Product code FRO · Class U
Dressing, Wound, Drug
19510(k)s in 12 months (707 all time)
7recalls in 12 months (82 all time)
56recalls that name a 510(k)
Top companies in FRO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2026 | K254168 | Actolind® (06.3637. Actolind® Gel Plus) ACTO GmbH, DE | FRO |
| Sep 11, 2026 | K254041 | SkinSmart Antimicrobial HydroGel Magic Science Supply, LLC | FRO |
| Aug 14, 2026 | K261646 | Redermax® Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd., CN | FRO |
| Aug 11, 2026 | K253665 | Vashe Plus Antimicrobial Solution Urgo Medical North America, LLC | FRO |
| Jun 24, 2026 | K261023 | Microdacyn Wound Irrigation Solution Sonoma Pharmaceuticals, Inc. | FRO |
| Jun 24, 2026 | K251929 | SilverCeuticals® Antimicrobial Wound Gel Silverceuticals, Inc. | FRO |
| Jun 17, 2026 | K261638 | Bonvadis® Oneness Biotech Co., Ltd., TW | FRO |
| May 13, 2026 | K254073 | StatSeal Disc Merit Medical Systems, Inc. | FRO |
| Apr 7, 2026 | K254191 | IWD-Gel InnovaCorium, Inc. | FRO |
| Mar 25, 2026 | K252023 | MiraChlor Antimicrobial Wound Solution Letus Corporation | FRO |
| Mar 13, 2026 | K251999 | Promogran Prisma Collagen Matrix with ORC and Silver Solventum Germany GmbH, DE | FRO |
| Mar 11, 2026 | K252028 | LUOFUCON® Antimicrobial Wound Gel Huizhou Foryou Medical Co., Ltd., CN | FRO |
| Feb 2, 2026 | K251582 | Redermax Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd., CN | FRO |
| Jan 23, 2026 | K252568 | New Day Skin Spray Silk Holdings, Inc. | FRO |
| Jan 12, 2026 | K250890 | SBC1 Cream Sioxmed, LLC | FRO |
| Jan 8, 2026 | K252759 | revyve® Antimicrobial Skin and Wound Cleanser Kane Biotech, Inc., CA | FRO |
| Jan 5, 2026 | K251757 | Puracyn® Plus Antimicrobial Irrigation Solution Innovacyn, Inc. | FRO |
| Dec 19, 2025 | K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) Qingdao Bright Moon Biomedical Materials Co., Ltd., CN | FRO |
| Nov 19, 2025 | K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Oct 14, 2025 | K250115 | Hemastyl() Wound Dressing Rapid Nexus Nanotech Wound Solutions, Inc. | FRO |
| Oct 10, 2025 | K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing Solventum US, LLC | FRO |
| Aug 27, 2025 | K243166 | Dermalage Infection Elimination Solutions, LLC | FRO |
| Jul 22, 2025 | K243415 | Granudacyn® Wound Irrigation Solution P.G.F. Industry Solutions GmbH, AT | FRO |
| Jun 9, 2025 | K251093 | Bonvadis® Oneness Biotech Co., Ltd., TW | FRO |
| May 2, 2025 | K243457 | Nixall Antimicrobial Solutions Skin & Wound Hydrogel Seriously Clean, Ltd. | FRO |
| Apr 21, 2025 | K243875 | Spectricept Skin and Wound Cleanser Spectrum Antimicrobials, Inc. | FRO |
| Mar 13, 2025 | K242406 | SiOxC Cream Sioxmed, LLC | FRO |
| Mar 6, 2025 | K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP Laboratorios Biogalenic S.A. DE C.V., SV | FRO |
| Dec 16, 2024 | K240809 | LUOFUCON® Silver Collagen Dressing Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Dec 9, 2024 | K242758 | Atrauman® Ag Hartmann USA, Inc. | FRO |
| Nov 13, 2024 | K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (B Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Nov 8, 2024 | K240510 | Microdacyn Hydrogel Sonoma Pharmaceuticals, Inc. | FRO |
| Oct 31, 2024 | K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo Bionova Medical, Inc. | FRO |
| Oct 21, 2024 | K222740 | 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, Speciality Fibres and Materials, Ltd., GB | FRO |
| Oct 17, 2024 | K211943 | Microlyte Ag/Lidocaine Imbed Biosciences | FRO |
| Oct 7, 2024 | K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dress Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Sep 20, 2024 | K240722 | Derma-R Cream (Derma-R Cream) Raya Pharmaceuticals, LLC | FRO |
| Sep 13, 2024 | K233399 | Microdacyn Wound Care Solution Sonoma Pharmaceuticals, Inc. | FRO |
| Aug 21, 2024 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo Bionova Medical, Inc. | FRO |
| Jul 31, 2024 | K241225 | Silverlon® Wound Contact, Burn Contact Dressing Argentum Medical, LLC | FRO |
| Jul 19, 2024 | K241809 | coactiv+ Antimicrobial Wound Gel Kane Biotech, Inc., CA | FRO |
| Jul 18, 2024 | K212521 | Field Shield Wound Dressing Kericure, Inc. | FRO |
| Jun 18, 2024 | K240552 | Irrisept Antimicrobial Wound Lavage Irrimax Corporation | FRO |
| May 31, 2024 | K232333 | Anti-bacterial bandage Jinhua Jingdi Medical Supplies Co., Ltd., CN | FRO |
| May 31, 2024 | K232080 | Puracyn® Plus Antimicrobial Irrigation Solution Innovacyn, Inc. | FRO |
| May 24, 2024 | K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Foshan United Medical Technologies, Ltd., CN | FRO |
| May 22, 2024 | K232655 | Bonvadis® Stemcyte, Inc. | FRO |
| Mar 27, 2024 | K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Mar 26, 2024 | K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) Medline Industries, LP | FRO |
| Mar 22, 2024 | K231953 | 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 Fi Coloplast Corp. | FRO |
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