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Dressing, Compression

FDA product code MHW · Class 1 · General Hospital

620
Registered devices
70
Adverse events
6
Recalls
2
510(k) clearances

Devices with this code

CoFlex TLC — Andover Healthcare, Inc.Sensi Wrap, Self-Adherent - Latex Free 1" x 5 yds Tan — Dynarex CorporationEZbra® Breast Dressing — EZBRA ADVANCED WOUND CARE LTDVive — VIVE HEALTH LLCCoflex TLC — Andover Healthcare, Inc.AMD-RITMED — AMD Medicom IncBATTLE BANDAGE — Safeguard US Operating, LLCAerowrap® Full Leg Tall Flex — SUN SCIENTIFIC, INC.AeroWrap™ Full Leg — SUN SCIENTIFIC, INC.AeroWrap™ — SUN SCIENTIFIC, INC.DeRoyal — DEROYAL INDUSTRIES, INC.AeroWrap™ Full Leg — SUN SCIENTIFIC, INC.AMD-RITMED — AMD Medicom IncSunWrap Radial Artery Arm Wrap — SUN SCIENTIFIC, INC.OmniTrustTM — Omni International Corp.SunWrap Forearm Right — SUN SCIENTIFIC, INC.MediChoice — OWENS & MINOR DISTRIBUTION, INC.Aerowrap® Full Leg Tall Flex — SUN SCIENTIFIC, INC.Sensi Wrap,Self-Adherent - Latex Free 3" x 5 yds Purple — Dynarex CorporationComfort Band — Tz Medical, Inc.Aerowrap® Full Leg Tall Flex — SUN SCIENTIFIC, INC.DeRoyal — DEROYAL INDUSTRIES, INC.AeroWrap™ Full Leg — SUN SCIENTIFIC, INC.Sensi-Wrap, Self Adherent — Dynarex Corporation

Recent recalls

DateFirmReason
2026-09-02Safeguard US Operating LLCCompression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irriga
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.