FDA applicant
A Plus Biotechnology Co., Ltd.
FDA records 3 decisions for A Plus Biotechnology Co., Ltd. (New Taipei City, TW) from 2023 to 2026: 3 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 21 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 A Plus Biotechnology Co., Ltd.’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 2023.
Planning a device like A Plus Biotechnology 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