BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    TSolution One w/ACG+ Surgical System

    FDA 510(k)
    FDA Class 2 ·Neurology

    DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES

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

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 15, 2017

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 7, 2011

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 8, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

    UNK BACTISEAL EVD CATHETER

    FDA Adverse Event
    Injury ·Product code JXG·November 14, 2017

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023