BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    STERI-OSS DRILLS AND TAPS

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SEROMA-CATH CLOSE DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·November 29, 2010

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NEK·January 9, 2013

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·July 7, 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