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

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    FDA 510(k)
    FDA Class 1 ·Microbiology

    RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS

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

    Aurora Surgiscope System

    FDA 510(k)
    FDA Class 2 ·Neurology

    GORE VIABAHN® ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code NIP·June 18, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·October 26, 2010

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·December 20, 2012

    Various Laparoscopy Packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Various convenience packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    Various convenience packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    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