Abbott - FDA 510(k) Cleared Devices
11
Total
11
Cleared
0
Denied
Abbott has 11 FDA 510(k) cleared cardiovascular devices. Based in St. Paul, US.
Latest FDA clearance: Sep 2025. Active since 2018.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Abbott
11 devices
Cleared
Sep 17, 2025
Assert-IQ (DM5000)
Cardiovascular
149d
Cleared
May 29, 2024
Lingo Glucose System
Chemistry
197d
Cleared
Dec 01, 2022
CentriMag Pre-connected Pack
Cardiovascular
122d
Cleared
Aug 18, 2022
EnSite X EP System
Cardiovascular
113d
Cleared
Oct 22, 2021
EnSite X EP System
Cardiovascular
113d
Cleared
Mar 11, 2021
WorkMate Claris System
Cardiovascular
29d
Cleared
Oct 18, 2019
Confirm Rx Insertable Cardiac Monitor
Cardiovascular
28d
Cleared
May 29, 2019
MitraClip G4 Steerable Guide Catheter
Cardiovascular
118d
Cleared
Mar 29, 2019
Confirm Rx Insertable Cardiac Monitor
Cardiovascular
151d
Cleared
Dec 12, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
Cardiovascular
29d
Cleared
Oct 19, 2018
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping...
Cardiovascular
25d