Mitraflex Cavity Wound Dressing

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K935783 ↗

FDA Product Code

KMF

Device Class

Class I

Regulation

21 CFR Part 880.5090

Advisory Committee

General Hospital

FDA Decision

SN

• Mediaid Universal Thermometer

  Class II

  FDA 510(k) K941673 Active Cleared 25 Aug 1994

• Spyroflex Skin Protector

  Unclassified

  FDA 510(k) K953885 Active Cleared 29 Nov 1995

• Basis Flexible Tip Digital Thermometer

  Class II

  FDA 510(k) K971045 Active Cleared 2 May 1997

• Mitraflex Pigmented Wound Dressing

  Unclassified

  FDA 510(k) K964701 Active Cleared 7 Feb 1997

• Spyroflex Pigmented Wound Dressing/Spyroflex Wound Dressing Tinted

  Unclassified

  FDA 510(k) K964398 Active Cleared 24 Oct 1997

• Spyrofoam Wound Dressing

  Class I

  FDA 510(k) K951730 Active Cleared 16 Jun 1995

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