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

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    KODAK EKTACHEM DTII SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450325063·

    REHASTIM 2, REHAMOVE 2

    FDA 510(k)
    FDA Class 2 ·Neurology

    MAROSIS PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLEX-NECK PERITONEAL DIALYSIS CATHETER

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code FJS·January 9, 2013

    WINGSPAN STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code NJE·December 2, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 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