BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    CONVAID - SPEECH AID

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340347907·SS VA LOCKING SCREW L28MM D5MM

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340346788·SS VA LOCKING SCREW L28MM D5MM STERILE

    MODIFICATION TO EPTFE GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 13, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 20, 2020

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·November 21, 2012

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 30, 2014

    X-STOP IPD SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC·Product code NQO·September 14, 2010

    MAXIFLO ULTRATHIN WITH UNITY CONTRUCTION

    FDA Adverse Event
    Injury ·VASCUTEK LTD.·Product code DSY·August 27, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 16, 2018

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 7, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 30, 2021

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·March 30, 2018

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 27, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 23, 2023

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 18, 2019

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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