BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    VIVID T8/VIVID T8 PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNUM INSTRUMENTATION

    FDA UDI
    Biomet Uk Ltd·05019279440283·

    M2a-Magnum™

    FDA UDI
    Biomet Orthopedics, LLC·00887868474293·

    HEARTSINE SAMARITAN PAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 3, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    E360 VENTILATOR

    FDA Adverse Event
    Other ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·June 15, 2011

    ARTEFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL, INC.·Product code LMH·September 16, 2022

    INVISION¿ TOTAL ANKLE SYSTEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 18, 2022

    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