BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    SUTURE REMOVAL SET(DISPLSABLE)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996180436·28Lx11Wx08H TRIAL,TIGER SHARK STRAIGHT

    HARDYDISK BACITRACIN, 10MCG, MODEL Z927

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAXTER INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code FGE·August 23, 2010

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LNH·March 16, 2018

    Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018