Heartbeam, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Heartbeam, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HeartBeam AIMIGo with 12-L ECG Synthesis Software System, HeartBeam AIMIGo(TM) System
2
Total
2
Cleared
0
Denied
Heartbeam, Inc. has 2 FDA 510(k) cleared medical devices. Based in Santa Clara, US.
Latest FDA clearance: Dec 2025. Active since 2024. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Heartbeam, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Veranex, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Heartbeam, Inc.
2 devices