BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    BLOOD GAS MIXTURE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Hematology

    ELECTONE/PA RECHARGEABLE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LIX·June 23, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·December 8, 2010

    11/13 S-ROM 44MM M SPEC+6

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 22, 2013

    Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FRC·February 17, 2012

    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