Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Abbott. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Abbott Medical with 60 510(k) clearances, 43 device recalls and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 17, 2026: EnSite™ X EP System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 17, 2026 | EnSite™ X EP SystemK261729 · DQK | 510(k) clearances |
| Jul 15, 2026 | EnSite™ X EP SystemK262006 · DQK | 510(k) clearances |
| Jun 17, 2026 | Amplatzer TorqVue Exchange SystemK261631 · DQY | 510(k) clearances |
| May 12, 2026 | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareClass II · Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successful | Device recalls |
| Apr 24, 2026 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)K253459 · NQQ | 510(k) clearances |
| Apr 24, 2026 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)K253459 · Radiology | AI-enabled devices |
| Apr 20, 2026 | EnSite™ X EP SystemK260212 · DQK | 510(k) clearances |
| Apr 16, 2026 | Disposable Radiofrequency CannulaK253907 · GXI | 510(k) clearances |
| Mar 13, 2026 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80K260499 · DQY | 510(k) clearances |
| Feb 13, 2026 | Armada™ 14 NC PTA CatheterK252512 · LIT | 510(k) clearances |
| Dec 18, 2025 | Assert-IQ (DM5100)K253516 · Cardiovascular | AI-enabled devices |
| Oct 6, 2025 | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400Class II · There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 324 | Device recalls |
| Oct 6, 2025 | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400Class II · There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 324 | Device recalls |
| Feb 15, 2025 | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 Class II · Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may res | Device recalls |
| Nov 21, 2024 | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operateClass II · Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of program | Device recalls |
| Oct 17, 2024 | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileClass II · A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established | Device recalls |
| Oct 1, 2024 | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted hClass III · Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a pow | Device recalls |
| Oct 1, 2024 | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitClass III · Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a pow | Device recalls |
| Jun 8, 2021 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemK210458 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
