FDA 510(k) Applications Received During October, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K143058 10/24/2014 PuraDerm Gel 3-D Matrix, Inc. Lisa Spirio
K143026 10/21/2014 Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity AALTO SCIENTIFIC LTD. ROBERT BURDA
K142978 10/15/2014 Audit MicroControls Linearity LQ Special Diabetes AALTO SCIENTIFIC LTD. Robert Burda
K142928 10/09/2014 FreeStyle Precision Neo Blood Glucose Monitoring System ABBOTT DIABETES CARE INC MICHELLE RICAFORT
K143106 10/29/2014 VEGA Knee System AESCULAP IMPLANT SYSTEMS, LLC Julie Tom Wing
K142970 10/14/2014 SterilContainer S System AESCULAP, INC. Denise R Adams
K143060 10/24/2014 Intelli-Ox AIR LIQUIDE HEALTHCARE ANGIE BEYER
K143114 10/30/2014 Sense4Baby System Model B+ (MSA) AIRSTRIP TECHNOLOGIES, INC. ROBERT ANDREW MILLER
K142884 10/02/2014 E-CUBE 12 ALPINION MEDICAL SYSTEMS CO., LTD Donghwan Kim
K143117 10/30/2014 Wire Sterilization Package with Indicators AMERICAN ORTHODONTICS TRANG ADAMS
K142889 10/03/2014 Celerity PICC Tip Confirmation System ANGIODYNAMICS, INC. Michael Hanley
K142983 10/16/2014 AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating ANGIOSCORE, INC. Kimberley Kline
K142971 10/14/2014 AMT Bridle - Nasal Tube Retention System Applied Medical Technology, Inc. Joshua Meinke
K142989 10/16/2014 Mini ONE Enteral Extension Set APPLIED MEDICAL TECHNOLOGY, INC. Joshua Meinke
K143001 10/17/2014 SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING ARGENTUM MEDICAL C. Richard Foster
K142914 10/07/2014 DacryoCATH ARMADILLO BIOMEDICAL, LLC Bruce Becker, M.D.
K143102 10/29/2014 Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions Arrow International, Inc. (Subsidiary of Teleflex Inc.) Debra Grodt
K143047 10/23/2014 Arthrex iBalance Patella Implant, Dome ARTHREX, INC. LAURA MEDLIN
K142863 10/01/2014 Univers Rivers Shoulder Prosthesis System Arthrex, Inc. Courtney Smith
K142999 10/17/2014 EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable ArthroCare Corporation Ashley M. Johnston
K142944 10/10/2014 ArthroPlan Digital Templating Software Arthromeda, Inc Elsa Abruzzo
K142942 10/14/2014 HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System ARTHROSURFACE INC. Dawn J. Wilson
DEN140030 10/01/2014 SpaceOAR System AUGMENIX , INC. Noel Rolon
K143082 10/27/2014 IV Administration Sets with 200(micro)m Blood Filter B. Braun Medical Inc. Angela J Caravella
K143067 10/24/2014 Carnation Ambulatory Monitor BARDY DIAGNOSTICS, INC. JON P. HUNT
K142985 10/16/2014 UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator BECKMAN COULTER, INC. Eimear Carr
K142888 10/02/2014 Fingertip Pulse Oximeter BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Lei Chen
K143103 10/29/2014 PROPENCIL Smoke Pencil BIO PROTECH, INC. Terry Kim
K143005 10/20/2014 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 BioFire Diagnostics, LLC Kristen Kanack
K143080 10/27/2014 FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System BioFire Diagnostics, LLC Kristen Kanack
K143022 10/21/2014 BioHorizons Tapered Internal Implants BIOHORIZONS IMPLANT SYSTEMS, INC. Michael Davis
K143120 10/30/2014 OrthoPulse BIOLUX RESEARCH LTD. Kevin Strange
K143023 10/21/2014 Nitinol Compression Plating System BioMedical Enterprises, Inc. Joe Soward
K143037 10/22/2014 SnapShot Fixation System BIOMET MANUFACTURING CORP. Adam Cargill
K142933 10/09/2014 Biomet Tibial trays BIOMET, INC. JASON HECKAMAN
K143009 10/20/2014 Echo Bi-Metric Microplasty Hip System BIOMET, INC. Julie Gantenberg, M.S.,RAC
K142882 10/02/2014 G7 Freedom and Offset Liners, Freedom Head, Size 32 Biomet, Inc. Becky Earl
