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

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    MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ambu USR, Ambu M

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

    2520274-2013-10186

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

    PORTEX 7.0MM SUCTIONAID TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL LTD.·Product code BTO·December 17, 2010

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·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