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 |
|---|---|---|---|---|---|
| 510(k) | K201100 | Bio-Medicus Life Support Catheter and Introducer | DWF | 2021-07-15 | View |
| 510(k) | K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | DSA | 2021-07-12 | View |
| 510(k) | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | MXD | 2021-06-11 | View |
| 510(k) | K211304 | LINQ II Insertable Cardiac Monitor | MXD | 2021-05-28 | View |
| 510(k) | K211057 | LigaPASS® Spinal System, CD Horizon™ Spinal System | OWI | 2021-05-27 | View |
| 510(k) | K192712 | Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter | DQY | 2020-08-03 | View |
| 510(k) | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | MXD | 2020-07-03 | View |
| 510(k) | K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | KRH | 2020-07-01 | View |
| 510(k) | K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | GWM | 2020-05-26 | View |
| 510(k) | K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface | KFM | 2020-05-21 | View |
| 510(k) | K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | 2020-05-13 | View |
| 510(k) | K200074 | O-arm O2 Imaging System | OWB | 2020-04-24 | View |
| 510(k) | K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | GWM | 2020-04-09 | View |
| 510(k) | K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | FTL | 2020-04-08 | View |
| 510(k) | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | FTL | 2020-03-27 | View |
| 510(k) | K200456 | Becker External Drainage and Monitoring System | GWM | 2020-03-26 | View |
| 510(k) | K191526 | Cardioblate CryoFlex Surgical Ablation System | OCL | 2019-10-01 | View |
| 510(k) | K191444 | Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir | DTZ | 2019-09-27 | View |
| 510(k) | K190574 | Patient Assistant Model PA97000 | DSI | 2019-09-24 | View |
| 510(k) | K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | KFM | 2019-08-27 | View |
No matching devices.
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