Dressing, Wound, Drug
FDA product code FRO · Unclassified · General, Plastic Surgery
708510(k) clearances
1PMA approvals
76recalls
Manufacturers
- Advanced Medical Solutions Limited 19
- Convatec, A Division of E.R. Squibb & Sons 16
- Huizhou Foryou Medical Devices Co., Ltd. 16
- Oculus Innovative Sciences 14
- Derma Sciences, Inc. 12
- Winner Medical Co., Ltd. 12
- 3M Company 10
- Argentum Medical, LLC 9
- Acrymed, Inc. 9
- Medline Industries, LP 9
- Puricore, Inc. 8
- Sonoma Pharmaceuticals, Inc. 8
- Argentum International, LLC 7
- Exciton Technologies, Inc. 7
- ConvaTec, Inc 7
- B. Braun Medical, Inc. 7
- Smith & Nephew, Inc. 7
- Johnson & Johnson Professionals, Inc. 6
- Hollister, Inc. 6
- Wilshire Medical Products 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 06/24/2026SE |
| K251929 | SilverCeuticals® Antimicrobial Wound GelFRO · Traditional | Silverceuticals, Inc. | 06/24/2026SE |
| K261638 | Bonvadis®FRO · Special | Oneness Biotech Co., Ltd. | 06/17/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | Merit Medical Systems, Inc. | 05/13/2026SE |
| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
| K251999 | Promogran Prisma Collagen Matrix with ORC and SilverFRO · Traditional | Solventum Germany GmbH | 03/13/2026SE |
| K252028 | LUOFUCON® Antimicrobial Wound GelFRO · Traditional | Huizhou Foryou Medical Co., Ltd. | 03/11/2026SE |
| K251582 | Redermax Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 02/02/2026SE |
| K252568 | New Day Skin SprayFRO · Traditional | Silk Holdings, Inc. | 01/23/2026SE |
| K250890 | SBC1 CreamFRO · Traditional | Sioxmed, LLC | 01/12/2026SE |
| K252759 | revyve® Antimicrobial Skin and Wound CleanserFRO · Traditional | Kane Biotech, Inc. | 01/08/2026SE |
| K251757 | Puracyn® Plus Antimicrobial Irrigation SolutionFRO · Traditional | Innovacyn, Inc. | 01/05/2026SE |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber…FRO · Traditional | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 12/19/2025SE |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)FRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 11/19/2025SE |
| K250115 | Hemastyl() Wound DressingFRO · Traditional | Rapid Nexus Nanotech Wound Solutions, Inc. | 10/14/2025SE |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial DressingFRO · Traditional | Solventum US, LLC | 10/10/2025SE |
| K243166 | DermalageFRO · Traditional | Infection Elimination Solutions, LLC | 08/27/2025SE |
| K243415 | Granudacyn® Wound Irrigation SolutionFRO · Traditional | P.G.F. Industry Solutions GmbH | 07/22/2025SE |
| K251093 | Bonvadis®FRO · Traditional | Oneness Biotech Co., Ltd. | 06/09/2025SE |
| K243457 | Nixall Antimicrobial Solutions Skin & Wound HydrogelFRO · Traditional | Seriously Clean, Ltd. | 05/02/2025SE |
| K243875 | Spectricept Skin and Wound CleanserFRO · Traditional | Spectrum Antimicrobials, Inc. | 04/21/2025SE |
| K242406 | SiOxC CreamFRO · Traditional | Sioxmed, LLC | 03/13/2025SE |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USPFRO · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 03/06/2025SE |
| K240809 | LUOFUCON® Silver Collagen DressingFRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 12/16/2024SE |
| K242758 | Atrauman® AgFRO · Traditional | Hartmann USA, Inc. | 12/09/2024SE |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…FRO · Special | Huizhou Foryou Medical Devices Co., Ltd. | 11/13/2024SE |
| K240510 | Microdacyn HydrogelFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 11/08/2024SE |
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloFRO · Special | Bionova Medical, Inc. | 10/31/2024SE |
| K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200…FRO · Traditional | Speciality Fibres and Materials, Ltd. | 10/21/2024SE |
| K211943 | Microlyte Ag/LidocaineFRO · Traditional | Imbed Biosciences | 10/17/2024SE |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver…FRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 10/07/2024SE |
| K240722 | Derma-R Cream (Derma-R Cream)FRO · Traditional | Raya Pharmaceuticals, LLC | 09/20/2024SE |
| K233399 | Microdacyn Wound Care SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 09/13/2024SE |
