FRO · Dressing, Wound, Drug
· Class U
Overview
| Product Code | FRO |
|---|---|
| Device Name | Dressing, Wound, Drug |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (20 of 703)
Showing 20 most recent of 703 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | May 13, 2026 | SESE |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | Apr 7, 2026 | SESE |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | Mar 25, 2026 | SESE |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | Mar 13, 2026 | SESE |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | Mar 11, 2026 | SESE |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Feb 2, 2026 | SESE |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | Jan 23, 2026 | SESE |
| K250890 | SBC1 Cream | Sioxmed, LLC | Jan 12, 2026 | SESE |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | Jan 8, 2026 | SESE |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | Jan 5, 2026 | SESE |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | Dec 19, 2025 | SESE |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | Nov 19, 2025 | SESE |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | Oct 14, 2025 | SESE |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | Oct 10, 2025 | SESE |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | Aug 27, 2025 | SESE |
| K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | Jul 22, 2025 | SESE |
| K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | Jun 9, 2025 | SESE |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | Seriously Clean, Ltd. | May 2, 2025 | SESE |
| K243875 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | Apr 21, 2025 | SESE |
| K242406 | SiOxC Cream | Sioxmed, LLC | Mar 13, 2025 | SESE |
Top Applicants
- Huizhou Foryou Medical Devices Co., Ltd. — 16 clearances
- Convatec, A Division of E.R. Squibb & Sons — 13 clearances
- Derma Sciences, Inc. — 12 clearances
- Winner Medical Co., Ltd. — 12 clearances
- 3M Company — 10 clearances
