FDA applicant

Sensimed AG

Waltham, MA1 decision2016–20160 recalls

FDA records 1 decision for Sensimed AG (Waltham, MA) in 2016: 1 De Novo grant. All are in product code PLZ (Ocular Pattern Recorder). 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2016

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Sensimed AG by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sensimed AG

Which product codes does it file in?

What has FDA decided for it lately?