FDA 510(k) Decisions During June, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K090060 06/02/2009 NEXLINK OCT SYSTEM, MODEL 7000 SERIES ABBOTT SPINE, INC. DAVID PADGETT
K090660 06/12/2009 AIRWAY BALLOON CATHETER INFLATION DEVICE ACCLARENT, INC. KERI YEN
K083144 06/16/2009 ACUMED CLAVICLE SCREW SYSTEM ACUMED LLC ALYSSA THOMAS
K090837 06/17/2009 STRATAPULSE TS AND STRATAPULSE ADVANCED MEDICAL PHOTONICS SCOTT PORTER
K090907 06/02/2009 PENTA LEAD KITS, MODELS: 3227-3234 ADVANCED NEUROMODULATION SYSTEMS AMY CLENDENING
K082068 06/25/2009 E. COLI PNA FISH ADVANDX, INC. HENRIK STENDER
K083772 06/04/2009 COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K090375 06/23/2009 ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K090347 06/18/2009 CAMLOG ABUTMENTS PS ALTATEC GMBH LINDA SCHULZ
K090934 06/02/2009 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC. SARAH MEYER
K090772 06/04/2009 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 ANDON HEALTH CO.,LTD LIU YI
K090770 06/04/2009 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 ANDON HEALTH CO.,LTD LIU YI
K090771 06/04/2009 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 ANDON HEALTH CO.,LTD LIU YI
K090769 06/04/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 ANDON HEALTH CO.,LTD LIU YI
K090768 06/04/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, ANDON HEALTH CO.,LTD LIU YI
K083687 06/11/2009 BAIXIN INTRAVASCULAR ADMINISTRATION SET ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. BIAN WEI QIANG
K091432 06/12/2009 XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K090583 06/26/2009 ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 APOLLO ENDOSURGERY, INC. GREG MATHISON
K090306 06/18/2009 ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT ARAGON SURGICAL INC. ALAN CURTIS
K091038 06/19/2009 AS 1000 ULTRASOUND WOUND THERAPY SYSTEM AROBELLA MEDICAL, LLC ELIAZ BABAEV
K083435 06/26/2009 ARTHREX UNIVERS II SHOULDER PEGGED GLENOID ARTHREX, INC. SALLY F OUST
K090393 06/23/2009 ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K091503 06/17/2009 MAGNUM MP FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K090615 06/03/2009 OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K082910 06/17/2009 CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, "XYZ" SILVER BANDAGES ASO LLC JONATHAN WARD
K090455 06/05/2009 PROVOX VEGA, MODEL 8130-8135 ATOS MEDICAL AB FERENC DAHNER
K090909 06/04/2009 C-QUR V -PATCH MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K083723 06/05/2009 A6 LUER ACCESS DEVICE B. BRAUN MEDICAL, INC. BONNIE J KINCAID, RAC
K090884 06/29/2009 PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. B. BRAUN MEDICAL, INC. ANGELA J CARAVELLA
K090680 06/10/2009 HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE BECTON DICKINSON & CO. JOHN ROBERTS
K090824 06/02/2009 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SABA MODJARRAD
K090971 06/05/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. KATHRYN BABKA CARR
K091317 06/25/2009 LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K090737 06/03/2009 HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI BIO-RAD LABORATORIES, INC. JOLENE BARTILSON
K090164 06/26/2009 CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER BIOLITEC, INC. JONATHAN S KAHAN
K080469 06/22/2009 VIDAS CA 15-3 ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K091126 06/18/2009 VITEK 2 GRAM POSITIVE DAPTOMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K091340 06/09/2009 THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 BOSTON SCIENTIFIC CORP. MARYBETH GAMBER
