FDA applicant

Lifescan Europe, A Division of Cilag GmbH

Zug, CH1 decision2017–20170 recalls

FDA records 1 decision for Lifescan Europe, A Division of Cilag GmbH (Zug, CH) in 2017: 1 510(k) clearance. All are in product code OPP (Pump, Infusion, Insulin Bolus). 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, general hospital panel, where it files most

How often FDA has decided Lifescan Europe, A Division of Cilag GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Lifescan Europe, A Division of Cilag GmbH by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Lifescan”

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

Lifescan, Inc. 42 Lifescan Europe 3

Lifescan Europe, A Division of Cilag GmbH

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 “Lifescan”