FDA applicant
Winner Medical Co., Ltd.
FDA records 18 decisions for Winner Medical Co., Ltd. (Shenzhen, CN) from 2019 to 2025: 18 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 213 days from receipt to decision, against 273 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 8 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 Winner Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Winner 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) ReportOther applicant names beginning “Winner”
FDA records each applicant name separately; these may or may not be the same firm.