BEUDAMED
    4 results · 8ms · Sources: EU EUDAMED, US FDA

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    iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

    FDA Enforcement
    Class I ·Ongoing·Medical Depot Inc.·May 21, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Enforcement
    Class I ·Ongoing·Max Mobility LLC·September 24, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Enforcement
    Class I ·Ongoing·Max Mobility LLC·February 19, 2025

    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

    FDA Enforcement
    Class I ·Ongoing·FHC, Inc.·November 20, 2024