| K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoFRO · Traditional | Bionova Medical, Inc. | 08/21/2024SE |
| K241225 | Silverlon® Wound Contact, Burn Contact DressingFRO · Traditional | Argentum Medical, LLC | 07/31/2024SE |
| K241809 | coactiv+ Antimicrobial Wound GelFRO · Special | Kane Biotech, Inc. | 07/19/2024SE |
| K212521 | Field Shield Wound DressingFRO · Traditional | Kericure, Inc. | 07/18/2024SE |
| K240552 | Irrisept Antimicrobial Wound LavageFRO · Traditional | Irrimax Corporation | 06/18/2024SE |
| K232333 | Anti-bacterial bandageFRO · Traditional | Jinhua Jingdi Medical Supplies Co., Ltd. | 05/31/2024SE |
| K232080 | Puracyn® Plus Antimicrobial Irrigation SolutionFRO · Traditional | Innovacyn, Inc. | 05/31/2024SE |
| K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S…FRO · Traditional | Foshan United Medical Technologies, Ltd. | 05/24/2024SE |
| K232655 | Bonvadis®FRO · Traditional | Stemcyte, Inc. | 05/22/2024SE |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingFRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 03/27/2024SE |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)FRO · Traditional | Medline Industries, LP | 03/26/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | Coloplast Corp. | 03/22/2024SE |
| K231088 | Copper Foam Dressing (Prescription and OTC)FRO · Traditional | Roosin Medical Co., Ltd. | 01/11/2024SE |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber…FRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 01/04/2024SE |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingFRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 12/21/2023SE |
| K231057 | Antibacterial Gel Wound DressingFRO · Traditional | Winner Medical Co., Ltd. | 12/01/2023SE |
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC)FRO · Traditional | Roosin Medical Co., Ltd. | 11/17/2023SE |
| K231564 | Skin and Wound CleanserFRO · Traditional | Winner Medical Co., Ltd. | 11/10/2023SE |
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMBFRO · Traditional | Advanced Medical Solutions, Ltd. | 10/26/2023SE |
| K222143 | Apis (R), Veris (TM)FRO · Traditional | Sweetbio, Inc. | 10/13/2023SE |
| K222025 | G4Derm / G4Derm Plus Synthetic Wound MatrixFRO · Traditional | Gel4med, Inc. | 10/11/2023SE |
| K221570 | Antibacterial bandageFRO · Traditional | Allmed Medical Products Co., Ltd. | 09/29/2023SE |
| K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam…FRO · Traditional | Smith & Nephew Medical Limited | 08/18/2023SE |
| K221311 | Antibacterial BandageFRO · Traditional | Winner Medical Co., Ltd. | 06/21/2023SE |
| K223259 | coactiv+ Antimicrobial Wound GelFRO · Traditional | Kane Biotech, Inc. | 05/24/2023SE |
| K223310 | Antimicrobial Silicone PHMB Foam Wound DressingFRO · Special | Advanced Medical Solutions Limited | 04/05/2023SE |
| K223377 | BIASURGE Advanced Surgical SolutionFRO · Traditional | Rochal Technologies, LLC | 03/30/2023SE |
| K220673 | Sterile Silver Alginate Wound DressingFRO · Traditional | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 03/16/2023SE |
| K221532 | PHMB Wound DressingFRO · Traditional | Winner Medical Co., Ltd. | 01/30/2023SE |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…FRO · Special | Winner Medical Co., Ltd. | 01/17/2023SE |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…FRO · Special | Winner Medical Co., Ltd. | 01/13/2023SE |
| K213514 | Spectricept Skin and Wound CleanserFRO · Traditional | Spectrum Antimicrobials, Inc. (Subsidiary of… | 01/13/2023SE |
| K221720 | Extra Silver Gelling Fiber DressingFRO · Traditional | Winner Medical Co., Ltd. | 12/21/2022SE |
| K220286 | ELECTROCYN somaFRO · Traditional | V3Bio Sdn. Bhd | 12/21/2022SE |
| K221218 | Silverlon Wound Contact, Burn Contact DressingsFRO · Traditional | Argentum Medical, Inc. | 10/26/2022SE |
| K222657 | MEBO Wound DressingFRO · Special | Mebo Life Science, Inc. | 10/18/2022SE |
| K212554 | Bonvadis Topical CreamFRO · Traditional | Stemcyte, Inc. | 08/19/2022SE |
| K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelFRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 04/22/2022SE |
| K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling…FRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 03/23/2022SE |
