BEUDAMED
    4 results · 7ms · Sources: EU EUDAMED, US FDA

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

    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·August 31, 2022

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Enforcement
    Class II ·Ongoing·DRE Medical Group Inc·July 5, 2023

    Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

    FDA Enforcement
    Class II ·Ongoing·SIN SISTEMA DE IMPLANTE NACIONAL S.A·January 22, 2025

    PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

    FDA Enforcement
    Class II ·Ongoing·Oculus Technologies of Mexico, S.A. de C.V.·June 10, 2026