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

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    SITE DIAPHRAGM CASSETTE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471183797·K-WIRE - SINGLE TROCAR 1.8mm DIA x 150mm

    MONOCLONAL ANTIBODY ANTI-CD19

    FDA 510(k)
    FDA Class 2 ·Hematology

    BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DURALOC 100 SERIES 56MM OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 9, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 15, 2010

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 6, 2026

    Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    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