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Medtronic, Inc. FDA Approvals
0 new drug approvals and 48 device clearances on file. Matched by name to MDT.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Protégé EverFlex Self-expanding Peripheral Stent System510(k)Sep 17, 2026Gastroenterology, Urology |
| LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)510(k)Aug 28, 2026Cardiovascular |
| Affera Integrated Mapping System510(k)Aug 21, 2026Cardiovascular |
| VitalFlow Set with Balance Biosurface510(k)Jul 31, 2026Cardiovascular |
| Concerto Versa Detachable Coil510(k)Jun 24, 2026Cardiovascular |
| Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae510(k)Apr 23, 2026Cardiovascular |
| Retrograde Coronary Sinus Perfusion Cannulae510(k)Feb 19, 2026Cardiovascular |
| Clearview Intracoronary Shunts510(k)Jan 20, 2026Cardiovascular |
| Bio-Medicus Life Support Catheter and Introducer510(k)Jan 15, 2026Cardiovascular |
| Concerto Versa Detachable Coil510(k)Jan 14, 2026Cardiovascular |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)510(k)Dec 19, 2025Cardiovascular |
| MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula510(k)Jun 20, 2025Cardiovascular |
| Medtronic Stedi Extra Support Guidewire510(k)Jun 13, 2025Cardiovascular |
| VitalFlow Console510(k)May 20, 2025Cardiovascular |
| SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)510(k)Mar 27, 2025Cardiovascular |
| Affera Integrated Mapping System510(k)Jan 17, 2025Cardiovascular |
| 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)510(k)Jan 17, 2025Cardiovascular |
| Magnetic Localization Patch Kit (AFR-00021)510(k)Dec 5, 2024Cardiovascular |
| Affera Integrated Mapping System; Impedance Localization Patch Kit510(k)Nov 1, 2024Cardiovascular |
| VitalFlow Set with Balance Biosurface510(k)Sep 12, 2024Cardiovascular |
| Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)510(k)Jun 12, 2024Cardiovascular |
| Amplatz Goose Neck Snare Kit510(k)Jun 3, 2024Cardiovascular |
| Bio-Medicus Life Support Catheter and Introducer510(k)Apr 19, 2024Cardiovascular |
| 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)510(k)Mar 28, 2024General, Plastic Surgery |
| LINQ II Insertable Cardiac Monitor (ICM)510(k)Mar 28, 2024Cardiovascular |
| Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)510(k)Mar 8, 2024Cardiovascular |
| DLP Silicone Coronary Artery Ostial Cannulae510(k)Dec 7, 2023Cardiovascular |
| LINQ II Insertable Cardiac Monitor510(k)Dec 6, 2023Cardiovascular |
| Cosine-10TM Diagnostic Catheter510(k)Dec 2, 2023Cardiovascular |
| LINQ II Insertable Cardiac Monitor (LNQ22)510(k)Oct 31, 2023Cardiovascular |
| FlexCath Contour Steerable Sheath510(k)Oct 31, 2023Cardiovascular |
| DLP Silicone Coronary Artery Ostial Cannulae510(k)May 4, 2023Cardiovascular |
| LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application510(k)Apr 26, 2023Cardiovascular |
| Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface510(k)Apr 19, 2023Cardiovascular |
| Affinity Fusion Oxygenator System510(k)Apr 6, 2023Cardiovascular |
| Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System510(k)Apr 5, 2023Cardiovascular |
| ClosureFast Endovenous Radiofrequency Ablation Catheter510(k)Mar 23, 2023General, Plastic Surgery |
| Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device510(k)Dec 22, 2022General, Plastic Surgery |
| LINQ II Insertable Cardiac Monitor510(k)Aug 25, 2022Cardiovascular |
| Bio-Medicus Life Support Catheter and Introducer510(k)Jan 14, 2022Cardiovascular |
| Chocolate PTA Balloon Catheter510(k)Dec 15, 2021Cardiovascular |
| TurboHawk Plus Directional Atherectomy System510(k)Aug 24, 2021Cardiovascular |
| Reveal LINQ Insertable Cardiac Monitor510(k)Jul 22, 2021Cardiovascular |
| Bio-Medicus Life Support Catheter and Introducer510(k)Jul 15, 2021Cardiovascular |
| Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables510(k)Jul 12, 2021Cardiovascular |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System510(k)Jun 11, 2021Cardiovascular |
| LINQ II Insertable Cardiac Monitor510(k)May 28, 2021Cardiovascular |
| LigaPASS® Spinal System, CD Horizon Spinal System510(k)May 27, 2021Orthopedic |