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Materialise NV FDA Approvals
0 new drug approvals and 17 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner510(k)Jun 9, 2026Orthopedic |
| Mimics Thoracic Planner510(k)Mar 12, 2026Radiology |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models510(k)Jan 7, 2026Neurology |
| Materialise TKA Guide System510(k)Jan 6, 2026Orthopedic |
| Materialise TKA Guide System510(k)Jul 14, 2025Orthopedic |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery510(k)Feb 21, 2025Dental |
| Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner510(k)Oct 18, 2024Orthopedic |
| Mimics Enlight CMF510(k)May 31, 2024Radiology |
| Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner510(k)May 22, 2024Orthopedic |
| Mimics Cardiac Planner510(k)Feb 12, 2024Radiology |
| Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner510(k)Nov 9, 2023Orthopedic |
| Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner510(k)Sep 12, 2023Orthopedic |
| Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner510(k)Mar 6, 2023Orthopedic |
| Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner510(k)Aug 17, 2022Orthopedic |
| Materialise TKA Guide System510(k)Jul 5, 2022Orthopedic |
| SurgiCase Viewer510(k)Jun 15, 2022Radiology |
| Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner510(k)Jan 12, 2022Orthopedic |