FDA applicant
Bayer Healthcare, LLC
FDA records 58 decisions for Bayer Healthcare, LLC (Tarrytown, NY) from 1980 to 2018: 55 510(k) clearances and 3 original PMA approvals. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and JIX (Calibrator, Multi-Analyte Mixture). Its devices cite 56 predicates, 21 of them its own earlier devices. 60 recalls are linked to its devices.
FDA’s records also spell it “Bayer Healthcare”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bayer Healthcare, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
6in 2024
Class I Class II/III not classified
Planning a device like Bayer Healthcare, LLC’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 “Bayer”
FDA records each applicant name separately; these may or may not be the same firm.