Materialise NV
Dispositifs autorisés FDA 510(k) et PMA — 34 produits
Publicité
Nombre total de dispositifs34
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260802 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2026-06-09 | Voir |
| 510(k) | K251964 | Mimics Thoracic Planner | LLZ | 2026-03-12 | Voir |
| 510(k) | K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | PPT | 2026-01-07 | Voir |
| 510(k) | K253793 | Materialise TKA Guide System | JWH | 2026-01-06 | Voir |
| 510(k) | K251554 | Materialise TKA Guide System | JWH | 2025-07-14 | Voir |
| 510(k) | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | DZJ | 2025-02-21 | Voir |
| 510(k) | K242813 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2024-10-18 | Voir |
| 510(k) | K223427 | Mimics Enlight CMF | LLZ | 2024-05-31 | Voir |
| 510(k) | K241143 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2024-05-22 | Voir |
| 510(k) | K233217 | Mimics Cardiac Planner | LLZ | 2024-02-12 | Voir |
| 510(k) | K233408 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2023-11-09 | Voir |
| 510(k) | K231112 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2023-09-12 | Voir |
| 510(k) | K230315 | Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | QHE | 2023-03-06 | Voir |
| 510(k) | K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | QHE | 2022-08-17 | Voir |
| 510(k) | K221337 | Materialise TKA Guide System | JWH | 2022-07-05 | Voir |
| 510(k) | K213684 | SurgiCase Viewer | LLZ | 2022-06-15 | Voir |
| 510(k) | K212569 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2022-01-12 | Voir |
| 510(k) | K202207 | Materialise PKA Guide System | HSX | 2020-10-02 | Voir |
| 510(k) | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | QHE | 2020-03-20 | Voir |
| 510(k) | K190286 | Materialise Glenoid Positioning System | KWS | 2019-07-08 | Voir |
Aucun dispositif correspondant.