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 |
|---|---|---|---|
| 10888277415027 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-04 |
| 10888277415010 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-09-04 |
| 10840330706183 | ProCure | Twin Med, LLC | 2026-04-08 |
| 10840330706176 | ProCure | Twin Med, LLC | 2026-04-08 |
| 10840330706169 | ProCure | Twin Med, LLC | 2026-04-08 |
| 10840330706152 | ProCure | Twin Med, LLC | 2026-04-08 |
| 00850017274006 | BIASURGE™ Advanced Surgical Solution | Sanara Medtech Inc. | 2023-10-26 |
| 00825439017265 | ColActive® Plus Powder Ag | Covalon Technologies Ltd | 2022-11-30 |
| 00825439011188 | ColActive® Plus 2"x2" | Covalon Technologies Ltd | 2022-11-30 |
| 00825439011218 | ColActive® Plus 4"x4" | Covalon Technologies Ltd | 2022-11-30 |
| 00825439011249 | ColActive® Plus 7"x7" | Covalon Technologies Ltd | 2022-11-30 |
| 00825439017241 | ColActive® Plus Powder | Covalon Technologies Ltd | 2022-11-30 |
| 00825439011331 | ColActive® Plus Ag 7"x7" | Covalon Technologies Ltd | 2022-11-30 |
| 00825439011300 | ColActive® Plus Ag 4"x4" | Covalon Technologies Ltd | 2022-11-30 |
| 00825439011270 | ColActive® Plus Ag 2"x2" | Covalon Technologies Ltd | 2022-11-30 |
| 00818582012805 | BLDG Active | Innovacyn, Inc. | 2022-10-24 |
| 00818582010931 | BLDG Active | Innovacyn, Inc. | 2022-10-24 |
| 00818582012423 | BLDG Active | Innovacyn, Inc. | 2022-10-20 |
| 04052199578729 | ColActive Plus Powder Ag Wound Filler | HARTMANN USA, INC. | 2021-08-27 |
| 04052199578750 | ColActive Plus Powder Wound Filler | HARTMANN USA, INC. | 2021-08-27 |
| 30612553024283 | ColActive Plus 4x4 | HARTMANN USA, INC. | 2020-09-01 |
| 30612553024290 | COLACTIVE PLUS 7x7 10/BX | HARTMANN USA, INC. | 2020-09-01 |
| 30612553024306 | ColActive Plus AG 2x2 600/cs | HARTMANN USA, INC. | 2020-09-01 |
| 30612553024313 | ColActive Plus AG 4x4 300/cs | HARTMANN USA, INC. | 2020-09-01 |
| 30612553024320 | COLACTIVE PLUS AG 7x7 10/BX | HARTMANN USA, INC. | 2020-09-01 |
| 30612553024276 | ColActive Plus 2x2 | HARTMANN USA, INC. | 2020-09-01 |
| 10612479258348 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-25 |
| 10612479258317 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-25 |
| 10612479235608 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-10 |
| 10612479235592 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-10 |