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Materialise NV

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories9
Latest Approval2026-03-12
TypeNumberDevice NameCodeDate
510(k) K251964 Mimics Thoracic Planner LLZ 2026-03-12 View
510(k) K253308 Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models PPT 2026-01-07 View
510(k) K253793 Materialise TKA Guide System JWH 2026-01-06 View
510(k) K251554 Materialise TKA Guide System JWH 2025-07-14 View
510(k) K243637 Materialise Personalized Guides and Models for Craniomaxillofacial Surgery DZJ 2025-02-21 View
510(k) K242813 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE 2024-10-18 View
510(k) K223427 Mimics Enlight CMF LLZ 2024-05-31 View
510(k) K241143 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE 2024-05-22 View
510(k) K233217 Mimics Cardiac Planner LLZ 2024-02-12 View
510(k) K233408 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE 2023-11-09 View
510(k) K231112 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE 2023-09-12 View
510(k) K230315 Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner QHE 2023-03-06 View
510(k) K220452 Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner QHE 2022-08-17 View
510(k) K221337 Materialise TKA Guide System JWH 2022-07-05 View
510(k) K213684 SurgiCase Viewer LLZ 2022-06-15 View
510(k) K212569 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE 2022-01-12 View
510(k) K202207 Materialise PKA Guide System HSX 2020-10-02 View
510(k) K193560 Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner QHE 2020-03-20 View
510(k) K190286 Materialise Glenoid Positioning System KWS 2019-07-08 View
510(k) K190874 Materialise Mimics Enlight LLZ 2019-06-05 View
510(k) K183105 Mimics Medical LLZ 2019-03-27 View
510(k) K173039 TruMatch CMF Titanium 3D Printed Implant JEY 2018-07-10 View
510(k) K173970 Materialise PKA Guide System HSX 2018-07-06 View
510(k) K173619 Mimics inPrint LLZ 2018-03-21 View
510(k) K173445 Materialise TKA Guide System JWH 2018-02-02 View
510(k) K172650 Materialise PKA Guide System HSX 2017-11-20 View
510(k) K172054 Materialise Glenoid Positioning System KWS 2017-11-03 View
510(k) K170272 TruMatch CMF Titanium 3D Printed Implant System JEY 2017-08-08 View
510(k) K170893 Materialise Glenoid Positioning System KWS 2017-06-19 View
510(k) K170419 SurgiCase Viewer LLZ 2017-05-11 View
510(k) K163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides PBF 2017-01-18 View
510(k) K162273 Materialise TKA Guide System JWH 2016-11-07 View
510(k) K153602 Materialise Glenoid Positioning System KWS 2016-04-26 View
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