Artera, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Artera, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ArteraAI Breast
2
Total
1
Cleared
1
Denied
Artera, Inc. has 1 FDA 510(k) cleared medical devices. Based in Los Altos, US.
Latest FDA clearance: May 2026. Active since 2025. Primary specialty: Pathology.
Browse the FDA 510(k) cleared devices submitted by Artera, Inc. Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Artera, Inc.
2 devices