FDA applicant
Biocompatibles, Inc.
FDA records 6 decisions for Biocompatibles, Inc. (Oxford, CT) from 1995 to 2011: 6 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and DQX (Wire, Guide, Catheter). No recall is linked to its devices.
FDA’s records also spell it “Biocompatibles , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biocompatibles, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biocompatibles, 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 “Biocompatibles”
FDA records each applicant name separately; these may or may not be the same firm.