BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    SENSATRACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RP UCLA Abutment Waxing Sleeve, Non-Hexed

    FDA UDI
    STERNGOLD DENTAL LLC·00841549110597·The UCLA-Type Abutment is attached directly to ...

    FOLEY CATHETER INSERTION TRAY (10CC)

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

    NIIC MODEL: DX901 ASPIRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCU-CHEK ® AVIVA

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code NBW·January 9, 2013

    ANIMAS INSULIN INFUSION PUMP

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

    TELIGEN

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

    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; 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