BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET

    FDA 510(k)
    FDA Class 1 ·Dental

    FLAME PHOTOMETERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    B-1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code BTR·April 23, 2014

    SOFTCLIX® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 19, 2010

    T-PAL SPACER APPLICATOR INNER SHAFT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code LXH·December 14, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017