FDA applicant

Bayer Corp., Agfa Div.

Ridgefield Park, NJ3 decisions1997–19982 recalls

FDA records 3 decisions for Bayer Corp., Agfa Div. (Ridgefield Park, NJ) from 1997 to 1998: 3 510(k) clearances. Most are in product codes IXW (Processor, Radiographic-Film, Automatic) and LMC (Camera, Multi Format, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Bayer Corp., Agfa Div.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bayer Corp., Agfa Div. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bayer Corp., Agfa Div. by year, 2007–2026Sources: 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 Group Diagnostics 2 Bayer U.S., LLC 1 Bayer Pharma AG 1

Bayer Corp., Agfa Div.

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?

What has been recalled?

Other applicant names beginning “Bayer”