FDA applicant
Trident S.R.L
FDA records 5 decisions for Trident S.R.L (Castenedolo, IT) from 2016 to 2023: 5 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and OAS (X-Ray, Tomography, Computed, Dental). Since 2016 its 510(k)s took a median of 36 days from receipt to decision, against 47 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Trident S.R.L’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Trident S.R.L’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Trident”
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