Mangere, NZ · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | Unknown | 3 | 2026-06-24 |
| FTM | Mesh, Surgical | Class II | General, Plastic Surgery | 1 | 2025-06-03 |
| NPL | Barrier, Animal Source, Intraoral | Class II | Dental | 1 | 2024-01-23 |
| BTA | — | — | — | 1 | 2023-04-07 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-24 | K260669 | Endoform Dermal Template | KGN | Unclassified | Unknown |
| 2025-06-03 | K250598 | Endoform Reconstructive Template - PLGA | FTM | Class II | General, Plastic Surgery |
| 2024-01-23 | K231305 | Endoform Dental Membrane | NPL | Class II | Dental |
| 2023-04-07 | K223373 | Enivo | BTA | — | — |
| 2021-03-31 | K200502 | Myriad Particles | KGN | Unclassified | Unknown |
| 2020-07-29 | K200413 | Symphony | KGN | Unclassified | Unknown |