FDA 510(k) Decisions During November, 2014  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K143026 11/21/2014 Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity AALTO SCIENTIFIC LTD. ROBERT BURDA
K143026 11/21/2014 Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity AALTO SCIENTIFIC LTD. ROBERT BURDA
K142978 11/20/2014 Audit MicroControls Linearity LQ Special Diabetes AALTO SCIENTIFIC LTD. Robert Burda
K142978 11/20/2014 Audit MicroControls Linearity LQ Special Diabetes AALTO SCIENTIFIC LTD. Robert Burda
K142467 11/24/2014 IntelAir Nasal Airway Support System ABEON MEDICAL CORPORATION ALLISON SLAGA
K141194 11/19/2014 FM-3000 FETAL MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K141038 11/12/2014 ANT MODEL 1 ADVANCED NUCLIDE TECHNOLOGIES, LLC SERGEY BAKLANOV, PH.D.
K133898 11/06/2014 NIOX VERO AIRWAY INFLAMMATION MONITOR AEROCRINE AB Susanne Parks
K143106 11/21/2014 VEGA Knee System AESCULAP IMPLANT SYSTEMS, LLC Julie Tom Wing
K143106 11/21/2014 VEGA Knee System AESCULAP IMPLANT SYSTEMS, LLC Julie Tom Wing
K142315 11/14/2014 MINOP Disposable Introducer 26F AESCULAP, INC. KATHY RACOSKY
K141993 11/06/2014 NAKOMA ACP ALLIANCE PARTNERS, LLC KELLEN HILLS
K142347 11/18/2014 Amedica Valeo II Interbody Fusion Device Amedica Corp William D Jordan
K142593 11/12/2014 AngioVac Cannula AngioDynamics, Inc. Wanda Carpinella
K142593 11/12/2014 AngioVac Cannula AngioDynamics, Inc. Wanda Carpinella
K143001 11/07/2014 SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING ARGENTUM MEDICAL C. Richard Foster
K143001 11/07/2014 SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING ARGENTUM MEDICAL C. Richard Foster
K143047 11/19/2014 Arthrex iBalance Patella Implant, Dome ARTHREX, INC. LAURA MEDLIN
K143047 11/19/2014 Arthrex iBalance Patella Implant, Dome ARTHREX, INC. LAURA MEDLIN
K142863 11/25/2014 Univers Rivers Shoulder Prosthesis System Arthrex, Inc. Courtney Smith
K142863 11/25/2014 Univers Rivers Shoulder Prosthesis System Arthrex, Inc. Courtney Smith
K142999 11/19/2014 EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable ArthroCare Corporation Ashley M. Johnston
K142999 11/19/2014 EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable ArthroCare Corporation Ashley M. Johnston
K142413 11/14/2014 TITAN Modular Total Shoulder System Ascension Orthopedics Jay Patel
K142203 11/25/2014 Atricure Cryo Module System; cryoICE cryoablation probe ATRICURE, INC. Jonathan McElwee
K141317 11/17/2014 ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE, INC. JUSTIN EGGLETON
K142147 11/24/2014 EEVA SYSTEM AUXOGYN, INC. JULIA S ANASTAS
K140595 11/17/2014 THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. LOUIS FRIES
K141342 11/14/2014 WEARABLE THERAPY GARMENTS AXIOBIONICS LLC ROBERT J BARD
K143157 11/12/2014 Coronis Fusion 4MP LED BARCO NV LIEVEN DE WANDEL
K143157 11/12/2014 Coronis Fusion 4MP LED BARCO NV LIEVEN DE WANDEL
K142600 11/19/2014 VIAL-MATE Adaptor BAXTER HEALTHCARE CORPORATION GARY CHUMBIMUNE
