BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310

    FDA 510(k)
    FDA Class 2 ·Dental

    SEEDNET, MODELS FP6T5, FP5T5, FP5T3

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

    MODIFICATION TO TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATE BD CHROMAGAR O-157 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

    PLATE BD CHROMAGAR O-157 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

    BLADELSS VP 11MM ST W/FIXATION

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·April 1, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 27, 2011

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    FDA Adverse Event
    Malfunction ·HILL-ROM COMPANY, INC.·Product code FNL·July 1, 2008

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022