Medtronic, Inc. - FDA 510(k) Cleared Devices
Recent clearances: LINQ II Insertable Cardiac Monitor (ICM) (LNQ22), Affera Integrated Mapping System, VitalFlow Set with Balance™ Biosurface
213
Total
212
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic, Inc. Cardiovascular ✕
175 devices
Cleared
Aug 28, 2026
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
Cardiovascular
28d
Cleared
Aug 21, 2026
Affera Integrated Mapping System
Cardiovascular
67d
Cleared
Jul 31, 2026
VitalFlow Set with Balance™ Biosurface
Cardiovascular
99d
Cleared
Jun 24, 2026
Concerto Versa™ Detachable Coil
Cardiovascular
20d
Cleared
Apr 23, 2026
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
Cardiovascular
91d
Cleared
Feb 19, 2026
Retrograde Coronary Sinus Perfusion Cannulae
Cardiovascular
146d
Cleared
Jan 20, 2026
Clearview Intracoronary Shunts
Cardiovascular
39d
Cleared
Jan 15, 2026
Bio-Medicus Life Support Catheter and Introducer
Cardiovascular
216d
Cleared
Jan 14, 2026
Concerto Versa™ Detachable Coil
Cardiovascular
70d
Cleared
Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48),...
Cardiovascular
80d
Cleared
Jun 20, 2025
MC2™ Two-Stage Venous Cannula
Cardiovascular
58d
Cleared
Jun 13, 2025
Medtronic Stedi Extra Support Guidewire
Cardiovascular
154d
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