BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Diamond Orthopedic Bone Fixation Screws and Pins

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SignaLoc Screw

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215116828·

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    MOSAIC LASER SYSTEM

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

    INCLUSIVE MINI IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013

    SYNCHRON LX I 725

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGA·July 1, 2011

    INTELECT ADVANCED COMBO MONOCHROME

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 29, 2008

    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019