BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    THIOGLYCOLLATE WITHOUT INDICATOR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209104727·KIT, COMBAT LIFE SAVER - DUC

    Intellidrop

    FDA 510(k)
    FDA Class 2 ·Neurology

    VesselNavigator Rel. 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACUSNARE POLYPECTOMY SNARE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 10, 2022

    CVC SET: 3-LUMEN 7 FR X 30 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·April 18, 2014

    HANCOCK II MITRAL 25MM

    FDA Adverse Event
    Death ·HEART VALVES SANTA ANA·Product code LWR·November 29, 2012

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·MERZ AESTHETICS, INC.·Product code LMH·September 28, 2010

    ACUSNARE POLYPECTOMY SNARE SOFT

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·July 13, 2023

    ACUSNARE POLYPECTOMY SNARE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·May 4, 2022

    Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    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