BEUDAMED
    9 results · 18ms · 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.

    OHMEDA CONTINUOUS SUCTION REGULATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K883239

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2009

    CAPD DISP DISCONNECT, UV FLASH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008

    E.S TECK ( ELECTRO SENSOR TECK)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Argen Clear Aligner

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·October 20, 2010

    CORAIL HA W/O COLLAR S11 145MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code KWA·December 21, 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