMINATION GLOVE BETTERCARE PLASTIC PRODUCTS CO., LTD. JIE LIU
K092301 10/22/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) BETTERCARE PLASTIC PRODUCTS CO., LTD. JIE LIU
K092294 10/21/2009 VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR BETTERCARE PLASTIC PRODUCTS CO., LTD. JIE LIU
K092035 10/15/2009 BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION BICON, LLC VINCENT J MORGAN
K092355 10/29/2009 MONOLISA ANTI-HAV EIA BIO-RAD LABORATORIES, INC. LINDA STASWICK
K092353 10/29/2009 MONOLISA ANTI-HAV IGM EIA BIO-RAD LABORATORIES, INC. LINDA STASWICK
K091414 10/21/2009 VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH BIOCARE CORP. JUDY WEI
K083927 10/01/2009 WATERLASE MD BIOLASE TECHNOLOGY, INC. IOANNA RIZOU
K092150 10/27/2009 COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT BIOMET, INC. SUSAN ALEXANDER
K090017 10/13/2009 CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES BIOSENSE WEBSTER, INC. BALAKA DAS
K091789 10/01/2009 CARTO RMT EP NAVIGATION SYSTEM V8 BIOSENSE WEBSTER, INC. DIANA THORSON
K092197 10/06/2009 PHOTEX30 DIODE LASER SERIES: 980, 810, 940 BIOTEX, INC. ASHOK GOWDA
K091440 10/09/2009 LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L BOVIE MEDICAL RICHARD KOZLOFF
K092212 10/09/2009 BUSSE SURGICAL DRAPES III BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K091913 10/30/2009 HI TECH IMPLANT, HT PHYSIO IMPLANT BY DENTAL SRL DANIELE POLI
K082207 10/23/2009 ORTHOCAD IQ CADENT, INC. LAURIE CLARKE
K092949 10/08/2009 IMAGEGRID RADIOLOGY VIEWER SYSTEM CANDELIS, INC. CARL ALETTO
K092616 10/21/2009 ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 CAO GROUP, INC. ROBERT K LARSEN
K093300 10/30/2009 ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K091471 10/15/2009 PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL CARTAGLOVES S.A. SAM KAO
K090487 10/19/2009 DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 COEUR, INC. DEBRA MANNING
K091703 10/14/2009 HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K092898 10/19/2009 CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES CONMED LINVATEC LORNA K LINVILLE
K091767 10/09/2009 3 WAY SILICONE FOLEY BALLOON CATHETER COOK UROLOGICAL, INC. BRENDA DAVIS
K092205 10/30/2009 PALINDROME P HEMODIALYSIS CATHETER COVIDIEN LP, FORMERLY REGISTERED AS KENDALL DANIEL CAMPION
K092195 10/01/2009 CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) CUTERA, INC. KATHY MAYNOR
K091736 10/30/2009 SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 DANIELS CORPORATION PTY, INC. ANDREA ARREDONDO
K092547 10/30/2009 DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX DENTIMAX KORINA A AKHONDZADEH
K093221 10/30/2009 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II DENTSPLY INTL., INC. HELEN LEWIS
K092882 10/21/2009 D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K092873 10/27/2009 REVERSE SHOULDER PROSTHESIS DJO SURGICAL TEFFANY HUTTO
K090055 10/27/2009 LOW & HIGH SPEED KIT DPM USA CORP. GEORGE ECHEVERRI
K090991 10/09/2009 COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO E-WOO TECHNOLOGY VINCENT LEE
K091305 10/23/2009 CLEARPATH EASYGLIDE LTD. PAUL DRYDEN
K092336 10/15/2009 C-THRU SPINAL SYSTEM EBI, L.P. VIVIAN KELLY
K092010 10/22/2009 PC ECG, MODEL SE-1010 EDAN INSTRUMENTS, INC. WILLIAM STERN
K092509 10/08/2009 EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES, LLC. KAREN JONES
K091709 10/13/2009 MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC EDWARDS LIFESCIENCES, LLC. JASON SMITH
K091871 10/23/2009 DK50 DS EKOM S.R.O. PAUL DRYDEN
K091000 10/26/2009 KNEEKG EMOVI EMMANUEL MONTINI
