4 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Enforcement
Class II
·Terminated·Stereotaxis Inc·November 18, 2020
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·October 11, 2023
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020