Home › Device types › FRO
Dressing, Wound, Drug
FDA product code FRO · Class U · Unknown
3,062
Registered devices
3,144
Adverse events
82
Recalls
707
510(k) clearances
Devices with this code
QUIKCLOT — TELEFLEX INCORPORATEDWell at Walgreens — WALGREEN CO.MEDLINE — MEDLINE INDUSTRIES, INC.SiOxC — Sioxmed, LLCDimora — Winner Medical Co., Ltd.H-E-B — H. E. BUTT GROCERY COMPANYMagic Molecule Antimicrobial Skin Spray — MAGIC SCIENCE SUPPLY LLCTegaderm™ — 3M COMPANYSilverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLCASAP OTC — Abl Medical, LLCRV-X1 — Gel4med, Inc.Silverstream — SilverStream Medical Ltd.McKesson — MCKESSON MEDICAL-SURGICAL INC.ACTICOAT 7 2" X 2" — SMITH & NEPHEW MEDICAL LIMITEDDukal — Dukal LLCTRITEC Silver — MILLIKEN HEALTHCARE PDTS, LLCQuikClot — Z-MEDICA, LLCCVS Health® — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMEDLINE — MEDLINE INDUSTRIES, INC.PermeaDerm — Stedical Scientific, Inc.Surgaflex — IMBED BIOSCIENCES, INC.CURAD — MEDLINE INDUSTRIES, INC.BloodSTOP — Lifescience Plus, Inc.Calcium Alginate Ag (Silver) Dressing (4x4 in) — Gentell, LLC
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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