BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODEL 8500 HAND HELD PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TOXOELISA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II

    FDA 510(k)
    FDA Class 2 ·Dental

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·June 25, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 2, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 2, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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