| Collagen Wound Dressing (K252001) | Winner Medical Co., Ltd. | 2025-10-10 |
| Procedure mask/Surgical mask/Face mask (K250082) | Winner Medical Co., Ltd. | 2025-06-18 |
| Antibacterial Gel Wound Dressing (K231057) | Winner Medical Co., Ltd. | 2023-12-01 |
| Skin and Wound Cleanser (K231564) | Winner Medical Co., Ltd. | 2023-11-10 |
| Collagen Wound Dressing (K231152) | Winner Medical Co., Ltd. | 2023-10-12 |
| Antibacterial Bandage (K221311) | Winner Medical Co., Ltd. | 2023-06-21 |
| Procedure mask/Surgical mask/Face mask (K223232) | Winner Medical Co., Ltd. | 2023-03-06 |
| PHMB Wound Dressing (K221532) | Winner Medical Co., Ltd. | 2023-01-30 |
| Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) (K221754) | Winner Medical Co., Ltd. | 2023-01-17 |
| Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (K221755) | Winner Medical Co., Ltd. | 2023-01-13 |
| Extra Silver Gelling Fiber Dressing (K221720) | Winner Medical Co., Ltd. | 2022-12-21 |
| 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 (K221819) | Winner Medical Co., Ltd. | 2022-09-19 |
| Procedure mask/Surgical mask/Face mask (K220194) | Winner Medical Co., Ltd. | 2022-05-17 |
| Silver Gelling Fiber Dressing (K210466) | Winner Medical Co., Ltd. | 2022-01-14 |
| Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (K202982) | Winner Medical Co., Ltd. | 2021-10-19 |
| Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border (K191819) | Winner Medical Co., Ltd. | 2020-05-14 |
| PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (K192463) | Winner Medical Co., Ltd. | 2020-05-14 |
| Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (K181315) | Winner Medical Co., Ltd. | 2019-02-14 |