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

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    CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074465456·CDH 7191835 HA COATED 8.5X35

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741918350·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674191835060·

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180543634·35mm Cervical Tooth Blade, Wide

    PLATEAU SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079

    FDA 510(k)
    FDA Class 2 ·Neurology

    DRIVER; SIZE 10

    FDA Adverse Event
    Malfunction ·K2M, INC.·Product code LXH·July 12, 2022

    QUICKFLEX XL LV LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, CRMD·Product code NIK·January 13, 2014

    CS100

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.,·Product code DSP·July 29, 2011

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 26, 2013

    GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·November 18, 2015

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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