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Materialise NV

FDA 510(k) & PMA Approved Devices — 34 products

Total Devices34
Categories9
Latest FDA decision2026-06-09
TypeNumberDevice NameCodeDateActions
510(k) K260802 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2026-06-09 View
510(k) K251964 Mimics Thoracic PlannerLLZ2026-03-12 View
510(k) K253308 Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPT2026-01-07 View
510(k) K253793 Materialise TKA Guide SystemJWH2026-01-06 View
510(k) K251554 Materialise TKA Guide SystemJWH2025-07-14 View
510(k) K243637 Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ2025-02-21 View
510(k) K242813 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-10-18 View
510(k) K223427 Mimics Enlight CMFLLZ2024-05-31 View
510(k) K241143 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-05-22 View
510(k) K233217 Mimics Cardiac PlannerLLZ2024-02-12 View
510(k) K233408 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-11-09 View
510(k) K231112 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-09-12 View
510(k) K230315 Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2023-03-06 View
510(k) K220452 Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2022-08-17 View
510(k) K221337 Materialise TKA Guide SystemJWH2022-07-05 View
510(k) K213684 SurgiCase ViewerLLZ2022-06-15 View
510(k) K212569 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2022-01-12 View
510(k) K202207 Materialise PKA Guide SystemHSX2020-10-02 View
510(k) K193560 Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerQHE2020-03-20 View
510(k) K190286 Materialise Glenoid Positioning SystemKWS2019-07-08 View

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