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

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    Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIGITAL FOREHEAD THERMOMETER, MODEL FS-100

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code OTN·May 23, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 27, 2014

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·June 29, 2011

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024