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) | K240693 | LINQ II™ Insertable Cardiac Monitor (ICM) | MXD | 2024-03-28 | View |
| 510(k) | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) | DQK | 2024-03-08 | View |
| 510(k) | K231206 | DLP Silicone Coronary Artery Ostial Cannulae | DWF | 2023-12-07 | View |
| 510(k) | K233562 | LINQ II Insertable Cardiac Monitor | MXD | 2023-12-06 | View |
| 510(k) | K233397 | Cosine-10TM Diagnostic Catheter | DRF | 2023-12-02 | View |
| 510(k) | K233320 | LINQ II™ Insertable Cardiac Monitor (LNQ22) | MXD | 2023-10-31 | View |
| 510(k) | K232321 | FlexCath Contour™ Steerable Sheath | DRA | 2023-10-31 | View |
| 510(k) | K230960 | DLP™ Silicone Coronary Artery Ostial Cannulae | DWF | 2023-05-04 | View |
| 510(k) | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | MXD | 2023-04-26 | View |
| 510(k) | K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface | QWF | 2023-04-19 | View |
| 510(k) | K230640 | Affinity Fusion™ Oxygenator System | DTZ | 2023-04-06 | View |
| 510(k) | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | MXD | 2023-04-05 | View |
| 510(k) | K223488 | ClosureFast™ Endovenous Radiofrequency Ablation Catheter | GEI | 2023-03-23 | View |
| 510(k) | K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | OCL | 2022-12-22 | View |
| 510(k) | K221962 | LINQ II Insertable Cardiac Monitor | MXD | 2022-08-25 | View |
| 510(k) | K201057 | Bio-Medicus Life Support Catheter and Introducer | QHW | 2022-01-14 | View |
| 510(k) | K213631 | Chocolate PTA Balloon Catheter | LIT | 2021-12-15 | View |
| PMA | P140032 | Pump, infusion, implanted, programmable | LKK | 2021-08-31 | View |
| 510(k) | K212027 | TurboHawk Plus Directional Atherectomy System | MCW | 2021-08-24 | View |
| 510(k) | K212008 | Reveal LINQ Insertable Cardiac Monitor | MXD | 2021-07-22 | View |
No matching devices.
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