Lifecore Biomedical, Inc. - FDA 510(k) Cleared Devices

Lifecore Biomedical, Inc. is a sterile injectable contract development and manufacturing organization (CDMO) and sodium hyaluronate producer with a manufacturing facility in Washington, US. The company specializes in formulation development, aseptic fill-finish, analytical testing, and stability services for pharmaceutical and medical device manufacturers.

Lifecore received 34 FDA 510(k) clearances from 34 total submissions, with clearances spanning 1991 to 2007. The company's regulatory focus was predominantly Dental devices, representing 97% of submissions. This includes dental implant systems, abutments, and bone graft materials. The company is currently inactive, with no clearances issued in more than five years, and should be treated as a historical regulatory record.

Lifecore's regulatory history reflects early entry into Dental device manufacturing and a subsequent strategic pivot toward CDMO services. The company was acquired by Landec Corporation in 2010 and became an independent public company in November 2022. Today, Lifecore operates as a specialized CDMO serving drugs, biologics, medical devices, and combination products globally.

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