FDA 510(k) Decisions During June, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K100631 06/22/2010 AFFIITY CP CENTRIFUGAL BLOOD PUMP MEDTRONIC INC. SUE FIDLER
K100756 06/02/2010 MALTA 3M ESPE AG DENTAL PRODUCTS DESI SOEGIARTO
K100908 06/22/2010 UNICEM HM 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K092638 06/15/2010 FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 ABBOTT DIABETES CARE INC. ARUL STERLIN
K101116 06/23/2010 HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH ABBOTT VASCULAR-CARDIAC THERAPIES KAY SETZER
K100623 06/09/2010 AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS LISA M BOYLE
K091859 06/03/2010 AESKU PR3 AESKU.DIAGNOSTICS SASCHA PFEIFFER
K091327 06/25/2010 ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES ALDEN OPTICAL LABS., INC. CHARLES CREIGHTON
K100001 06/25/2010 MOBIVISION ALMANA MEDICAL IMAGING DANIEL KAMM, P.E.
K100685 06/18/2010 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K100129 06/11/2010 AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X AMBU A/S SANJAY PARIKH
K100746 06/11/2010 FIBER ONE AMERICAN MEDICAL SYSTEMS DARLENE CROCKETT-BILLIG
K100807 06/07/2010 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 AMERICAN MEDICAL SYSTEMS, INC. DONNA SEMLAK
K100940 06/29/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 ANDON HEALTH CO.,LTD LIU YI
K101017 06/17/2010 ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS ANGIODYNAMICS, INC. S. MICHAEL SHARP
K082102 06/14/2010 GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 APOLLO ENDOSURGERY, INC. DENNIS MCWILLIAMS
K092938 06/18/2010 HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 APP PHARMACEUTICALS, LLC ARTHUR WARD
K093819 06/09/2010 ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) ARKRAY FACTORY USA, INC. TOM SPEIKERS
K100652 06/23/2010 ACL TIGHTROPE ARTHREX, INC. GEENA AUGUSTINE
K101448 06/21/2010 OPUS SPEEDSCREW SYSTEM ARTHROCARE CORP. LAURA N KASPEROWICZ
K100176 06/16/2010 ASCENSION ANKLE FUSION PLATE SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K092233 06/25/2010 SURGIMESH XD ASPIDE MEDICAL HOWARD M HOLSTEIN
K093679 06/10/2010 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 ATRICURE, INC. JAMES LUCKY
K100501 06/18/2010 MULTIFUNCTIONAL LINEAR PEN ATRICURE, INC. JAMES LUCKY
K094056 06/03/2010 HOTDOG MULTI FUNCTION CONTROLLER AUGUSTINE BIOMEDICAL & DESIGN, LLC JAMES ECKLEIN
K093197 06/23/2010 CORONIS FUSION 10MP, MODEL MDCG-10130 BARCO NV LIEVEN DE WANDEL
K101111 06/18/2010 HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 BARRX MEDICAL INC VIORICA FILIMON
K101385 06/22/2010 DUAL LUER LOCK CAP, MODEL 2C6250 BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K101529 06/14/2010 BD DIRECTIGEN EZ FLU A+B ASSAY BECTON DICKINSON & CO. GREGORY P PAYNE
K101502 06/29/2010 BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 BECTON DICKINSON & CO. MARY ANNE ALSBERGE
K100775 06/03/2010 BD INTIMA II CLOSED IV CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K101461 06/24/2010 BD DIRECTIGEN EX FLU A+B BECTON, DICKINSON AND COMPANY GREGORY PAYNE
K091912 06/23/2010 B-GENIN AND R-GENIN BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K093630 06/03/2010 BIODENTA DENTAL IMPLANT SYSTEM BIODENTA SWISS AG DAVID EILER
K101481 06/23/2010 BIOMERS TRANSLUCENT ORTHODONTIC BRACKET BIOMERS PRODUCTS, LLC GEORGE ALIPHTIRAS