K092289 10/20/2009 EMS AIR-FLOW HANDY PERIO EMS ELECTRO MEDICAL SYSTEMS SA CYNTHIA J NOLTE
K091542 10/20/2009 ESTECH EASYFLOW CANNULA WITH GUIDEWIRE ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K092783 10/22/2009 DEBP ENKO LTD. SINAN KAZAZOGLU
K092111 10/02/2009 ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 ENTOMED AB CHARLOTTE MATTISSON
K092418 10/23/2009 ENTRACARE GASTROSTOMY FEEDING TUBE ENTRACARE, LLC BRANDON CONVERSE
K092913 10/16/2009 EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 EP MEDSYSTEMS SUSHMA RAO
K092887 10/21/2009 EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K091290 10/29/2009 ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 ETHICON ENDO-SURGERY, INC. TOM BOSTICCO
K091458 10/15/2009 HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 EV3 NEUROVASCULAR TOM DAUGHTERS
K092770 10/09/2009 SIMPLYGO HANDS FREE BREAST PUMP EVENFLO COMPANY, INC. AMY NEFF
K092297 10/09/2009 ELETONE CREAM FERNDALE PHARMA GROUP, INC. RICHARD A HAMER
K092218 10/06/2009 FLEXICARE BREATHING FILTERS FLEXICARE MEDICAL LTD. DAVID MOYNHAM
K093234 10/30/2009 INTEGRATED REGISTRATION GE MEDICAL SYSTEMS SCS SOPHIE LE LOARER
K091833 10/16/2009 GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. GEMORE TECHNOLOGY CO., LTD. BODEN LAI
K092471 10/02/2009 MODEL SENTINELLA 102 GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A SEVERINE MOINE
K092623 10/30/2009 F.A.S.T. SYSTEM SED AND CXD GENESIS MEDICAL INTERVENTIONAL, INC. ANNE WORDEN
K091918 10/07/2009 ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO GENORAY CO., LTD. SHIN KUK YOO
K092513 10/09/2009 RAINBOW BLOCK GENOSS CO., LTD. EUNKYUNG SON
K091878 10/06/2009 OSSEOLINK DENTAL IMPLANT SYSTEM GLOBAL IMPLANT SOLUTIONS, LLC STUART R GOLDMAN
K093023 10/29/2009 PTFE PEELABLE INTRODUCER GREATBATCH MEDICAL KRISTI FOX
K082891 10/20/2009 LENSTAR, MODEL LS900 HAAG-STREIT AG LENA SATTLER
K092650 10/09/2009 HEARTWAY POWER MOBILITY SCOOTER, S12 HEARTWAY MEDICAL PRODUCTS CO., LTD. KE MIN JEN
K092037 10/02/2009 LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. CINDY GREEN
K092245 10/28/2009 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 HONSUN (NANTONG) CO., LTD DAVID ZHANG
K083552 10/09/2009 MAXMORESPINE TOM STICK HOOGLAND SPINE PRODUCTS GMBH BORIS MIKLITZ
K092570 10/16/2009 ABX PENTRA TPU CAL, MODEL A11A01898 HORIBA ABX SAS CAROLINE FERRER
K092561 10/20/2009 REJUVENATE MODULAR STEM HOWMEDICA OSTEONICS CORP ESTELA CELI
K090897 10/23/2009 TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT HOWMEDICA OSTEONICS CORP AVITAL MERL-MARGULIES
K092834 10/08/2009 HOFFMAN XPRESS LINE EXTENSION HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K092381 10/27/2009 IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION IBALANCE MEDICAL, INC. JANICE M HOGAN
K090712 10/02/2009 EOCENE SYSTEM INFOPIA CO., LTD MARIA F GRIFFIN
K092544 10/26/2009 INSTRUMED VASCULAR CLAMPS INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K090563 10/09/2009 HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K091100 10/23/2009 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM INTERLACE MEDICAL, INC. JONATHAN S KAHAN
K092177 10/15/2009 MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 INVATEC S.P.A. STEVE CAMP
K092361 10/29/2009 REEF HP 0.035" OTW PTA BALLOON DILATATION CATHETER INVATEC S.P.A. JOHN CLAY
K091787 10/09/2009 MODEL 6000 TWO PARAMETER BEDSIDE MONITOR IVY BIOMEDICAL SYSTEMS, INC. JENNIFER LAINE
K091065 10/16/2009 AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 J. MORITA USA, INC. KEITH BARRITT
K092432 10/09/2009 AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) JAWON MEDICAL CO., LTD. H L JUNG
