BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DJ ORTHOPEDICS POST SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE

    FDA 510(k)
    FDA Class 2 ·Dental

    Cook

    FDA UDI
    COOK INCORPORATED·00827002085398·Central Venous Catheter Set

    Cook

    FDA UDI
    COOK INCORPORATED·00827002085404·Central Venous Catheter Set

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·April 11, 2013

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 8, 2014

    ASCENSIA CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 1, 2008

    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