FDA 510(k) Decisions During August, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K101339 08/31/2010 ARCHER SUPER STIFF GUIDEWIRES MEDTRONIC INC. COLLEEN MULLINS
K093828 08/12/2010 KYPH X HV-R BONE CEMENT MEDTRONIC INC. MARY ROSE
K101212 08/07/2010 MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R MEDTRONIC INC. BECKY HANNACK
K101226 08/31/2010 AUDIT MICROCV RF/CRP LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K093604 08/25/2010 ETEST MOXIFLOXACIN 0.002-32 UG/ML AB BIOMERIEUX ASA KARLSSON
K101038 08/17/2010 RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER ACCELETRONICS DIGITAL IMAGING, LLC. STEVE SCHWARZ
K101150 08/13/2010 PICC WAND PEELABLE SAFETY INTRODUCER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K093879 08/06/2010 MISSION SALIVA ALCOHOL TEST STRIP ACON LABORATORIES, INC. RICHARD LENART
K101717 08/20/2010 DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING AEROBINE, INC YONG W KIM
K091692 08/12/2010 AESCULAP PEEK CRANIOFIX AESCULAP, INC. LISA M BOYLE
K102081 08/06/2010 ENDOSCOPIC CLIP SYSTEM AESCULAP, INC. DENISE ADAMS
K101937 08/11/2010 HYBRID TROCAR SYSTEM AESCULAP, INC. DENISE ADAMS
K101289 08/03/2010 SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB AIR TECHNIQUES, INC. PABLO MARTINEZ
K093821 08/27/2010 FS ALIGNER ALLESEE ORTHODONTIC APPLIANCES WENDY GARMAN
K101561 08/27/2010 TX1 TISSUE REMOVAL SYSTEM AMERICAN OPTISURGICAL, INC. DAVID SALZBERG
K101950 08/31/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 ANDON HEALTH CO.,LTD LIU YI
K102037 08/13/2010 AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K094043 08/17/2010 LIGAMENTOTAXOR AREX USA ELLEN HOKANSON
K093999 08/10/2010 ARP POV SPORT ARP MANUFACTURING, INC LEWIS WARD
K100635 08/27/2010 ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 ARROW INTL., INC. TRACY MADDOCK
K100448 08/30/2010 ASCENSION MODULAR TOTAL SHOULDER SYSTEM ASCENSION ORTHOPEDICS, INC. STANLEY J HARRIS
K100502 08/02/2010 ASCENSION TOTAL PLATE SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K101004 08/16/2010 ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K100743 08/10/2010 ATLAS SPINE PIVOTING SYSTEM ATLAS SPINE INC. JEANNETTE G DAILEY
K101647 08/06/2010 WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 AVINGER, INC. HIMANSHU PATEL
K102022 08/06/2010 WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S AVINGER, INC. HIMANSHU PATEL
K101325 08/17/2010 STELLARIS PC VISION ENHANCEMENT SYSTEM BAUSCH & LOMB, INC. NED LUCE
K101372 08/10/2010 DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K092767 08/20/2010 BBL CHROMAGAR MRSA II BECTON DICKINSON & CO. PAUL SWIFT
K100622 08/27/2010 BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 BELIMED SAUTER AG HANS STADLER
K101122 08/09/2010 BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS BENZ RESEARCH AND DEVELOPMENT CORP. GIOVANNY ESPINOSA
K101595 08/06/2010 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE BETTER CARE PLASTIC TECHNOLOGY CP., LTD JIE LIU
K100556 08/02/2010 SLENDERTONE FLEX MAX, MODEL 517 US BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K093954 08/24/2010 BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES JUANG WANG
K091303 08/02/2010 LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV BIO-RAD LABORATORIES SUZANNE S PARSONS
K101658 08/11/2010 WATERLASE MD TURBO PLUS MODEL 7200XXX BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K101485 08/26/2010 ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E BISCO, INC. MICHELLE SCHULTZ- TAING
K101875 08/23/2010 BK BLANK MODEL 20,40,65,90 BK MEDENT CO., LTD. PRISCILLA CHUNG
K102082 08/23/2010 EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 BOSTON SCIENTIFIC CORP. LAURIE PANNELLA
K100843 08/17/2010 ABREU, MODEL 700 BRAIN TUNNELGENIX TECHNOLOGIES CORP DANIEL KAMM
K101591 08/06/2010 STINGRAY ORIENTING BALLOON CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K100786 08/13/2010 MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX BSD MEDICAL CORP. DIXIE TOOLSON SELLS
K093920 08/06/2010 BUSSE EPIDURAL CATHETER KIT BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K101462 08/16/2010 ASCEND BLUE AC MESH; ASCEND BLUE PC MESH CALDERA MEDICAL, INC. VICKI GAIL
