BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    COLORADO NEEDLE ELECTRODE

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

    VIVALITH 5, - MDL-201A & TDL-201A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    FUJIFILM Ultrasonic Endoscope

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTRASONIC DISSECTOR

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code LFL·May 27, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 11, 2010

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MED CORP·Product code MKJ·November 6, 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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020