BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    SURGICAL DRILL BITS

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    INION OTPS BIODEGRADABLE PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    A-TONE IPL SYSTEM

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 26, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012

    S.M.A.R.T. NITINOL STENT SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code FGE·September 13, 2010

    T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadmill is intended for use in Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems Ultrasound & Primary Care Diagnostics, LL·July 25, 2018

    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