K101475 06/18/2010 COMPRESS ANTI-ROTATION SPINDLES BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K100409 06/23/2010 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY MS, RAC
K101063 06/23/2010 SLEEVE WITH ZIPLOOP FIXATION DEVICES BIOMET SPORTS MEDICINE ROBERT FRIDDLE
K092052 06/18/2010 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K101030 06/03/2010 MODIFICATION TO HBS HEADLESS BONE SCREW BIOPRO, INC. DAVID MRAK
K091928 06/16/2010 10 X 10 VISION BIOPTICS, INC. AKIF BAYSAL
K093566 06/18/2010 CARTO XP EP NAVIGATION SYSTEM, VERSION 10 BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K093376 06/18/2010 LASSO NAV CATHETER BIOSENSE WEBSTER, INC. WAYNE HOHMAN
K101138 06/22/2010 SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 BIOSENSE WEBSTER, INC. MELISSA C SCHULTZ, RAC, MMS
K101345 06/22/2010 WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, BIOSENSE WEBSTER, INC. BALAKA DAS
K092987 06/11/2010 INRATIO/INRATIO2 TEST STRIPS BIOSITE INCORPORATED KARIN A HUGES
K100885 06/07/2010 FETAL MONITOR MODEL: BT-200T BISTOS CO., LTD. YOUNG CHI
K100929 06/16/2010 UNIMOM ALLEGRO BLUE EGG CO HONG J HYUN
K093078 06/23/2010 UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K093118 06/11/2010 BRAINLAB KNEE ARTHROSCOPY BRAINLAB AG RAINER BIRKENBACH
K101431 06/25/2010 ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS C.R. BARD, INC. JONI CREAL
K100947 06/28/2010 FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 CALIBRA MEDICAL, INC. RICHARD J MEADER
K101639 06/25/2010 CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. CLAY ANSELMO
K093211 06/03/2010 CARECENTER MD CARDIAC SCIENCE CORPORATION THERESA MYERS
K101018 06/25/2010 CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 CARDICA, INC. MATTHEW E CHROUST
K092915 06/23/2010 CEDARA WEBACCESS, MODEL: 2.4 CEDARA SOFTWARE CORP. CAROL NAKAGAWA
K092917 06/24/2010 STERN'S S250 NORDAM CEFLA S.C. BERTHOIN CLAUDE
K101564 06/22/2010 CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
K100822 06/01/2010 XPERT MRSA/SA NASAL ASSAY CEPHEID RUSSEL K ENNS
K093931 06/10/2010 BLOOD PRESSURE METER, MODEL CH-4532 CITIZEN SYSTEMS JAPAN CO., LTD. NATHAN A BEAVER
K094022 06/11/2010 THE WATER LILY CLEARWATER PRODUCTS, LLC E.J. SMITH
K093351 06/16/2010 COLLAWOUND ART COLLAMATRIX, INC DENNIS J.N. SEAH
K093320 06/18/2010 DRYODINE CADEXOMER-IODINE GEL COLLEGIUM PHARMACEUTICAL INCORPORATED MARK W TRUMBORE
K101297 06/03/2010 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 COLOPLAST A/S ANGELA BYLAND
K100542 06/24/2010 CONSENSUS REVISION KNEE SYSTEM CONSENSUS ORTHOPEDICS, INC LUKE ROSE
K101127 06/11/2010 PATIENT MONITOR, MODEL PM50 CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K093619 06/17/2010 EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E COOK IRELAND LTD JACINTA KILMARTIN
K101131 06/17/2010 FIDUCIAL MARKERS COSMAN MEDICAL, INC. LOUIS FALCONE
K093196 06/25/2010 BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 COUSIN BIOTECH S.A.S. FRANCK PELLETIER
K100045 06/25/2010 OCTO DALIM SURGNET CORPORATION PETER CHUNG
K100638 06/18/2010 VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K101421 06/15/2010 MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K101523 06/17/2010 CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. RUTH WU
K093357 06/24/2010 DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K101612 06/30/2010 ZEN CORDLESS PROPHY SYSTEM DISCUS DENTAL, LLC WINKIE WONG
K100438 06/23/2010 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM EBI, L.P. VIVIAN KELLY
