Company · US
ABBOTT MEDICAL
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
60510(k) clearances (10 in 12 months)
43recalls (1 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 19 |
| DQK | Computer, Diagnostic, Programmable | 14 |
| DQY | Catheter, Percutaneous | 13 |
| DYB | Introducer, Catheter | 6 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | 6 |
| NPT | Aortic Valve, Prosthesis, Percutaneously Delivered | 5 |
| PNJ | Leadless Pacemaker | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| DQX | Wire, Guide, Catheter | 3 |
| GXD | Generator, Lesion, Radiofrequency | 3 |
| GXI | Probe, Radiofrequency Lesion | 3 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 3 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 3 |
| NVZ | Pulse Generator, Permanent, Implantable | 2 |
| OBJ | Catheter, Ultrasound, Intravascular | 2 |
| QEZ | Aspiration Thrombectomy Catheter | 2 |
| DRA | Catheter, Steerable | 1 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 |
| KRH | Ring, Annuloplasty | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2026 | K261729 | EnSite X EP System Abbott Medical | DQK |
| Jul 15, 2026 | K262006 | EnSite X EP System Abbott Medical | DQK |
| Jun 17, 2026 | K261631 | Amplatzer TorqVue Exchange System Abbott Medical | DQY |
| Apr 24, 2026 | K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade ABBOTT MEDICAL | NQQ |
| Apr 20, 2026 | K260212 | EnSite X EP System ABBOTT MEDICAL | DQK |
| Apr 16, 2026 | K253907 | Disposable Radiofrequency Cannula ABBOTT MEDICAL | GXI |
| Mar 13, 2026 | K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-A ABBOTT MEDICAL | DQY |
| Feb 13, 2026 | K252512 | Armada 14 NC PTA Catheter ABBOTT MEDICAL | LIT |
| Dec 18, 2025 | K253516 | Assert-IQ (DM5100) ABBOTT MEDICAL | MXD |
| Dec 17, 2025 | K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) ABBOTT MEDICAL | DQY |
| Oct 29, 2025 | K253232 | Seguin Annuloplasty Ring ABBOTT MEDICAL | KRH |
| Oct 3, 2025 | K250031 | Amplatzer Guidewire ABBOTT MEDICAL | DQX |
| Sep 25, 2025 | K252013 | EnSite X EP System ABBOTT MEDICAL | DQK |
| Sep 4, 2025 | K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Soft ABBOTT MEDICAL | DQK |
| Jul 30, 2025 | K251234 | EnSite X EP System ABBOTT MEDICAL | DQK |
| Jul 25, 2025 | K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire ABBOTT MEDICAL | DQX |
| May 27, 2025 | K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) ABBOTT MEDICAL | GXI |
| May 23, 2025 | K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; ABBOTT MEDICAL | OBJ |
| May 20, 2025 | K251231 | ViewFlex X ICE Catheter, Sensor Enabled ABBOTT MEDICAL | OBJ |
| Apr 25, 2025 | K250426 | Amulet Steerable Delivery Sheath ABBOTT MEDICAL | DQY |
| Apr 4, 2025 | K243549 | JETi Hydrodynamic Thrombectomy System ABBOTT MEDICAL | QEZ |
| Dec 31, 2024 | K243224 | MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) ABBOTT MEDICAL | DQY |
| Dec 13, 2024 | K243493 | Agilis NxT Steerable Introducer Dual-Reach ABBOTT MEDICAL | DYB |
| Nov 6, 2024 | K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire ABBOTT MEDICAL | DQX |
| Aug 26, 2024 | K241538 | TriClip Steerable Guide Catheter ABBOTT MEDICAL | DQY |
| Aug 9, 2024 | K242016 | EnSite X EP System ABBOTT MEDICAL | DQK |
| Jul 9, 2024 | K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled ABBOTT MEDICAL | MTD |
| Jun 13, 2024 | K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) ABBOTT MEDICAL | DYB |
| Jan 26, 2024 | K234118 | CentriMag Acute Circulatory Support System ABBOTT MEDICAL | QNR |
| Dec 19, 2023 | K232458 | JETiHydrodynamic Thrombectomy System ABBOTT MEDICAL | QEZ |
| Sep 29, 2023 | K232690 | Amulet Steerable Delivery Sheath ABBOTT MEDICAL | DQY |
| Sep 8, 2023 | K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 ABBOTT MEDICAL | NQQ |
| Aug 10, 2023 | K231415 | EnSite X EP System ABBOTT MEDICAL | DQK |
| Jun 30, 2023 | K231588 | ViewFlex Eco Reprocessed ICE Catheter ABBOTT MEDICAL | OWQ |
| Jun 2, 2023 | K231311 | CPS Direct Universal slittable outer guide catheter (DS2C029) ABBOTT MEDICAL | DQY |
| May 17, 2023 | K230286 | Assert-IQ Insertable Cardiac Monitor ABBOTT MEDICAL | MXC |
| May 3, 2023 | K230934 | ViewFlex Eco Reprocessed ICE Catheter ABBOTT MEDICAL | OWQ |
| Apr 14, 2023 | K230411 | Dragonfly OpStar Imaging Catheter ABBOTT MEDICAL | DQO |
| Mar 1, 2023 | K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 40 ABBOTT MEDICAL | DYB |
| Dec 27, 2022 | K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Abla ABBOTT MEDICAL | DQK |
| Dec 19, 2022 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter ABBOTT MEDICAL | OWQ |
| Sep 28, 2022 | K221397 | MitraClip G4 Steerable Guide Catheter ABBOTT MEDICAL | DRA |
| Jun 30, 2022 | K221750 | CPS AIM Universal II Slittable Inner Catheter ABBOTT MEDICAL | DQY |
| Apr 30, 2022 | K220243 | Ultiri Measurement System ABBOTT MEDICAL | DQK |
| Apr 1, 2022 | K213494 | Aveir Retrieval Catheter ABBOTT MEDICAL | MMX |
