BEUDAMED
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    BACTIGEN - N.MENNINIGITIDIS TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRIO MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 30, 2014

    KONA

    FDA Adverse Event
    Injury ·RADIANCY LTD.·Product code GEX·November 14, 2012

    CAPSURE SP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 23, 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