Medtronic, Inc. - FDA 510(k) Cleared Devices
208
Total
207
Cleared
0
Denied
170 devices
Cleared
Apr 26, 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Cardiovascular
57d
Cleared
Apr 19, 2023
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO)...
Cardiovascular
190d
Cleared
Apr 06, 2023
Affinity Fusion™ Oxygenator System
Cardiovascular
29d
Cleared
Apr 05, 2023
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor,...
Cardiovascular
121d
Cleared
Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
Cardiovascular
30d
Cleared
Aug 25, 2022
LINQ II Insertable Cardiac Monitor
Cardiovascular
51d
Cleared
Jan 14, 2022
Bio-Medicus Life Support Catheter and Introducer
Cardiovascular
633d
Cleared
Dec 15, 2021
Chocolate PTA Balloon Catheter
Cardiovascular
28d
Cleared
Aug 24, 2021
TurboHawk Plus Directional Atherectomy System
Cardiovascular
56d
Cleared
Jul 22, 2021
Reveal LINQ Insertable Cardiac Monitor
Cardiovascular
24d
Cleared
Jul 15, 2021
Bio-Medicus Life Support Catheter and Introducer
Cardiovascular
447d
Cleared
Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
Cardiovascular
217d
Cleared
Jun 11, 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Cardiovascular
112d
Cleared
May 28, 2021
LINQ II Insertable Cardiac Monitor
Cardiovascular
29d
Cleared
Aug 03, 2020
Attain Select II + SureValve delivery catheter system, Attain Command +...
Cardiovascular
311d
Cleared
Jul 03, 2020
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command...
Cardiovascular
99d
Cleared
Jul 01, 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band,...
Cardiovascular
30d
Cleared
May 21, 2020
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
Cardiovascular
29d
Cleared
May 13, 2020
Medtronic Model 5392 External Pulse Generator (EPG)
Cardiovascular
26d
Cleared
Oct 01, 2019
Cardioblate CryoFlex Surgical Ablation System
Cardiovascular
113d
Cleared
Sep 27, 2019
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with...
Cardiovascular
119d
Cleared
Sep 24, 2019
Patient Assistant Model PA97000
Cardiovascular
202d
Cleared
Aug 27, 2019
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
Cardiovascular
126d
Cleared
May 17, 2019
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator...
Cardiovascular
29d
Cleared
Apr 30, 2019
Medtronic Model 5392 External Pulse Generator (EPG)
Cardiovascular
29d
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