Derma Sciences, Inc.
North Attleboro, MA, US
Derma Sciences, Inc. appears in FDA device records in North Attleboro, MA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Derma Sciences, Inc. between 1992 and 2015. The busiest year on record is 1995, with 9. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 9 |
| 1996 | 1 |
| 1997 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2011 | 2 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150985 | Medihoney Wound Gel | FRO | Substantially Equivalent | |
| K133279 | MEDIHONEY WOUND DRESSINGS | FRO | Substantially Equivalent | |
| K110546 | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY | FRO | Substantially Equivalent | |
| K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY | FRO | Substantially Equivalent | |
| K081584 | DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | FRO | Substantially Equivalent | |
| K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | FRO | Substantially Equivalent | |
| K072956 | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY | FRO | Substantially Equivalent | |
| K970660 | DERMAGRAN WOUND MANAGEMENT SYSTEM | KMF | Substantially Equivalent | |
| K963603 | DERMAGRAN HYDROPHILIC OINTMENT | KMF | Substantially Equivalent for Some Indications | |
| K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC | FRO | Substantially Equivalent | |
| K954742 | DERMAGRAN WET DRESSING (ZINC-SALINE) | FRO | Substantially Equivalent | |
| K954740 | DERMAGRAN WOUND DRESSING | FRO | Substantially Equivalent | |
| K954739 | DERMAGRAN HYDROPHILIC OINTMENT | FRO | Substantially Equivalent | |
| K954738 | DERMAGRAN HYDROPHILIC WOUND DRESSING | MGP | Substantially Equivalent | |
| K954741 | DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) | MGQ | Substantially Equivalent for Some Indications | |
| K954664 | DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING | MGQ | Substantially Equivalent for Some Indications | |
| K951499 | DERMAGRAN HYDROPHILIC OINTMENT | KMF | Substantially Equivalent | |
| K945802 | DERMAGRAN WOUND CLEANSER WITH ZINC | KMF | Substantially Equivalent | |
| K944491 | DERMAGRAN HYDROPHILIC OINTMENT | KMF | Substantially Equivalent for Some Indications | |
| K924754 | DERMAGRAN WOUND DRESSING | FRO | Substantially Equivalent | |
| K913344 | DERMAGRAN WET DRESSING (ZINC-SALINE) | MGQ | Substantially Equivalent | |
| K914746 | DERMAGRAN WET DRESSING | MGQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain