5 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
FDA Enforcement
Class II
·Ongoing·Contego Medical LLC·October 22, 2025
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
FDA Enforcement
Class II
·Ongoing·Biocartis Nv·January 22, 2025
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
FDA Enforcement
Class II
·Ongoing·BARCO NV·October 5, 2022
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)
FDA Enforcement
Class II
·Ongoing·Agfa Healthcare NV·October 16, 2024
Agfa HealthCare Enterprise Imaging XERO Viewer
FDA Enforcement
Class II
·Ongoing·Agfa Healthcare NV·February 1, 2023