K142600 11/19/2014 VIAL-MATE Adaptor BAXTER HEALTHCARE CORPORATION GARY CHUMBIMUNE
K142023 11/20/2014 LUNA INTERBODY SYSTEM BENVENUE MEDICAL, INC. CINDY DOMECUS, R.A.C. (US & EU)
K142219 11/13/2014 GammaBeam 100 Best Theratronics Limited Mike de van der Schueren
K142640 11/06/2014 Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator BIO COMPRESSION SYSTEMS, INC. Barbara Whitman
K142640 11/06/2014 Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator BIO COMPRESSION SYSTEMS, INC. Barbara Whitman
K142099 11/17/2014 CUTANEOUS ELECTRODES BIO PROTECH, INC. Terry Kim
K133303 11/19/2014 PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device BIO-ANALYSIS, INC. REGINA J O'MEARA
K142292 11/17/2014 Speed, Speed Shift, Speed Titan, Speed Arc BioMedical Enterprises, Inc. Joe Soward
K142658 11/13/2014 Biomet Headless Compression and Twist-off Screws BIOMET MANUFACTURING CORP. Victoria Scheitlin
K142658 11/13/2014 Biomet Headless Compression and Twist-off Screws BIOMET MANUFACTURING CORP. Victoria Scheitlin
K141263 11/19/2014 TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS BIOMET MANUFACTURING CORP. JARED COOPER
K133518 11/05/2014 MAXAN ANTERIOR CERVICAL PLATE SYSTEM BIOMET SPINE (AKA EBI, LLC) KIMBERLY MCCOY
K142020 11/05/2014 LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 BIOMONDE ROSINA ROBINSON, RN, MED, RAC
K142513 11/13/2014 Barricade Embolization Coil System BLOCKADE MEDICAL Rebecca K Pine
DEN140025 11/17/2014 BrainScope Ahead 100 BRAINSCOPE COMPANY, INC Michael E. Singer
K140732 11/07/2014 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS CANDELA CORP. SAM WADE
K140497 11/19/2014 ECVUE MAPPING SYSTEM CARDIOINSIGHT TECHNOLOGIES, INC CHRISTINA V VACCA
K143234 11/20/2014 MaxZero Administration Sets CAREFUSION LARRY WALKER
K143234 11/20/2014 MaxZero Administration Sets CAREFUSION LARRY WALKER
K141844 11/18/2014 RESCAN 700, CALLISTO EYE CARL ZEISS MEDITEC AG MANDY AMBRECHT
K142399 11/19/2014 DualCap IV Pole Strips(Disinfectant Caps for Male Luers) CATHETER CONNECTIONS, INC. Donald d Soloman
K142047 11/12/2014 EIDON CENTERVUE SPA ROGER GRAY
K141942 11/07/2014 MIDLINE II TI CENTINEL SPINE, INC. JUSTIN EGGLETON
K142045 11/22/2014 XPERT FLU/RSV XC ASSAY CEPHEID SCOTT A CAMPBELL,PH.D.,MBA
K142501 11/26/2014 Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System CEPHEID KERRY J. FLOM
K141606 11/17/2014 SURGICAL GOWN COBES INDUSTRIES CO., LTD. LYNN FU
K142496 11/24/2014 Collagen Dental Membrane - Conformable IIBP COLLAGEN MATRIX, INC. GLORIA ZUCLICH
K141909 11/05/2014 COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP COLLAGEN MATRIX, INC. PEGGY HANSEN
K141718 11/13/2014 INTERNAL HYDRATING GEL COMBE INCORPORATED PUSHPA RAO
K130019 11/18/2014 J-SCREW COMPRESSION SCREW COMPETITIVE ENGINEERING INC. DAVID M DAVIS
K142161 11/14/2014 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K140085 11/18/2014 UNIVERSA PERCULTANEOUS DRAINAGE CATHETER COOK INCORPORATED ELYSIA EASTON
K142301 11/12/2014 Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath COOK VASCULAR, INC. Thomas J. Kardos
