BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    LUMINOS AGILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Base Plate

    FDA UDI
    Noras MRI products GmbH·04251269201745·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776164621·Murphy Gall Bladder Retractor , blade wide

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089402946·

    INSYTE AUTOG BC WING PNK 20GA X 1.0IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 1, 2020

    ZIEHM VISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENGAGE/ENGAGE TR INTRODUCERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2022

    ATTUNE MEDIAL ANAT PAT 35MM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code JWH·August 15, 2024

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·May 14, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·September 23, 2014

    RENAISSANCE 26 STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·May 18, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 3, 2020

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024