K091510 06/26/2009 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 BOSTON SCIENTIFIC CORPORATION MARYBETH GAMBER
K091035 06/24/2009 FULL BREATH SLEEP APPLIANCE LOWER (FBSL) BRYAN KEROPIAN DDS BRYAN KEROPIAN
K091370 06/05/2009 RADIA STEERABLE DIAGNOSTIC CATHETER C.R. BARD, INC. JULIA BRODERICK
K091545 06/15/2009 DIGITAL RADIOGRAPHY CXDI-60C CANON INC. SHEILA DRISCOLL
K091636 06/22/2009 OSTENE CT, AOC CT, OSTEOTENE, CERETENE CEREMED INC. TADEUSZ WELLISZ
K091032 06/22/2009 CERNER PROVISION WORKSTATION (VERSION 2.5) CERNER CORP. SHELLEY S LOOBY
K090632 06/01/2009 COMPEX REHAB CHATTANOOGA GROUP NORA C.R. YORK
K083640 06/29/2009 DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D CHOONGWAE MEDICAL CORP. CHARLIE MACK
K083716 06/08/2009 FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K090970 06/12/2009 FLOCONTROL , MODEL 1028 COAXIA, INC. SHARON D KVISTAD
K090720 06/17/2009 COCHLEAR BAHA BP100 COCHLEAR BONE ANCHORED SYSTEMS AB SEAN BUNDY
K091346 06/02/2009 CODMAN HAKIM MICRO II VALVE CODMAN & SHURTLEFF, INC. SHARON MCDERMOTT
K083895 06/23/2009 CODMAN ISOCOOL BIPOLAR FORCEPS CODMAN & SHURTLEFF, INC. EMILY E VALERIO
K090894 06/25/2009 COLLAWOUND WOUND DRESSING COLLAMATRIX CO., INC. DENNIS J.N. SEAH
K091315 06/05/2009 COVIDIEN EXTENDED TIP APPLICATOR CONFLUENT SURGICAL,INC SEAN REYNOLDS
K090560 06/29/2009 CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS CONMED LINVATEC REBECCA ROBERTS
K090671 06/11/2009 PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K091527 06/12/2009 ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER COOK, INC. NATHAN SIMON
K091325 06/29/2009 TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS COOPER SURGICAL THOMAS G WILLIAMS
K090696 06/19/2009 NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM CORVENTIS, INC. MADHURI BHAT
K090284 06/05/2009 RES-Q INFANT WEDGE AND SLING CR ENTERPRISES, LLC. CRAIG A TROOP
K090566 06/01/2009 PATHWAY AVID CUSTOM SPINE, INC. SAAD ATTIYAH
K091449 06/18/2009 DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 DATASCOPE CORP., CARDIAC ASSIST DIVISION DOLLY MISTRY
K081259 06/15/2009 DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC ED HORTON
K091096 06/18/2009 NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 DENTAL SOLUTIONS, INC. ANDREW PAENG
K091660 06/12/2009 CUSTOM COMFORT NIGHTGUARD VERSION 2 DENTEK ORAL CARE, INC. HOWARD M HOLSTEIN
K082843 06/19/2009 MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM DENTIS CO. LTD. JUNG BAE BANG
K090998 06/12/2009 DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K090877 06/26/2009 PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K090648 06/10/2009 VIPER 2 SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K090431 06/22/2009 DEXIS SOFTWARE DEXIS LLC CLAUDIA ORTIZ
K090307 06/18/2009 DDI ULTRASONIC NEBULIZER SYSTEM DIAGNOSTIC DEVICES, INC. E.J SMITH
K091680 06/19/2009 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. WILLIAM STERN
K090367 06/03/2009 SE-601 SERIES ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. WILLIAM STERN
K083008 06/10/2009 COOLSKIN ELBIO CO., LTD JAY MANSOUR
K083292 06/10/2009 HABIB ENDOHPB EMCISION, LTD. NAGY HABIB
K090415 06/01/2009 EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM EMINENT SPINE DAVE FREEHILL
K090922 06/05/2009 EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR EMPI SANDRA WALROD
