Mallinckrodt Critical Care - FDA 510(k) Cleared Devices

Mallinckrodt Critical Care, is a medical device manufacturer based in McHenry, US. Now part of Mallinckrodt plc following a 2025 merger and subsequent restructuring, the company maintains a significant historical regulatory record in critical care and specialty medical devices.

The company received 92 FDA 510(k) clearances from 92 total submissions between 1976 and 1989. Device clearances span anesthesiology, cardiovascular, gastroenterology, and general hospital categories. Notable cleared products include tracheal tubes, temperature monitoring systems, catheters, and related critical care instruments. The company is currently inactive with no submissions recorded in the past five years and should be treated as a historical regulatory record.

Explore the complete list of FDA 510(k) cleared device names, product codes, and clearance dates in the database.