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

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    GENNY DENNY IV SHIELD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 13, 2024

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 9, 2013

    SPACEMAKER EXTRA VIEW BALLOON - OVAL

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GCJ·November 16, 2010

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 13, 2024

    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