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) | K250075 | Medtronic Stedi Extra Support Guidewire | DQX | 2025-06-13 | View |
| PMA | P090013 | Implantable pulse generator, pacemaker (non-CRT) | LWP | 2025-06-05 | View |
| 510(k) | K250199 | VitalFlow Console | QNR | 2025-05-20 | View |
| 510(k) | K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | DQY | 2025-03-27 | View |
| PMA | P970012 | Pulse generator, permanent, implantable | NVZ | 2025-03-20 | View |
| PMA | P990001 | Pulse generator, permanent, implantable | NVZ | 2025-03-20 | View |
| PMA | P930022 | Pulse generator, permanent, implantable | NVZ | 2025-03-20 | View |
| PMA | P850051 | Pulse-generator, single chamber, sensor driven, implantable | LWO | 2025-03-20 | View |
| 510(k) | K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) | LDF | 2025-01-17 | View |
| 510(k) | K243892 | Affera Integrated Mapping System | DQK | 2025-01-17 | View |
| 510(k) | K243435 | Magnetic Localization Patch Kit (AFR-00021) | DQK | 2024-12-05 | View |
| PMA | P990034 | Pump, infusion, implanted, programmable | LKK | 2024-11-22 | View |
| 510(k) | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | DQK | 2024-11-01 | View |
| 510(k) | K240880 | VitalFlow Set with Balance Biosurface | QJZ | 2024-09-12 | View |
| PMA | P930029 | Cardiac ablation percutaneous catheter | LPB | 2024-07-01 | View |
| 510(k) | K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | DTZ | 2024-06-12 | View |
| 510(k) | K241259 | Amplatz Goose Neck Snare Kit | MMX | 2024-06-03 | View |
| PMA | P870078 | replacement Heart-valve | DYE | 2024-04-22 | View |
| 510(k) | K240534 | Bio-Medicus Life Support Catheter and Introducer | QHW | 2024-04-19 | View |
| 510(k) | K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) | NEY | 2024-03-28 | View |
No matching devices.
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