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Lifecore Biomedical, Inc.

Also registered as LIFECORE BIOMEDICAL LLC

United StatesFDA applicant, unverified

Devices
36
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Lifecore Biomedical, Inc. makes

Lifecore Biomedical, Inc. manufactures bone graft plasters, including hydroxyapatite and calcium sulfate formulations, and dental implant systems. These include self-tapping implants (5, 5.5, and 6mm), conical abutments, angled abutment systems, and esthetic contour zirconia abutments. The company also produces temporary healing caps for dental implants and endosseous implant systems with hex or hydroxyapatite coatings.

The portfolio includes Class II and Class III devices, regulated under FDA pathways such as the 510(k) and PMA processes. Products are listed in the FDA’s 510(k) and PMA registries. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue36

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Rows 1-36 of 36

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Lifecore Biomedical, Inc., initiated on 2004-06-03. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 3 Jun 2004 Z-1073-04 Unclassified (pre-2012) Terminated Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa. Distribution: Throughout the U.S., Germany, France, Korea, Columbia, Chile and Korea Submission number: K935137

Frequently asked questions

How many devices does Lifecore Biomedical, Inc. have in the registry?

The registry currently lists 36 devices for Lifecore Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lifecore Biomedical, Inc.'s devices?

Among its 36 most recently registered devices, Lifecore Biomedical, Inc. has devices listed in FDA 510(k) (35 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Lifecore Biomedical, Inc.'s devices fall under?

Among its 36 most recently registered devices, the classes recorded for Lifecore Biomedical, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Lifecore Biomedical, Inc.?

FDA recall records list 1 recall initiated by Lifecore Biomedical, Inc., the most recent initiated on 3 Jun 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Lifecore Biomedical, Inc. in the registry?

The most recently registered devices listed for Lifecore Biomedical, Inc. include HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER, STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026, CAPSET CALCIUM SULFATE BONE GRAFT PLASTER and RESTORE HA DENTAL IMPLANT SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.