Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K080383 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Duoderm(R) Adhesive Compression Bandage, Modified

  Class I

  FDA 510(k) K912550 Active Cleared 14 Aug 1991

• Duoderm Dressings, Cgf Dressings, Paste Full Thick

  Unclassified

  FDA 510(k) K904852 Active Cleared 25 Jan 1991

• Stomahesive Skin Barrier Sterile

  Class I

  FDA 510(k) K851840 Active Cleared 24 Jun 1985

• Allkare Barrier Wipe

  Class I

  FDA 510(k) K925004 Active Cleared 12 Jan 1994

• Duoderm* Extra Thin Flexible Hydrocolloid Dressing

  Class I

  FDA 510(k) K891696 Active Cleared 4 May 1989

• Nonwoven Pad

  Class I

  FDA 510(k) K980720 Active Cleared 15 Apr 1998

See all devices from Convatec, A Division of E.R. Squibb & Sons →