# Bayer U.S., LLC

- Location (FDA's records): Indianaola, PA
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: PQH (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bracco Injeneering: 1 (https://510kreport.com/company/bracco-injeneering)

## Firms that cite its devices most
- Bayer Medical Care, Inc.: 1 (https://510kreport.com/company/bayer-medical-care)

## Its most-cited devices
- K173913: MEDRAD® Imaging Bulk Package Transfer Set (2018), cited by 1

## Recent decisions
- K173913: MEDRAD® Imaging Bulk Package Transfer Set (May 4, 2018)

Source page: https://510kreport.com/company/bayer-us