BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    LACTATE DEHYDROGENASE (LDH-L)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SILIC FOLEY CATH 5/15ML/5

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·August 8, 2014

    CONTROLLER, SERVO, INSPIRON

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PTFE SURGICAL SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·October 25, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 19, 2012

    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    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