K090109 06/24/2009 BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD EPOCAL, INC. ROY LAYER
K091322 06/01/2009 CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G ETHICON ENDO-SURGERY, INC. ASIFA VONHOF
K083669 06/08/2009 OBI EUROTEKNIKA EMMANUEL MONTINI
K091362 06/29/2009 CERAMIC PEDATRIC PREFORMED CROWN EZ-PEDO INC JEFFREY FISHER
K083690 06/23/2009 FEMVUE(TM) CATHETER SYSTEM FEMASYS INC. MARC FINCH
K091591 06/17/2009 FLEXICARE MEDICAL ENDOTRACHEAL TUBES FLEXICARE MEDICAL LTD. DAVID MOYNHAM
K090621 06/19/2009 FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 FLOWCARDIA, INC. DUSTIN MICHAELS
K090933 06/05/2009 BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS FORESTADENT BERNHARD FORSTER GMBH MICHAEL FIEB
K090126 06/29/2009 FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, FOTONA D.D. STOJAN TROST
K090821 06/10/2009 CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L FRANKENMAN INTERNATIONAL LIMITED JEAN ASQUITH
K083158 06/05/2009 EXALIS, SOFTWARE VERSION 1.15 GAMBRO, INC. KAE MILLER
K091106 06/17/2009 EQUIA GC AMERICA, INC. MARK HEISS
K090747 06/10/2009 MI FLOW (GCUC-450) GC AMERICA, INC. MARK HEISS
K091658 06/29/2009 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 GE HEALTHCARE ALAN TOTAH
K091673 06/24/2009 GE LIGHTSPEED ACT FP16 GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K090283 06/05/2009 CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 GENCHEM, INC. JAMES M HENNEMAN
K090565 06/30/2009 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K091151 06/01/2009 POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN GX CORPORATION SDN BHD FOO K PU
K090412 06/01/2009 POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). GX CORPORATION SDN BHD FOO KHON PU
K090468 06/15/2009 HAMILTON-C2 HAMILTON MEDICAL AG JOERG SCHNEIDER
K090910 06/30/2009 HANSO ACUPUNCTURE NEEDLE HANSOL MEDICAL CO. PETER CHUN
K091103 06/15/2009 GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K091368 06/04/2009 R2 DIGITALNOW HD(DIGITALNOW HD) HOLOGIC, INC. MICHAELA MAHL
K090132 06/09/2009 MAXMORESPINE SPINAL SYSTEM HOOGLAND SPINE PRODUCTS GMBH BORIS MIKLITZ
K091161 06/16/2009 REJUVENATE MONOLITHIC SIZE 4 HIP STEM HOWMEDICA OSTEONICS CORP ESTELA CELI
K083899 06/01/2009 REVLITE Q-SWITCHED ND:YAG LASER SYSTEM HOYA CONBIO, INC LIZA BURNS
K082883 06/16/2009 EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR I-SEE VISION TECHNOLOGY INC JENNIFER REICH
K082880 06/16/2009 EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS I-SEE VISION TECHNOLOGY INC JENNIFER REICH
K082879 06/16/2009 EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR I-SEE VISION TECHNOLOGY INC JENNIFER REICH
K082450 06/30/2009 IDR ICRCO INC. THOMAS CHANEY
K082196 06/16/2009 STATIC VESSEL ANALYZER IMEDOS GMBH HANS STROMEYER
K090958 06/18/2009 INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS LLC DAVID TRUEBLOOD
K090611 06/04/2009 REVOLUTION FULL CORE BIOPSY INRAD MELISSA LALOMIA
K090209 06/02/2009 HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K083520 06/23/2009 INTELEPACS, MODEL VERSION 3.X.X INTELERAD MEDICAL SYSTEMS INCORPORATED ANIBAL JODORCOVSKY
K091323 06/04/2009 MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) INTERMEDIC ARFRAN, S.A. ANNE WORDEN
K090767 06/11/2009 PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER INTERVENTIONAL SPINE, INC. CAROL EMERSON
K091001 06/29/2009 MYRIAN 1.4 INTRASENSE FREDERIC BANEGAS
