FDA applicant

Bauerfeind AG

Zeulenroda-Triebes, DE3 decisions1986–20130 recalls

FDA records 3 decisions for Bauerfeind AG (Zeulenroda-Triebes, DE) from 1986 to 2013: 3 510(k) clearances. Most are in product codes DWL (Stocking, Medical Support (To Prevent Pooling…) and JOM (Plethysmograph, Photoelectric, Pneumatic Or…). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bauerfeind GmbH & Co.”.

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 Bauerfeind AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Bauerfeind AG

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?