K143110 10/29/2014 GALAXY MIS Screw System BM KOREA JUNE HAN
K143006 10/20/2014 GUARDIAN-SG Inflatable Bone Expander System BM KOREA CO., LTD. June Han
K142973 10/14/2014 Resolution Clip Boston Scientific Corporation Elena Nieves
K142922 10/08/2014 SpyGlass DS Direct Visualization System BOSTON SCIENTIFIC CORPORATION CARTER NAVARRO
K142975 10/14/2014 Bovie Ultimate High Frequency Electrosurgical Generator Bovie Medical Corporation Moshe Citronowicz
K143040 10/22/2014 Exilis XP BTL INDUSTRIES INC Jan Zarsky
K143109 10/29/2014 XP300 BTL INDUSTRIES, INC Jan Zarsky
K142873 10/01/2014 OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners C.R.Bard Inc. Christine Lloyd
K142943 10/10/2014 Metallic Locking Bone Plate and Screw Canwell Medical Co., Ltd Chen Hui
K143016 10/20/2014 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home CARDINAL HEALTH Tatyana Bogdan
K142916 10/07/2014 SVED Wound Treatment System CARDINAL HEALTH Tatyana Bogdan
K142990 10/16/2014 Insta-Gard Surgical and Procedure Face Mask Cardinal Health 200, LLC Lavenia Ford
K142959 10/14/2014 Vyntus Walk CAREFUSION GERMANY 234 GMBH Elmar Niedermeyer
K142862 10/01/2014 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). Careplus (M) SDN BHD Lim Kwee Shyan
K142858 10/01/2014 POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) Careplus (M) SDN BHD Lim Kwee Shyan
K143024 10/21/2014 CAS-One Liver CAScination AG Matthias Peterhans
DEN140032 10/20/2014 Cereve Sleep System CEREVE, INC. Eric Nofzinger
K142982 10/15/2014 OPUS 5100 Diagnostic Doppler Ultrasound System Chang Gung Medical Technology Co., Ltd. CHENG MING CHEN
K143002 10/20/2014 Metallic Locking Bone Plate and Screw System Changzhou Dingjian Medical Appliance Co., Ltd Li Qingsong
K143013 10/20/2014 Spinal Inner Fixation System Changzhou Dingjian Medical Appliance Co., Ltd Li Quinsong
K142907 10/06/2014 Baha 5 Sound Processor COCHLEAR AMERICAS Sean Bundy
K143077 10/27/2014 Trevo XP ProVue Retriever (6X25mm) CONCENTRIC MEDICAL, INC. Bill Hyatt
K142887 10/02/2014 SIS Inguinal Hernia Repair Graft COOK BIOTECH INCORPRATED Perry W Guinn
K143100 10/28/2014 NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta Cossington Ltd Diana Mandell Horwitz, Ph.D.,RAC
K143134 10/31/2014 NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System Cossington Ltd Diana Mandell Horwitz
K142934 10/09/2014 CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved COVIDIEN Deborah Fleetham
K143088 10/28/2014 GastriSail Gastric Positioning System COVIDIEN Debbie Peacock
K143018 10/20/2014 Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors Covidien Wei Zhao
K142929 10/09/2014 Ligasure Blunt Tip Sealer/Divider COVIDIEN CELSO DURAN
K142869 10/01/2014 Premium Surgiclip III COVIDIEN Michael Koczocik
K143091 10/28/2014 Surgisleeve Wound Protector Covidien LLC Michael Koczocik
K143105 10/29/2014 Picosure Workstation CYNOSURE, INC. Kelli McMillan
K143092 10/28/2014 Tensyn Plug DALLEN MEDICAL, INC. Al Memmolo
K142881 10/02/2014 DMRC Dual Cure Orthodontic Band Cement DANVILLE MATERIALS, LLC. Dong Hua
K142886 10/02/2014 DMRC Self-Cure Bracket Adhesive One Step and Primer DANVILLE MATERIALS, LLC. Dong Hua
K142880 10/02/2014 DMRC Light Cure Orthodontic Adhesive System Daville Materials LLC Dong Hua
K142932 10/09/2014 Deltex Medical KDP72 Doppler Probe DELTEX MEDICAL LIMITED Paul Dwane
K142987 10/16/2014 DD Bio Z, DD Bio ZX(square), DD BioZX(square) color DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT) Gerhard de Boer
K143033 10/22/2014 DENTCA DENTURE BASE DENTCA, INC. Jason Lee
K142962 10/14/2014 PROTOCOL Incision Dressing DEROYAL INDUSTRIES Elizabeth Wheeler
