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

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    SHILEY BCD PLUS HEAT EXCHANGER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457233473·Internal Hex FD

    LaVid FMTS DIAGNOSTIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROFEMUR LX REVISION 5/8 COATED HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    ENDOPATH** XCEL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 25, 2010

    PROMOTE PLUS CRT-D, DF-4 CONNECTOR

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

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 19, 2012

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL 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