BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    K-CAP-E, STERILE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACRA-CUT WIRE PASS DRILL

    FDA 510(k)
    FDA Class 2 ·Neurology

    COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE

    FDA 510(k)
    FDA Class 2 ·Dental

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL INC.·Product code FPA·July 3, 2024

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 15, 2015

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 15, 2013

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 4, 2014

    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

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021