Medtronic, Inc. - FDA 510(k) Cleared Devices
208
Total
207
Cleared
0
Denied
170 devices
Cleared
Apr 12, 2019
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
Cardiovascular
116d
Cleared
Apr 03, 2019
Bio-Medicus Insertion Kit
Cardiovascular
29d
Cleared
Mar 22, 2019
Telescope Guide Extension Catheter
Cardiovascular
109d
Cleared
Mar 18, 2019
Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity...
Cardiovascular
90d
Cleared
Mar 15, 2019
SelectSite C304-HIS Deflectable Catheter System
Cardiovascular
88d
Cleared
Nov 08, 2018
CardioInsight Cardiac Mapping System
Cardiovascular
113d
Cleared
Oct 19, 2018
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure...
Cardiovascular
29d
Cleared
Aug 21, 2018
Medtronic Model 5392 External Pulse Generator (EPG)
Cardiovascular
28d
Cleared
Apr 19, 2018
Medtronic Model 53401 External Pulse Generator (EPG)
Cardiovascular
16d
Cleared
Mar 22, 2018
Bio-Medicus Adult Cannulae and Introducer
Cardiovascular
30d
Cleared
Mar 22, 2018
Bio-Medicus Adult Cannulae Kit
Cardiovascular
30d
Cleared
Nov 20, 2017
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator...
Cardiovascular
54d
Cleared
Oct 27, 2017
Tubing Pack
Cardiovascular
119d
Cleared
Oct 25, 2017
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion...
Cardiovascular
54d
Cleared
Jun 02, 2017
Tubing Pack
Cardiovascular
30d
Cleared
Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
Cardiovascular
17d
Cleared
Feb 28, 2017
CareLink SmartSync Device Manager - Pacing System Analyzer
Cardiovascular
123d
Cleared
Feb 23, 2017
Reveal LINQ
Cardiovascular
134d
Cleared
Feb 14, 2017
Reveal LINQ Insertable Cardiac Monitor
Cardiovascular
67d
Cleared
Feb 10, 2017
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
Cardiovascular
130d
Cleared
Feb 01, 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
Cardiovascular
100d
Cleared
Dec 06, 2016
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
Cardiovascular
50d
Cleared
Nov 15, 2016
Achieve Advance Mapping Catheter
Cardiovascular
29d
Cleared
Oct 18, 2016
Medtronic Temporary External Pacemaker 53401
Cardiovascular
85d
Cleared
Oct 12, 2016
Medtronic Model 5392 External Pulse Generator (EPG)
Cardiovascular
29d
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