BEUDAMED
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    EMIT ST URINE CANNABINOID ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HELICOBACTER PYLORI IGG ELISA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PINNACLE SECTOR II CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 30, 2014

    CLICK X

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·November 21, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2015

    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