Medical Device Manufacturer · US , Mchenry , IL

Mallinckrodt Group, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1976

Total

Cleared

Denied

Mallinckrodt Group, Inc. is a pharmaceutical and medical device company based in McHenry, US. Now part of a restructured corporate family following a 2025 merger and subsequent spin-off, the company's regulatory history reflects its historical role in medical device manufacturing.

Mallinckrodt received 27 FDA 510(k) clearances from 27 total submissions, with no denied submissions on record. The company's cleared devices span radiology, cardiovascular, gastroenterology, and surgical specialties, with clearances issued between 1976 and 1995. This regulatory record is now historical, as the company has not received new FDA 510(k) clearances in more than five years.

The company's device portfolio included radiology imaging systems, urological equipment, cardiovascular catheters, and surgical supplies. Notable cleared devices encompassed digital injection systems, image processing and storage devices, wall-mounted radiography stands, and specialized surgical drapes and gowns.

Explore the complete regulatory record, including device names, product codes, and clearance dates, to review Mallinckrodt's FDA 510(k) submission history.

FDA 510(k) Regulatory Record - Mallinckrodt Group, Inc.

27 devices

1-12 of 27