Medical Device Manufacturer · CN , Shenzhen

Winner Medical Co., Ltd. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2019
18
Total
18
Cleared
0
Denied

FDA 510(k) cleared devices by Winner Medical Co., Ltd. General & Plastic Surgery

14 devices
1-14 of 14
Cleared Oct 10, 2025
Collagen Wound Dressing
K252001 · KGN
General & Plastic Surgery · 105d
Cleared Dec 01, 2023
Antibacterial Gel Wound Dressing
K231057 · FRO
General & Plastic Surgery · 232d
Cleared Nov 10, 2023
Skin and Wound Cleanser
K231564 · FRO
General & Plastic Surgery · 163d
Cleared Oct 12, 2023
Collagen Wound Dressing
K231152 · KGN
General & Plastic Surgery · 171d
Cleared Jun 21, 2023
Antibacterial Bandage
K221311 · FRO
General & Plastic Surgery · 412d
Cleared Jan 30, 2023
PHMB Wound Dressing
K221532 · FRO
General & Plastic Surgery · 249d
Cleared Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
K221754 · FRO
General & Plastic Surgery · 215d
Cleared Jan 13, 2023
Antimicrobial gauze sponge dressing
K221755 · FRO
General & Plastic Surgery · 211d
Cleared Dec 21, 2022
Extra Silver Gelling Fiber Dressing
K221720 · FRO
General & Plastic Surgery · 191d
Cleared Jan 14, 2022
Silver Gelling Fiber Dressing
K210466 · FRO
General & Plastic Surgery · 332d
Cleared Oct 19, 2021
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would...
K202982 · FRO
General & Plastic Surgery · 384d
Cleared May 14, 2020
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam...
K191819 · FRO
General & Plastic Surgery · 314d
Cleared May 14, 2020
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB...
K192463 · FRO
General & Plastic Surgery · 248d
Cleared Feb 14, 2019
Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing,...
K181315 · FRO
General & Plastic Surgery · 272d
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