Product code FRO
- Device name
- Dressing, Wound, Drug
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P870069S003 | BIOBRANE (R) II BLUE LABEL PRODUCT | Udl Laboratories, Inc. | 1991-02-22 |
| P870069S001 | BIOBRANE | Udl Laboratories, Inc. | 1990-03-08 |
| P870069 | BIOBRANE(R) II | Udl Laboratories, Inc. | 1989-10-20 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | 2026-09-22 |
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026-09-11 |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-08-14 |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 2026-08-11 |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | 2025-08-27 |
| K243415 | Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH | 2025-07-22 |
| K251093 | Bonvadis® | Oneness Biotech Co., Ltd. | 2025-06-09 |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | Seriously Clean, Ltd. | 2025-05-02 |
| K243875 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | 2025-04-21 |
| K242406 | SiOxC Cream | Sioxmed, LLC | 2025-03-13 |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-03-06 |
| K240809 | LUOFUCON® Silver Collagen Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2024-12-16 |
| K242758 | Atrauman® Ag | Hartmann USA, Inc. | 2024-12-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00818582013628 | Puracyn Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-10-16 |
| 05059884011164 | Suprasorb Liquacel Ag | SPECIALITY FIBRES AND MATERIALS LIMITED | 2026-10-15 |
| 05059884011171 | Suprasorb Liquacel Ag | SPECIALITY FIBRES AND MATERIALS LIMITED | 2026-10-15 |
| 05059884011188 | Suprasorb Liquacel Ag | SPECIALITY FIBRES AND MATERIALS LIMITED | 2026-10-15 |
| 05059884011195 | Suprasorb Liquacel Ag | SPECIALITY FIBRES AND MATERIALS LIMITED | 2026-10-15 |
| 05059884011201 | Suprasorb Liquacel Ag | SPECIALITY FIBRES AND MATERIALS LIMITED | 2026-10-15 |
| 05059884011218 | Suprasorb Liquacel Ag | SPECIALITY FIBRES AND MATERIALS LIMITED | 2026-10-15 |
| 05059884011225 | Suprasorb Liquacel Ag | SPECIALITY FIBRES AND MATERIALS LIMITED | 2026-10-15 |
| 10841277111405 | Novera Seam | Harps USA, Inc. | 2026-10-14 |
| 00841277111408 | Novera Seam | Harps USA, Inc. | 2026-10-14 |
| 00841277111392 | Novera Seam | Harps USA, Inc. | 2026-10-14 |
| 10841277111382 | Novera Seam | Harps USA, Inc. | 2026-10-14 |
| 00841277111378 | Novera Seam | Harps USA, Inc. | 2026-10-14 |
| 00841277111385 | Novera Seam | Harps USA, Inc. | 2026-10-14 |
| 00050428034712 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-10-10 |
| 00050428034743 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-10-10 |
| 00050428142349 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-10-10 |
| 00050428341728 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-10-10 |
| 10885380214813 | Dermacea | Cardinal Health 200, LLC | 2026-10-09 |
| 10885380214820 | Dermacea | Cardinal Health 200, LLC | 2026-10-09 |
| 10885380214837 | Dermacea | Cardinal Health 200, LLC | 2026-10-09 |
| 10885380214844 | Dermacea | Cardinal Health 200, LLC | 2026-10-09 |
| 10885380214851 | Dermacea | Cardinal Health 200, LLC | 2026-10-09 |
| 06977727072259 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-10-08 |
| 06977727072266 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-10-08 |
| 00841277111323 | Novera Renew | Harps USA, Inc. | 2026-08-26 |
| 00841277111224 | Novera Renew | Harps USA, Inc. | 2026-08-26 |
| 00841277111200 | Novera Renew | Harps USA, Inc. | 2026-08-26 |
| 00841277111187 | Novera Renew | Harps USA, Inc. | 2026-08-26 |
| 09421906017496 | Endoform™ Antimicrobial Restorative Bioscaffold | AROA BIOSURGERY LIMITED | 2021-08-20 |