BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    AOR X-RAY ALIGMENT PAD

    FDA 510(k)
    FDA Class 1 ·Radiology

    CAPNOGRAPH

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MICROFIL CONTOURING INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Dental

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 7, 2012

    THERAKOS CELLEX SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·March 5, 2014

    ALTA MALLET NO REPLACEMENT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·September 14, 2010

    GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·November 21, 2018

    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