FDA applicant
Opxion Technology, Inc.
FDA records 1 decision for Opxion Technology, Inc. (New Taipei City, TW) in 2025: 1 510(k) clearance. All are in product code NQQ (System, Imaging, Optical Coherence Tomography…). Its devices cite 1 predicate, 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 Opxion Technology, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Opxion Technology, Inc.’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) Report