Abbott - FDA 510(k) Cleared Devices

Abbott, is a global healthcare company developing life-changing medical devices and solutions. The company operates with a manufacturing facility in St. Paul, Minnesota. Abbott serves patients across multiple therapeutic areas including diabetes care, nutrition, diagnostics, and cardiovascular health.

Abbott has received 12 FDA 510(k) clearances from 12 total submissions, with no denied submissions on record. The company's regulatory focus centers on Cardiovascular devices, which represent 91% of its FDA 510(k) portfolio. Abbott's first clearance was granted in 2018, with the most recent clearance in 2025, demonstrating sustained innovation and active market engagement.

Abbott's cleared Cardiovascular devices include cardiac mapping systems, insertable cardiac monitors, steerable guide catheters, and circulatory support technologies. These products address critical needs in arrhythmia management, cardiac monitoring, and interventional cardiology. The company's portfolio reflects deep expertise in electrophysiology and advanced cardiac care solutions.

Explore Abbott's complete FDA 510(k) clearance history, including device names, product codes, and clearance dates in the database.