Materialise NV - FDA 510(k) Cleared Devices

Materialise NV is a Belgian 3D printing and additive manufacturing company headquartered in Leuven. The company specializes in digital design and 3D printing solutions for medical applications.

Materialise NV has received 60 FDA 510(k) clearances from 60 total submissions since its first clearance in 1997. The company's regulatory portfolio spans orthopedic devices, surgical planning software, and personalized surgical guides and models. Recent cleared devices include systems for knee and shoulder surgery, craniomaxillofacial surgical planning, and cardiac and thoracic imaging applications. The latest FDA 510(k) clearance was in 2026, confirming the company remains actively engaged in regulatory submissions.

Materialise NV's cleared devices reflect expertise in surgical planning and personalized surgical guides across multiple specialties. Notable product lines include imaging and planning software for radiology, orthopedic surgical guidance systems, and custom surgical models for complex procedures. The company's technology enables surgeons to plan and execute procedures with patient-specific anatomical models and digital tools.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.