K093725 08/30/2010 CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C CANADA ENDOSCOPE CORPORATION ROGER LECLERC
K102012 08/17/2010 DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K100143 08/13/2010 PILOT DIODE LASER, MODEL 002-00139 CAO GROUP, INC. ROBERT LARSEN
K101452 08/09/2010 CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW CAPINTEC, INC. MARY ANNE DELL
K100055 08/30/2010 BLOOD PRESSURE METER, MODEL CH-609 CITIZEN SYSTEMS JAPAN CO., LTD. NATHAN A BEAVER
K101361 08/04/2010 REEFLEX PTA CATHETER CLEARSTREAM TECHNOLOGIES, LTD. FIONA N MHULLAIN
K100156 08/11/2010 COLLAGEN DENTAL MEMBRANE V COLLAGEN MATRIX, INC. PEGGY HANSEN
K102025 08/11/2010 COMBAT READY CLAMP COMBAT MEDICAL SYSTEMS, LLC CALLEY HERZOG
K101915 08/06/2010 VASOPRESS SUPREME MINI MODEL VP500DM COMPRESSION THERAPY CONCEPTS, INC. LEONARD NASS
K101198 08/04/2010 CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K COMPUTERIZED SCREENING, INC. SAM KUMAR
K101100 08/26/2010 CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 CONMED LINVATEC JOHN CUSACK
K100879 08/04/2010 CONTRALCO CONTRALCO CAMILLE D THORNTON
K101728 08/25/2010 FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE COOK, INC. SEAN WERNER
K101877 08/06/2010 OCCLUSION BALLOON CATHETER MODEL OBC COOK, INC. LISA WEBB
K100841 08/19/2010 BONEOPTIMIZER CURASAN AG CYNTHIA J.M. NOLTE, PH.D.
K102169 08/30/2010 CYBERWAND LITHOTRIPTER CYBERSONICS, INC. JEFF VAITEKUNAS
K101719 08/25/2010 TACAMO MANUAL WHEELCHAIR DALTON INSTRUMENT CORP. MEI LEIN
K101493 08/19/2010 ADVANCED GLASS IONOMER (K-130) RESTORATIVE DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K091310 08/11/2010 ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 DFINE, INC. SANDEEP SABOO
K092937 08/02/2010 STA-HYBRID HEP CALIBRATOR DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K092029 08/06/2010 VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K100749 08/31/2010 FREQUENCER MODEL V2X DYMEDSO INC. JEAN BIGONEY
K091090 08/09/2010 DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 E-WOO TECHNOLOGY VINCENT LEE
K100376 08/06/2010 EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 EARLYSENSE LTD. DALIA ARGAMAN
K101960 08/10/2010 SONOTRAX SERIES ULTRASONIC POCKET DOPPLER EDAN INSTRUMENTS, INC. YUE QIUHONG
K100988 08/17/2010 HUMAPEN LUXURA HD ELI LILLY AND COMPANY STEVEN T JOHNSON PE, MBA
K100390 08/25/2010 SURGIMAX/ SURGIMAX PLUS ELLIQUENCE LLC JOSEPH AZARY
K101967 08/12/2010 NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' ELLMAN INT'L INC. JONATHAN ACHENBACH
K093622 08/20/2010 AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 ENCISION, INC. JUDITH V KING
K100741 08/02/2010 REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K101298 08/05/2010 ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS ENDOCHOICE, INC. THERON GOBER
K092991 08/13/2010 O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) ENVIRONMENTAL TECTONICS CORP. GENE DAVIS
DEN090008 08/24/2010 ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL Kevin Walls
K082609 08/24/2010 ERCHONIA ML SCANNER (MLS) ERCHONIA MEDICAL KEVIN WALLS
K101605 08/31/2010 MYLABONE ULTRASOUND SYSTEM ESAOTE EUROPE B.V. ALLISON SCOTT
K101272 08/20/2010 MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 ESSEX INDUSTRIES, INC. KEN SEISE
K101909 08/02/2010 EXACTECH EQUINOXE, PLATFORM FRACTURE STEM EXACTECH, INC. GRAHAM L CUTHBERT
K101981 08/02/2010 OPTETRAK LOGIC COMBINATION TIBIAL TRAY EXACTECH, INC. PATRICK HUGHES
K102167 08/17/2010 LO-50 LED LIGHT SOURCE FIBEROPTICS TECHNOLOGY, INC. ALLAN GUILLOTTE
K100753 08/20/2010 FLIGHT 60 VENTILATOR, MODEL F-60 FLIGHT MEDICAL LTD. SHOSHANA FRIEDMAN
K101152 08/18/2010 NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 FOCUS MEDICAL, LLC. JOHN LEE
K102149 08/13/2010 GAUNYING INFRARED LAMP FOSHAN GAUNYING ELECTRONICS CO., LTD. LADI LEE
K101387 08/03/2010 DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN FUDAKANG INDUSTRIES CO., LTD STEPHEN LING
K101878 08/31/2010 GE LOGIQ P5 MODEL H44662LD GE HEALTHCARE BRYAN BEHN
K102113 08/12/2010 GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD. YALAN WU
