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

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    B2-MICRO CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    DUAL CHEST PAD, LEFT

    FDA UDI
    MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430101021·

    EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLOW-NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PYRAMESH® IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014

    DXTEND SCREW LOCK D4.5X30MM

    FDA Adverse Event
    Malfunction ·DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575·Product code KWS·May 30, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·November 20, 2012

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 12, 2015

    PYRAMESH IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016

    PROVOX BRUSH

    FDA Adverse Event
    Injury ·ATOS MEDICAL AB·Product code LRC·January 17, 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