| K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large DressingFRO · Traditional | 3M Healthcare Business Group | 02/24/2022SE |
| K210466 | Silver Gelling Fiber DressingFRO · Traditional | Winner Medical Co., Ltd. | 01/14/2022SE |
| K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC…FRO · Traditional | Winner Medical Co., Ltd. | 10/19/2021SE |
| K203446 | TorrentX Wound WashFRO · Traditional | Next Science, LLC | 09/23/2021SE |
| K211972 | Omeza Collagen MatrixFRO · Traditional | Omeza, LLC | 09/01/2021SE |
| K210974 | High Performance Antimicrobial Gelling Fiber with SilverFRO · Special | Advanced Medical Solutions, Ltd. | 05/12/2021SE |
| K203835 | MIS SolutionFRO · Traditional | Next Science, LLC | 04/23/2021SE |
| K201138 | AMSure® Single Use Saline Topical SolutionFRO · Traditional | Amsino Medical, Inc. | 04/14/2021SE |
| K201324 | Antibacterial BandageFRO · Traditional | Jiangsu Excellence Medical Supplies Co., Ltd. | 02/05/2021SE |
| K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…FRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 01/28/2021SE |
| K200821 | anti-bacterial bandageFRO · Traditional | Planet (Suzhou) Medical Products Co., Ltd. | 10/19/2020SE |
| K200767 | SilverStream GelFRO · Traditional | Enzysurge , Ltd. | 10/08/2020SE |
| K200835 | 3M Tegaderm CHG Chlorhexidine Gluconate Gel PadFRO · Traditional | 3M Company | 09/04/2020SE |
| K193439 | MEBO Wound DressingFRO · Traditional | Mebo Life Science, Inc. | 09/04/2020SE |
| K200641 | HaloGUARD Protective Disc with CHGFRO · Traditional | Attwill Medical Solutions | 09/03/2020SE |
| K192478 | LT Antibacterial Alginate with Silver DressingFRO · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 06/17/2020SE |
| K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam…FRO · Traditional | Winner Medical Co., Ltd. | 05/14/2020SE |
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…FRO · Traditional | Winner Medical Co., Ltd. | 05/14/2020SE |
| K193085 | PuraDERM GelFRO · Traditional | 3-D Matrix, Inc. | 05/11/2020SE |
| K190129 | AC5 Topical GelFRO · Traditional | Arch Therapeutics, Inc. | 03/11/2020SE |
| K191536 | Biatain Silicone AgFRO · Traditional | Coloplast A/S | 02/21/2020SE |
| K192527 | Rochal Antimicrobial Wound GelFRO · Traditional | Rochal Industries, LLC | 02/07/2020SE |
| K190756 | IodoflexFRO · Traditional | Smith & Nephew Medical, Ltd. | 12/20/2019SE |
| K190730 | IodosorbFRO · Traditional | Smith & Nephew Medical, Ltd. | 12/20/2019SE |
| K190268 | Hydrofera Blue READY - BorderFRO · Traditional | Hydrofera, LLC | 11/06/2019SE |
| K190342 | BIAFINE Topical CreamFRO · Traditional | Bausch Health Americas Incorporated | 10/18/2019SE |
| K183681 | Protego Antimicrobial Wound DressingFRO · Traditional | Global Health Solutions (Dba Turn Therapeutics) | 10/11/2019SE |
| K181428 | Clyra Wound Irrigation SolutionFRO · Traditional | Clyra Medical Technologies, Inc. | 09/20/2019SE |
| K181478 | Roosin Xeroform Petrolatum DressingFRO · Traditional | Roosin Medical Co., Ltd. | 09/13/2019SE |
| K183662 | Saline Wound Wash, SteriCleanse(TM)FRO · Traditional | Ascent Consumer Products, Inc. | 09/12/2019SE |
| K183208 | Suprasorb A + Ag RFRO · Traditional | Speciality Fibres and Materials, Ltd. | 08/15/2019SE |
| K190819 | Silicone PHMB Foam Wound DressingFRO · Traditional | Advanced Medical Solutions, Ltd. | 07/25/2019SE |
| K190343 | Silverlon Wound Contact, Burn Contact DressingsFRO · Traditional | Argentum Medical, LLC | 07/18/2019SE |
| K182725 | ApisFRO · Traditional | Sweetbio, Inc. | 05/31/2019SE |
| K183645 | Silver High Performance DressingFRO · Traditional | Advanced Medical Solutions, Ltd. | 05/29/2019SE |
| K190224 | Medline Burn and Wound Dressing (OTC)FRO · Traditional | Medline Industries, Inc. | 03/08/2019SE |
| K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial…FRO · Traditional | Winner Medical Co., Ltd. | 02/14/2019SE |
| K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…FRO · Traditional | Argentum Medical, LLC | 01/14/2019SE |
| K182681 | AC5 Topical GelFRO · Traditional | Arch Therapeutics, Inc. | 12/14/2018SE |
| K180533 | Procellera Composite Antibacterial Wound DressingFRO · Traditional | Vomaris Wound Care, Inc. | 12/10/2018SE |
