2 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025