K143127 10/31/2014 CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style DISPO-MED (MALAYSIA) SDN BHD NC LEOW
K143071 10/27/2014 Nacera Pearl DOCERAM MEDICAL CERAMICS GMBH Stefan Drude
K142877 10/01/2014 EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV DANIELLE SLEEGERS
K142986 10/16/2014 SagiNova Eckert & Ziegler BEBIG GmbH Michel Lafuente
K143098 10/28/2014 3MP Color LCD monitor, RadiForce RS340 EIZO CORPORATION HIROAKI HASHIMOTO
K143007 10/20/2014 Erchonia Zerona Z6 OTC ERCHONIA CORPORATION Steve Shanks
K143129 10/31/2014 easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) EziSurg Medical Co.,Ltd. Johnny Yan
K143035 10/22/2014 Flight 60 Ventilator FLIGHT MEDICAL INNOVATIONS LTD. Yanir Shaked
K143124 10/31/2014 KA01 Chitosan Wound Dressing FOSHAN UNITED MEDICAL TECHNOLOGIES LTD. JOHN CEN
K142895 10/03/2014 LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators FUJIREBIO DIAGNOSTICS, INC Diana Dickson
K143108 10/29/2014 HealthGuard-15 FUTREX, INC. Carole Rosenthal
K142938 10/09/2014 G3 Active Plate Large Fragment System GENESIS FRACTURE CARE, INC. Michael Bottlang
K143095 10/28/2014 MiniStim MS-IVB Peripheral Nerve Stimulator Halyard Health, Inc. Lindsey Hedlund
K142968 10/14/2014 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co.,Ltd. Sarah Su
K142997 10/10/2014 RTHawk, HeartVista Workstation with RTHawk HEARTVISTA, INC. James J Rogers
K142891 10/03/2014 HEPATIQ HEPATIQ LLC Dipu Ghosh
K142974 10/14/2014 Extension Sets Hospira, Inc David Blonski
K143087 10/27/2014 Hospira Blood Set HOSPIRA, INC. Charles Neitzel
K143015 10/20/2014 Hospira Primary Sets Hospira, Inc. Anju Kurian
K143093 10/28/2014 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) HOTSPUR TECHNOLOGIES, INC., Eric Ankerud, JD
K142911 10/06/2014 ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) HUAILAI ZM PLASTIC PRODUCTS CO., LTD ZHUAHAO ZHANG
K142994 10/16/2014 IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers IMMUNODIAGNOSTIC SYSTEMS LTD. Mick Fenton
K143011 10/20/2014 2014 InterActive/SwishActive System Implant Direct Sybron Manufacturing LLC Debleena Sinha
K142952 10/10/2014 InMode Diolaze Device INMODE MD LTD. Ahava Stein
K142956 10/14/2014 NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit Integrated Healing Technologies Ian Baird
K142939 10/09/2014 Revolution Spinal Fixation System INTELLIGENT IMPLANT SYSTEMS, LLC Michael Nutt
K142937 10/09/2014 Endoscope Sterilization Tray INTUITIVE SURGICAL, INC. Nadine Nasr
K143132 10/31/2014 IS4000 8mm Harmonic ACE Curved Shears INTUITIVE SURGICAL, INC. EARLE CANTY
K143003 10/20/2014 iPulse Smooth Skin Gold Hair Removal System Ipulse Limited Mike Kiernan
K142957 10/14/2014 Ideal pedicle screw spinal system JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. Wei Li
K143070 10/27/2014 Disposable Safety Self-destructive Syringes, 5 ML Jiangsu Yile Medical Article Co.,Ltd. Feng Xingyuan
K143034 10/22/2014 Jintronix JINTRONIX INC. Mark Evin
K142930 10/09/2014 Exam Vue DR JPI HEALTHCARE CO., LTD Wonsik (Stanley) Youn
K143076 10/27/2014 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K142920 10/08/2014 KM Needles (Acupuncture Needle) K.M.S. INC. CHUL HUI KIM
K143104 10/29/2014 Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X KETTENBACH GMBH & CO KG Katja Simon
K143053 10/23/2014 KIMGUARD ONE-STEP Sterilization Wrap KIMBERLY-CLARK HEALTH CARE MONICA KING
K143131 10/31/2014 Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile Kossan International Sdn. Bhd. Cho Sow Fong
K143017 10/20/2014 Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver LABORATOIRES URGO SOPHIE FORTIN