K101080 06/21/2010 NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN HARALD JUNG
K100425 06/17/2010 HASKAL TORQUE DEVICE ELCAM MEDICAL A.C.A.L. SHAY SHAHAM
K100902 06/24/2010 AEDIS(TM) EMBED TECHNOLOGY LLC HOWARD STAMER
K100711 06/09/2010 SUCTION IRRIGATION ELECTRODES AND ADAPTERS ENCISION, INC. JUDITH V KING
K100900 06/18/2010 MOTIVATION KNEE SYSTEM ENCORE MEDICAL, L.P. ELIZABETH ONDERLINDE
K101333 06/14/2010 CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. DEVONNE PAVLAK
K093297 06/09/2010 EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE EPOCAL, INC. ROY LAYER
K101430 06/22/2010 MLS-AC DERMA SCANNER ERCHONIA CORPORATION KEVIN WALLS
K100509 06/08/2010 THL1 LASER ERCHONIA CORPORATION KEVIN WALLS
K100931 06/25/2010 MYLABTWICE, MODEL 6200 ESAOTE, S.P.A. ALLISON SCOTT
K093340 06/11/2010 PASR/QUIETNITE EXACT SUPPLIES LTD. JONATHAN PARKINSON
K100333 06/21/2010 FIAB SPA, MODELS F7244, F7233, F7234, F7277 FIAB SPA FRANCESCO BATISTINI
K101277 06/04/2010 ORION II (HEAVY DUTY 350 LBS AND 500 LBS) FUTURE MOBILITY HEALTHCARE INC. ABDULSAMAD PANCHBHAYA
K101492 06/23/2010 8 CHANNEL CARDIAC PHASED ARRAY COIL GE HEALTHCARE COILS (USA INSTRUMENTS INC.) MICHAEL S PRETO
K092992 06/29/2010 A4-XLR8 FOAM DRESSING GENADYNE BIOTECHNOLOGIES, INC. E.J. SMITH
K101440 06/18/2010 GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 GENERIC MEDICAL DEVICES, INC. JEFF MORGAN
K092667 06/03/2010 GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT GENX INTL., INC. MICHAEL D CECCHI
K100563 06/02/2010 GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA GEON CORPORATION JENNIFER REICH
K101344 06/28/2010 G+ SYSTEM GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) WILLIAM MATTHEWS
K100896 06/17/2010 GYRUS ACMI HALO PKS CUTTING FORCEPS GYRUS ACMI, INC. LORRAINE CALZETTA
K094009 06/14/2010 HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI HALT MEDICAL INC RUSS DELONZOR
K090803 06/30/2010 HANSON MEDICAL FACIAL IMPLANTS HANSON MEDICAL, INC. GERALD HANSON
K101002 06/08/2010 A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K101362 06/17/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K093729 06/08/2010 GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I HEMCON MEDICAL TECHNOLOGIES EUROPE LTD KEVIN HAWKINS
K093466 06/17/2010 HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGH THISTLETHWAITE
K101242 06/11/2010 GENESIS DM MODEL: 6053000A1 HONEYWELL HOMMED, LLC EMILY HEI
K101137 06/22/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVE HONGZE PLASTIC TECHNOLOGY CO., LTD KATHY LIU
K101438 06/17/2010 T2 GREATER TROCHANTER NAIL HOWMEDICA OSTEONICS CORP MELISSA MATARESE
K100884 06/25/2010 STRYKER KNIFELIGHT HOWMEDICA OSTEONICS CORP. AVITAL MERL-MARGULIES
K101713 06/29/2010 LIPCOLLECTOR II HUMAN MED AG INGE MATTHIESEN
K100989 06/25/2010 ZURA TEE SYSTEM WITH CLARITEE PROBE IMACOR INC. RICHARD LANZILLOTTO
K091849 06/25/2010 IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET IMMUNODIAGNOSTIC SYSTEMS, INC. KEN GIBBS
K100233 06/14/2010 SUDOSCAN IMPETO MEDICAL KYE CHEUNG
K093993 06/30/2010 LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 INFRAREDX, INC. STEVEN J CHARTIER
K093623 06/18/2010 GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K101178 06/29/2010 MODIFICATION TO INTEL HEALTH GUIDE PHS6000 INTEL CORP. MAUREEN GLYNN
K100773 06/23/2010 KAI SPOT MODEL KMS 200 KAI MEDICAL, INC. ROBERT NAKATA
