Abbott Medical - FDA 510(k) Cleared Devices
Recent clearances: OPTIS Mobile Next Imaging System (1014932), EnSite™ X EP System, Disposable Radiofrequency Cannula
57
Total
57
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Medical Cardiovascular ✕
53 devices
Cleared
CT
Apr 24, 2026
OPTIS Mobile Next Imaging System (1014932)
Cardiovascular
199d
Cleared
Apr 20, 2026
EnSite™ X EP System
Cardiovascular
87d
Cleared
Mar 13, 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
Cardiovascular
28d
Cleared
Feb 13, 2026
Armada™ 14 NC PTA Catheter
Cardiovascular
186d
Cleared
Dec 18, 2025
Assert-IQ (DM5100)
Cardiovascular
36d
Cleared
Dec 17, 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
Cardiovascular
138d
Cleared
Oct 29, 2025
Seguin Annuloplasty Ring
Cardiovascular
30d
Cleared
Oct 03, 2025
Amplatzer Guidewire
Cardiovascular
269d
Cleared
Sep 25, 2025
EnSite™ X EP System
Cardiovascular
90d
Cleared
Sep 04, 2025
EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01)
Cardiovascular
115d
Cleared
Jul 30, 2025
EnSite™ X EP System
Cardiovascular
99d
Cleared
Jul 25, 2025
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
Cardiovascular
150d
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