BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    SHILEY SPECIALIZED TRACHEOSTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 24, 2014

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·October 22, 2010

    UNIFY QUADRA, CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·December 28, 2012

    Bivona Aire-Cuf Endotracheal Tube

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 3, 2021