FDA applicant

Binder GmbH

Tuttlingen, DE1 decision2003–20030 recalls

FDA records 1 decision for Binder GmbH (Tuttlingen, DE) in 2003: 1 510(k) clearance. All are in product code MQG (Accessory, Assisted Reproduction). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Binder GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Binder GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Binder”

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

Binder Biomedical, Inc. 2

Binder GmbH

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Binder”