FDA applicant

Heine USA, Ltd.

Cary, NC1 decision1995–19950 recalls

FDA records 1 decision for Heine USA, Ltd. (Cary, NC) in 1995: 1 510(k) clearance. All are in product code HOX (Chart, Visual Acuity). 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 Heine USA, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heine USA, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Heine”

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

Heine Optotechnik GmbH & Co. KG 7

Heine USA, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Heine”