BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    POLYURETHANE SOLUTION 29% W/W

    FDA 510(k)
    FDA Class 2 ·Dental

    AZIDE AGAR W/5% SHEEP BLOOD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AUTOMASTER

    FDA 510(k)

    POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·February 6, 2013

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·July 18, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 3, 2011

    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