BEUDAMED
    18 results · 18ms · Sources: EU EUDAMED, US FDA

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    ASSISTO ARM SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Neurology

    PHILIPS BV26 MOBILE C-ARM STAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    GDM B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    Total Gym Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·1 Manufacturer·1 Device

    GRI-Alleset Limited B.V.

    Authorized representative
    🇳🇱 Netherlands·1 Manufacturer·2024 Devices

    Arm slings

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·MIXED.Industries B.V.·1 device

    Arm Sling

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Lomed Nederland·3 devices

    Free Lock (gripping system for arm prosthesis / arm orthosis)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Stel Orthopedie·2 devices

    More2C camera arm

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ECG Excellence BV·1 device

    GRI-Alleset Limited B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    Pakpaal met papegaai arm

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Aleidis Specials B.V.·1 device

    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

    FDA Enforcement
    Class II ·Ongoing·IHB OPERATIONS B.V.·December 13, 2023

    Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 27, 2023

    Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722026 Allura Xper FD10 722028 Allura Xper FD20 722033 Allura Xper FD10 OR Table 722035 Allura Xper FD20 OR Table 722043 Integris Allura 15 & 12 (monoplane) 72246 Poly G - OMCP - VISUB - CCD (H5000)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 27, 2023

    Azurion 7 M20. Fluoroscopic X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·July 30, 2025

    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices