BEUDAMED
    7 results · 33ms · Sources: EU EUDAMED, US FDA

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    ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEGION Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TELEFLEX GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·February 8, 2013

    ZEVEX INFINITY PUMP

    FDA Adverse Event
    Injury ·MOOG·Product code LZH·December 29, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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