Abbott

Abbott — FDA 510(k) Submissions

Abbott has submitted 11 FDA 510(k) premarket notifications since 2018, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Programmable, Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection), Catheter, Steerable, Oxygenator, Cardiopulmonary Bypass, Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter . Use the specialty filter in the sidebar to narrow results.