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

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    Filters Regulation: Us FDA ×

    Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cellusheet, Cellufil

    FDA 510(k)
    FDA Unclassified ·Unknown

    THE GNATHOMETER

    FDA 510(k)
    FDA Class 2 ·Dental

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 18, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    SROM*STM ST,36+8L NK,18X13X160

    FDA Adverse Event
    Malfunction ·DEPUY (IRELAND) - 9616671·Product code JDI·July 18, 2013

    CD HORIZON SOLERA 5.5/6.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·July 1, 2025

    CD HORIZON SOLERA 5.5/6.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·April 22, 2024

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025