BEUDAMED
    8 results · 35ms · Sources: EU EUDAMED, US FDA

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    MALLEABLE PTFE COATED BRAIN SPATULAE

    FDA 510(k)
    FDA Class 1 ·Neurology

    RADIATION THERAPY TREAT. PLAN. SYS.

    FDA 510(k)
    FDA Class 2 ·Radiology

    TABATABA COTESTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 19, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·December 19, 2012

    Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    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