Medical Device Manufacturer · IL , Caesarea

Cardiacsense - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023

Total

Cleared

Denied

Cardiacsense has 2 FDA 510(k) cleared medical devices. Based in Caesarea, IL.

Latest FDA clearance: May 2024. Active since 2023. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Cardiacsense Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by RQM+ as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Cardiacsense

2 devices

1-2 of 2

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

RQM+

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 11, 2026