BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    MicroSTAAR Injector System Cartridges

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PATHWAY - ATS/CHEPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    VESSEL GUARDIAN

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 7, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 24, 2011

    LLD #1

    FDA Adverse Event
    Malfunction ·SPECTRANETICS·Product code MFA·August 21, 2008

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024