BEUDAMED
    22 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Netherlands ×

    IntelliSpace Cardiovascular 5

    Device
    EU MDR · Eu Md Class 2a ·Philips Medical Systems Nederland B.V.·On the market·30 countries

    IntelliSpace Cardiovascular 6

    Device
    EU MDR · Eu Md Class 2a ·Philips Medical Systems Nederland B.V.·On the market·30 countries

    IntelliSpace Cardiovascular 7

    Device
    EU MDR · Eu Md Class 2a ·Philips Medical Systems Nederland B.V.·On the market·30 countries

    IntelliSpace Cardiovascular 8

    Device
    EU MDR · Eu Md Class 2a ·Philips Medical Systems Nederland B.V.·On the market·31 countries

    Philips IntelliSpace Cardiovascular

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips IntelliSpace Cardiovascular

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cardiovascular Monitoring Application Software

    Device
    EU MDD · Eu Md Class 2a ·Happitech·On the market·1 country

    IntelliSpace Cardiovascular

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Philips Medical Systems Nederland B.V.·4 devices

    Circle Cardiovascular Imaging B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    Circle Cardiovascular Imaging B.V.

    Authorized representative
    🇳🇱 Netherlands·2 Manufacturers·7 Devices

    QDossier B.V.

    Authorized representative
    🇳🇱 Netherlands·2 Manufacturers·9 Devices

    Philips IntelliSpace Cardiovascular software, Model 830089.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·March 12, 2025

    IntelliSpace Cardiovascular, Software 8.0.0.4.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·September 17, 2025

    Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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

    Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 Allura Xper FD20 722013 Allura XPER FD20 BIPLANE 722014 Allura Xper FD10 OR Table 722015 Allura Xper FD20 OR Table 722019 Allura Xper FD10/10 OR Table 722020 Allura Xper FD20 Biplane OR Table 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722024 Allura Xper FD10/10 OR Table 722025 Allura Xper FD20 Biplane OR Table 722026 Allura Xper FD10 722027 Allura Xper FD10/10 722028 Allura Xper FD20 722029 Allura Xper FD20/10 722031 Allura CV20 722033 Allura Xper FD10 OR Table 722034 Allura Xper FD10/10 OR Table 722035 Allura Xper FD20 OR Table 722036 Allura Xper FD20/10 OR Table 722038 Allura Xper FD20/20 722039 Allura Xper FD20/20 OR Table 722058 Allura Xper FD20/15 722059 Allura Xper FD20/15 OR Table 722123 Field extensions Xper cardio 722124 Field extensions Xper vascular 722126 SmartPath to upgrade Allura to AlluraClarity cardio 722127 SmartPath to upgrade Allura to AlluraClarity vascular 722133 Field ext. Xper cardio systems R7.6 722134 Field ext. Xper vascular systems 722400 Cardio Vascular-Allura Centron 722030 INTEGRIS CV 722043 INTEGRIS Allura 15-12 (mono) 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

    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

    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

    3mensio Workstation (Vascular Fenestrated) software

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