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

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    Carestream DRX-1 System with DRX Plus 4343 Detectors

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPACELABS MULTI-PARAMETER MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMBU MARK IV BABY RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013

    VIPER MIS CANNULATED POLYAXIAL SCREW 6X45MM

    FDA Adverse Event
    Malfunction ·DEPUY SPINE, INC.·Product code NKB·June 17, 2011

    POLYFLUX LR CAPILLARY DIALZYER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023