Cosmo Artificial Intelligence - Ai, Ltd. is one of 55 FDA 510(k) medical device manufacturers from Ireland in the dataset, ranked by real submission volume.
Cosmo Artificial Intelligence - Ai, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: GI Genius™ Module 300 (GGM300-US), GI Genius™ Module 100 (GGM100.US), GI Genius™ Module 100 (GGM100.US)
6
Total
5
Cleared
1
Denied
Cosmo Artificial Intelligence - Ai, Ltd. has 5 FDA 510(k) cleared medical devices. Based in Dublin, IE.
Latest FDA clearance: May 2026. Active since 2021. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Cosmo Artificial Intelligence - Ai, Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Donawa Lifescience Consulting Srl and Donawa Lifescience Consluting Srl.
FDA 510(k) Regulatory Record - Cosmo Artificial Intelligence - Ai, Ltd.
6 devices
Cleared
May 29, 2026
GI Genius™ Module 300 (GGM300-US)
Gastroenterology & Urology
32d
Cleared
Jul 25, 2024
GI Genius™ Module 100 (GGM100.US)
Gastroenterology & Urology
27d
Cleared
Jan 12, 2024
GI Genius™ Module 100 (GGM100.US)
Gastroenterology & Urology
28d
Cleared
May 19, 2023
GI Genius System 100 and GI Genius System 200
Gastroenterology & Urology
28d
Cleared
Jul 23, 2021
GI Genius
Gastroenterology & Urology
30d
Not Cleared
Apr 09, 2021
GI Genius
Gastroenterology & Urology
213d