BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Self-adhesive Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    TM2000, MODEL 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ear Thermometer, Model ET001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BASIX COMPAK INFLATION SYRINGE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 27, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 17, 2011

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code NJL·October 30, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019