Spyroflex Pigmented Wound Dressing/Spyroflex Wound Dressing Tinted

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964398 ↗

FDA Product Code

MGP

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• 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

• Spyrofoam Wound Dressing

  Class I

  FDA 510(k) K951730 Active Cleared 16 Jun 1995

• A Gel Wound Dressing

  Unclassified

  FDA 510(k) K951862 Active Cleared 12 Jul 1995

See all devices from Polymedica Industries, Inc. →