Medical Device Manufacturer · IE , Galway

Merit Medical System, Inc. - FDA 510(k) Cleared Devices

5 submissions · 4 cleared · Since 2020

Total

Cleared

Denied

Merit Medical System, Inc. has 4 FDA 510(k) cleared medical devices. Based in Galway, IE.

Latest FDA clearance: Sep 2025. Active since 2020. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Merit Medical System, Inc. Filter by specialty or product code using the sidebar.

1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Merit Medical System, Inc.

5 devices

1-5 of 5

Data Source

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

Last updated: Apr 27, 2026