BEUDAMED
    9 results · 33ms · Sources: EU EUDAMED, US FDA

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    COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAXO2+, MODEL A AND AE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MSFX Mikron Cervical Anterior Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPERATING CYSTOSCOPE-URETHROSCOPE

    FDA Adverse Event
    Death ·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS·Product code GZB·June 18, 2014

    MESH

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 30, 2013

    VERSYS HIP SYSTEM FEMORAL HEAD

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

    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