Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

62 results for "Materialise NV"
1–24 of 62
Search insights Median review: 120d Cleared: 100% Top manufacturer: Materialise NV Lead specialty: Orthopedic
Cleared Oct 09, 2026
CMF Titanium Splints
K260913 · DZJ
Materialise NV
Dental · 204d
Cleared Jun 09, 2026
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K260802 · QHE
Materialise NV
Orthopedic · 90d
Cleared Mar 12, 2026
Mimics Thoracic Planner
K251964 · LLZ
Materialise NV
Radiology · 259d
Cleared Jan 07, 2026
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery...
K253308 · PPT
Materialise NV
Neurology · 100d
Cleared Jan 06, 2026
Materialise TKA Guide System
K253793 · JWH
Materialise NV
Orthopedic · 39d
Cleared Jul 14, 2025
Materialise TKA Guide System
K251554 · JWH
Materialise NV
Orthopedic · 54d
Cleared Feb 21, 2025
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K243637 · DZJ
Materialise NV
Dental · 88d
Cleared Oct 18, 2024
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K242813 · QHE
Materialise NV
Orthopedic · 30d
Cleared May 31, 2024
Mimics Enlight CMF
K223427 · LLZ
Materialise NV
Dental · 564d
Cleared May 22, 2024
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K241143 · QHE
Materialise NV
Orthopedic · 27d
Cleared Feb 12, 2024
Mimics Cardiac Planner
K233217 · LLZ
Materialise NV
Radiology · 137d
Cleared Nov 09, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K233408 · QHE
Materialise NV
Orthopedic · 34d
Cleared Sep 12, 2023
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K231112 · QHE
Materialise NV
Orthopedic · 146d
Cleared Mar 06, 2023
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase...
K230315 · QHE
Materialise NV
Orthopedic · 28d
Cleared Aug 17, 2022
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase...
K220452 · QHE
Materialise NV
Orthopedic · 181d
Cleared Jul 05, 2022
Materialise TKA Guide System
K221337 · JWH
Materialise NV
Orthopedic · 57d
Cleared Jun 15, 2022
SurgiCase Viewer
K213684 · LLZ
Materialise NV
Radiology · 205d
Cleared Jan 12, 2022
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K212569 · QHE
Materialise NV
Orthopedic · 149d
Cleared Oct 02, 2020
Materialise PKA Guide System
K202207 · HSX
Materialise NV
Orthopedic · 57d
Cleared Mar 20, 2020
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder...
K193560 · QHE
Materialise NV
Orthopedic · 88d
Cleared Jul 08, 2019
Materialise Glenoid Positioning System
K190286 · KWS
Materialise NV
Orthopedic · 147d
Cleared Jun 05, 2019
Materialise Mimics Enlight
K190874 · LLZ
Materialise NV
Radiology · 62d
Cleared Mar 27, 2019
Mimics Medical
K183105 · LLZ
Materialise NV
Radiology · 139d
Cleared Jul 10, 2018
TruMatch CMF Titanium 3D Printed Implant
K173039 · JEY
Materialise NV
Dental · 285d