| K182680 | KerraContact Ag Perf Advanced Perforated Silver Wound DressingFRO · Special | Exciton Technologies, Inc. | 12/06/2018SE |
| K180643 | MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)FRO · Traditional | Medcu Technologies , Ltd. | 11/23/2018SE |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound FlushFRO · Traditional | Amsino International, Inc. | 09/07/2018SE |
| K181074 | Simple Science Antimicrobial Facial and Eyelid CleanserFRO · Traditional | Simple Science, LLC | 08/17/2018SE |
| K173549 | BiafineFRO · Traditional | Valeant Pharmaceuticals | 08/13/2018SE |
| K173844 | Titan Ag 200FRO · Traditional | Specialty Fibres and Materials, Ltd. | 08/09/2018SE |
| K180634 | Surgical Silver Post Operative DressingFRO · Traditional | Advanced Medical Solutions, Ltd. | 08/07/2018SE |
| K181197 | PHMB Foam Wound DressingFRO · Traditional | Advanced Medical Solutions, Ltd. | 08/03/2018SE |
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO · Traditional | Convatec Limited | 07/20/2018SE |
| K173911 | Medline Burn and Wound DressingFRO · Traditional | Medline Industries, Inc. | 07/19/2018SE |
| K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPFRO · Traditional | Medline Industries, Inc. | 07/02/2018SE |
| K172570 | ALGS6 Ag Alginate Wound DressingFRO · Traditional | Foshan United Medical Technologies, Ltd. | 05/11/2018SE |
| K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingFRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 05/01/2018SE |
| K172747 | Hyaluronic Acid Topical Wound CreamFRO · Traditional | Virchow Biotech Pvt, Ltd. | 04/27/2018SE |
| K180305 | Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)FRO · Traditional | Aquilabs Us, LLC | 04/13/2018SE |
| K173072 | Algidex Ag Silver Alginate Wound DressingFRO · Traditional | Deroyal Industries, Inc. | 04/04/2018SE |
| K173896 | Microcyn Antimicrobial HydrogelFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 04/02/2018SE |
| K172338 | Catasyn Advanced Technology Wound HydrogelFRO · Traditional | Synedgen, Inc. | 02/21/2018SE |
| K171935 | Alevicyn SG Antimicrobial GelFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 12/01/2017SE |
| K172622 | Microcyn Antimicrobial Skin and Wound CleanserFRO · Traditional | Sonoma Pharmaceuticals | 11/21/2017SE |
| K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced…FRO · Traditional | 3M Company, 3M Healthcare | 11/21/2017SE |
| K172318 | Endoform Silver Dermal TemplateFRO · Traditional | Aroa Biosurgery | 11/17/2017SE |
| K172851 | Microcyn Plus Antimicrobial Wound Care SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 11/15/2017SE |
| K172486 | Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…FRO · Traditional | Anexa Biomedical, Inc. | 09/21/2017SE |
| K171191 | Hexagen DermFRO · Traditional | Global Health Solutions, LLC | 08/25/2017SE |
| K171041 | SilverSealFRO · Traditional | Alliqua Biomedical, Inc. | 08/22/2017SE |
| K170911 | NEOCERA Advanced Barrier CreamFRO · Traditional | Exeltis USA Dermatology, LLC | 08/22/2017SE |
| K171225 | Sorbact Wound Dressing-Ribbon GauzeFRO · Traditional | Abigo Medical AB | 08/21/2017SE |
| K171727 | Hydrocleanse Antimicrobial Skin and Wound Care SolutionFRO · Traditional | Sonoma Pharmaceuticals | 07/26/2017SE |
| K163062 | PHMB Antimicrobial Foam Wound DressingFRO · Traditional | Advanced Medical Solutions, Ltd. | 07/25/2017SE |
| K170407 | BD ChloraShield IV Dressing with CHG AntimicrobialFRO · Traditional | Avery Dennison Belgie Bvba | 07/17/2017SE |
| K170270 | Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineFRO · Traditional | Ls Scientific Inc. D.B.A. Kse Scientific | 06/23/2017SE |
| K153138 | Cerdak BasicFRO · Traditional | Bu Polysciences Equipment & Trading, LLC | 06/23/2017SE |
| K163430 | Prontosan Wound GelFRO · Traditional | B.Braun Medical, Inc. | 05/23/2017SE |
| K162017 | Ross Ru Wound Dressing GelFRO · Traditional | Biotd S.A. | 04/20/2017SE |
| K170077 | LUOFUCON Silicone Ag Foam Dressing with BorderFRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 03/30/2017SE |
| K163529 | ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…FRO · Traditional | Avery Dennison Corporation | 03/29/2017SE |