| Mar 9, 2022 | K220340 | Amplatzer Steerable Delivery Sheath ABBOTT MEDICAL | DQY |
| Jan 21, 2022 | K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS ABBOTT MEDICAL | GXD |
| Nov 11, 2021 | K213364 | EnSite X EP System ABBOTT MEDICAL | DQK |
| Sep 27, 2021 | K212738 | Amplatzer Talisman Delivery Sheath ABBOTT MEDICAL | DQY |
| Sep 27, 2021 | K212026 | Amplatzer Steerable Delivery Sheath ABBOTT MEDICAL | DQY |
Newest 50 of 60.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2026 | Abbott Medical Merlin" Patient Care System (PCS) software
Merlin" PCS 3650 programmer Model 3330 software Open, Classified |
PNJ | None listed |
| Nov 7, 2025 | Abbott Medical Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 Open, Classified |
MHY | None listed |
| Nov 7, 2025 | Abbott Medical Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 Open, Classified |
LGW | None listed |
| Apr 14, 2025 | Abbott Medical 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 Open, Classified |
PNJ | None listed |
| Dec 23, 2024 | Abbott Medical 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 i Open, Classified |
PNJ | None listed |
| Nov 26, 2024 | Abbott Medical Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150
Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter
configured for multiple patient use. It can receive inform Open, Classified |
NVZ | None listed |
| Nov 26, 2024 | Abbott Medical Merlin@home Transmitter REF EX1100
The Merlin@home" (M@h) transmitter is intended to transfer stored data from
the patient s implanted heart device to Merlin.net" Patient Care Network (PCN)
to facili Open, Classified |
NVZ | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile Open, Classified |
NPT | None listed |
| Jul 25, 2024 | Abbott Medical Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Open, Classified |
MHY | None listed |
| Jul 25, 2024 | Abbott Medical Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Open, Classified |
MHY | None listed |
| Jul 25, 2024 | Abbott Medical Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Open, Classified |
MHY | None listed |
| Jul 25, 2024 | Abbott Medical Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Open, Classified |
MHY | None listed |
| Jul 16, 2024 | Abbott Medical Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only Open, Classified |
PMP | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 16, 2024 | Abbott Medical Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only Open, Classified |
LGW | None listed |
| Jul 3, 2024 | Abbott Medical Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Open, Classified |
MHY | None listed |
| Apr 29, 2024 | Abbott Medical Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Open, Classified |
PNJ | None listed |
| Sep 19, 2023 | Abbott Medical Gallant HF Cardiac Resynchronization Therapy Defibrillator:
HF CRT-D REF CDHFA500Q
Neutrino HF Cardiac Resynchronization Therapy Defibrillator:
NxT HF CRT-D REF CDHFA600Q
Entrant HF Cardiac Resynchr Open, Classified |
NIK | None listed |
| Sep 19, 2023 | Abbott Medical Gallant VR Implantable Cardioverter Defibrillator:
VR ICD REF CDVRA500Q
Gallant DR Implantable Cardioverter Defibrillator:
DR ICD REF CDDRA500Q
Neutrino VR Implantable Cardioverter Defibrillator:
NxT Open, Classified |
LWS | None listed |
| Sep 11, 2023 | Abbott Medical Infinity 7 Implantable Pulse Generator REF 6662
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Infinity 5 Implantable Pulse Generator REF 6660
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim DRG Implantable Pulse Generator REF 3664
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with u Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim Plus 7 Implantable Pulse Generator REF 3672
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads wit Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim Plus 5 Implantable Pulse Generator REF 3670
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads wit Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim" XR 7 Implantable Pulse Generator REF 3662
(previously known as Proclaim" 7 Elite IPG)
Product Description:
The implantable pulse generator (IPG) is an electronic device designed to be conne Open, Classified |
LGW | None listed |
| Sep 11, 2023 | Abbott Medical Proclaim XR 5 Implantable Pulse Genterator REF 3660
(previously known as Proclaim" 5 Elite IPG) Model 3660
Product Description:
The implantable pulse generator (IPG) is an electronic device designed Open, Classified |
LGW | None listed |
| Dec 9, 2019 | Abbott Medical Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, cl Terminated |
DYB | K914090 |
| Dec 9, 2019 | Abbott Medical Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 Terminated |
DYB | K954317 |
| Nov 11, 2019 | Abbott Medical CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geom Terminated |
GXI | K090955 |
| Oct 14, 2019 | Abbott Medical Radiofrequency Grounding Pad, REF RF-DGP-L Terminated |
GXD | K111576 |