FDA applicant

Haag-Streit AG

Koeniz, Bern, CH4 decisions1998–20144 recalls

FDA records 4 decisions for Haag-Streit AG (Koeniz, Bern, CH) from 1998 to 2014: 4 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and NFJ (System, Image Management, Ophthalmic). Its devices cite 7 predicates, 1 of them its own earlier devices. 4 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, ophthalmic panel, where it files most

How often FDA has decided Haag-Streit AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Haag-Streit”

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

Haag-Streit Holding AG 1 Haag-Streit USA, Inc. 1

Haag-Streit AG

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 “Haag-Streit”