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

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    TomoTherapy Treatment Delivery System with iDMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RADIAL ARTERY COMPRESSION TOURNIQUET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACL TIGHTROPE DOUBLE BUNDLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

    6000 CMS IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 23, 2013

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·July 22, 2011

    ENDURANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·February 5, 2018

    RHYTHMIA HDX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

    Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·November 20, 2013

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·Product code DQX·May 21, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·December 28, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 17, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 3, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·October 31, 2023