FDA applicant
Lifecore Biomedical, Inc.
FDA records 35 decisions for Lifecore Biomedical, Inc. (Chaska, MN) from 1991 to 2007: 34 510(k) clearances and 1 original PMA approval. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 54 predicates, 28 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lifecore Biomedical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2007
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Lifecore Biomedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report