Medical Device Manufacturer · IE , Galway

Aerogen, Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2011

Total

Cleared

Denied

Aerogen, Ltd. has 5 FDA 510(k) cleared medical devices. Based in Galway, IE.

Latest FDA clearance: Sep 2025. Active since 2011. Primary specialty: Anesthesiology.

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

510(k) submissions have been managed by Aerogen Ltd. C/O Promedic, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Aerogen, Ltd.

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