BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    GONOPOX TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Y-CLICK CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANESTHESIA KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    2520274-2013-10067

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code MNI·February 11, 2013

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·December 16, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 28, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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