ABBOTT MEDICAL
ABBOTT MEDICAL holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2026, with 43 FDA device recalls on record.
Name variants for ABBOTT MEDICAL
as filed with FDA- ABBOTT MEDICAL
- Abbott Medical
Top product codes for ABBOTT MEDICAL
FDA recalls by ABBOTT MEDICAL
10 most recent of 43- Z-2405-2026 — Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Z-0458-2026 — Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Z-0459-2026 — Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
- Z-1557-2025 — Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
- Z-0753-2025 — The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
- Z-0495-2025 — Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
- Z-0494-2025 — Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
- Z-0493-2025 — Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
- Z-0492-2025 — Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
- Z-0491-2025 — Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by ABBOTT MEDICAL
- K262006 — EnSite X EP System
- K261631 — Amplatzer TorqVue Exchange System
- K253459 — OPTIS Mobile Next Imaging System (1014932) +2 more
- K260212 — EnSite X EP System
- K253907 — Disposable Radiofrequency Cannula
- K260499 — Amplatzer Trevisio Intravascular Delivery System +1 more
- K252512 — Armada 14 NC PTA Catheter
- K253516 — Assert-IQ (DM5100)
- K252417 — Amplatzer Piccolo Delivery System (9-PDS-04F-045)
- K253232 — Seguin Annuloplasty Ring
- K250031 — Amplatzer Guidewire
- K252013 — EnSite X EP System
- K251463 — EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01) +1 more
- K251234 — EnSite X EP System
- K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
- K251211 — ViewFlex Xtra ICE Catheter +5 more
- K251231 — ViewFlex X ICE Catheter, Sensor Enabled
- K250426 — Amulet Steerable Delivery Sheath
- K243549 — JETi Hydrodynamic Thrombectomy System
- K243224 — MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)
- K243493 — Agilis NxT Steerable Introducer Dual-Reach
- K240997 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K241538 — TriClip Steerable Guide Catheter
- K242016 — EnSite X EP System
- K241372 — Advisor HD Grid X Mapping Catheter, Sensor Enabled
- K241370 — Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
- K234118 — CentriMag Acute Circulatory Support System
- K232458 — JETiHydrodynamic Thrombectomy System
- K232690 — Amulet Steerable Delivery Sheath
- K232386 — ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
- K231415 — EnSite X EP System
- K231588 — ViewFlex Eco Reprocessed ICE Catheter
- K231311 — CPS Direct Universal slittable outer guide catheter (DS2C029)
- K230286 — Assert-IQ Insertable Cardiac Monitor
- K230934 — ViewFlex Eco Reprocessed ICE Catheter
- K230411 — Dragonfly OpStar Imaging Catheter
- K230283 — 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)
- K223094 — EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade +1 more
- K222217 — ViewFlex Xtra Reprocessed ICE Catheter
- K221397 — MitraClip G4 Steerable Guide Catheter
- K221750 — CPS AIM Universal II Slittable Inner Catheter
- K220243 — Ultiri Measurement System
- K213494 — Aveir Retrieval Catheter
- K220340 — Amplatzer Steerable Delivery Sheath
- K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS
- K213364 — EnSite X EP System
- K212026 — Amplatzer Steerable Delivery Sheath
- K212738 — Amplatzer Talisman Delivery Sheath
- K211989 — Aveir Introducer
- K210458 — OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
- K202066 — 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
- K201610 — IonicRF Generator
- K201148 — EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
- K201181 — EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
- K192267 — ILUMIEN System with AptiVue Software version D.3
- K192019 — Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
- K192037 — Advisor VL Circular Mapping Catheter, Sensor Enabled
- K190581 — Amplatzer Trevisio Intravascular Delivery System
Data sourced from openFDA. This site is unofficial and independent of the FDA.