BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124627·Modular Offset Stem 17mm x 150mm x 4mm

    IVENT101

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WRIST FUSION PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN VALVE/SHUNT

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·September 25, 2015

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 8, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019