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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ProFlu+ Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 2, 2020

    ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERRAD SEALSURE CHEMICAL INDICATOR TAPE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DRA·October 8, 2014

    SCREW-IN

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

    ACTIVA RC

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·June 28, 2011

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·October 27, 2022

    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

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021