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Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey

by Derma Sciences, Inc.

510(k) K110546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110546 Date27 Jul 2011ClearedStatusActive

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-2507-2025 FDA Class II initiated 5 Aug 2025
    • Ongoing Z-2508-2025 FDA Class II initiated 5 Aug 2025
    • Ongoing Z-2509-2025 FDA Class II initiated 5 Aug 2025
    • Ongoing Z-2511-2025 FDA Class II initiated 5 Aug 2025
    • Ongoing Z-2510-2025 FDA Class II initiated 5 Aug 2025

    Packaging failures were identified which could lead to a breach in the sterile barrier.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRO
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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