FDA applicant

Hygeia Sciences

Newton, MA4 decisions1986–19880 recalls

FDA records 4 decisions for Hygeia Sciences (Newton, MA) from 1986 to 1988: 4 510(k) clearances. Most are in product codes DHA (System, Test, Human Chorionic Gonadotropin) and GTY (Antigens, All Groups, Streptococcus Spp.). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Hygeia Sciences since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Hygeia”

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

Hygeia II Medical Group, Inc. 4 Hygeia, Ltd. 2 Hygeia Medical, Inc. 1

Hygeia Sciences

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hygeia”