Abbott Medical - FDA 510(k) Cleared Devices

Abbott Medical, is a global healthcare technology company headquartered in Santa Clara, US. The company specializes in life-changing medical devices and diagnostic solutions across multiple therapeutic areas.

Abbott Medical maintains a strong FDA 510(k) regulatory record with 57 FDA 510(k) clearances from 57 total submissions. The company's primary focus is Cardiovascular devices, which represent 94% of its submission portfolio. Clearances span from 2019 to 2026, with recent activity demonstrating continued innovation in interventional cardiology and electrophysiology systems.

Recent cleared devices include intravascular delivery systems, percutaneous transluminal angioplasty catheters, guidewires, and advanced electrophysiology mapping platforms. These products reflect Abbott Medical's emphasis on minimally invasive Cardiovascular interventions and cardiac rhythm management technologies.

Explore the complete list of device names, product codes, and clearance dates in the database to review Abbott Medical's full regulatory portfolio and recent submissions.

2 devices have linked clinical trials registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.