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

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    REUMAGEN ASL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209136568·

    EMIT PHENYTOIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LANDERS VITRECTOMY LENS RING SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 9, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 5, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 3, 2012

    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