FDA applicant

Higa Manufacturing, Ltd.

Walker, MI1 decision1984–19840 recalls

FDA records 1 decision for Higa Manufacturing, Ltd. (Walker, MI) in 1984: 1 510(k) clearance. All are in product code EIS (Remover, Crown). 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, dental panel, where it files most

How often FDA has decided Higa Manufacturing, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Higa Manufacturing, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Higa Manufacturing, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?