BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    ACCULIF TL CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hand Pump Aluminium

    FDA UDI
    Noras MRI products GmbH·04251269201523·

    SYNAPSE 3D CARDIAC TOOLS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·October 2, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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