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

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    RESTORATION HA ACETABULAR CUP SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRATHIN/SP LENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PICOALEX

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

    UNK CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·April 8, 2019

    INTEGRIS

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code JAA·January 23, 2013

    IAB: 8 FR - 40 CC

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·December 3, 2010

    UNIFY CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 18, 2014

    CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·October 10, 2018

    ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·June 28, 2019

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025