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Abbott Medical FDA Approvals
0 new drug approvals and 52 device clearances on file. This applicant is not matched to a listed company.
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A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| EnSite X EP System510(k)Sep 17, 2026Cardiovascular |
| EnSite X EP System510(k)Jul 15, 2026Cardiovascular |
| Amplatzer TorqVue Exchange System510(k)Jun 17, 2026Cardiovascular |
| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)510(k)Apr 24, 2026Radiology |
| EnSite X EP System510(k)Apr 20, 2026Cardiovascular |
| Disposable Radiofrequency Cannula510(k)Apr 16, 2026Neurology |
| Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80510(k)Mar 13, 2026Cardiovascular |
| Armada 14 NC PTA Catheter510(k)Feb 13, 2026Cardiovascular |
| Assert-IQ (DM5100)510(k)Dec 18, 2025Cardiovascular |
| Amplatzer Piccolo Delivery System (9-PDS-04F-045)510(k)Dec 17, 2025Cardiovascular |
| Seguin Annuloplasty Ring510(k)Oct 29, 2025Cardiovascular |
| Amplatzer Guidewire510(k)Oct 3, 2025Cardiovascular |
| EnSite X EP System510(k)Sep 25, 2025Cardiovascular |
| EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)510(k)Sep 4, 2025Cardiovascular |
| EnSite X EP System510(k)Jul 30, 2025Cardiovascular |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire510(k)Jul 25, 2025Cardiovascular |
| Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)510(k)May 27, 2025Neurology |
| 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-Reach510(k)May 23, 2025Cardiovascular |
| ViewFlex X ICE Catheter, Sensor Enabled510(k)May 20, 2025Cardiovascular |
| Amulet Steerable Delivery Sheath510(k)Apr 25, 2025Cardiovascular |
| JETi Hydrodynamic Thrombectomy System510(k)Apr 4, 2025Cardiovascular |
| MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)510(k)Dec 31, 2024Cardiovascular |
| Agilis NxT Steerable Introducer Dual-Reach510(k)Dec 13, 2024Cardiovascular |
| Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire510(k)Nov 6, 2024Cardiovascular |
| TriClip Steerable Guide Catheter510(k)Aug 26, 2024Cardiovascular |
| EnSite X EP System510(k)Aug 9, 2024Cardiovascular |
| Advisor HD Grid X Mapping Catheter, Sensor Enabled510(k)Jul 9, 2024Cardiovascular |
| Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)510(k)Jun 13, 2024Cardiovascular |
| CentriMag Acute Circulatory Support System510(k)Jan 26, 2024Cardiovascular |
| JETiHydrodynamic Thrombectomy System510(k)Dec 19, 2023Cardiovascular |
| Amulet Steerable Delivery Sheath510(k)Sep 29, 2023Cardiovascular |
| ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6510(k)Sep 8, 2023Radiology |
| EnSite X EP System510(k)Aug 10, 2023Cardiovascular |
| ViewFlex Eco Reprocessed ICE Catheter510(k)Jun 30, 2023Cardiovascular |
| CPS Direct Universal slittable outer guide catheter (DS2C029)510(k)Jun 2, 2023Cardiovascular |
| Assert-IQ Insertable Cardiac Monitor510(k)May 17, 2023Cardiovascular |
| ViewFlex Eco Reprocessed ICE Catheter510(k)May 3, 2023Cardiovascular |
| Dragonfly OpStar Imaging Catheter510(k)Apr 14, 2023Cardiovascular |
| 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)510(k)Mar 1, 2023Cardiovascular |
| EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License510(k)Dec 27, 2022Cardiovascular |
| ViewFlex Xtra Reprocessed ICE Catheter510(k)Dec 19, 2022Cardiovascular |
| MitraClip G4 Steerable Guide Catheter510(k)Sep 28, 2022Cardiovascular |
| CPS AIM Universal II Slittable Inner Catheter510(k)Jun 30, 2022Cardiovascular |
| Ultiri Measurement System510(k)Apr 30, 2022Cardiovascular |
| Aveir Retrieval Catheter510(k)Apr 1, 2022Cardiovascular |
| Amplatzer Steerable Delivery Sheath510(k)Mar 9, 2022Cardiovascular |
| Abbott Medical Grounding Pad, model RF-DGP-IS510(k)Jan 21, 2022Neurology |
| EnSite X EP System510(k)Nov 11, 2021Cardiovascular |
| Amplatzer Talisman Delivery Sheath510(k)Sep 27, 2021Cardiovascular |
| Amplatzer Steerable Delivery Sheath510(k)Sep 27, 2021Cardiovascular |
| Aveir Introducer510(k)Jul 27, 2021Cardiovascular |
| OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System510(k)Jun 8, 2021Radiology |