FROFDA Class U
Dressing, Wound, Drug
Device family · Unknown
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
704
Manufacturers
85
Flagged signals
17
Adverse-event reports
2,505
Code matrix
| FDA product code | FRO |
| Device class | Class U |
| Regulation | — |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 3 | 95.0 | 193 |
| Other | 2012 | 12 | 90.7 | 978 |
| Other | 2014 | 5 | 89.9 | 356 |
| Other | 2013 | 4 | 78.2 | 233 |
| Other | 2010 | 20 | 66.9 | 1,234 |
| Other | 2012 | 3 | 58.7 | 117 |
| Death | 2020 | 4 | 50.5 | 149 |
| Other | 2014 | 5 | 42.1 | 162 |
| Death | 2020 | 4 | 41.3 | 121 |
| Other | 2013 | 11 | 36.8 | 348 |
| Other | 2011 | 4 | 30.2 | 86 |
| Other | 2012 | 6 | 25.4 | 118 |
| Other | 2014 | 7 | 23.4 | 129 |
| Other | 2013 | 5 | 21.2 | 77 |
| Death | 2023 | 4 | 3.9 | 6 |
| Death | 2023 | 4 | 3.9 | 6 |
| Injury | 2021 | 6 | 2.6 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class U family · 2,505 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Convatec, A Division of E.R. Squibb & Sons | 13 | 2002 | — |
| Winner Medical Co., Ltd. | 12 | 2023 | — |
| 3M COMPANY | 10 | 2020 | — |
| ADVANCED MEDICAL SOLUTIONS LIMITED | 9 | 2023 | — |
| MEDLINE INDUSTRIES, INC. | 8 | 2019 | — |
| Smith & Nephew, Inc. | 7 | 2011 | — |
| B.Braun Medical, Inc. | 7 | 2017 | — |
| Hollister, Inc. | 6 | 1995 | — |
| Johnson & Johnson Professionals, Inc. | 6 | 1986 | — |
| COLOPLAST CORP. | 6 | 2024 | — |
| LABORATOIRES URGO | 6 | 2015 | — |
| Coloplast A/S | 6 | 2020 | — |
| ARGENTUM MEDICAL, LLC | 5 | 2024 | — |
| Sonoma Pharmaceuticals, Inc. | 5 | 2024 | — |
| LINKS MEDICAL PRODUCTS, INC. | 4 | 2014 | — |
| FERRIS MFG. CORP. | 4 | 2003 | — |
| NEXT SCIENCE, LLC | 4 | 2021 | — |
| ABIGO Medical AB | 4 | 2017 | — |
| Beiersdorf, Inc. | 4 | 1989 | — |
| HYDROFERA, LLC | 4 | 2019 | — |
| Avery Dennison Belgie BVBA | 4 | 2017 | — |
| Innovacyn, Inc. | 4 | 2026 | — |
| Udl Laboratories, Inc. | 3 | 1991 | — |
| C.R. Bard, Inc. | 3 | 1986 | — |
| Southwest Technologies, Inc. | 3 | 2010 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
IWD-Gel · InnovaCorium, Inc.510(k) · 2026-04-07
MiraChlor Antimicrobial Wound Solution · Letus Corporation510(k) · 2026-03-25
Promogran Prisma Collagen Matrix with ORC and Silver · Solventum Germany GmbH510(k) · 2026-03-13
LUOFUCON® Antimicrobial Wound Gel · Huizhou Foryou Medical Co., Ltd.510(k) · 2026-03-11
Redermax Antibacterial Wound Matrix · Beijing Kreate Medical Co., Ltd.510(k) · 2026-02-02
New Day Skin Spray · Silk Holdings, Inc.510(k) · 2026-01-23
SBC1 Cream · Sioxmed, LLC510(k) · 2026-01-12
revyve® Antimicrobial Skin and Wound Cleanser · Kane Biotech, Inc.510(k) · 2026-01-08
Puracyn® Plus Antimicrobial Irrigation Solution · Innovacyn, Inc.510(k) · 2026-01-05
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) · Qingdao Bright Moon Biomedical Materials Co., Ltd.510(k) · 2025-12-19
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) · Huizhou Foryou Medical Devices Co., Ltd.510(k) · 2025-11-19
Hemastyl() Wound Dressing · Rapid Nexus Nanotech Wound Solutions, Inc.510(k) · 2025-10-14
Tegaderm Post-Op Transparent Antimicrobial Dressing · Solventum US, LLC510(k) · 2025-10-10
Dermalage · Infection Elimination Solutions, LLC510(k) · 2025-08-27
Granudacyn® Wound Irrigation Solution · P.G.F. Industry Solutions GmbH510(k) · 2025-07-22
Bonvadis® · Oneness Biotech Co., Ltd.510(k) · 2025-06-09
Nixall Antimicrobial Solutions Skin & Wound Hydrogel · Seriously Clean, Ltd.510(k) · 2025-05-02
Spectricept Skin and Wound Cleanser · Spectrum Antimicrobials, Inc.510(k) · 2025-04-21
SiOxC Cream · Sioxmed, LLC510(k) · 2025-03-13
Sterile Water USP and Sterile 0.9% Normal Saline USP · Laboratorios Biogalenic S.A. DE C.V.510(k) · 2025-03-06
LUOFUCON® Silver Collagen Dressing · Huizhou Foryou Medical Devices Co., Ltd.510(k) · 2024-12-16
Atrauman® Ag · Hartmann USA, Inc.510(k) · 2024-12-09
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.510(k) · 2024-11-13
Microdacyn Hydrogel · Sonoma Pharmaceuticals, Inc.510(k) · 2024-11-08
Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo · Bionova Medical, Inc.510(k) · 2024-10-31
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.