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Dressing, Compression

FDA product code MHW · Class 1 · General Hospital

545
Registered devices
70
Adverse events
5
Recalls
2
510(k) clearances

Devices with this code

MediChoice — OWENS & MINOR DISTRIBUTION, INC.Sensi-Wrap, Self Adherent — Dynarex CorporationSensi Wrap,Self-Adherent - Latex Free 3" x 5 yds Purple — Dynarex CorporationSensi-Wrap, Self Adherent — Dynarex CorporationAMD-RITMED DISTECH STRETCH — AMD Medicom IncPROCARE — DJO, LLCAeroWrap™ Full Leg — SUN SCIENTIFIC, INC.Vive — VIVE HEALTH LLCEZbra® Breast Dressing — EZBRA ADVANCED WOUND CARE LTDAeroWrap™ Flex Medium Bilateral — SUN SCIENTIFIC, INC.SAFEGUARD FOCUS™ — Merit Medical Systems, Inc.MediChoice — OWENS & MINOR DISTRIBUTION, INC.OmniTrustTM — OMNI INTERNATIONAL CORP.AMD-RITMED DISTECH STRETCH — AMD Medicom IncFifthPulse — Jeg & Sons Inc.Vive — VIVE HEALTH LLCAeroWrap™ Full Leg — SUN SCIENTIFIC, INC.Sensi-Wrap, Self Adherent — Dynarex CorporationDeRoyal — DEROYAL INDUSTRIES, INC.AeroWrap™ Full Leg — SUN SCIENTIFIC, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.SunWrap Forearm U Bladder Right — SUN SCIENTIFIC, INC.BATTLE BANDAGE — Safeguard US Operating, LLC

Recent recalls

DateFirmReason
2016-02-24Amd RitmedProduct does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.
2006-08-16International Medsurg Connection, Inc.The bandages labeled as sterile had not been sterilized prior to distribution.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.