Home › Device types › FRO
Dressing, Wound, Drug
FDA product code FRO · Class U · Unknown
3,165
Registered devices
3,321
Adverse events
82
Recalls
707
510(k) clearances
Devices with this code
INTEGRA® VolTAC™ — Integra Lifesciences CorporationExcilon — Cardinal Health, Inc.CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDVaseline — Cardinal Health 200, LLCInnomed — Zhejiang Longterm Medical Technology Co., Ltd.INTEGRA® VolTAC™ — Integra Lifesciences CorporationColActive® Plus 4"x4" — Covalon Technologies LtdMicrolyte Matrix — IMBED BIOSCIENCES, INC.Adventure Medical Kits — Adventure Ready BrandsBD — BECTON, DICKINSON AND COMPANYAxiostat Gauze — AXIO BIOSOLUTIONS PRIVATE LIMITEDSorbalgon Ag st 15x15cm P5 — HARTMANN USA, INC.Bonvadis Topical Cream — ONENESS BIOTECH CO., LTD.Tegaderm™ — 3M COMPANYProcellera Single Layer — ARTHREX, INC.PermeaDerm® — Stedical Scientific, Inc.Puracyn® Plus Professional Formula — Innovacyn, Inc.SteriCare Solutions — NURSE ASSIST, INC.AMSure® Sterile Water for lrrigation USP 500 mL — AMSINO INTERNATIONAL, INC.Phoenix Surgical Wound Matrix Fenestrated — NANOFIBER SOLUTIONS, INC.SteriCare Solutions — NURSE ASSIST, INC.CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDTheraBond 3D antimicrobial barrier systems — ARGENTUM MEDICAL, LLCAQUACEL AG BURN — CONVATEC, PURCHASING DEPARTMENT
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | ConvaTec, Inc | Surgical dressing manufactured out of specification (greater thickness). |
| 2026-04-27 | Oculus Technologies of Mexico, S.A. de C.V. | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibilit |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assuranc |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assuranc |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
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