DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY— 510(k) K080315
Substantially EquivalentDerma Sciences, Inc.
FDA 510(k) clearance K080315 for DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY, Substantially Equivalent on 2008-04-23. Applicant: Derma Sciences, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Derma Sciences, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code FRO
view allMore clearances from Derma Sciences, Inc.
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K080315
K-number listed on FDA's recall record- Z-2505-2025 — 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 Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.
- Z-2506-2025 — 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 Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.
- Z-0054-2025 — 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)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080315.
Data sourced from openFDA. This site is unofficial and independent of the FDA.