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

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    CIBA CORNING ACS FT3 IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MANDREL GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EBI ESL SPINE SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COONRAD/MORREY ULNAR ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDB·December 21, 2010

    ARTEFILL DERMAL FILLER

    FDA Adverse Event
    Injury ·SUNEVA MEDICAL INC.·Product code LMH·January 30, 2013

    BONE SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·July 17, 2014

    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