FDA applicant
Bayer Medical Care, Inc.
FDA records 11 decisions for Bayer Medical Care, Inc. (Indianaola, PA) from 2015 to 2026: 11 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and PQH (Iodinated Contrast Media Transfer Tubing Set). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 5 of them its own earlier devices. 4 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 Medical Care, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Bayer Medical Care, 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 “Bayer”
FDA records each applicant name separately; these may or may not be the same firm.