| K162217 | LoyonFRO · Traditional | Oculus Innovative Sciences | 03/23/2017SE |
| K163188 | Next Science Wound Gel (Rx)FRO · Traditional | Next Science, LLC | 03/06/2017SE |
| K161991 | CurasiteFRO · Traditional | Izun Pharmaceuticals | 03/03/2017SE |
| K162508 | KerraCel Ag Gelling Fiber Silver DressingFRO · Traditional | Exciton Technologies, Inc. | 02/13/2017SE |
| K160695 | Talymed SuspensionFRO · Traditional | Marine Polymer Technologies, Inc. | 12/06/2016SE |
| K160872 | PolyPlex Wound DressingFRO · Traditional | Global Health Solutions, LLC | 11/23/2016SE |
| K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL…FRO · Traditional | B.Braun Medical, Inc. | 11/10/2016SE |
| K152533 | Xonrid GelFRO · Traditional | Helsinn Healthcare SA | 10/28/2016SE |
| K152970 | Dynarex Xeroform Petrolatum DressingFRO · Traditional | Dynarex Corporation | 10/03/2016SE |
| K161212 | Atteris Antimicrobial Skin ProtectantFRO · Traditional | Rochal Industries, LLC | 09/30/2016SE |
| K153565 | Donasorb Silver Wound DressingFRO · Traditional | Virchow Biotech Pvt, Ltd. | 09/22/2016SE |
| K161658 | Anexa Wound Flush, Sterile Water & Sterile Normal SalineFRO · Traditional | Anexa Biomedical, Inc. | 09/14/2016SE |
| K153723 | ACTICOAT Surgical DressingFRO · Traditional | Smith & Nephew Medical Limited | 09/14/2016SE |
| K160783 | ProcelleraFRO · Traditional | Vomaris Innovations, Inc. | 09/07/2016SE |
| K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL…FRO · Traditional | Strukmyer Medical, LLC | 08/29/2016SE |
| K160379 | Exufiber Ag+FRO · Traditional | Molnlycke Health Care Us, LLC | 08/25/2016SE |
| K161034 | Microcyn Plus Wound Care SolutionFRO · Traditional | Oculus Innovative Sciences | 08/19/2016SE |
| K160022 | LUOFUCON Silicone Ag foam dressingFRO · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 08/17/2016SE |
| K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm GloveFRO · Traditional | Permeaderm, Inc. | 08/08/2016SE |
| K153756 | Microlyte AgFRO · Traditional | Imbed Biosciences, Inc. | 08/04/2016SE |
| K161289 | DURAFIBER AgFRO · Traditional | Smith & Nephew Medical Limited | 08/03/2016SE |
| K160192 | Atteris Antimicrobial Skin & Wound CleanserFRO · Traditional | Rochal Industries, LLC | 07/28/2016SE |
| K150208 | Dakin's Skin and Wound CleanserFRO · Traditional | Century Pharmaceuticals, Inc. | 07/21/2016SE |
| K153674 | Sorbact Foam Gentle Border, Sorbact SuperabsorbentFRO · Traditional | Abigo Medical AB | 07/01/2016SE |
| K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…FRO · Traditional | Simple Science, LLC | 06/10/2016SE |
| K152519 | MTR550 (Tentative) Antimicrobial Silver Wound GelFRO · Traditional | Medical Technology Research, Inc. | 06/02/2016SE |
| K152544 | Agem Ag Mesh Dressing with SilverFRO · Traditional | Shenzhen Yuanxing Nano-Pharma Co., Ltd. | 05/23/2016SE |
| K150914 | Dash-Topic Plus CreamFRO · Traditional | Founders Science Group, LLC | 04/21/2016SE |
| K153648 | Microcyn Plus Skin and Wound HydrogelFRO · Traditional | Oculus Innovative Sciences | 04/19/2016SE |
| K143605 | Nutraseb Facial CreamFRO · Traditional | Isdin Corp. | 04/14/2016SE |
| K151185 | AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash…FRO · Traditional | Abl Medical, LLC | 02/05/2016SE |
| K152926 | AQUACEL Ag Surgical SP DressingFRO · Special | Convatec Limited | 01/21/2016SE |
| K150676 | L-Mesitran Dressing Family II- Soft and TulleFRO · Traditional | Theo Manufacturing BV | 12/23/2015SE |
| K151168 | Nexodyn AOS Wound Care SolutionFRO · Traditional | Apr Applied Pharma Research SA | 12/22/2015SE |
| K150792 | Next Science Wound GelFRO · Traditional | Next Science, LLC | 12/17/2015SE |
| K152945 | Alevicyn SG Antipruritic GelFRO · Traditional | Oculus Innovative Sciences | 12/15/2015SE |
| K151186 | Stay Fresh Hydrocolloid dressingFRO · Traditional | Sarasota Medical Products, Inc. | 11/27/2015SE |
| K152055 | Ceramax Skin Barrier CreamFRO · Traditional | Oculus Innovative Sciences | 11/23/2015SE |
| K150985 | Medihoney Wound GelFRO · Traditional | Derma Sciences, Inc. | 11/19/2015SE |
| K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus…FRO · Traditional | Innovacyn, Inc. | 11/19/2015SE |
