| Microdacyn Wound Irrigation Solution (K261023) | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| SilverCeuticals® Antimicrobial Wound Gel (K251929) | Silverceuticals, Inc. | 2026-06-24 |
| Bonvadis® (K261638) | Oneness Biotech Co., Ltd. | 2026-06-17 |
| StatSeal Disc (K254073) | Merit Medical Systems, Inc. | 2026-05-13 |
| IWD-Gel™ (K254191) | InnovaCorium, Inc. | 2026-04-07 |
| MiraChlor Antimicrobial Wound Solution (K252023) | Letus Corporation | 2026-03-25 |
| Promogran Prisma™ Collagen Matrix with ORC and Silver (K251999) | Solventum Germany GmbH | 2026-03-13 |
| LUOFUCON® Antimicrobial Wound Gel (K252028) | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| Redermax Antibacterial Wound Matrix (K251582) | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| New Day Skin Spray (K252568) | Silk Holdings, Inc. | 2026-01-23 |
| SBC1 Cream (K250890) | Sioxmed, LLC | 2026-01-12 |
| revyve® Antimicrobial Skin and Wound Cleanser (K252759) | Kane Biotech, Inc. | 2026-01-08 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K251757) | Innovacyn, Inc. | 2026-01-05 |
| Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) (K252167) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (K250642) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
| Hemastyl(™) Wound Dressing (K250115) | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| Tegaderm Post-Op Transparent Antimicrobial Dressing (K251866) | Solventum US, LLC | 2025-10-10 |
| Dermalage (K243166) | Infection Elimination Solutions, LLC | 2025-08-27 |
| Granudacyn® Wound Irrigation Solution (K243415) | P.G.F. Industry Solutions GmbH | 2025-07-22 |
| Bonvadis® (K251093) | Oneness Biotech Co., Ltd. | 2025-06-09 |
| Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel (K243457) | Seriously Clean, Ltd. | 2025-05-02 |
| Spectricept Skin and Wound Cleanser (K243875) | Spectrum Antimicrobials, Inc. | 2025-04-21 |
| SiOxC Cream (K242406) | Sioxmed, LLC | 2025-03-13 |
| Sterile Water USP and Sterile 0.9% Normal Saline USP (K243001) | Laboratorios Biogalenic S.A. DE C.V. | 2025-03-06 |
| LUOFUCON® Silver Collagen Dressing (K240809) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-12-16 |
| Atrauman® Ag (K242758) | Hartmann USA, Inc. | 2024-12-09 |
| LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (K242856) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-11-13 |
| Microdacyn Hydrogel (K240510) | Sonoma Pharmaceuticals, Inc. | 2024-11-08 |
| Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (K243181) | Bionova Medical, Inc. | 2024-10-31 |
| Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch (K222740) | Speciality Fibres and Materials, Ltd. | 2024-10-21 |
| Microlyte Ag/Lidocaine (K211943) | Imbed Biosciences | 2024-10-17 |
| LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) (K240485) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-10-07 |
| Derma-R Cream (Derma-R Cream) (K240722) | Raya Pharmaceuticals, LLC | 2024-09-20 |
| Microdacyn Wound Care Solution (K233399) | Sonoma Pharmaceuticals, Inc. | 2024-09-13 |
| Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (K240298) | Bionova Medical, Inc. | 2024-08-21 |
| Silverlon® Wound Contact, Burn Contact Dressing (K241225) | Argentum Medical, LLC | 2024-07-31 |
| coactiv+™ Antimicrobial Wound Gel (K241809) | Kane Biotech, Inc. | 2024-07-19 |
| Field Shield Wound Dressing (K212521) | Kericure, Inc. | 2024-07-18 |
| Irrisept Antimicrobial Wound Lavage (K240552) | Irrimax Corporation | 2024-06-18 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K232080) | Innovacyn, Inc. | 2024-05-31 |
| Anti-bacterial bandage (K232333) | Jinhua Jingdi Medical Supplies Co., Ltd. | 2024-05-31 |
| ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC (K233111) | Foshan United Medical Technologies, Ltd. | 2024-05-24 |
| Bonvadis® (K232655) | Stemcyte, Inc. | 2024-05-22 |
| LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (K223360) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-03-27 |
| PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) (K233151) | Medline Industries, LP | 2024-03-26 |
| Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) (K231953) | Coloplast Corp. | 2024-03-22 |
| Copper Foam Dressing (Prescription and OTC) (K231088) | Roosin Medical Co., Ltd. | 2024-01-11 |
| LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing (K221110) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-01-04 |
| LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing (K223359) | Huizhou Foryou Medical Devices Co., Ltd. | 2023-12-21 |
| Antibacterial Gel Wound Dressing (K231057) | Winner Medical Co., Ltd. | 2023-12-01 |
| Polyver Silver Alginate Dressing (Prescription and OTC) (K230190) | Roosin Medical Co., Ltd. | 2023-11-17 |
| Skin and Wound Cleanser (K231564) | Winner Medical Co., Ltd. | 2023-11-10 |
| Antimicrobial Gelling Fiber Dressing with PHMB (K213473) | Advanced Medical Solutions, Ltd. | 2023-10-26 |
| APIS (R), VERIS (TM) (K222143) | Sweetbio, Inc. | 2023-10-13 |
| G4Derm / G4Derm Plus Synthetic Wound Matrix (K222025) | Gel4med, Inc. | 2023-10-11 |
| Antibacterial bandage (K221570) | Allmed Medical Products Co., Ltd. | 2023-09-29 |
| ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing (K223526) | Smith & Nephew Medical Limited | 2023-08-18 |
| Antibacterial Bandage (K221311) | Winner Medical Co., Ltd. | 2023-06-21 |
| coactiv+™ Antimicrobial Wound Gel (K223259) | Kane Biotech, Inc. | 2023-05-24 |
| Antimicrobial Silicone PHMB Foam Wound Dressing (K223310) | Advanced Medical Solutions Limited | 2023-04-05 |
| BIASURGE Advanced Surgical Solution (K223377) | Rochal Technologies, LLC | 2023-03-30 |
| Sterile Silver Alginate Wound Dressing (K220673) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2023-03-16 |
| 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 |
| Spectricept Skin and Wound Cleanser (K213514) | Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | 2023-01-13 |
| Extra Silver Gelling Fiber Dressing (K221720) | Winner Medical Co., Ltd. | 2022-12-21 |
| ELECTROCYN soma (K220286) | V3Bio Sdn. Bhd | 2022-12-21 |
| Silverlon Wound Contact, Burn Contact Dressings (K221218) | Argentum Medical, Inc. | 2022-10-26 |
| MEBO Wound Dressing (K222657) | Mebo Life Science, Inc. | 2022-10-18 |
| Bonvadis Topical Cream (K212554) | Stemcyte, Inc. | 2022-08-19 |
| LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel (K211123) | Huizhou Foryou Medical Devices Co., Ltd. | 2022-04-22 |
| LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing (K210718) | Huizhou Foryou Medical Devices Co., Ltd. | 2022-03-23 |
| PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing (K210135) | 3M Healthcare Business Group | 2022-02-24 |
| 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 |
| TorrentX Wound Wash (K203446) | Next Science, LLC | 2021-09-23 |
| Omeza Collagen Matrix (K211972) | Omeza, LLC | 2021-09-01 |
| High Performance Antimicrobial Gelling Fiber with Silver (K210974) | Advanced Medical Solutions, Ltd. | 2021-05-12 |
| MIS Solution (K203835) | Next Science, LLC | 2021-04-23 |
| AMSure® Single Use Saline Topical Solution (K201138) | Amsino Medical, Inc. | 2021-04-14 |
| Antibacterial Bandage (K201324) | Jiangsu Excellence Medical Supplies Co., Ltd. | 2021-02-05 |
| LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) (K201016) | Huizhou Foryou Medical Devices Co., Ltd. | 2021-01-28 |
| anti-bacterial bandage (K200821) | Planet (Suzhou) Medical Products Co., Ltd. | 2020-10-19 |
| SilverStream Gel (K200767) | Enzysurge , Ltd. | 2020-10-08 |
| MEBO Wound Dressing (K193439) | Mebo Life Science, Inc. | 2020-09-04 |
| 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad (K200835) | 3M Company | 2020-09-04 |
| HaloGUARD Protective Disc with CHG (K200641) | Attwill Medical Solutions | 2020-09-03 |
| LT Antibacterial Alginate with Silver Dressing (K192478) | Zhejiang Longterm Medical Technology Co., Ltd. | 2020-06-17 |
| 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 |
| PuraDERM Gel (K193085) | 3-D Matrix, Inc. | 2020-05-11 |
| AC5 Topical Gel (K190129) | Arch Therapeutics, Inc. | 2020-03-11 |
| Biatain Silicone Ag (K191536) | Coloplast A/S | 2020-02-21 |
| Rochal Antimicrobial Wound Gel (K192527) | Rochal Industries, LLC | 2020-02-07 |
| IODOSORB (K190730) | Smith & Nephew Medical, Ltd. | 2019-12-20 |
| IODOFLEX (K190756) | Smith & Nephew Medical, Ltd. | 2019-12-20 |
| Hydrofera Blue READY - Border (K190268) | Hydrofera, LLC | 2019-11-06 |
| BIAFINE Topical Cream (K190342) | Bausch Health Americas Incorporated | 2019-10-18 |
| Protego Antimicrobial Wound Dressing (K183681) | Global Health Solutions (Dba Turn Therapeutics) | 2019-10-11 |