Winner Medical Co., Ltd.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories4
Latest Approval2025-10-10
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252001 | Collagen Wound Dressing | KGN | 2025-10-10 | View |
| 510(k) | K250082 | Procedure mask/Surgical mask/Face mask | FXX | 2025-06-18 | View |
| 510(k) | K231057 | Antibacterial Gel Wound Dressing | FRO | 2023-12-01 | View |
| 510(k) | K231564 | Skin and Wound Cleanser | FRO | 2023-11-10 | View |
| 510(k) | K231152 | Collagen Wound Dressing | KGN | 2023-10-12 | View |
| 510(k) | K221311 | Antibacterial Bandage | FRO | 2023-06-21 | View |
| 510(k) | K223232 | Procedure mask/Surgical mask/Face mask | FXX | 2023-03-06 | View |
| 510(k) | K221532 | PHMB Wound Dressing | FRO | 2023-01-30 | View |
| 510(k) | K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) | FRO | 2023-01-17 | View |
| 510(k) | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | FRO | 2023-01-13 | View |
| 510(k) | K221720 | Extra Silver Gelling Fiber Dressing | FRO | 2022-12-21 | View |
| 510(k) | K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown | FYA | 2022-09-19 | View |
| 510(k) | K220194 | Procedure mask/Surgical mask/Face mask | FXX | 2022-05-17 | View |
| 510(k) | K210466 | Silver Gelling Fiber Dressing | FRO | 2022-01-14 | View |
| 510(k) | K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) | FRO | 2021-10-19 | View |
| 510(k) | K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border | FRO | 2020-05-14 | View |
| 510(k) | K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | FRO | 2020-05-14 | View |
| 510(k) | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing | FRO | 2019-02-14 | View |
No matching devices.