Abbott Laboratories - FDA 510(k) Cleared Devices

Abbott Laboratories, is an American multinational medical devices and health care company headquartered in Abbott Park, Illinois. The company operates in over 160 countries and produces pharmaceuticals, diagnostics, nutritional products, and medical devices.

Abbott maintains a substantial FDA 510(k) regulatory record with 868 FDA 510(k) cleared devices from 883 total submissions since 1976. The company's cleared devices span chemistry, microbiology, hematology, immunology, and toxicology categories. The latest clearance in 2025 reflects continued regulatory activity and product development.

Abbott's diagnostic and medical device portfolio includes widely recognized products such as i-STAT, Alinity systems, FreeStyle Libre, and MitraClip. Recent FDA 510(k) clearances demonstrate ongoing innovation in clinical chemistry, immunoassay, and hematology instrumentation.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database below.

510(k) submissions have been managed by Entela, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.