FDA applicant
Leo Medical Co., Ltd.
FDA records 2 decisions for Leo Medical Co., Ltd. (Changzhou, CN) from 2018 to 2024: 2 510(k) clearances. Most are in product codes FHN (Ligator, Hemorrhoidal) and FGE (Stents, Drains And Dilators For The Biliary…). 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 Leo Medical 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 2018.
Planning a device like Leo Medical 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