BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

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    Focalyx Fusion

    FDA Enforcement
    Class II ·Ongoing·Focalyx Technologies, LLC.·February 11, 2026

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030

    FDA Enforcement
    Class II ·Ongoing·Chamberlain Technologies LLC·June 25, 2025

    SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

    FDA Enforcement
    Class II ·Ongoing·Chamberlain Technologies LLC·June 25, 2025

    SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030

    FDA Enforcement
    Class II ·Ongoing·Chamberlain Technologies LLC·June 25, 2025

    SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415

    FDA Enforcement
    Class II ·Ongoing·Chamberlain Technologies LLC·June 25, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    X-Guide Handpiece Adaptor Sleeve 3, Model P010727

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    X-Guide Handpiece Adaptor Sleeve 1, Model P010701

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·April 10, 2024

    cone-beam CT system

    FDA Enforcement
    Class II ·Ongoing·KaVo Dental Technologies LLC·May 1, 2019

    X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

    FDA Enforcement
    Class II ·Ongoing·X-NAV Technologies, LLC·November 16, 2022