BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SURGICAL PREP RAZOR, STRAIGHT TYPE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACTIVE VERTICAL CORRECTOR APPLIANCE

    FDA 510(k)
    FDA Class 1 ·Dental

    ESCORT ECG MONITOR SIEMENS SIRECUST 466

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 16, 2014

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code EZW·December 14, 2012

    IMMULITE 2500

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJQ·October 12, 2010

    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