K092431 10/08/2009 BODY COMPOSITION ANALYZER, MODEL: IOI 353 JAWON MEDICAL CO., LTD. H L JUNG
K091679 10/02/2009 LEFORTE SYSTEM BONE PLATE JEIL MEDICAL CORPORATION SHIN KUK YOO
K092806 10/09/2009 AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 K-JUMP HEALTH CO., LTD. JASON CHENG
K090919 10/02/2009 KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE KENSEY NASH CORP. ALYSSA SCHWARTZ
K091499 10/22/2009 MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) KENSEY NASH CORP. ALYSSA SCHWARTZ
K091613 10/07/2009 TAKE 1 KERR CORP. COLLEEN BOSWELL
K092867 10/01/2009 IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT KETTENBACH GMBH & CO KG MICHAELA ZINKE
K092717 10/30/2009 DIRECT DIGITIZER, REGIUS MODEL 210 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSEL MUNVES
K092281 10/27/2009 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC. KIYOYUKI ARIKAWA
K092536 10/30/2009 SPINAL FIXATION SYSTEM LANX, INC. JANICE M HOGAN
K091915 10/27/2009 FLUID ISOLATION DEVICE LENSTEC, INC. JIMMY CHACKO
K090051 10/08/2009 LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 LEVITRONIX LLC. SUSAN HAMANN
K090006 10/15/2009 LIFEBRIDGE B2T, MODEL 7001 LIFEBRIDGE MEDIZINTECHNIK AG KATHLEEN JOHNSON
K091115 10/30/2009 ECO2 LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K090689 10/29/2009 QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 MAQUET CARDIOPULMONARY AG INGRID RICHTER
K092838 10/15/2009 MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 MASIMO CORPORATION MARGUERITE THOMLINSON
K091696 10/26/2009 SAVI WIRELESS, MODEL PM500 MEDICOMP, INC. SUSAN GOLDSTEIN-FALK
K091780 10/16/2009 GUIDED MEASUREMENT CATHETER (GMC) MEDIGUIDE, LTD. JONATHAN S KAHAN
K091781 10/16/2009 GUIDED MEDICAL POSITIONING SYSTEM (GMPS) MEDIGUIDE, LTD. JONATHAN S KAHAN
K090568 10/02/2009 MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K092676 10/02/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. LILA JOE
K093058 10/26/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. JENNIFER MCBRIDE
K092303 10/27/2009 MERIT LAUREATE HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K091584 10/09/2009 MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K091540 10/08/2009 MTD 4000 METTLER ELECTRONICS CORP. ROBERT FLEMING
K092456 10/23/2009 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K093002 10/28/2009 AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 MICROVENTION, INC. NAOMI GONG
K092581 10/30/2009 MITS DICOM GATEWAY AND IMAGE MANAGER MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. KE-MIN JEN
K091217 10/02/2009 DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ JOY
K092566 10/09/2009 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) NANOSPHERE, INC GREGORY W SHIPP
K092957 10/21/2009 VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST NANOSPHERE, INC GREGORY SHIPP
K092292 10/28/2009 CHECKPOINT NDI MEDICAL LLC JULIE GRILL
K092085 10/07/2009 ISPIRA RESUSCITATION UNIT NEOFORCE GROUP, INC. MONICA FERRANTE
K090866 10/21/2009 NEUROCALM MODEL 1 AND 2 NEUROMED DEVICES, INC ROBERT SEIPLE
K091721 10/02/2009 CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 NEW MEDICAL TECHNOLOGIES GMBH VINCE D'ALESSANDRO
K091803 10/09/2009 SMARTTRACK SYSTEM NEXUS6, LTD. GARTH SUTHERLAND
K091848 10/16/2009 NOBEL/PROCERA IMPLANT BRIDGE NOBEL BIOCARE AB HERBERT CRANE
K091907 10/06/2009 NOBELPROCERA IMPLANT BRIDGE ZIRCONIA NOBEL BIOCARE AB HERBERT CRANE
K092678 10/01/2009 EVISION DATA MANAGEMENT SOFTWARE NONIN MEDICAL, INC. LORI M ROTH
