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 |
|---|---|---|---|
| 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 |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-11-13 |
| K240510 | Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. | 2024-11-08 |
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | 2024-10-31 |
| 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, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch | Speciality Fibres and Materials, Ltd. | 2024-10-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04046961025153 | Prontosan® | B. BRAUN MEDICAL INC. | 2026-08-09 |
| 00050428034880 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-08-08 |
| 00050428034873 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-08-08 |
| 10197344169436 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-08-07 |
| 10197344169429 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-08-07 |
| 10197344169405 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-07-31 |
| 00818582013802 | Puracyn® Plus Professional Formula | Innovacyn, Inc. | 2026-07-31 |
| 00818582013796 | Puracyn® Plus Professional Formula | Innovacyn, Inc. | 2026-07-31 |
| 00852421007683 | Pure&Clean | Pure & Clean, LLC | 2026-07-29 |
| 00852421007850 | Pure&Clean | Pure & Clean, LLC | 2026-07-29 |
| 04260056880667 | XPERIENCE Advanced Surgical Irrigation | OSARTIS GmbH | 2026-07-28 |
| 10841495149815 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-07-27 |
| B665AVX030011 | VIA Linx | Arch Therapeutics, Inc. | 2026-07-24 |
| B665AC510011 | AC5 Advanced Wound System | Arch Therapeutics, Inc. | 2026-07-24 |
| 00850088144635 | CARBOU | Ningbo kehu Medical Technology Co.,Ltd. | 2026-07-10 |
| 00850088144628 | CARBOU | Ningbo kehu Medical Technology Co.,Ltd. | 2026-07-10 |
| 00850088144611 | CARBOU | Ningbo kehu Medical Technology Co.,Ltd. | 2026-07-10 |
| 00850088144604 | CARBOU | Ningbo kehu Medical Technology Co.,Ltd. | 2026-07-10 |
| 00850087488266 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00850087488259 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00850087488006 | Ceeport | CEEPORT INC. | 2026-05-22 |
| 10888277701595 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-09-24 |
| 10888277701649 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-09-24 |
| 10888277701632 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-09-24 |
| 10888277701625 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-09-24 |
| 10888277701618 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-09-24 |
| 10888277701588 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-09-24 |
| 00852421007027 | Pure&Clean | Pure & Clean, LLC | 2023-08-04 |
| 00852421007034 | Pure&Clean | Pure & Clean, LLC | 2023-08-04 |
| 00852421007089 | Pure&Clean | Pure & Clean, LLC | 2023-08-03 |