K143010 10/20/2014 LENSAR Laser System - fs 3D LENSAR, INC. MOHINDER MERCHEA
K142991 10/16/2014 LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA LifeGlobal Group, LLC Michael D. Cecchi
K142860 10/01/2014 Lumenis M22 System Lumenis Ltd. Yoram Levy
K143086 10/27/2014 VX120 Ophthalmic Diagnostic Device LUNEAU SAS Isabelle Durand
K143119 10/30/2014 LT-300 Video Colposcope Lutech Industries, Inc. Ron Vachula
K142964 10/14/2014 VALIDATE Anemia Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY, LLC James Champlin
K142969 10/14/2014 ANI Monitor MDOLORIS MEDICAL SYSTEMS SAS MATHILDE COLLET
K142906 10/06/2014 APTUS Wrist 2.5 System MEDARTIS AG Andrea Schweizer
K143068 10/24/2014 Medical Monofilament Sensory Screening Toool Medical Monofilament Manufacturing Michelle Hardiman
K143111 10/29/2014 Codman Certas Plus Programmable Valve; Codman Certas Toll Kit MEDOS INTERNATIONAL SARL Michelle Godin
K143031 10/21/2014 mcompass Biofeedback Anorectal Manometry System MEDSPIRA, LLC JIM QUACKENBUSH
K143019 10/20/2014 CD HORIZON Spinal System, IPC POWEREASE System Medtronic Sofamor Danek USA, Inc. Lila Joe
K143083 10/27/2014 Bio-Medicus Pediatric Cannula and Introducers MEDTRONIC, INC BRUCE BACKLUND
K143073 10/27/2014 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface Medtronic, Inc. Jessica Sixberry
K143107 10/29/2014 DLP Vein Graft Cannula MEDTRONIC, INC. KEVIN LAM
K143032 10/22/2014 eMotion Faros ECG Mobile MEGA ELECTRONICS LTD. Taneli Vaaraniemi
K142998 10/17/2014 CPX Control Breast Tissue Expander MENTOR WORLDWIDE LLC Manchi Cheung
K142912 10/06/2014 Merits Yoga Power Scooter, S542 MERITS HEALTH PRODUCTS CO., LTD. Vincent Chen
K142883 10/02/2014 MindChild Meridian M100 Fetal Heart Rate Monitor Mindchild Medical Jim Robertson
K143020 10/20/2014 LiverMultiScan MIRADA MEDICAL LTD. Gwilym Owen
K142918 10/07/2014 EndoTool SubQ MONARCH MEDICAL TECHNOLOGIES STUART LONG
K143101 10/29/2014 Helio A7 Manual Wheelchair, Move Manual Wheelchair MOTION COMPOSITES Vincent Leuyer
K142866 10/01/2014 Myoscience iovera system Myoscience, Inc Tracey Henry
K143041 10/22/2014 Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter Natec Medical Ltd Xavier De Buchere
K143036 10/22/2014 Ebony PTA 0.035 Peripheral Dilatation Catheter Natec Medical Ltd Xavier De Buchere
K142951 10/10/2014 MD210C3 21.3 Diagnostic Imaging LCD Monitor NEC DISPLAY SOLUTIONS LTD. Satoru Kotani
K143135 10/31/2014 Spring Coil Guidewire NeoMetrics, Inc. Gene Champeau
K142903 10/06/2014 neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US NEOSURGICAL LTD Oria Brennan
K143061 10/24/2014 Activ Ankle Locking Plating System NEWCLIP TECHNICS Gaelle Lussori
K143049 10/23/2014 LYNC intramedullary implant NOVASTEP Gilles Audic
K143065 10/24/2014 NuVasive ALIF Buttress Plate System NUVASIVE, INCORPORATED Michelle Cheung
K142917 10/07/2014 BP652N (HEM-6300-Z) OMRON Healthcare, Inc Renee Thornborough
K142953 10/10/2014 OCT-Camera OptoMedical Technologies GmbH Alexander Holzhey
K142897 10/03/2014 P200DTx OPTOS PLC. GUNHILD PAULSEN
K142993 10/16/2014 QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument ORION DIAGNOSTICA OY ANJA KONTIO
K143069 10/27/2014 HEMASORBPLUS press Resorable Hemostatic Bone Putty ORTHOCON, INC. Howard L Schrayer
K143039 10/22/2014 CrossRoads Screw System ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM VERNON HARTDEGEN
K143125 10/31/2014 Orthofix True Lok Hexapod System VI.3 Orthofix Srl Gianluca Ricadona
K143028 10/21/2014 Azure Anterior Cervical Plate System ORTHOFIX, INC. Natalia Volosen
K143074 10/27/2014 Sherpa Pak Cardiac Transport System PARAGONIX TECHNOLOGIES, INC. Lisa Anderson
