BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    X°Port Lung Preservation System; X°Port Lung Preservation Solution

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Access hsTnI

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OnPoint Augmented Reality Spine System

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 17, 2018

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 12, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 11, 2014

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·July 23, 2013

    TECNIS SYNERGY OPTIBLUE IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code POE·September 23, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019