BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    Side stream EtCO2 Module for QMAPP

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

    SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

    FDA 510(k)
    FDA Class 2 ·Radiology

    HIGH SPEED EMG MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Corsano Health BV

    Authorized representative
    🇳🇱 Netherlands·1 Manufacturer

    Universal Actuator Modules

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Focal Meditech BV·6 devices

    Patient Identification Module (PIM)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Cablon Medical B.V.·1 device

    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

    BD Kiestra" ReadA; Catalog No.: 446948.

    FDA Enforcement
    Class II ·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026

    IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·May 14, 2025

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026