BEUDAMED
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    Filters Classification: Class Ii × Country: Netherlands × Clear all

    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

    FDA Enforcement
    Class II ·Ongoing·IHB OPERATIONS B.V.·December 13, 2023

    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

    FDA Enforcement
    Class II ·Completed·CardioTek BV·July 12, 2017

    Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 14, 2024

    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Nucletron BV·November 1, 2017

    Intera 1.5T, Model Numbers: 781195 and 781295;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·April 24, 2019

    Allura Xper FD10 and FD20. X-ray Imaging System.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 9, 2023

    SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023

    2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023

    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.

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

    OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·July 4, 2018

    OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·July 4, 2018

    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 20, 2023

    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

    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

    FDA Enforcement
    Class II ·Terminated·Nucletron BV·January 8, 2020

    SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·March 6, 2019

    Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 6, 2023

    Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.

    FDA Enforcement
    Class II ·Ongoing·MOTEK MEDICAL B.V.·June 3, 2020

    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024

    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