50 results
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28ms
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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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HAS-BLED Score
Device
EU MDR
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Eu Md Class 2a
·Evidencio·On the market·2 countries
HAS-BLED Score for Major Bleeding Risk Calculator
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Evidencio·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
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
FDA Enforcement
Class II
·Ongoing·Technomed Europe·September 18, 2024
Allura Xper FD20/20 OR Table; System Code: 722039;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ALLURA Xper FD10F; System Code: 722002;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20/15 OR Table; System Code: 722059;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD10C; System Code: 722001;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·April 30, 2025
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·August 7, 2019
Allura Xper FD20 OR Table; Model Number: 722023;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
Allura Xper FD20; Model Number: 722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
Allura Xper FD20/10; Model Number: 722029;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
Allura Xper FD20/20; Model Number: 722038;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
Allura Xper FD10F; Model Number: 722002;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
Allura Xper FD10/10; Model Number: 722005;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
Allura Xper FD10/10; Model Number: 722011;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
Allura Xper FD10/10; Model Number: 722027;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026