BEUDAMED
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    Epildream HP 4000 MED

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NUVASIVE PRECEPT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 25, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·July 12, 2013

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-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