BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    AMYLASE (ETHYLIDENE PNGPG7) KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RDI HSFERRITIN KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    M-Fix Acromioclavicular Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)

    FDA Enforcement
    Class II ·Terminated·R82 A/S·May 22, 2019

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2014

    CE INFUSOR LV10, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·January 7, 2011

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·August 8, 2025

    Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)

    FDA Recall
    Terminated ·Product code INM·March 28, 2019