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    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.

    FDA Enforcement
    Class II ·Terminated·Claymount Assembli·July 9, 2014

    Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·June 30, 2021

    TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;

    FDA Enforcement
    Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

    3mensio Workstation (Vascular Fenestrated) software

    FDA Enforcement
    Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

    FDA Enforcement
    Class III ·Terminated·ELITech Group B.V.·October 9, 2019

    TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;

    FDA Enforcement
    Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

    TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

    FDA Enforcement
    Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

    Stomacare EasyOpener

    Device
    EU MDR · Eu Md Class 1 ·Basko Healthcare b.v.·On the market·32 countries

    Clubycare

    Device
    EU MDR · Eu Md Class 1 ·Basko Healthcare b.v.·On the market·32 countries

    Ankura

    Device
    EU MDD · Eu Md Class 3 ·LifeTech Scientific (Europe) B.V.·On the market·32 countries

    Cover cotton for Luna

    Device
    EU MDR · Eu Md Class 1 ·REBACARE B.V.·On the market

    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

    Ankura™ TAA Stent Graft System

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·LifeTech Scientific (Europe) B.V.·1 device

    Nofa Care B.V.

    Importer
    🇳🇱 Netherlands

    Sonoma Pharmaceuticals Netherlands B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    Comfortable Nederland BV

    Manufacturer
    🇳🇱 Netherlands

    Twizzler BV

    Manufacturer
    🇳🇱 Netherlands

    Maastricht Instruments

    Manufacturer
    🇳🇱 Netherlands

    Resyca B.V.

    Manufacturer
    🇳🇱 Netherlands·1 Basic UDI-DI·2 Devices

    Gynotec B.V.

    Manufacturer
    🇳🇱 Netherlands