BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678320·Proximity 4-Level ACP, 82 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678337·Proximity 4-Level X-Lordotic ACP, 82 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678351·Proximity 4-Level ACP, 82 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678344·Proximity 4-Level X-Lordotic ACP, 82 mm

    STEAROTHERMOHILUS SPORE STRIPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·May 20, 2014

    CXD II

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code KDJ·October 1, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 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