BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor

    FDA 510(k)
    FDA Class 2 ·Dental

    ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM

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

    MILESTONE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    AUTOSYRINGE INFUSION PUMP MODEL AS50

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 26, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 11, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025