BEUDAMED
    8 results · 32ms · Sources: EU EUDAMED, US FDA

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    CKHEMO, MODEL CKHEMO VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NEVYAS AUTOPRESS EYE COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DENTAL ROOT ELEVATOR

    FDA 510(k)
    FDA Class 2 ·Dental

    HAMILTON C-2

    FDA Adverse Event
    HAMILTON MEDICAL·Product code CBK·February 27, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 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