K102155 08/31/2010 MR RADIATION ONCOLOGY OPTIONS GE MEDICAL SYSTEMS, LLC TRACEY FOX
K093175 08/25/2010 WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES GUANGZHOU WONDFO BIOTECH CO., LTD. HOWARD MANN
K100551 08/12/2010 ORLOCATE SYSTEM MODEL ORL 100 HALDOR ADVANCED TECHNOLOGIES LTD SARIT GELBART GAL-ROM
K100389 08/12/2010 HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT HANDPIECE HEADQUARTERS TINA STEFFAINE-OAK
K101329 08/19/2010 SYNERGY CT PICC HEALTH LINE INTERNATIONAL CORPORATION NOLA BENSTOG
K101358 08/24/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K100963 08/06/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT CHU XIAOAN
K101892 08/27/2010 HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- HEINE OPTOTECHNIK GMBH & CO. KG. THOMAS WEBER
K093079 08/02/2010 TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U HOBBS MEDICAL, INC. EMILY MADSEN
K101677 08/11/2010 HOSPIRA INFUSION BLOOD SETS HOSPIRA, INC. KAREN KEENER
K101029 08/16/2010 KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH HUGE DENTAL MATERIAL CO., LTD. JING LI
K092892 08/03/2010 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 I-MING SANITARY MATERIALS CO., LTD. SARA HOU
K093868 08/05/2010 I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K091529 08/04/2010 ICAD VERALOOK CTC CAD SOFTWARE ICAD, INC. JOHN A DELUCIA
K101052 08/11/2010 OMNI III PATIENT MONITOR INFINIUM MEDICAL JOHN OBRIEN
K093204 08/23/2010 INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM INNOVATIVE MED, INC. JEFFREY KOLSTER
K093783 08/23/2010 INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT INNOVIA, LLC BRUCE WEBER
K100518 08/31/2010 INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K102127 08/27/2010 ENDOTRACHEAL TUBE CHANGERS INSTRUMENTATION INDUSTRIES, INC. DORIS WALTER
K100846 08/16/2010 IMC SURGICAL FACE MASK INTERNATIONAL MEDSURG CONNECTION PETER KIM
K101279 08/04/2010 CORRIDOR4DM V2010 MODEL: V2010 INVIA DAVID ROTHKOPF
K101359 08/20/2010 INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K101508 08/06/2010 MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K091539 08/31/2010 IQ 200 URINE ANALIZER BODY FLUIDS MODULE IRIS DIAGNOSTICS WILLIAM M DOUGHERTY
K100975 08/17/2010 NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K100978 08/12/2010 POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K100977 08/12/2010 PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K101207 08/02/2010 NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S KEVIN A THOMAS
K100098 08/13/2010 PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE JM SYSTEM CO., LTD. KEVIN WALLS, RAC
K100851 08/02/2010 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K101747 08/04/2010 BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE KAZ USA, INC (A SUBSIDIARYOF KAZ INC) RAJ KASBEKAR
K101660 08/11/2010 ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 KEPLER MEDTEC F. DAVID ROTHKOPF
K100912 08/19/2010 DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K102014 08/31/2010 TENS STIMULATOR, MODELS 2800 AND 3000 KOALATY PRODUCTS, INC. KANG JIANG PING
K093043 08/20/2010 ZIRCONIA SYRINGE NEEDLE KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD CHAO-SHENT CHAO
K101364 08/16/2010 LANX FACET SCREW SYSTEM LANX, INC. MICHAEL FUNK
K100935 08/06/2010 LANX SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K101645 08/26/2010 NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF LATEXX MANUFACTURING SDN.BHD. TERENCE LIM SIN KOOI
K102129 08/27/2010 LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR LEVITRONIX LLC. FARZAD PARSAIE
K101691 08/10/2010 LIFELINES PHOTIC STIMULATOR LIFELINES LTD. E. J AMITH
K101098 08/17/2010 REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 LIL DRUG STORE PRODUCTS, INC. PATRICIA MILLER
K101241 08/17/2010 REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) LIL DRUG STORE PRODUCTS, INC. PATRICIA L MILLER
K091047 08/18/2010 NEONATE ARRAY COILS LMT MEDICAL SYSTEMS GMBH KRISTINA LUETJE
K093420 08/26/2010 XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K101199 08/27/2010 GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, MAQUET CRITICAL CARE AB WHITNEY TORNING
