FDA applicant
Well Lead Medical (Hainan) Co., Ltd.
FDA records 1 decision for Well Lead Medical (Hainan) Co., Ltd. (Haikou, CN) in 2024: 1 510(k) clearance. All are in product code MJC (Catheter, Urological (Antimicrobial) And…). Its devices cite 1 predicate, 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 Well Lead Medical (Hainan) 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 2024.
Planning a device like Well Lead Medical (Hainan) 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) ReportOther applicant names beginning “Well”
FDA records each applicant name separately; these may or may not be the same firm.