BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE MANUAL RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AquaC UNO H

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

    IMAGECHECKER CT CAD SOFTWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNK CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·April 8, 2019

    NC QUANTUM APEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·February 5, 2013

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·December 14, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2014

    OPERATING CYSTOSCOPE-URETHROSCOPE

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

    CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·October 10, 2018

    12.0MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code JDS·November 1, 2016

    Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44

    FDA Enforcement
    Class II ·Ongoing·Steris Corporation·May 10, 2023

    ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·June 28, 2019