Kerecis
Medical device makerAI in IcelandAI, part of ColoplastAI. FDA records under 2 spellings of its name, each linked to the record.
- 510(k) clearances: 12
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Oct 30, 2026 | Kerecis Express (50250)K260058 · KGN | 510(k) clearances |
| Jul 16, 2025 | Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusK251845 · KGN | 510(k) clearances |
| Jul 15, 2025 | Kerecis SurgiBind (50241)K251844 · OXH | 510(k) clearances |
| Jun 4, 2025 | Tendon Protect (50242)K243843 · OWY | 510(k) clearances |
| Aug 21, 2024 | Kerecis Parvus (50207)K241080 · KGN | 510(k) clearances |
| Sep 30, 2022 | Kerecis OralK213904 · NPL | 510(k) clearances |
| Jun 29, 2022 | Kerecis SiliconeK213231 · KGN | 510(k) clearances |
| May 2, 2021 | Kerecis ReconstructK202430 · OXH | 510(k) clearances |
Canada and Imports
Matched by company name- Active Health Canada device licences
- 1, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- kerecis.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built