K141523 11/25/2014 ALLY UPS COOPER SURGICAL, INC. TIM M LOHNES
K140438 11/14/2014 MICRO GUIDE CATHETER ELITE CORDIS CORP., A JOHNSON & JOHNSON CO. Michelle Ragozzine Rodgers
K140573 11/24/2014 WOUNDCLOT HEMOSTATIC GAUZE CORE SCIENTIFIC LTD. AHAVA STEIN
K142012 11/20/2014 FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS CORPAK MEDSYSTEMS STEPHANIE WASIELEWKI
K142695 11/26/2014 Cytosponge Cell Collection Device Covidien LLC Richelle Hover
K142695 11/26/2014 Cytosponge Cell Collection Device Covidien LLC Richelle Hover
K143091 11/26/2014 Surgisleeve Wound Protector Covidien LLC Michael Koczocik
K143091 11/26/2014 Surgisleeve Wound Protector Covidien LLC Michael Koczocik
K140566 11/24/2014 SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE CROSSTEX INTERNATIONAL MICHAEL G NOLAN
K142072 11/24/2014 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) CUSTOM ORTHOPAEDIC SOLUTIONS, INC. JUSTIN J BAKER,PHD
K140727 11/06/2014 CUTERA PICOSECOND LASER SYSTEM CUTERA, INC. BRADLEY RENTON
K142428 11/13/2014 Shock Pulse-SE Lithotripsy System CYBERWAND II CYBERSONICS, INC. Jeff Vaitekunas
K141503 11/10/2014 DENALI 501CEMENT DENALI CORPORATION JAN G STANNARD
K141457 11/12/2014 DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS DENTIUM CO. LTD. SHERYL HIGGINS
K142185 11/19/2014 EXPEDIUM VERSE SPINE SYSTEM DEPUY SPINE, INC. CATHERINE KILSHAW
K142587 11/18/2014 Vertical Expandable Prosthetic Titanium Rib Depuy Synthes Spine, Inc. Catherine Kilshaw
K142587 11/18/2014 Vertical Expandable Prosthetic Titanium Rib Depuy Synthes Spine, Inc. Catherine Kilshaw
K133434 11/26/2014 GENESIS II DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K133175 11/13/2014 DRAEGER JAUNDICE METER JM-105 DRAEGER MEDICAL SYSTEMS, INC. BRYAN OVERTON
DEN100024 11/07/2014 ZAP-IT! ECOBRANDS LTD. Kevin Walls
K141958 11/18/2014 ERB ENDORECTAL BALLOON EDGE MEDICAL LLC GREGORY MATHISON
K143261 11/21/2014 2.3MP Color LCD Monitor, RadiForce MX242W EIZO CORPORATION Hiroaki Hashimoto
K143261 11/21/2014 2.3MP Color LCD Monitor, RadiForce MX242W EIZO CORPORATION Hiroaki Hashimoto
K143098 11/18/2014 3MP Color LCD monitor, RadiForce RS340 EIZO CORPORATION HIROAKI HASHIMOTO
K143098 11/18/2014 3MP Color LCD monitor, RadiForce RS340 EIZO CORPORATION HIROAKI HASHIMOTO
K141990 11/07/2014 ENCORE HUMERAL SHOULDER STEM ENCORE MEDICAL, L.P. TEFFANY HUTTO
K140130 11/06/2014 X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED ENCORE MEDICAL, L.P. TEFFANY HUTTO
K140389 11/07/2014 CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 ENTROTECH LIFE SCIENCES INC. VALERIE DEFIESTA-NG
K141952 11/24/2014 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED ETHICON ENDO-SURGERY, INC. LINDA HILL
K133446 11/14/2014 HEPARIN LOCK / FLUSH SYRINGES Excelsior Medical Corporation JOHN LINFANTE
K142810 11/14/2014 WEGO-PGCL Absorbable Surgical Monofilament Suture FOOSIN MEDICAL SUPPLIES INC.LTD Suxia Zhao
K142810 11/14/2014 WEGO-PGCL Absorbable Surgical Monofilament Suture FOOSIN MEDICAL SUPPLIES INC.LTD Suxia Zhao
K142098 11/24/2014 SIGNA PET/MR GE MEDICAL SYSTEMS, LLC ROBIN MARTIN
K143156 11/18/2014 Sentinella 102; Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- Jose Montes
K143156 11/18/2014 Sentinella 102; Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- Jose Montes
K142938 11/26/2014 G3 Active Plate Large Fragment System GENESIS FRACTURE CARE, INC. Michael Bottlang
K142938 11/26/2014 G3 Active Plate Large Fragment System GENESIS FRACTURE CARE, INC. Michael Bottlang
K140041 11/28/2014 ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM GENORAY CO., LTD. KAITLYNN MIN
K133766 11/24/2014 HUMICARE D900 GRUENDLER GMBH JIM CASSI
K142270 11/25/2014 LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE HARTALEGA SDB. BHD. KUAN KAM HON
DEN130045 11/26/2014 HEARTFLOW FFRCT HEARTFLOW Dustin Michaels
K140934 11/12/2014 HIOSSEN IMPLANT SYSTEM HIOSSEN INC. PATRICK LIM
K142029 11/26/2014 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HOLOGIC, INC. SARAH FAIRFIELD
K141792 11/25/2014 GENESIS TOUCH SYSTEM HONEYWELL HOMMED CLAUDIA JACKSON
K142367 11/25/2014 Hospira Primary Sets HOSPIRA, INC. CATHERINE KANG
K141872 11/21/2014 SUDOSCAN IMPETO MEDICAL INC Calley Herzog
K141341 11/14/2014 CL DETECT RAPID TEST INBIOS INTERNATIONAL INC. ESTELA RAYCHAUDHURI
K141158 11/26/2014 APEX INCONTROL MEDICAL, LLC JESSICA ANDRESHAK
K141682 11/24/2014 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc. STEVEN J CHARTIER
K141644 11/07/2014 INNOVASIS CRANIAL SYSTEM INNOVASIS, INC. MARSHALL MCCARTY
K141967 11/07/2014 PUREFILL OXYGEN COMPRESSOR INOVO, INC. PAUL DRYDEN
K140078 11/14/2014 TECOTHERM NEO (T NEO) INSPIRATION HEALTHCARE LTD WAYNE IDDON
K140439 11/13/2014 OMNIPOD INSULIN MANAGEMENT SYSTEM INSULET CORPORATION ANTONETTE M DELEO, RAC
K141668 11/06/2014 CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION JANET C KAY
K141674 11/06/2014 CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA LIFESCIENCES CORPORATION TIMOTHY CONNORS
K142238 11/24/2014 MAYFIELD Skull Clamp INTEGRA LIFESCIENCES CORPORATION Brian Hoy
K140716 11/24/2014 OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE INTERVENTIONAL SPINE, INC. JANE METCALF
K142668 11/21/2014 Lesion-Loc Iodine I-125 Seed/Needle Intramedical Imaging, LLC Farhad Daghighian
K142668 11/21/2014 Lesion-Loc Iodine I-125 Seed/Needle Intramedical Imaging, LLC Farhad Daghighian
K141338 11/04/2014 LIAT STREP A ASSAY IQUUM INC Lingjun Chen
K142681 11/21/2014 ZEUS (ZIO ECG Utilization Service) System iRhythm Technologies, Inc. Rich Laguna
K142681 11/21/2014 ZEUS (ZIO ECG Utilization Service) System iRhythm Technologies, Inc. Rich Laguna
K142389 11/25/2014 Variolink Esthetic IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K143076 11/12/2014 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K143076 11/12/2014 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K142016 11/06/2014 CAPRI K2M, INC. NANCY GIEZEN
K140963 11/10/2014 KIMGUARD SMART-FOLD STERILIZATION WRAP KIMBERLY-CLARK CORP. THOMAS KOZMA, PH.D.
