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

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    AUTO REFF-30

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    3M™ ESPE™

    FDA UDI
    3M COMPANY·30605861031333·3M™ ESPE™ Gold Anodized Crown Refills, First Bi...

    Terumo Pen Injector Needle 34

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RS85 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOFINITY TORIC (COMFILCON A)

    FDA Adverse Event
    Injury ·COOPERVISION MANUFACTURING, LTD.·Product code LPM·December 21, 2010

    DRILL SLEEVE AXSOS 4.0MM LOCKING SET

    FDA Adverse Event
    Malfunction ·STRYKER GMBH (MDR)·Product code LXH·July 17, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W.L. GORE & ASSOCIATES·Product code MIH·December 20, 2012

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020

    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