BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    GAMBRO PULSATILE MONITOR PLM 10-200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707064947·TUBE MIM CONV 22/51 T-10 R+8 UL

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707058434·DB TUBE MIM CONV 22/51 T-10 R+8 UL

    IMED-Z FLUID STATUS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·June 2, 2014

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·November 21, 2012

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·August 31, 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