510(k) K110546 ยท FRO Dressing, Wound, Drug
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
| Applicant | Derma Sciences, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 27, 2011 |
| Received | Feb 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney HCS Sheet Dressing with Leptospermum
Model/Catalog Number: 31612, 31622, 31644
Product Description: MEDIHONEY HCS SHEET DRESSING with LEPTOSPERMUM HONEY i Open, Classified |
FRO | None listed |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Adhesive Hydrogel Sheet Dressing
Model/Catalog Number: 31720, 31740
Product Description: MEDIHONEY Adhesive Hydrogel Sheet Dressing with
Leptospermum Hone Open, Classified |
FRO | None listed |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Hydrogel
Model/Catalog Number: 31620, 31640
Product Description: MEDIHONEY Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound d Open, Classified |
FRO | None listed |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney Hydrogel Adhesive Sheet
Model/Catalog Number: 31722, 31744
Product Description: MEDIHONEY HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist w Open, Classified |
FRO | None listed |
| Sep 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) Brand Name: MediHoney
Product Name: MediHoney HCS Surgical Adhesive Sheet
Model/Catalog Number: 31738
Product Description: MEDIHONEY HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.