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

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    Medical Face Mask (M001)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD ULTRA-FINE¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 26, 2023

    ImageSPECTRUM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VISIONS PV .035 DITITAL IVUS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·March 21, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·November 3, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·August 17, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 28, 2013

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021