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

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    Hexanium ACIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATOM 1 (MODEL: BRC 2200)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·November 3, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 18, 2011

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 1, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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