BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    OPUS FT4 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    XLIF

    FDA UDI
    Nuvasive, Inc.·00887517840776·XLIF XL Paddle Sizer, 7mm Bullleted

    FIXOS

    FDA UDI
    Stryker GmbH·07613327083187·Drawer Tag - 4.0 mm Instruments

    TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HIOSSEN PROSTHETIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·December 17, 2010

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code JDQ·July 17, 2014

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·December 19, 2012

    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