K100821 06/11/2010 PREVENA INCISION MANAGEMENT SYSTEM KCI USA, INC. MARGARET MARSH
K093810 06/18/2010 BF-NAVI KGT INC. RICHARD VINCINS
K092194 06/16/2010 POLYBONE DENTAL KYUNGWON MEDICAL CO., LTD. JOYCE BANG
K100373 06/30/2010 TYCHE PEDICLE SCREW SYSTEM KYUNGWON MEDICAL CO., LTD. JOYCE BANG
K093193 06/08/2010 LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) LA GLOVE (M) SDN. BHD. G BASKARAN
K100429 06/11/2010 URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER LABORATOIRES URGO SOPHIE FORTIN
K100430 06/11/2010 URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER LABORATOIRES URGO SOPHIE FORTIN
K093335 06/18/2010 LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) LAGLOVE (M) SDN. BHD. G BASKARAN
K101320 06/24/2010 VASOVAPOR LEXION MEDICAL, LLC. BERNARD HORWATH
K092985 06/28/2010 BELLECUP LIBRETTE, INC NEAL KOLBER
K093662 06/24/2010 ECHOBRIGHT LIFE-TECH, INC. JEFF KASOFF
K093537 06/04/2010 HANAROSTENT ESOPHAGUS (CCC) M.I. TECH CO., LTD. BRANDON CHOI
K092781 06/23/2010 MAM TWISTER MAM INTERNATIONAL AG MICHAEL TEDESCO
K101274 06/11/2010 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM MAQUET CARDIOVASCULAR, LLC MARK H SMITH
K101399 06/17/2010 COAXIAL INTRODUCER SET MARTECH MEDICAL PRODUCTS SUSAN PILEGGI
K100403 06/23/2010 MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 MASIMO CORPORATION MARGUERITE THOMLINSON
K100366 06/14/2010 MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY MAXTER CATHETERS M. BERNARD DAURELLE
K100217 06/08/2010 LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 MEDIANA CO., LTD. CHARLIE MACK
K100388 06/22/2010 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS MEDICAL ILLUMINATION INTERNATIONAL, INC. WAYNE GEROW
K101406 06/16/2010 ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 MEDRAD INTERVENTIONAL/POSSIS DOUG ATKINS
K100798 06/23/2010 MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C MEDRAD, INC. SUSAN LYNN FELIX
K092564 06/17/2010 O-ARM IMAGING SYSTEM MEDTRONIC NAVIGATION, INC. (LITTLETON) SETH KUZDZAL
K100175 06/02/2010 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK JUSTINE VIERA
K100214 06/25/2010 CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK LEE GRANT
K094042 06/30/2010 PEEK PREVAIL CERVICAL INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK JUSTINE VIERA
K101074 06/22/2010 MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SARAH FAIRFIELD
K093104 06/25/2010 MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM MEDYSSEY CO., LTD. PATRICK D MOORE
K101546 06/23/2010 ENDOFORM DENTAL TEMPLATE MESYNTHES LTD MARY MCNAMARA
K100754 06/09/2010 GRAFT DELIVERY SYSTEM MODEL SA-6115 MICROMEDICS, INC. THOMAS A LOPAC
K101013 06/07/2010 MODIFICATION TO SCINTRON IV MIE GMBH NORMAN VON HOLLEN
K100905 06/02/2010 HYDROFIX SURGICAL SHEET MIMEDX GROUP, INC LOUISE FOCHT
K090608 06/14/2010 MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) MINTA MEDICAL LIMITED ANDREW EDWARDS
K101228 06/23/2010 MIRADA XD MIRADA MEDICAL LTD. GWILYM OWEN
K101115 06/18/2010 ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 MORTARA INSTRUMENT, INC CHARLES MORREALE
K100447 06/25/2010 MYOSCIENCE CRYO-TOUCH MYOSCIENCE INC TRACEY HENRY
K100497 06/21/2010 QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) N.M.B. MEDICAL APPLICATIONS, LTD. HILA WACHSLER-AVRAHAMI
K093949 06/16/2010 OLYMPIC BRAINZ MONITOR MODEL OBM70001 NATUS MEDICAL, INC. GOLDY SINGH
