FDA applicant
Trophy
FDA records 15 decisions for Trophy (Croissy-Beaubourg, FR) from 2008 to 2020: 15 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 51 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Trophy’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Trophy’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 “Trophy”
FDA records each applicant name separately; these may or may not be the same firm.