K092101 10/21/2009 REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES NONIN MEDICAL, INC. LORI ROTH
K092253 10/08/2009 MODIFICATION TO FMRI HARDWARE SYSTEM NORDICNEUROLAB CHANDANA GURUNG BHANDARI
K092011 10/28/2009 NORM SPINAL SYSTEM NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR NURAY DOGAN
K090190 10/09/2009 WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM NUCLEMED S.A. RAYMOND KELLY
K092804 10/08/2009 MICROSELECTRON HDR V2, MODEL 105.999 NUCLETRON CORP. ELAINA COLBY
K091386 10/02/2009 MICROFUSE DUAL RATE INFUSER NUMIA MEDICAL TECHNOLOGY, LLC ERIC FLACHBART
K091623 10/09/2009 LAMINOPLASTY FIXATION SYSTEM NUVASIVE, INC. HAN FAN
K092287 10/06/2009 NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K091064 10/27/2009 NAVILAS LASER SYSTEM OD -OS GMBH JUDY GORDON
K092309 10/30/2009 SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K092443 10/23/2009 INTERFACE ACETABULAR CUP LINERS OMNI LIFE SCIENCE, INC. WILLIAM MCCALLUM
K093251 10/29/2009 OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K092939 10/09/2009 PATLOG 2.0 ONCOLOG MEDICAL QA AB JAN TORNQVIST
K092014 10/08/2009 SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER ONSET MEDICAL CORPORATION
K092039 10/16/2009 IDENTEVENT, VERSION 1.0G OPTIMA NEUROSCIENCE, INC. PAULA WILKERSON
K092056 10/01/2009 OPTOMED SMARTSCOPE, MODEL M3-1 EY1 OPTOMED OY LAURA OJALA
K090705 10/09/2009 BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT ORTHO DEVELOPMENT CORP. JOHANNE YOUNG
K090474 10/19/2009 ORTHOREX INTRA-OPERATIVE LOAD SENSOR ORTHOSENSOR, INC. JON WARD
K083077 10/26/2009 ULC SPINAL PEDICLE SCREW SYSTEM OTIS BIOTECH CO., LTD JISUK YOO
K091446 10/27/2009 MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE, RAC, CCRA
K091512 10/30/2009 BUILD-IT LIGHT CURE PENTRON CLINICAL TECHNOLOGIES WENDY GARMAN
K090008 10/15/2009 TANDA RESTORE, MODEL PTSCS PHAROS LIFE CORPORATION PHIL CUSCUNA
K092747 10/09/2009 PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MICHAEL A CHILBERT
K091389 10/22/2009 EQUALSHIELD LUER LOCK CONNECTOR PAIR PLASTMED, LTD. ELISSA BURG
K090703 10/20/2009 POLY-CHEM 90 GLUCOSE POLYMEDCO, INC. HELEN LANDICHO
K092961 10/23/2009 JAZZY FRONTIE PRIDE MOBILITY PRODUCTS CORP. KIMBERLY BLAKE
K090641 10/23/2009 CURIOS PROGENTIX ORTHOBIOLOGY B.V. YVONNE P BOVELL
K092034 10/19/2009 POWDER FREE NITRILE EXAMINATION GLOVES, BLACK PT. SMART GLOVE INDONESIA SOON TUCK KWAN
K090639 10/29/2009 EXELO2, MODEL 4010 QUANTEL DERMA GMBH MICHAEL JOHNSON
K091433 10/28/2009 R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL R & D SYSTEMS, INC. NANCY RING
K092105 10/09/2009 RADIANALYZER XPRESS RADI MEDICAL SYSTEMS AB MATS GRANLUND
K092408 10/14/2009 RHYTHM OF LIFE, MODEL R0901-05 RAPID RESPONSE SOLUTIONS, LLC JORGE MILAN
K082756 10/21/2009 RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR RAVEN BIOLOGICAL LABORATORIES, INC. WENDY ROYALTY-HANN
K092026 10/02/2009 EASYCARE TX, TX LINK RESMED LTD. DAVID D'CRUZ
K090539 10/30/2009 BIPAP AUTOSV ADVANCED RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K091191 10/23/2009 GAS TRANSFILL RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP ZITA A YURKO
K093116 10/21/2009 MODIFICATION TO: RAMP INFLUENZA A/B ASSAY RESPONSE BIOMEDICAL CORP. KEN PILGRIM
K083260 10/16/2009 ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN ROCHE DIAGNOSTICS JACK ROGERS
K092585 10/30/2009 ELECSYS RUBELLA IGGA CALCHECK 5 ROCHE DIAGNOSTICS KELLY FRENCH
K092070 10/06/2009 INTERPLATE C RSB SPINE LLC. KAREN E WARDEN
K090361 10/08/2009 REMOTE INFRARED THERMOMETER, MODEL RC002 RYCOM ELECTRON TECHNOLOGY LIMITED DIANA HONG
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