BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    ATAC 1500 CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014

    ULTIMAT L4 X L4, LIEBEL-FLARSHEIM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXICLIP EXCS-M

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 15, 2010

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MPRI·Product code DTB·December 12, 2012

    S-ICD SYSTEM

    FDA Adverse Event
    Malfunction ·CAMERON HEALTH·Product code LWS·June 24, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024