BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    MODEL 704

    FDA 510(k)
    FDA Class 2 ·Neurology

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080792·Inserter Sleeve

    THE CANARY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    VAMOS ANESTHETIC GAS MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 2, 2010

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·January 11, 2013

    ENERGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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