ABBOTT MEDICAL
FDA 510(k) & PMA Approved Devices — 60 products
Total Devices60
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261729 | EnSite™ X EP System | DQK | 2026-09-17 | View |
| 510(k) | K262006 | EnSite™ X EP System | DQK | 2026-07-15 | View |
| 510(k) | K261631 | Amplatzer TorqVue Exchange System | DQY | 2026-06-17 | View |
| 510(k) | K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | NQQ | 2026-04-24 | View |
| 510(k) | K260212 | EnSite™ X EP System | DQK | 2026-04-20 | View |
| 510(k) | K253907 | Disposable Radiofrequency Cannula | GXI | 2026-04-16 | View |
| 510(k) | K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | DQY | 2026-03-13 | View |
| 510(k) | K252512 | Armada™ 14 NC PTA Catheter | LIT | 2026-02-13 | View |
| 510(k) | K253516 | Assert-IQ (DM5100) | MXD | 2025-12-18 | View |
| 510(k) | K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | DQY | 2025-12-17 | View |
| 510(k) | K253232 | Seguin Annuloplasty Ring | KRH | 2025-10-29 | View |
| 510(k) | K250031 | Amplatzer Guidewire | DQX | 2025-10-03 | View |
| 510(k) | K252013 | EnSite™ X EP System | DQK | 2025-09-25 | View |
| 510(k) | K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | DQK | 2025-09-04 | View |
| 510(k) | K251234 | EnSite™ X EP System | DQK | 2025-07-30 | View |
| 510(k) | K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | DQX | 2025-07-25 | View |
| 510(k) | K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | GXI | 2025-05-27 | View |
| 510(k) | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ | OBJ | 2025-05-23 | View |
| 510(k) | K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ | OBJ | 2025-05-20 | View |
| 510(k) | K250426 | Amulet™ Steerable Delivery Sheath | DQY | 2025-04-25 | View |
No matching devices.