BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    OptiMesh Multiplanar Expandable Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARVIEW TOTAL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARVIEW UTERINE MANIPULATOR

    FDA Adverse Event
    Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·September 1, 2011

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022