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

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    ASTHMA MONITOR AM2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DVX SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DTRAX Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMERGE¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·February 27, 2013

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·February 7, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014

    IMPELLA 5.5

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·December 16, 2025

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026