BEUDAMED
    3 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 14, 2026

    Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 25, 2024

    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·March 25, 2026