K091020 06/12/2009 BLUEPHASE 20I IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K090704 06/17/2009 MULTILINK IMPLANT IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K091019 06/04/2009 SPEEDCEM IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K090422 06/17/2009 LUCAS 2 JOLIFE AB HOWARD M HOLSTEIN
K083753 06/19/2009 SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU K-JUMP HEALTH CO., LTD. JASON CHENG
K083256 06/26/2009 ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 K-JUMP HEALTH CO., LTD. JASON CHENG
K091253 06/04/2009 THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS K2M, INC. RICHARD W WOODS
K090273 06/05/2009 KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 KAI SENSORS, INC AMY DROITCOUR
K090786 06/18/2009 KENS INTERNAL FIXATION SYSTEM KENS FINEMEDTECH SDN. BHD LEOW K HOOI
K090397 06/05/2009 XPI ANGLED ABUTMENTS KEYSTONE DENTAL, INC. CAROLYN BITETTI
K082505 06/12/2009 KLS MARTIN ELECTROSURGICAL INSTRUMENTS KL MARTIN L.P. TOM FAUCETT
K083195 06/05/2009 MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN LANG DENTAL MFG. CO., INC. CHAH M SHEN
K090443 06/05/2009 PLANET 55, MODEL 100 LARSEN & TOUBRO LIMITED YOLANDA SMITH
K090172 06/05/2009 STAR 55 MODEL 100 LARSEN & TOUBRO LIMITED S.B. BHOSALE
K090507 06/25/2009 MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM LDR SPINE USA NOAH BARTSCH
K083580 06/22/2009 ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 LED INTELLECTUAL PROPERTIES, LLC ROBERT T WAGNER
K082367 06/12/2009 INFANT SLEEP BEANIE LIFE INNOVATIONS LLC JANE SCOTT
K090865 06/26/2009 LIFE SPINE FACET SCREW SPINAL SYSTEM LIFE SPINE MURALI AUDIPUDY
K090835 06/22/2009 CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR LINVATEC CORP. JOY LOVETT
K091549 06/23/2009 CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM LINVATEC CORP. JOHN CUSACK
K091667 06/25/2009 XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K091225 06/25/2009 VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET MAINE STANDARDS CO. HOLLY CRESSMAN
K083644 06/19/2009 MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP MAKO SURGICAL CORP. WILLIAM TAPIA
K090763 06/17/2009 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM MAKO SURGICAL CORPORATION WILLIAM F TAPIA
K090511 06/12/2009 QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K083275 06/09/2009 PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 MAX ENDOSCOPY INC. MICHAEL WOLF
K091518 06/18/2009 CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM MCUBE TECHNOLOGY CO., LTD. CHARLIE MACK
K091400 06/11/2009 MODIFICATION TO AVIE A1C TEST SYSTEM MEC DYNAMICS CORP EMMANUEL MPOCK
K091069 06/01/2009 MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K083862 06/05/2009 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM MEDAPPS, INC. KENT DICKS
K091466 06/17/2009 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 MEDCOMP SUSAN PILEGGI
K090721 06/16/2009 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 MEDTRONIC PETER LIU
K082166 06/02/2009 MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK MICHELLE OBENAUER
K083016 06/16/2009 ACTHYDERM MICROLAB AMERICAS INC E J SMITH
K091589 06/10/2009 MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K091641 06/30/2009 HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) MICROVENTION, INC. NAOMI GONG
K090891 06/22/2009 MICROPLEX COIL SYSTEM-COSMOS MICROVENTION, INC. NAOMI GONG
K091504 06/19/2009 MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 MICRUS ENDOVASCULAR CORPORATION TED RUPPEL
K090668 06/23/2009 VISION TOOLS MILLENSYS CHRISTINE NICHOLS
