Medtronic, Inc.
FDA 510(k) & PMA Approved Devices — 141 products
Total Devices141
Categories58
Latest FDA decision2026-08-28
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P060025 | heart-valve, non-allograft tissue | LWR | 2019-08-21 | View |
| 510(k) | K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac | DTZ | 2019-05-17 | View |
| 510(k) | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | 2019-04-30 | View |
| 510(k) | K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | DTZ | 2019-04-12 | View |
| 510(k) | K190557 | Bio-Medicus Insertion Kit | DWF | 2019-04-03 | View |
| 510(k) | K183353 | Telescope Guide Extension Catheter | DQY | 2019-03-22 | View |
| 510(k) | K183511 | Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241) | DTZ | 2019-03-18 | View |
| 510(k) | K183493 | SelectSite C304-HIS Deflectable Catheter System | DQY | 2019-03-15 | View |
| 510(k) | K181918 | CardioInsight Cardiac Mapping System | DQK | 2018-11-08 | View |
| 510(k) | K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port | DWF | 2018-10-19 | View |
| 510(k) | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | 2018-08-21 | View |
| 510(k) | K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | FTL | 2018-06-07 | View |
| 510(k) | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | FTL | 2018-04-24 | View |
| 510(k) | K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | DTE | 2018-04-19 | View |
| 510(k) | K180456 | Bio-Medicus Adult Cannulae Kit | DWF | 2018-03-22 | View |
| 510(k) | K180453 | Bio-Medicus Adult Cannulae and Introducer | DWF | 2018-03-22 | View |
| 510(k) | K173664 | Medtronic O-arm O2 Imaging System | OWB | 2017-12-29 | View |
| 510(k) | K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface | DTZ | 2017-11-20 | View |
| 510(k) | K171979 | Tubing Pack | DWF | 2017-10-27 | View |
| 510(k) | K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir | DTZ | 2017-10-25 | View |
No matching devices.
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Related Clinical Trials
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