BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    NeuroICH

    FDA 510(k)
    FDA Class 2 ·Radiology

    SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FSM·July 8, 2013

    ONCENTRA-VISIR

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOGEL PL MICRO SURGICAL GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 20, 2008

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025