K100665 06/24/2010 MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX NEEDLETECH PRODUCTS, INC. RICK TRIPP
K092107 06/15/2010 VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 NIDACON INTERNATIONAL AB DANIEL KAMM
K093102 06/03/2010 AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K093643 06/24/2010 MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS NOBELBIOCARE AB HERBERT CRANE
K093853 06/04/2010 SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES NONIN MEDICAL, INC. LORI ROTH
K093109 06/18/2010 NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3") 32 G TIP * 5 MM(1/5') NOVO NORDISK INC. CINDY CAO
K100043 06/16/2010 COROENT XLR STANDALONE SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K093319 06/23/2010 NUVASIVE VUEPOINT OCT SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K093951 06/15/2010 OUCHLESS MODEL PN10114 OCCAM DESIGN VAS ABRAMOV
K093395 06/17/2010 OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K101451 06/22/2010 APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD OMNI LIFE SCIENCE, INC. RADHIKA PONDICHERRY
K101575 06/30/2010 APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 OMNLIFE SCIENCE RADHIKA PONDICHERRY
K100861 06/17/2010 R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 OPTOVUE, INC. AZIMUN JAMAL
K093442 06/10/2010 GUIDED GROWTH SYSTEM ORTHOFIX INC. MARY BIGGERS
K100833 06/03/2010 SYLE SMARTIP OSSPRAY LTD DAVID GREENSPAN
K100815 06/16/2010 OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 OXYPULSE JAMES A DUNNING
K093975 06/04/2010 SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 PAN GLOBAL IMPLANT HAROLD BERGMAN
K092983 06/07/2010 PANPAC HSG CATHETER SET PANPAC MEDICAL CORPORATION YEN-MING PAN
K101044 06/10/2010 RETRIEVE IMPLANT CEMENT PARKELL, INC. DANIEL R SCHECHTER
K100546 06/03/2010 PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE PARKERMEDICALINC LEWIS WARD
K101334 06/11/2010 JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON PATHWAY MEDICAL TECHNOLOGIES, INC. CYNDY ADAMS
K101221 06/02/2010 JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K092967 06/08/2010 PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE PATHWORK DIAGNOSTICS ANNA LONGWELL
K100101 06/11/2010 GSP NEONATALGALT KIT, MODEL 3303-001U PERKINELMER, INC. KAY TAYLOR
K091845 06/07/2010 CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM PHADIA US INC. MARTIN ROBERT MANN
K100099 06/14/2010 ORAL/ENTERAL SYRINGES PHILIPS CHILDREN'S MEDICAL VENTURES LISA CASAVANT
K100495 06/22/2010 PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 PHILIPS ELECTRONICS UK LIMITED MIRIAM SHARIF-MURRAY
K101449 06/18/2010 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN ANDREAS SUCHI
K100708 06/04/2010 PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES PIONEER SURGICAL TECHNOLOGY EMILY M DOWNS
K092731 06/10/2010 VIBRO-TRAC PNEUMEX, INC. JEAN ASQUITH
K101218 06/17/2010 PATCHASSIST POLYTOUCH MEDICAL LTD LEO BASTA
K091807 06/28/2010 MEDPOR FIXATION SYSTEM POREX SURGICAL, INC. JERRI MANN
K100545 06/04/2010 SLEEPRIGHT POWER PRODUCTS, INC.-SPLINTEK MELAINE HASEK
K101262 06/10/2010 FLEXI-LITE PRESSURE-TECH, INC. MARIA GRIFFIN
K100539 06/17/2010 PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE PREVENTIVE TECHNOLOGIES, INC. KENNETH S PETERSON
K100781 06/21/2010 OBSIDIAN CERAMIC BLOCKS PRISMATIK DENTALCRAFT, INC. KEITH ALLRED
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