K083685 06/25/2009 ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 MRI MANUFACTURING AND RESEARCH, INC. SUZANNE DEW
K090426 06/12/2009 VAKU-8 BLOOD COLLECTION NEEDLES MYCO MEDICAL SUPPLIES, INC. SANJIV KUMAR
K080941 06/18/2009 BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM N.I. MEDICAL, LTD. JAMES COLLIE
K090034 06/02/2009 EASY ON-PC SPIROMETER NDD MEDIZITECHNIK AG JERRY MASIELLO
K090885 06/29/2009 NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER NEPHROS, INC. VIKKI M O'CONNOR
K091609 06/30/2009 NEWDEAL COMPRESSION PLATE NEWDEAL SAS JUDITH E O'GRADY
K083352 06/12/2009 VEINWAVE, TC3000 NEWLANDS CLINICAL TRIALS LTD WILLIAM GREENROSE
K090984 06/30/2009 INERTIA PEDICLE SCREW SYSTEM NEXXT SPINE LLC KAREN WARDEN
K090630 06/02/2009 NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) NOBEL BIOCARE AB HERBERT CRANE
K090807 06/30/2009 REGIONAL OXIMETER SYSTEM, MODEL 7600 NONIN MEDICAL, INC. LORI M ROTH
K091546 06/24/2009 NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 NORAS MRI PRODUCTS GMBH ZAHED SEDIGHIANI
K090546 06/08/2009 MODIFICATION TO NORDICICE SOFTWARE NORDICIMAGINGLAB AS CHANDANA G BHANDARI
K083583 06/30/2009 XPRESSE INJECTION SYSTEM NORDSON EFD JEFF PEMBROKE
K080365 06/29/2009 MORCE POWER PLUS AND VARIOCARVE MORCELLATOR NOUVAG AG ERICH FORSTER
K091484 06/15/2009 NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GALSSER
K091598 06/29/2009 LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS NUCLETRON CORP. ELAINA COLBY
K090706 06/15/2009 ONCENTRA SIMULATION 2.3 NUCLETRON CORPORATION ELAINE COLBY
K090298 06/08/2009 NUVASIVE NEURO VISION SYSTEM NUVASIVE, INC. HAN FAN
K090206 06/02/2009 OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER OCULUS INNOVATIVE SCIENCES, INC. ANTOINETTE DOUGLAS
K090938 06/04/2009 FLOW CONTROLLER ODYSSEY MEDICAL, INC. TERRY R GREEN
K090980 06/29/2009 HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L OLYMPUS WINTER & IBE GMBH STACY A KUESNER
K091602 06/18/2009 MUCHECK V8 ONCOLOGY DATA SYSTEMS, INC. VINCE RUMINER
K090289 06/15/2009 CLAVICLE PLATING SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K080108 06/05/2009 CORTOSS BONE AUGMENTATION MATERIAL ORTHOVITA, INC. GINA M NAGVAJARA
K090114 06/04/2009 MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S OSCOR INC. MILA DOSKOCIL
K083057 06/02/2009 I-MAX TOUCH OWANDY CLAUDE D BERTHOIN
K090525 06/01/2009 LOI SYSTEM PALOMAR MEDICAL PRODUCTS, INC. SHARON TIMBERLAKE
K090099 06/19/2009 DSS STABILIZATION SYSTEM PARADIGM SPINE, LLC JUSTIN EGGLETON
K090923 06/30/2009 PARCUS GRAFT FIXATION SYSTEM PARCUS MEDICAL, LLC BARTON BRACY
K083616 06/12/2009 PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS PATHOLASE, INC ANNE WORDEN
K091509 06/19/2009 JETSTREAM G2 NXT SYSTEM, MODEL PV20300 PATHWAY MEDICAL TECHNOLOGIES, INC. BRIT BAIRD
K091478 06/18/2009 TREVAIR CHAIR PATMONT MOTOR WERKS, INC. STEVEN J PATMONT
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K090399 06/10/2009 TRIOS SYSTEM VIORA LTD. JOSEF LUZON
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K091243 06/26/2009 ORTHOLOC ANKLE PLATING SYSTEM (APS) WRIGHT MEDICAL TECHNOLOGY, INC. SARAH HOLTGREWE
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K090198 06/23/2009 JIAJIAN SELF-ADHESIVE ELECTRODE WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. DORIS DONG
K091669 06/18/2009 OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III XIOAO MDT TECHNOLOGY CO LTD DIANA HONG
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