| K152923 | BD ChloraShield IV Dressing with CHG AntimicrobialFRO · Special | Avery Dennison Belgie Bvba | 11/05/2015SE |
| K142592 | CleanSmart Wound CleanserFRO · Traditional | Simple Science, LLC | 09/02/2015SE |
| K143444 | SynePure Wound CleanserFRO · Traditional | Synedgen, Inc. | 08/21/2015SE |
| K143017 | Urgoclean Ag, Antibacterial Absorbent Wound Dressing with SilverFRO · Traditional | Laboratoires Urgo | 08/07/2015SE |
| K142962 | PROTOCOL Incision DressingFRO · Traditional | Deroyal Industries | 07/23/2015SE |
| K133279 | Medihoney Wound DressingsFRO · Traditional | Derma Sciences, Inc. | 06/25/2015SE |
| K143590 | Alevicyn SG Antipruritic GelFRO · Traditional | Oculus Innovative Sciences | 06/04/2015SE |
PMA approvals
- P870069 Biobrane(R) II · Udl Laboratories, Inc. · 10/20/1989
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2677-2026 Class II | Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile RSurgical dressing manufactured out of specification (greater thickness). | ConvaTec, Inc | 06/08/2026Open, Classified |
| Z-2275-2026 Class II | PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component.… | Oculus Technologies of Mexico, S.A. de C.V. | 04/27/2026Open, Classified |
| Z-1365-2026 Class II | Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment…Potential packaging failures, which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 01/16/2026Open, Classified |
| Z-1364-2026 Class II | MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2)…Potential packaging failures, which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 01/16/2026Open, Classified |
| Z-1363-2026 Class II | MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2)…Potential packaging failures, which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 01/16/2026Open, Classified |
| Z-1435-2026 Class II | Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE…Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured… | Medline Industries, LP | 01/05/2026Open, Classified |
| Z-1431-2026 Class II | Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9%…Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured… | Medline Industries, LP | 01/05/2026Open, Classified |
| Z-2512-2025 Class II | Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-2511-2025 Class II | Brand Name: MediHoney Product Name: MediHoney HCS Surgical Adhesive Sheet Model/Catalog…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-2510-2025 Class II | Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-2509-2025 Class II | Brand Name: MediHoney Product Name: MediHoney Hydrogel Model/Catalog Number: 31620…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-2508-2025 Class II | Brand Name: MediHoney Product Name: MediHoney Adhesive Hydrogel Sheet Dressing…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-2507-2025 Class II | Brand Name: MediHoney Product Name: MediHoney HCS Sheet Dressing with Leptospermum…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-2506-2025 Class II | Brand Name: MediHoney Product Name: MediHoney Tube Model/Catalog Number: 31515 and 31535…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-2505-2025 Class II | Brand Name: MediHoney Product Name: MediHoney Paste Model/Catalog Number: 31505 Product…Packaging failures were identified which could lead to a breach in the sterile barrier. | Integra LifeSciences Corp. (NeuroSciences) | 08/05/2025Open, Classified |
| Z-1706-2025 Class II | Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… | MEDLINE INDUSTRIES, LP - Northfield | 03/19/2025Open, Classified |
| Z-1705-2025 Class II | Medline Sterile Water, USP, 100mL, REF RDI30295It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… | MEDLINE INDUSTRIES, LP - Northfield | 03/19/2025Open, Classified |
| Z-1168-2025 Class II | Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel…Potential that the induction seal is not completely sealed to the device tube packaging. | Integra LifeSciences Corp. | 01/10/2025Open, Classified |
| Z-0054-2025 Class II | MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR…There is a potential for pinholes in the applicator pouch film which creates a sterility concern. | Integra LifeSciences Corp. | 09/13/2024Open, Classified |
