FDA applicant
Coreleader Biotech Co., Ltd.
FDA records 9 decisions for Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW) from 2011 to 2015: 9 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and QSY (Hemostatic Wound Dressing Without Thrombin Or…). 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 Coreleader Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
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