BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    PERCUTANEOUS TRIG. FINGER RELEASE KNIFE

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

    LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONSTRAINED VANGUARD DCM TIBIAL BEARING 12MM X 63/67MM

    FDA Adverse Event
    Death ·BIOMET ORTHOPEDICS·Product code JWH·October 14, 2016

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 30, 2014

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 18, 2012

    GRASEBY MS26 SYRINGE DRIVER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code FRN·September 16, 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