| Z-0038-2025 Class II | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658RContamination with foreign substance matter | 3M Company - Health Care Business | 08/14/2024Open, Classified |
| Z-0514-2024 Class I | Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120…Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have… | Nurse Assist, LLC | 11/06/2023Open, Classified |
| Z-0513-2024 Class I | Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE…Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have… | Nurse Assist, LLC | 11/06/2023Open, Classified |
| Z-1982-2023 Class II | MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF…Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization… | MEDLINE INDUSTRIES, LP - Northfield | 05/03/2023Open, Classified |
| Z-0723-2023 Class II | ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesiveConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the… | ConvaTec, Inc | 11/15/2022Open, Classified |
| Z-1808-2022 Class III | a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b.…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1807-2022 Class III | 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1806-2022 Class III | a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4"…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1805-2022 Class III | a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1804-2022 Class III | a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1803-2022 Class III | Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1798-2022 Class III | a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1796-2022 Class III | a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen /…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1030-2022 Class II | Restrata, Part Number RWM1-2X2Misprinted expiration date on the shelf-box | Acera Surgical Inc | 03/21/2022Terminated |
| Z-0805-2022 Class III | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | CellEra LLC | 12/15/2021Terminated |
| Z-0804-2022 Class III | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | CellEra LLC | 12/15/2021Terminated |
| Z-0803-2022 Class III | 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | CellEra LLC | 12/15/2021Terminated |
| Z-0802-2022 Class III | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | CellEra LLC | 12/15/2021Terminated |
| Z-0801-2022 Class III | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | CellEra LLC | 12/15/2021Terminated |
| Z-0211-2022 Class II | QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model /…Lack of Packaging seal integrity may result in a sterile barrier breach. | Z-Medica, LLC | 09/22/2021Terminated |
| Z-1910-2020 Class II | Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 03/26/2020Open, Classified |
| Z-1909-2020 Class II | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 03/26/2020Open, Classified |
| Z-1908-2020 Class II | Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 03/26/2020Open, Classified |
| Z-1907-2020 Class II | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 03/26/2020Open, Classified |
| Z-1626-2020 Class II | Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 02/27/2020Open, Classified |
| Z-1625-2020 Class II | Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 02/27/2020Open, Classified |
| Z-1624-2020 Class II | Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 02/27/2020Open, Classified |
| Z-1623-2020 Class II | Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a…During an FDA audit, it was discovered that the product was not properly registered with FDA. | Gentell, Inc | 02/27/2020Open, Classified |
| Z-0687-2020 Class II | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC…Elasto-Gel Wound Dressing may be contaminated with mold. | Southwest Technologies Inc | 11/18/2019Terminated |
| Z-2423-2018 Class II | Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix…Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging… | Anika Therapeutics, Inc. | 05/10/2018Terminated |
| Z-1627-2018 Class II | Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net.…A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP)… | Conseal International, Inc. | 04/25/2018Terminated |