K143054 10/23/2014 Sherpa Pak Kidney Transport System PARAGONIX TECHNOLOGIES, INC. Lisa Anderson
K142870 10/01/2014 Penumbra Embolectomy Aspiration System [INDIGO System] PENUMBRA, INC. Michael Mahl
K143014 10/20/2014 F5 PERMOBIL AB Jan Astrom
K142935 10/09/2014 CareEvent PHILIPS MEDICAL SYSTEMS Theresa Poole
K143057 10/24/2014 M3290B Philips IntelliVue Information Center iX PHILIPS MEDICAL SYSTEMS Theresa Poole
K143128 10/30/2014 mDIXON XD PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. JAN VAN DE KERKHOF
K143044 10/22/2014 CAAS A-Valve PIE MEDICAL IMAGING B.V. Florie Daniels
K142879 10/02/2014 BTM Wound Dressing POLYNOVO BIOMATERIALS PTY LTD Philip Powell
K142941 10/09/2014 Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. PT MEDISAFE TECHNOLOGIES Anil Taneja
K142868 10/01/2014 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
K142898 10/06/2014 ABL800 FLEX with AQURE connectivity Radiometer Medical Aps. Lasse Post Moller
K143000 10/17/2014 RIS500 RAY CO.,LTD KYUNGHA SEO
K142960 10/14/2014 Propeller System 2014-R Reciprocal Labs David Hubanks
K142867 10/01/2014 Reliance Posterior Cervical-Thoracic System Reliance Medical Systems, LLC Bret M. Berry
K143126 10/31/2014 Renovis S141 Lumbar Interbody Cage System Renovis Surgical Technologies Josh Brown
K142988 10/16/2014 Sleepware G3 RESPIRONICS, INC. DANIELA AIZPITARTE
K143029 10/21/2014 Digital Diagnostic X-ray System (GC80) SAMSUNG ELECTRONICS CO., LTD. KIM CHULSIN
K143089 10/28/2014 WS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K143094 10/28/2014 QuantaFlo SEMLER SCIENTIFIC, INC. BOB MCRAE
K142992 10/16/2014 TULIP Natural Rubber Latex Surgeon's Glove (Powdered) SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD Xiaoyan Wang
K142924 10/08/2014 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family SHASER, INC. ANTHONY BURNS
K142892 10/03/2014 Powder-free Clear Vinyl Patient Examination Gloves Shenyi(Shandong) Plastic Products, Co.Ltd Tyler Li
K142976 10/14/2014 UltraTENS Shenzhen Dongdixin Technology Co., Ltd Qilian Liu
K142864 10/01/2014 ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) SIEMENS HEALTHCARE DIAGNOSTICS, INC. Fatima Pacheco
K142878 10/02/2014 IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Donna Velasquez
K142876 10/01/2014 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems SIEMENS MEDICAL SOLUTIONS USA, INC. NANCY BURKE
K142955 10/14/2014 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power SIEMENS MEDICAL SOLUTIONS USA, INC. Kimberly Mangum
K143072 10/27/2014 ENROUTE Transcarotid Neuroprotection System SILK ROAD MEDICAL, INC Richard M Ruedy
K142948 10/10/2014 BIOSURE REGENESORB interference Screw Smith & Nephew, Inc Vivek Mukhatyar
K142979 10/15/2014 RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters SMITH & NEPHEW, INC. Laurea Reynolds
K143133 10/31/2014 RENASYS? EZ MAX Negative Pressure Wound Therapy Device, RENASYS? AB Abdominal Dressing Kit with Soft Port Device SMITH & NEPHEW, INC. LAURA REYNOLDS
K143096 10/28/2014 SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA Smith & Nephew, Inc. Jeff Sprague
K143115 10/30/2014 The VersaJet II Hydrosurgery System SMITH & NEPHEW, INC. Laura Reynolds
K143050 10/23/2014 VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K142908 10/06/2014 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh SOFRADIM PRODUCTION Eric Jague
K142900 10/06/2014 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh SOFRADIM PRODUCTION Eric Jague
K143042 10/22/2014 SonarMed AirWave, Airway Monitoring System SONARMED, INC. Laura Lyons
