BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    BANANA CUFF

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

    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE

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

    STOCKERTIR PURGE CONTROL (APC) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 30, 2014

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION (SULLIVAN LAKE)·Product code LGW·November 21, 2012

    CYLOS DR

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·September 17, 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

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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