FDA applicant

Emerald Medical, Inc.

Great Neck, NY4 decisions1996–20030 recalls

FDA records 4 decisions for Emerald Medical, Inc. (Great Neck, NY) from 1996 to 2003: 4 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and HRX (Arthroscope). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, general hospital panel, where it files most

How often FDA has decided Emerald Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Emerald Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Emerald”

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

Emerald Glove Manufacturing Sdn Bhd 1

Emerald Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Emerald”