K142945 10/10/2014 Sonoma Fibula Repair System SONOMA ORTHOPEDIC PRODUCTS, INC. RICK EPSTEIN
K142995 10/16/2014 SOPIX SOPRO - ACTEON GROUP PHILIPPE BOYER
K142980 10/15/2014 Proficient (TM) Facet Screw Spine System SPINE WAVE, INC. ROAIDA JOHNSON
K142996 10/16/2014 StaXx(R) XD System SPINE WAVE, INC. Roaida Johnson
K142909 10/06/2014 Flexible 19G EBUS Needle SPIRATION, INC. Cyndy J Adams
K142890 10/03/2014 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Singl STRAUMANN USA, LLC Jennifer M. Jackson
K143085 10/27/2014 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach STRYKER ORTHOPAEDICS Denise Daugert
K143063 10/24/2014 Stryker SonicPin System, Stryker SonicAnchor System STRYKER TRAUMA GMBH Estela Celi
K142984 10/16/2014 Leo Minor SUNNEX, INC. TISH MENDICK
K143078 10/27/2014 Bookwalter Gordon Adjustable Compression Element SYMMETRY SURGICAL Victoria Rogers
K143123 10/31/2014 Synergetics PHOTON EX Synergetics Dan Regan
K143090 10/28/2014 LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID TALLADIUM, INC. ELINA FASKHUTDINOVA
K143004 10/20/2014 VENTURI MiNO TG600/14 TALLEY GROUP LTD. ROBERT WILLIAM MACDONALD
K142954 10/10/2014 PTA 14 Balloon Dilatation Catheter OTW Texas Medical Technologies, Inc. Aaron Chiu
K143051 10/23/2014 ArgenIS Titanium Abutments THE ARGEN CORPORATION Maria Rao
K143118 10/30/2014 Human Microalbumin kit for use on SPAPLUS THE BINDING SITE GROUP LTD Marianne Sender
K142894 10/03/2014 TCS Blend Thermoplastic Comfort Systems, Inc. Marilin Posca
K142940 10/09/2014 Endoskeleton TCS System TITAN SPINE, LLC Jane Rodd
K143059 10/24/2014 TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) TONE-A-MATIC INTERNATIONAL INC. MANUEL CHUCK
K142901 10/14/2014 RhythmView Workstation Topera, Inc. Dennis Pozzo
K143008 10/20/2014 Vantage Titan 3T TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143046 10/22/2014 Xario 100, V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143027 10/21/2014 Xario 200, V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143075 10/27/2014 ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set TOSOH BIOSCIENCE, INC. ROBERT L WICK
K143113 10/30/2014 Klassic BiPolar System Total Joint Orthopedics Chris Weaber
K142926 10/08/2014 iBreastExam UE LIFESCIENCES, INC. MIHIR SHAH
K143043 10/22/2014 Tanning Lamp UNILAM CO., LTD. YoungBoo Cho
K143038 10/22/2014 Gel-Block 10X embolization pledgets VASCULAR SOLUTIONS, INC. ADAM ETTL
K142946 10/10/2014 TIVA Velano Vascular, Inc. Tiffini Diage
K142965 10/14/2014 Virtuoso System for IHC PR (1E2) using iScan HT Ventana Medical Systems, Inc. Morteza Minaee
K142910 10/06/2014 Legacy BX Venus Concept USA Inc. Lilia Schlosberg
K143079 10/27/2014 Endovascular Stent Planning Software VITAL IMAGES, INC. Parthiv Shah
K142919 10/08/2014 EXA Viztek LLC Josip Cermin
K143122 10/31/2014 Volcano iFR Harvest Software (Offline) Volcano Corporation Neeta Sharma
K142923 10/08/2014 TraumaCad Mobile Release 1.0 Voyant Health Ltd Yael Guttentag
K142950 10/10/2014 Acrobat Calibrated Tip Wire Guide Wilson-Cook Medical, Inc Doris A Hawks
K143025 10/21/2014 TOTAL COMPRESSION PLATING SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. Jeanine Redden
K143055 10/23/2014 Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla YTY INDUSTRY (MANJUNG) SDN. BHD. Arivalagan Subramaniam
K143052 10/23/2014 Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. Wen-Han Chen
K143066 10/24/2014 Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers ZIMMER, INC. PATRICK MCULLAGH
K142915 10/07/2014 ZOLL X Series ZOLL MEDICAL CORPORATION Tammay Shukla


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