BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    WOUND CARE TRAY A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPECTRA OPTIA APHERESIS SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 24, 2010

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 3, 2014

    ACCU-CHEK TENDER LINK

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·December 21, 2012

    ARCOS MODULAR REVISION SYSTEM CONE PROXIMAL BODY TYPE 1 TAPER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·February 22, 2017

    ACTIVE ARTICULATION HIP SYSTEM DUAL MOBILITY BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·February 22, 2017

    G7 OSSEOTI ACETABULAR SHELL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·February 22, 2017

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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