Materialise NV
FDA 510(k) & PMA Approved 器材 — 34 products
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器材總數34
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最新 FDA 裁決
| 類型 | 編號 | 器材名稱 | 代碼 | 日期 | 操作 |
|---|---|---|---|---|---|
| 510(k) | K260802 | Materialise Shoulder System™,Materialise Shoulder Guide 及 Model,SurgiCase Shoulder Planner | QHE | 2026-06-09 | 查看 |
| 510(k) | K251964 | 模擬胸腔計劃器 | LLZ | 2026-03-12 | 查看 |
| 510(k) | K253308 | Materialise 頭顎面外科手術個人化導引和模型 CMF 鋼钛導引;CMF 塑膠模型 | PPT | 2026-01-07 | 查看 |
| 510(k) | K253793 | Materialise 骨關節置换導引系統 | JWH | 2026-01-06 | 查看 |
| 510(k) | K251554 | Materialise 骨關節置换導引系統 | JWH | 2025-07-14 | 查看 |
| 510(k) | K243637 | Materialise個人化頭顱顏面手術導引和模型 | DZJ | 2025-02-21 | 查看 |
| 510(k) | K242813 | Materialise Shoulder System™,Materialise Shoulder Guide 及 Model,SurgiCase Shoulder Planner | QHE | 2024-10-18 | 查看 |
| 510(k) | K223427 | 模擬啟明CMF | LLZ | 2024-05-31 | 查看 |
| 510(k) | K241143 | Materialise Shoulder System™,Materialise Shoulder Guide 及 Model,SurgiCase Shoulder Planner | QHE | 2024-05-22 | 查看 |
| 510(k) | K233217 | 模擬心臟計劃器 | LLZ | 2024-02-12 | 查看 |
| 510(k) | K233408 | Materialise Shoulder System™,Materialise Shoulder Guide 及 Model,SurgiCase Shoulder Planner | QHE | 2023-11-09 | 查看 |
| 510(k) | K231112 | Materialise Shoulder System™,Materialise Shoulder Guide 及 Model,SurgiCase Shoulder Planner | QHE | 2023-09-12 | 查看 |
| 510(k) | K230315 | Materialise Shoulder System™ 材質化肩關節系統 Materialise Shoulder Guide 和 Model SurgiCase Shoulder Planner | QHE | 2023-03-06 | 查看 |
| 510(k) | K220452 | Materialise Shoulder System™ 材質化肩關節系統 Materialise Shoulder Guide 和模型 SurgiCase Shoulder 规劃器 | QHE | 2022-08-17 | 查看 |
| 510(k) | K221337 | Materialise 骨關節置换導引系統 | JWH | 2022-07-05 | 查看 |
| 510(k) | K213684 | SurgiCase 查覽器 | LLZ | 2022-06-15 | 查看 |
| 510(k) | K212569 | Materialise Shoulder System™,Materialise Shoulder Guide 及 Model,SurgiCase Shoulder Planner | QHE | 2022-01-12 | 查看 |
| 510(k) | K202207 | Materialise PKA導引系統 | HSX | 2020-10-02 | 查看 |
| 510(k) | K193560 | Materialise肩部導引和模型、Materialise SurgiCase肩部計劃器、Materialise肩部計劃器、SurgiCase肩部計劃器、SurgiCase計劃器 | QHE | 2020-03-20 | 查看 |
| 510(k) | K190286 | Materialise 閃骨定位系統 | KWS | 2019-07-08 | 查看 |
沒有符合的裝置。