Ultrafera Wound Dressing

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964614 ↗

FDA Product Code

KMF

Device Class

Class I

Regulation

21 CFR Part 880.5090

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Non-Adhera Adhesive Pad 3X4

  Class I

  FDA 510(k) K853334 Active Cleared 21 Aug 1985

• Tricot Adhesive Bandage

  Class I

  FDA 510(k) K852462 Active Cleared 26 Jul 1985

• White Cross Sterile Pad 4IN. X 4IN.

  Not classified

  FDA 510(k) K854809 Active Cleared 13 Jan 1986

• Awc Butterfly Wound Closures

  Class I

  FDA 510(k) K894802 Active Cleared 31 Jan 1990

• Non-Adherent Pad

  Unclassified

  FDA 510(k) K852412 Active Cleared 29 Jul 1985

• 3 X 4 Non-Adherent Pad

  Not classified

  FDA 510(k) K850595 Active Cleared 11 Mar 1985

See all devices from American White Cross, Inc. →