BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    Metal Bone Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    priti®multidisc ZrO2

    FDA UDI
    Pritidenta GmbH·04251366905003·

    Tizian Blank 5.0

    FDA UDI
    Pritidenta GmbH·04251366906048·

    NEEDLE 22GA 1-1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·June 12, 2025

    NEEDLE 22GA 1-1/2IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·June 12, 2025

    NO-POKES NEEDLE SAFETY DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLEVER CHOICE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·October 16, 2022

    BOSTON SCIENTIFIC INTRODUCER MODEL # 5661ST

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC/GUIDANT·Product code DYB·November 4, 2008

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    INVAMEX·Product code IOR·August 23, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2013

    HEARTSTART MRX MONITOR/DEFIB

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MKJ·December 18, 2023

    CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 27, 2025

    CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 27, 2025

    CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 27, 2025

    HEARTSTART MRX MONITOR/DEFIB

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MKJ·February 5, 2023

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 30, 2025

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 23, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025