Bioderm Calcium Alginate Dressing

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

510(k) Number

K980451 ↗

FDA Product Code

KMF

Device Class

Class I

Regulation

21 CFR Part 880.5090

Advisory Committee

General Hospital

FDA Decision

SN

• Bioderm Eid Male External Incontinence Device

  Class I

  FDA 510(k) K963950 Active Cleared 10 Jan 1997

• Bioderm Foam Wound Dressing

  Class I

  FDA 510(k) K973429 Active Cleared 1 Dec 1997

• Bioderm Medical Foam Wound Dressing

  Class I

  FDA 510(k) K950619 Active Cleared 25 Apr 1995

• Bioderm Medical Hydrogel Island Dressing

  Class I

  FDA 510(k) K951166 Active Cleared 21 Jun 1995

• Bioderm Medical Composite Wound Dressing

  Unclassified

  FDA 510(k) K946292 Active Cleared 6 Feb 1995

• Bioderm Pvp Foam Wound Dressing

  Class I

  FDA 510(k) K963602 Active Cleared 30 Oct 1996

See all devices from Bioderm, Inc. →