Medtronic
FDA 510(k) & PMA Approved Devices — 27 products
Total Devices27
Categories16
Latest FDA decision2026-08-05
SEC Filings: 1 filings on record. Latest: 10-K (2026-06-18). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P100047 | Ventricular (assist) bypass | DSQ | 2026-08-05 | View |
| 510(k) | K253530 | Trexon™ Monofilament Synthetic Absorbable Suture | GAM | 2026-05-28 | View |
| 510(k) | K251744 | Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter | DTM | 2026-01-16 | View |
| 510(k) | K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | MTD | 2024-08-07 | View |
| 510(k) | K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | DTR | 2024-02-23 | View |
| 510(k) | K223494 | CD Horizon Spinal System | NKB | 2023-01-23 | View |
| 510(k) | K223178 | SelectSite C304 Deflectable Catheter System, C315 Delivery System | DQY | 2022-11-08 | View |
| 510(k) | K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | DQY | 2022-11-07 | View |
| 510(k) | K221244 | CD Horizon™ Spinal System | NKB | 2022-05-25 | View |
| 510(k) | K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | DTZ | 2021-09-16 | View |
| 510(k) | K211596 | CD Horizon Spinal System | OLO | 2021-06-23 | View |
| 510(k) | K210637 | CD Horizon™ Spinal System | NKB | 2021-04-30 | View |
| 510(k) | K210449 | Infinity™ OCT System, PASS OCT® Spinal System | NKG | 2021-03-18 | View |
| 510(k) | K202771 | CD Horizon Spinal System | NKB | 2020-10-19 | View |
| 510(k) | K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement | PML | 2020-08-19 | View |
| 510(k) | K200514 | Cardioblate Gemini-s Surgical Ablation Device | OCL | 2020-06-03 | View |
| 510(k) | K191851 | VS3-IR | OWN | 2019-11-25 | View |
| 510(k) | K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead | LDF | 2019-08-08 | View |
| 510(k) | K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | DRF | 2019-07-30 | View |
| 510(k) | K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | DRF | 2019-07-30 | View |
No matching devices.
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