BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    MODIFIED Q-SERIES OF TREADMILLS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628

    FDA 510(k)
    FDA Class 2 ·Hematology

    ALADIN (TM)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 19, 2014

    MITEK FMS 4.0MM ROUND BUR

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·October 20, 2010

    HEARTMATE II LVAS, EUROPE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·December 19, 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