Materialise NV

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
60
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251964Mimics Thoracic PlannerMarch 12, 2026
K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF January 7, 2026
K253793Materialise TKA Guide SystemJanuary 6, 2026
K251554Materialise TKA Guide SystemJuly 14, 2025
K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryFebruary 21, 2025
K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerOctober 18, 2024
K223427Mimics Enlight CMFMay 31, 2024
K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMay 22, 2024
K233217Mimics Cardiac PlannerFebruary 12, 2024
K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerNovember 9, 2023
K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerSeptember 12, 2023
K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerMarch 6, 2023
K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerAugust 17, 2022
K221337Materialise TKA Guide SystemJuly 5, 2022
K213684SurgiCase ViewerJune 15, 2022
K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerJanuary 12, 2022
K202207Materialise PKA Guide SystemOctober 2, 2020
K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder March 20, 2020
K190286Materialise Glenoid Positioning SystemJuly 8, 2019
K190874Materialise Mimics EnlightJune 5, 2019