K142197 11/21/2014 ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 KONICA MINOLTA INC. SHIGEYUKI KOJIMA
K140352 11/13/2014 VERAPLUG KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS ARCHNA JOHNSON
K142393 11/25/2014 PREDICATE III GUIDEWIRE LAKE REGION MEDICAL MATHEW PEXA
K141877 11/10/2014 LEAF PATIENT MONITORING SYSTEM LEAF HEALTHCARE, INC. RONALD S WARREN
K140768 11/25/2014 TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD. ARTHUR GODDARD
K133997 11/21/2014 LG SMARTHEALTH LG ELECTRONICS DIANE SUDDUTH
K142139 11/07/2014 SMR 40MM GLENOSPHERE LIMACORPORATE S.P.A. STEPHEN PEOPLES
K142215 11/07/2014 Power Twin21-50/Power Twin21-100 LIVETEC GMBH Klaus Reichebach
K141555 11/06/2014 ADVANTAGE LUTRONIC CORPORATION JHUNG W VOJIR
K141989 11/13/2014 MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION JONATHAN REEVES
K140569 11/19/2014 ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) MAQUET CARDIOPULMONARY AG SARAH BETZ
K140492 11/13/2014 NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE MARVAO MEDICAL DEVICES, LTD. CHRISTINE NICHOLS
K142394 11/25/2014 Masimo Root Monitoring System and Accesories MASIMO CORPORATION MARGUERITE THOMLINSON
K140222 11/17/2014 SAIPH KNEE SYSTEM MATORTHO MARCOS VELEZ-DURAN
K142303 11/20/2014 NeumoFilt Ergo/Neumo Filt BiteOn Medical Respiratory Devices S.L. Jose Alberto Hernandez
K140738 11/04/2014 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL AUDREY VION
K142684 11/06/2014 FlexCath Select Steerable Sheath (10 French) Medtronic CryoCath LP Vanessa Ware
K142684 11/06/2014 FlexCath Select Steerable Sheath (10 French) Medtronic CryoCath LP Vanessa Ware
K142673 11/18/2014 Bio-Medicus Adult Cannulae and Introducer Medtronic, Inc Bruce Backlund
K142673 11/18/2014 Bio-Medicus Adult Cannulae and Introducer Medtronic, Inc Bruce Backlund
K141377 11/21/2014 BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K140382 11/25/2014 AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY MERIT MEDICAL SYSTEMS, INC. DAN LINDSAY
K142265 11/13/2014 ONE Snare Endovascular Microsnare System MERIT MEDICAL SYSTEMS, INC. Mark Mullaney
K141408 11/26/2014 RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. CLEA FEIGHT
K142550 11/07/2014 EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments MICROPORT ORTHOPEDICS INC. Caroline Fryar
K142550 11/07/2014 EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments MICROPORT ORTHOPEDICS INC. Caroline Fryar
K142601 11/14/2014 Panorama Patient Monitoring Network Mindray DS USA, Inc. Diane Arpino
K134006 11/21/2014 DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED THOMAS CHAN TSZ FUNG
K133989 11/25/2014 AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM MORTARA INSTRUMENT, INC. AMY YANG
K141811 11/19/2014 MORTARA MONITORING WAVEFORM VIEWER MORTARA INSTRUMENT, INC. AMY YANG
K141771 11/07/2014 PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY NANOSTRING TECHNOLOGIES INC. SYLVA KRIZAN
K142903 11/12/2014 neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US NEOSURGICAL LTD Oria Brennan
K142903 11/12/2014 neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US NEOSURGICAL LTD Oria Brennan
K141462 11/19/2014 VARIA-NCI NEUROCHAOS SOLUTIONS, INC. ELISA MALDONADO-HOLMERTZ
K142470 11/05/2014 E-Shield Multi-paried Subdermal Needle Electrodes NEUROINVENT INC. CHAO SHENT-CHAO
K140586 11/17/2014 ASCEND ELECTRODE NEUROMETRIX, INC. RAINER MAAS
K142060 11/18/2014 TRANSOM ANTERIOR CERVICAL PLATE NEUROSTRUCTURES, INC. MEREDITH MAY
K133507 11/05/2014 GUIDOSS NIBEC CO LTD DANIEL NAM
K142424 11/25/2014 DR300 HOLTER MONITOR NORTH EAST MONITORING INC. SHERRY STEELE
K141994 11/14/2014 BULK FILL FLOWABLE COMPOSITE NOVOCOL, INC. CORA BRACHO-TROCONIS
