FDA applicant

Higi Sh, LLC

Monrovia, CA2 decisions2015–20170 recalls

FDA records 2 decisions for Higi Sh, LLC (Monrovia, CA) from 2015 to 2017: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). 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, cardiovascular panel, where it files most

How often FDA has decided Higi Sh, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Higi Sh, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Higi Sh, LLC

Which product codes does it file in?

What has FDA decided for it lately?