BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    Hana/ProFx Traction Boot Large (pr)

    FDA UDI
    MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430106651·Left and Right boots

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678405·Proximity 4-Level ACP, 86 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678436·Proximity 4-Level ACP, 86 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678412·Proximity 4-Level X-Lordotic ACP, 86 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376678429·Proximity 4-Level X-Lordotic ACP, 86 mm

    Halo

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROTECT TOOTH DESENSITIZER

    FDA 510(k)
    FDA Class 2 ·Dental

    RECONSTITUTION DEVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·October 1, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012

    4F PEDIATRIC PIGTAIL CATHETER

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL, INC.·Product code DQO·May 29, 2014

    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