K141968 11/14/2014 NUVASIVE NVM5 SYSTEM NUVASIVE, INC. JEREMY MARKOVICH
K142299 11/25/2014 CoRoent Small Interlock System NUVASIVE, INCORPORATED Cynthia Adams
K141896 11/20/2014 COROENT SYSTEM NUVASIVE, INCORPORATED OLGA LEWIS
K142499 11/19/2014 Reline System NUVASIVE, INCORPORATED Olga Lewis
K142594 11/28/2014 nva, nvp, nvt NVISION BIOMEDICAL TECHNOLOGIES, LLC Brian Kieser
K142594 11/28/2014 nva, nvp, nvt NVISION BIOMEDICAL TECHNOLOGIES, LLC Brian Kieser
K142525 11/21/2014 PK Lap Loop Olympus Winter & Ibe GmbH Graham A.L. Baillie
K140807 11/12/2014 COMPOSITE ORTHODONTIC BRACKETS ORTHO SPECIALTIES PAULA WENDLAND
K141571 11/12/2014 ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM ORTHOFIX SRL TROY BROOKS
K133827 11/17/2014 A-LINK Z OSTEO VASIVE LLC KEVIN A THOMAS
K141794 11/19/2014 ENDO-MARYLAND DISSECTOR OVESCO ENDOSCOPY AG TANJA R LINZER
K140923 11/18/2014 TRACTION POLYPECTOMY SNARE OVESCO ENDOSCOPY AG TANJA LINZER
K133980 11/07/2014 PANTHEON ELECTROSTIMULATOR PANTHEON RESEARCH YOLANDA SMITH
K143074 11/25/2014 Sherpa Pak Cardiac Transport System PARAGONIX TECHNOLOGIES, INC. Lisa Anderson
K143074 11/25/2014 Sherpa Pak Cardiac Transport System PARAGONIX TECHNOLOGIES, INC. Lisa Anderson
K143054 11/25/2014 Sherpa Pak Kidney Transport System PARAGONIX TECHNOLOGIES, INC. Lisa Anderson
K143054 11/25/2014 Sherpa Pak Kidney Transport System PARAGONIX TECHNOLOGIES, INC. Lisa Anderson
K140884 11/26/2014 SYMETREX LONG TERM HEMODIALYSIS CATHETER PHASE ONE MEDICAL ADITYA SUKTHANKAR
K133674 11/21/2014 PHILIPS IQON SPECTRAL CT PHILIPS HEALTHCARE (CLEVELAND) CATHERINE M CONNELL
K140535 11/25/2014 PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH MICHAEL ASMALSKY
K141839 11/17/2014 PREMIER ETCH PREMIER DENTAL PRODUCTS CO. VINCENT D'ALESSANDRO
K142118 11/25/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE PRISMATIK DENTALCRAFT, INC. BRANDON SHEPARD
K142115 11/13/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT PRISMATIK DENTALCRAFT, INC. BRANDON SHEPARD
K141887 11/06/2014 OBSIDIAN PRESS (ALL CERAMIC AND POM) PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K142868 11/21/2014 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin Purple Surgical International Limited Jason Howes
K142868 11/21/2014 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin Purple Surgical International Limited Jason Howes
K142802 11/24/2014 Atlas SPEEDER Head/Neck Quality Electrodynamics, LLC Kathleen Aras
K142802 11/24/2014 Atlas SPEEDER Head/Neck Quality Electrodynamics, LLC Kathleen Aras
K132691 11/13/2014 ABL90 FLEX RADIOMETER MEDICAL APS SOREN BOGESTRAND
K140193 11/04/2014 DUREX EMBRACE PERSONAL LUBRICANT RECKITT BENCKISER, LLC SAPANA AMIN
K141649 11/05/2014 SPEX SUPPORT CATHETER REFLOW MEDICAL Rebecca K Pine
K141676 11/04/2014 RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM Renovis Surgical Technologies, Inc. Sharyn Orton, Ph.D.
K140424 11/14/2014 RESPIRONICS REUSABLE HEATED TUBING RESPIRONICS, INC. ALEXANDER L FRIEDMAN
K141617 11/14/2014 CLEANERXT ROTATIONAL THROMBECTOMY SYSTEM, CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM REX MEDICAL, L.P. SUSAN D GOLDSTEIN-FALK
K141928 11/25/2014 COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR Roche Diagnostics Operations (RDO) NOEL K MENCIAS
K140910 11/19/2014 CENTERCROSS CATHETER ROXWOOD MEDICAL, INC. MEHRDAD FARHANGNIA
K142243 11/18/2014 LessRay with Tracking SAFERAY SPINE, LLC Michael Alrutz
K143089 11/26/2014 WS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K143089 11/26/2014 WS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K141755 11/19/2014 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
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