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.

Merit Medical System, Inc. is one of 55 FDA 510(k) medical device manufacturers from Ireland in the dataset, ranked by real submission volume.

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

5 devices

1-5 of 5