FDA applicant

Hygeia, Ltd.

Bangkok, Thailand, TH2 decisions1989–20100 recalls

FDA records 2 decisions for Hygeia, Ltd. (Bangkok, Thailand, TH) from 1989 to 2010: 2 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hygeia, Inc.”.

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 Hygeia, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hygeia, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Hygeia”

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

Hygeia Sciences 4 Hygeia II Medical Group, Inc. 4 Hygeia Medical, Inc. 1

Hygeia, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Hygeia”