Product code FRO
Current FDA Classification
- 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
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 |
|---|---|---|---|
| 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 |
| K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 2024-10-17 |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-10-07 |
| K240722 | Derma-R Cream (Derma-R Cream) | Raya Pharmaceuticals, LLC | 2024-09-20 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06977727072228 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 06977727072235 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 06977727072242 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 06977727072419 | SurCura Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 06977727072426 | SurCura Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 06977727072433 | SurCura Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 06977727072440 | SurCura Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 06977727072211 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-03-23 |
| 04719883980380 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 04719883980397 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 04719883980373 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 04719883980366 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 04719883980342 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 04719883980311 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 04719883980090 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 00050428339770 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-03-20 |
| 04719883980359 | Bonvadis Topical Cream | ONENESS BIOTECH CO., LTD. | 2026-03-20 |
| 05060996770023 | Acutarex | Alliance Healing Technologies, LLC | 2026-03-13 |
| 00618474000541 | PuraPly Antimicrobial Surgical Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000534 | PuraPly Antimicrobial Surgical Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000503 | PuraPly Antimicrobial Surgical Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000497 | PuraPly Antimicrobial Surgical Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000329 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000312 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000305 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000299 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000190 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000183 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000176 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |
| 00618474000169 | PuraPly Antimicrobial Wound Matrix | ORGANOGENESIS INC. | 2026-03-12 |