| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
| Amplatzer TorqVue Exchange System (K261631) | Abbott Medical | 2026-06-17 |
| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
| Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499) | ABBOTT MEDICAL | 2026-03-13 |
| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |
| Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (K252417) | ABBOTT MEDICAL | 2025-12-17 |
| Seguin Annuloplasty Ring (K253232) | ABBOTT MEDICAL | 2025-10-29 |
| Amplatzer Guidewire (K250031) | ABBOTT MEDICAL | 2025-10-03 |
| EnSite™ X EP System (K252013) | ABBOTT MEDICAL | 2025-09-25 |
| EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (K251463) | ABBOTT MEDICAL | 2025-09-04 |
| EnSite™ X EP System (K251234) | ABBOTT MEDICAL | 2025-07-30 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K250552) | ABBOTT MEDICAL | 2025-07-25 |
| Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (K242841) | ABBOTT MEDICAL | 2025-05-27 |
| 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™ (K251211) | ABBOTT MEDICAL | 2025-05-23 |
| ViewFlex™ X ICE Catheter, Sensor Enabled™ (K251231) | ABBOTT MEDICAL | 2025-05-20 |
| Amulet™ Steerable Delivery Sheath (K250426) | ABBOTT MEDICAL | 2025-04-25 |
| JETi Hydrodynamic Thrombectomy System (K243549) | ABBOTT MEDICAL | 2025-04-04 |
| MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) (K243224) | ABBOTT MEDICAL | 2024-12-31 |
| Agilis NxT Steerable Introducer Dual-Reach (K243493) | ABBOTT MEDICAL | 2024-12-13 |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997) | ABBOTT MEDICAL | 2024-11-06 |
| TriClip Steerable Guide Catheter (K241538) | ABBOTT MEDICAL | 2024-08-26 |
| EnSite™ X EP System (K242016) | ABBOTT MEDICAL | 2024-08-09 |
| Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K241372) | ABBOTT MEDICAL | 2024-07-09 |
| Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) (K241370) | ABBOTT MEDICAL | 2024-06-13 |
| CentriMag™ Acute Circulatory Support System (K234118) | ABBOTT MEDICAL | 2024-01-26 |
| JETi™Hydrodynamic Thrombectomy System (K232458) | ABBOTT MEDICAL | 2023-12-19 |
| Amulet™ Steerable Delivery Sheath (K232690) | ABBOTT MEDICAL | 2023-09-29 |
| ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 (K232386) | ABBOTT MEDICAL | 2023-09-08 |
| EnSite™ X EP System (K231415) | ABBOTT MEDICAL | 2023-08-10 |
| ViewFlex™ Eco Reprocessed ICE Catheter (K231588) | ABBOTT MEDICAL | 2023-06-30 |
| CPS Direct™ Universal slittable outer guide catheter (DS2C029) (K231311) | ABBOTT MEDICAL | 2023-06-02 |
| Assert-IQ™ Insertable Cardiac Monitor (K230286) | ABBOTT MEDICAL | 2023-05-17 |
| ViewFlex™ Eco Reprocessed ICE Catheter (K230934) | ABBOTT MEDICAL | 2023-05-03 |
| Dragonfly OpStar™ Imaging Catheter (K230411) | ABBOTT MEDICAL | 2023-04-14 |
| Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) (K230283) | ABBOTT MEDICAL | 2023-03-01 |
| EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License (K223094) | ABBOTT MEDICAL | 2022-12-27 |
| ViewFlex Xtra Reprocessed ICE Catheter (K222217) | ABBOTT MEDICAL | 2022-12-19 |
| MitraClip G4 Steerable Guide Catheter (K221397) | ABBOTT MEDICAL | 2022-09-28 |
| CPS AIM Universal II Slittable Inner Catheter (K221750) | ABBOTT MEDICAL | 2022-06-30 |
| Ultiri Measurement System (K220243) | ABBOTT MEDICAL | 2022-04-30 |
| Aveir Retrieval Catheter (K213494) | ABBOTT MEDICAL | 2022-04-01 |
| Amplatzer Steerable Delivery Sheath (K220340) | ABBOTT MEDICAL | 2022-03-09 |
| Abbott Medical Grounding Pad, model RF-DGP-IS (K203293) | ABBOTT MEDICAL | 2022-01-21 |
| EnSite X EP System (K213364) | ABBOTT MEDICAL | 2021-11-11 |
| Amplatzer Talisman Delivery Sheath (K212738) | ABBOTT MEDICAL | 2021-09-27 |
| Amplatzer Steerable Delivery Sheath (K212026) | ABBOTT MEDICAL | 2021-09-27 |
| Aveir Introducer (K211989) | ABBOTT MEDICAL | 2021-07-27 |
| OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (K210458) | ABBOTT MEDICAL | 2021-06-08 |
| EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (K202066) | ABBOTT MEDICAL | 2020-11-25 |
| IonicRF Generator (K201610) | ABBOTT MEDICAL | 2020-10-21 |
| EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System (K201181) | ABBOTT MEDICAL | 2020-06-26 |
| EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License (K201148) | ABBOTT MEDICAL | 2020-06-26 |
| ILUMIEN System with AptiVue Software version D.3 (K192267) | ABBOTT MEDICAL | 2019-12-17 |
| Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019) | ABBOTT MEDICAL | 2019-11-08 |
| Advisor VL Circular Mapping Catheter, Sensor Enabled (K192037) | ABBOTT MEDICAL | 2019-09-17 |
| Amplatzer Trevisio Intravascular Delivery System (K190581) | ABBOTT MEDICAL | 2019-04-05 |