K101503 08/04/2010 DUSIMETRY CHECK MATH RESOLUTIONS, LLC. WENDEL D RENNER
K102130 08/26/2010 TENZING SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K093753 08/26/2010 MDPO FRAME SYSTEM MDPO, LLC MARIE MARLOW
K101832 08/27/2010 BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. TRUDY D ESTRIDGE
K101134 08/09/2010 VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 MEDICEL AG JOHN COGGAN
K102065 08/06/2010 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. PARK KYEONG-MI
K101070 08/31/2010 EXPEDIUM SPINE SYSTEM MEDOS INTERNATIONAL SARL DAPHNEY GERMAIN
K100693 08/10/2010 AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING MEDTRADE PRODUCTS LIMITED JONATHAN D RANFIELD
K101168 08/24/2010 LEGEND POWER ADAPTER MODEL: 6475000 MEDTRONIC SOFAMOR DANEK THERESA LEISTER
K100763 08/27/2010 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K094021 08/06/2010 ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I MICROSULIS MEDICAL LIMITED DENISE REXHAUS
K101542 08/06/2010 HEADWAY 17 ADVANCED MICROCATHETER MICROVENTION, INC. NAOMI GONG
K101330 08/27/2010 MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE MIDWEST REPROCESSING CENTER LLC JEROME JAMES
K101702 08/27/2010 MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS MIDWEST REPROCESSING CENTER LLC JEROME JAMES
K101653 08/02/2010 MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES MILTEX, INC. JENNIFER BOSLEY, MBA, RAC
K102148 08/17/2010 CURIEPACS (DICOM PACS SOFTWARE) MOKSHA DIGITAL SOFTWARE PVT LIMITED DEEPAK SHARMA
K093689 08/31/2010 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS MR MEDICAL SOLUTIONS LLC FAHAD ALRADADY
K093304 08/11/2010 PROTEKTOR 32 NATUS MEDICAL, INC. GOLDY SINGH
K101632 08/24/2010 METAFLEXCOIL NEOCOIL, LLC BRIAN BROWN
K100288 08/03/2010 NEOMED ENTERAL ONLY EXTENSION SET NEOMED, INC. PENNY NORTHCUTT
K102028 08/04/2010 NEOTRACT ANCHOR SYSTEM MODEL TAS400 NEOTRACT, INC. KEVIN F MACDONALD
K100512 08/20/2010 NOBELPROCERA IPS E.MAX CROWN NOBEL BIOCARE AB HERBERT CRANE
K101714 08/31/2010 NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS NOBEL BIOCARE AB HERBERT CRANE
K101633 08/27/2010 NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K100102 08/31/2010 CS-SERIES-FP OMEGA MEDICAL IMAGING, INC. JAMES PRINCEHORN
K100819 08/02/2010 THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER ONSET MEDICAL CORPORATION JOSEPH BISHOP
K100367 08/27/2010 MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 ORIGIO A/S RONALD G LEONARDI
K100245 08/17/2010 HS/HG PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K091424 08/18/2010 OSTA MAXIGRO AND REGIGRO OSTA TECHNOLOGIES JAY MANSOUR
K100354 08/17/2010 PRIMAL OK INTERSPINOUS FUSION SYSTEM OSTEOMED L.P. KAREN E WARDEN
K082800 08/26/2010 STAR/VENT INTERNAL HEX SCREW IMPLANT PARK DENTAL RESEARCH CORP. DANIEL J MANELLI
K093916 08/23/2010 NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U PERKINELMER, INC. KAY TAYLOR
K093553 08/13/2010 POSTURETEK PERSEUS ALTHETICS,LLC KEITH BARRITT
K093459 08/13/2010 ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 PHADIA US INC. MARTIN ROBERT MANN
K101424 08/17/2010 PHARMACARIBE INHALED SALINE SOLUTIONS PHARMACARIBE PAUL DRYDEN
K102005 08/09/2010 ALLURA XPER OR TABLE SERIES PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. LYNN HARMER
K101600 08/31/2010 INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K093692 08/11/2010 QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES PIONEER SURGICAL TECHNOLOGY EMILY M DOWNS
K093771 08/10/2010 QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY EMILY DOWNS
K101889 08/27/2010 DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE PIVOTAL HEALTH SOLUTIONS PHILLIP KLEIN
K101342 08/20/2010 OSIRIX MD PIXMEO SARL CARL ALLETTO
K100918 08/09/2010 VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 PURICORE INC. DENNIS MAHONEY
K100124 08/31/2010 FASTX STERNAL INTRAOSSEOUS DEVICE PYNG MEDICAL CORP. MAYA BUTTERFIELD
K101390 08/13/2010 FASTPACK TSH IMMUNOASSAY QUALIGEN, INC. MICHAEL S POIRIER
K102175 08/25/2010 RAPIDVUE HCG TEST QUIDEL CORPORATION MICHELLE BODIEN
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