510(k) K080315 ยท FRO Dressing, Wound, Drug
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
| Applicant | Derma Sciences, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Apr 23, 2008 |
| Received | Feb 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Paste
Model/Catalog Number: 31505
Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermu Open, Classified |
FRO | None listed |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Tube
Model/Catalog Number: 31515 and 31535
Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active L Open, Classified |
FRO | None listed |
| Oct 10, 2024 | Integra LifeSciences Corp. MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.