FDA applicant
Bayer Corp.
FDA records 96 decisions for Bayer Corp. (Tarrytown, NY) from 1989 to 2003: 96 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and JIR (Indicator Method, Protein Or Albumin (Urinary…). Its devices cite 12 predicates, 4 of them its own earlier devices. 36 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bayer Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bayer Corp. since 2007.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Bayer Corp.’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.