Company ยท CN
Winner Medical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2025. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 2025 | K252001 | Collagen Wound Dressing Winner Medical Co., Ltd., CN | KGN |
| Jun 18, 2025 | K250082 | Procedure mask/Surgical mask/Face mask Winner Medical Co., Ltd., CN | FXX |
| Dec 1, 2023 | K231057 | Antibacterial Gel Wound Dressing Winner Medical Co., Ltd., CN | FRO |
| Nov 10, 2023 | K231564 | Skin and Wound Cleanser Winner Medical Co., Ltd., CN | FRO |
| Oct 12, 2023 | K231152 | Collagen Wound Dressing Winner Medical Co., Ltd., CN | KGN |
| Jun 21, 2023 | K221311 | Antibacterial Bandage Winner Medical Co., Ltd., CN | FRO |
| Mar 6, 2023 | K223232 | Procedure mask/Surgical mask/Face mask Winner Medical Co., Ltd., CN | FXX |
| Jan 30, 2023 | K221532 | PHMB Wound Dressing Winner Medical Co., Ltd., CN | FRO |
| Jan 17, 2023 | K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Winner Medical Co., Ltd., CN | FRO |
| Jan 13, 2023 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing Winner Medical Co., Ltd., CN | FRO |
| Dec 21, 2022 | K221720 | Extra Silver Gelling Fiber Dressing Winner Medical Co., Ltd., CN | FRO |
| Sep 19, 2022 | K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS S Winner Medical Co., Ltd., CN | FYA |
| May 17, 2022 | K220194 | Procedure mask/Surgical mask/Face mask Winner Medical Co., Ltd., CN | FXX |
| Jan 14, 2022 | K210466 | Silver Gelling Fiber Dressing Winner Medical Co., Ltd., CN | FRO |
| Oct 19, 2021 | K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) Winner Medical Co., Ltd., CN | FRO |
| May 14, 2020 | K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing w Winner Medical Co., Ltd., CN | FRO |
| May 14, 2020 | K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Bord Winner Medical Co., Ltd., CN | FRO |
| Feb 14, 2019 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing Winner Medical Co., Ltd., CN | FRO |
| Dec 13, 2005 | K051242 | WINNER SELF SEAL STERILIZATION POUCH Winner Medical (Usa), Inc. | KCT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||