FDA applicant
Braxx Biotech Co., Ltd.
FDA records 2 decisions for Braxx Biotech Co., Ltd. (Taipei City, TW) from 2019 to 2024: 2 510(k) clearances. All are in product code JAQ (System, Applicator, Radionuclide…). Its devices cite 1 predicate, 1 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 Braxx Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Braxx Biotech Co., Ltd.’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