FDA applicant

Bayer U.S., LLC

Indianaola, PA1 decision2018–20180 recalls

FDA records 1 decision for Bayer U.S., LLC (Indianaola, PA) in 2018: 1 510(k) clearance. All are in product code PQH (Iodinated Contrast Media Transfer Tubing Set). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Bayer U.S., LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Bayer U.S., LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Bayer”

FDA records each applicant name separately; these may or may not be the same firm.

Bayer Corp. 96 Bayer Healthcare, LLC 58 Bayer Diagnostics Corp. 32 Bayer Medical Care, Inc. 11 Bayer Healthcare, Diagnostics Division 3 Bayer Corp., Agfa Div. 3 Bayer Group Diagnostics 2 Bayer Pharma AG 1

Bayer U.S., LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bayer”