BEUDAMED
    33 results · 27ms · Sources: EU EUDAMED, US FDA

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    NEUROLAC NERVE GUIDE

    FDA 510(k)
    FDA Class 2 ·Neurology

    E - Guide Tint

    Device
    EU MDR · Eu Md Class 1 ·Vertex-Dental B.V.·On the market

    NEUROLAC(R) NERVE GUIDE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Primum Hydrophilic Guiding Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

    FDA 510(k)
    FDA Class 2 ·Neurology

    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

    FDA Enforcement
    Class II ·Terminated·Nucletron BV·January 8, 2020

    Surgical Guide Resins, Photo-Cured

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Vertex-Dental B.V.·7 devices

    Azurion 7 M20. X-ray Image guided Therapy System.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 9, 2023

    Philips Medical Systems Nederland B.V.

    Authorized representative
    🇳🇱 Netherlands·21 Manufacturers·1029 Devices

    Allura CV20 System Code: 722031

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    AlluraXperFD20/10 System Code: (1) 722029

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    Allura Xper FD10C System Code: (1) 722001

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    Allura Xper FD20/20 System Code: (1) 722038

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    AlluraXperFD20/15 System Code: (1) 722058

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    Azurion 3 M12 System Code: (1) 722063 (2) 722221

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    Azurion 5 M12 System Code: (1) 722227 (2) 722231

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025

    Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 12, 2025