FDA applicant
Li Medical Corporation, Ltd.
FDA records 3 decisions for Li Medical Corporation, Ltd. (Xizhi Dist., TW) from 2024 to 2025: 3 510(k) clearances. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and HHK (Curette, Suction, Endometrial (And Accessories)). Its devices cite 3 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 Li Medical Corporation, 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 2024.
Planning a device like Li Medical Corporation, 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