BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY

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

    LONG LENGTH DYAX NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELM PTA BALLON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 9, 2017

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 14, 2014

    SYNERGY

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 12, 2010

    CUSTOM PAK

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code KYG·January 9, 2013

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2025

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 23, 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