ABBOTT MEDICAL
FDA 510(k) & PMA Approved Dispositivos — 60 products
Publicidad
Total de dispositivos60
Categorías0
Última decisión de la FDA
| Tipo | Número | Nombre del dispositivo | Código | Fecha | Acciones |
|---|---|---|---|---|---|
| 510(k) | K261729 | EnSite™ X EP System | DQK | 2026-09-17 | Ver |
| 510(k) | K262006 | EnSite™ X EP System | DQK | 2026-07-15 | Ver |
| 510(k) | K261631 | Amplatzer TorqVue Exchange System | DQY | 2026-06-17 | Ver |
| 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 | Ver |
| 510(k) | K260212 | EnSite™ X EP System | DQK | 2026-04-20 | Ver |
| 510(k) | K253907 | Disposable Radiofrequency Cannula | GXI | 2026-04-16 | Ver |
| 510(k) | K260499 | Sistema de Entrega Intravascular Amplatzer™ Trevisio™; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | DQY | 2026-03-13 | Ver |
| 510(k) | K252512 | Catheter Armada™ 14 NC PTA | LIT | 2026-02-13 | Ver |
| 510(k) | K253516 | Assert-IQ (DM5100) | MXD | 2025-12-18 | Ver |
| 510(k) | K252417 | Sistema de Entrega Amplatzer Piccolo™ (9-PDS-04F-045) | DQY | 2025-12-17 | Ver |
| 510(k) | K253232 | Seguin Annuloplasty Ring | KRH | 2025-10-29 | Ver |
| 510(k) | K250031 | Amplatzer Guía | DQX | 2025-10-03 | Ver |
| 510(k) | K252013 | EnSite™ X EP System | DQK | 2025-09-25 | Ver |
| 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 | Ver |
| 510(k) | K251234 | EnSite™ X EP System | DQK | 2025-07-30 | Ver |
| 510(k) | K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | DQX | 2025-07-25 | Ver |
| 510(k) | K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | GXI | 2025-05-27 | Ver |
| 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 | Ver |
| 510(k) | K251231 | ViewFlex™ X ICE Catheter, Sensor Enabled™ | OBJ | 2025-05-20 | Ver |
| 510(k) | K250426 | Amulet™ Steerable Delivery Sheath | DQY | 2025-04-25 | Ver |
No hay dispositivos coincidentes.