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

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    MS-30 AUTOMATIC PERIMETER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MaxZero Administration Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIGHT DRAPE

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

    IACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 21, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·UNKNOWN MANUFACTURING FACILITY·Product code FKX·December 31, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2014

    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