Materialise NV - FDA 510(k) Cleared Devices
Recent clearances: Mimics Thoracic Planner, Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides, Materialise TKA Guide System
60
Total
60
Cleared
0
Denied
FDA 510(k) Regulatory Record - Materialise NV Orthopedic ✕
38 devices
Cleared
Jan 06, 2026
Materialise TKA Guide System
Orthopedic
39d
Cleared
Jul 14, 2025
Materialise TKA Guide System
Orthopedic
54d
Cleared
Oct 18, 2024
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
Orthopedic
30d
Cleared
May 22, 2024
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
Orthopedic
27d
Cleared
Nov 09, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
Orthopedic
34d
Cleared
Sep 12, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
Orthopedic
146d
Cleared
Mar 06, 2023
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase...
Orthopedic
28d
Cleared
Aug 17, 2022
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase...
Orthopedic
181d
Cleared
Jul 05, 2022
Materialise TKA Guide System
Orthopedic
57d
Cleared
Jan 12, 2022
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
Orthopedic
149d
Cleared
Oct 02, 2020
Materialise PKA Guide System
Orthopedic
57d
Cleared
Mar 20, 2020
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder...
Orthopedic
88d
Looking for a specific device from Materialise NV? Search by device name or K-number.
Search all Materialise NV devices