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

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    Cryocare CS Surgical System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 20, 2020

    GE VEO RECONSTRUCTION OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CURRENT VR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 8, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 7, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew Inc.·December 11, 2024

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021

    DIDECO EOS ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021

    SORIN LIFEKIT D905 EOS ECMO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Injury ·CONMED UTICA·Product code GEI·May 18, 2023

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022

    DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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