Medical Device Manufacturer · US , San Francisco , CA

AliveCor, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2012
19
Total
19
Cleared
0
Denied

AliveCor, Inc. has 19 FDA 510(k) cleared cardiovascular devices. Based in San Francisco, US.

Latest FDA clearance: Jan 2026. Active since 2012.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Mdqr, LLC as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - AliveCor, Inc.
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