FDA applicant

Agfa-Gevaert, Inc.

West Germany, DE4 decisions1979–20010 recalls

FDA records 4 decisions for Agfa-Gevaert, Inc. (West Germany, DE) from 1979 to 2001: 4 510(k) clearances. Most are in product codes LMC (Camera, Multi Format, Radiological) and IXW (Processor, Radiographic-Film, Automatic). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Agfa-Gevaert AG”.

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 Agfa-Gevaert, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Agfa-Gevaert, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Agfa-Gevaert, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Agfa-Gevaert”

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

Agfa Healthcare N.V. 35 Agfa Corp. 29 Agfa Medical Imaging 1

Agfa-Gevaert, Inc.

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 “Agfa-Gevaert”