Winner Medical Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 18
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252001 | Collagen Wound Dressing | October 10, 2025 |
| K250082 | Procedure mask/Surgical mask/Face mask | June 18, 2025 |
| K231057 | Antibacterial Gel Wound Dressing | December 1, 2023 |
| K231564 | Skin and Wound Cleanser | November 10, 2023 |
| K231152 | Collagen Wound Dressing | October 12, 2023 |
| K221311 | Antibacterial Bandage | June 21, 2023 |
| K223232 | Procedure mask/Surgical mask/Face mask | March 6, 2023 |
| K221532 | PHMB Wound Dressing | January 30, 2023 |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC | January 17, 2023 |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sp | January 13, 2023 |
| K221720 | Extra Silver Gelling Fiber Dressing | December 21, 2022 |
| K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;4 | September 19, 2022 |
| K220194 | Procedure mask/Surgical mask/Face mask | May 17, 2022 |
| K210466 | Silver Gelling Fiber Dressing | January 14, 2022 |
| K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) | October 19, 2021 |
| K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone | May 14, 2020 |
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foa | May 14, 2020 |
| K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sp | February 14, 2019 |