FDA applicant
Biomet 3i, Inc.
FDA records 32 decisions for Biomet 3i, Inc. (Palm Beach Gardens, FL) from 2007 to 2025: 32 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 47 predicates, 19 of them its own earlier devices. 138 recalls are linked to its devices.
FDA’s records also spell it “Biomet 3i”, “Biomet 3i, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet 3i, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
23in 2020
Class I Class II/III not classified
Planning a device like Biomet 3i, 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) ReportOther applicant names beginning “Biomet”
FDA records each applicant name separately; these may or may not be the same firm.