FDA applicant
FUJIFILM Healthcare Americas Corporation
FDA records 13 decisions for FUJIFILM Healthcare Americas Corporation (Lexington, MA) from 2023 to 2026: 13 510(k) clearances. Most are in product codes FDA (Enteroscope And Accessories) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 2 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 FUJIFILM Healthcare Americas Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like FUJIFILM Healthcare Americas Corporation’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 “FUJIFILM”
FDA records each applicant name separately; these may or may not be the same firm.