Company ยท US
Abbott
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (2 in 12 months)
41recalls (1 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 14 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 9 |
| DQY | Catheter, Percutaneous | 6 |
| DQK | Computer, Diagnostic, Programmable | 5 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 3 |
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 2 |
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | 2 |
| DRA | Catheter, Steerable | 1 |
| DSQ | Ventricular (Assist) Bypass | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DYB | Introducer, Catheter | 1 |
| GXD | Generator, Lesion, Radiofrequency | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| LCD | Enzyme Immunoassay, Gentamicin | 1 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 1 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 1 |
| NGV | System, Appendage Closure, Left Atrial | 1 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 1 |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2026 | K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter Abbott | DQY |
| Apr 24, 2026 | K260993 | Amplatzer TorqVue Delivery System Abbott | DQY |
| Sep 17, 2025 | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) Abbott | MXD |
| May 29, 2024 | K233655 | Lingo Glucose System Abbott | SAF |
| Dec 1, 2022 | K222297 | CentriMag Pre-connected Pack Abbott | DTZ |
| Aug 18, 2022 | K221213 | EnSite X EP System Abbott | DQK |
| Oct 22, 2021 | K212061 | EnSite X EP System Abbott | DQK |
| Mar 11, 2021 | K210392 | WorkMate Claris System Abbott | DQK |
| Oct 18, 2019 | K192593 | Confirm Rx Insertable Cardiac Monitor Abbott | MXC |
| May 29, 2019 | K190167 | MitraClip G4 Steerable Guide Catheter Abbott | DRA |
| Mar 29, 2019 | K182981 | Confirm Rx Insertable Cardiac Monitor Abbott | MXC |
| Dec 12, 2018 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott | DQK |
| Oct 19, 2018 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 Abbott | DQK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2026 | Abbott Amplatzer Amulet Left Atrial Appendage Occluder
Model Numbers
1. 9-ACP2-007-016
2. 9-ACP2-007-018
3. 9-ACP2-007-020
4. 9-ACP2-007-022
5. 9-ACP2-010-025
6. 9-ACP2-010-028
7. 9-ACP2-010-031
8. 9-ACP2-0 Open, Classified |
NGV | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter Open, Classified |
OAE | None listed |
| Apr 21, 2025 | Abbott Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 Open, Classified |
DQY | K162228 |
| Apr 21, 2025 | Abbott Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 Open, Classified |
DQY | K131063 |
| Apr 4, 2024 | Abbott GmbH Alinity i Anti-HCV Reagent Kit, List Number 08P0521 Open, Classified |
MZO | None listed |
| Apr 4, 2024 | Abbott GmbH ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 Open, Classified |
MZO | None listed |
| Nov 2, 2023 | Abbott Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator Open, Classified |
GXD | K111576 |
| Jul 11, 2023 | Abbott Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). Open, Classified |
DQY | K220340 |
| Jul 7, 2022 | Abbott Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation. Terminated |
OAE | None listed |
| Apr 28, 2022 | Abbott FIRMap" Catheter, 60mm Basket Terminated |
MTD | K142182 |
| Mar 24, 2022 | Abbott Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile. Terminated |
OAE | None listed |
| Mar 24, 2022 | Abbott Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile. Terminated |
OAE | None listed |
| Nov 16, 2021 | Abbott Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM Terminated |
DYB | None listed |
| Nov 9, 2021 | Abbott Amplatzer Steerable Delivery Sheath Terminated |
DQY | K212026 |
| Jun 19, 2020 | Abbott Gmbh & Co. KG Alinity ci series System Control Module (SCM); LN 3R70-01
Alinity ci series software versions, 3.1.1 and below Terminated |
JJE | None listed |
| May 22, 2020 | Abbott TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a Terminated |
OAE | None listed |
| May 12, 2020 | Abbott Gmbh & Co. KG Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. Terminated |
JJE | None listed |
| May 12, 2020 | Abbott Gmbh & Co. KG ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure approp Open, Classified |
LCD | K102699 |
| Mar 9, 2020 | Abbott Gmbh & Co. KG ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. Terminated |
LOL | K113704 |
| Feb 28, 2020 | Abbott Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical
The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program Terminated |
NIK | None listed |
| Jan 24, 2020 | Abbott Gmbh & Co. KG LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module. Terminated |
JJE | None listed |
| Nov 26, 2019 | Abbott Gmbh & Co. KG ARCHITECT HAVAB-G Calibrator, REF 6L27-01 Terminated |
LOL | K113704 |
| Oct 23, 2019 | Abbott GmBH & Co. KG Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada Terminated |
KHS | K060295 |
| Sep 16, 2019 | Abbott Gmbh & Co. KG Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution Open, Classified |
JJE | None listed |
| Sep 16, 2019 | Abbott Gmbh & Co. KG Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution Open, Classified |
JJE | None listed |
| Sep 16, 2019 | Abbott Gmbh & Co. KG Alinity ci Level Sensor, Bulk Solution Open, Classified |
JJE | None listed |
| Jun 10, 2019 | Abbott Gmbh & Co. KG Alinity ci -series System ControlModule, Part Number 03R70 01
Product Usage:
The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and im Terminated |
JJE | None listed |
| May 21, 2019 | Abbott Gmbh & Co. KG The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules.
The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL Terminated |
JJE | None listed |
| Apr 25, 2019 | Abbott St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile.
Product Usage:
The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wire Terminated |
MXC | K163407 |
| Apr 15, 2019 | Abbott Gmbh & Co. KG Alinity c Cuvette Segments, List Number 04S47-01
Product Usage:
The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistr Terminated |
JJE | None listed |
| Apr 5, 2019 | Abbott Gmbh & Co. KG Alinity i Processing Module, 03R65 01, with the below components.
a. TED (Thermo Electric Device) Engine,
Reagent cooler;
b. CABLE, POWER OUT, TED CNTRLER
Product Usage:
The Alinity i processing Terminated |
JJE | None listed |
| Mar 7, 2019 | Abbott Gmbh & Co. KG Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , a Terminated |
JJE | None listed |
| Feb 26, 2019 | Abbott Gmbh & Co. KG Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and a Terminated |
JJE | None listed |
| Feb 26, 2019 | Abbott Gmbh & Co. KG Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and Terminated |
JJE | None listed |
| Dec 20, 2018 | Abbott Gmbh & Co. KG Alinity i Processing Module,
(a) Part Number 03R65-01
(b) Part Number A-30108552-01
(c) Part Number A-30109694-01
Product Usage:
The Alinity i processing module is a fully automated immunoassay ana Terminated |
JJE | None listed |
| May 17, 2018 | Abbott Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3
Indicated for providing short-term hemodynamic support in patients with advanced refractory left Terminated |
DSQ | None listed |
| Dec 14, 2017 | Abbott Gmbh & Co. KG ARCHITECT DHEA-S Reagent
Product Usage:
It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plas Terminated |
JKC | None listed |