FDA applicant

Neuro-Eye Diagnostic Systems, LLC

Houston, TX1 decision2022–20220 recalls

FDA records 1 decision for Neuro-Eye Diagnostic Systems, LLC (Houston, TX) in 2022: 1 510(k) clearance. All are in product code QTW (Digital Amsler Grid). 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, ophthalmic panel, where it files most

How often FDA has decided Neuro-Eye Diagnostic Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Neuro-Eye Diagnostic Systems, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Neuro-Eye”

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

Neuro Navigational Corp. 23 Neuro Supplies, Inc. 5 Neuro Technology 5 Neuro Kinetics, Inc. 4 Neuro Resource Group, Inc. 4 Neuro Therm, Inc. 3 Neuro Scan Labs 3 Neuro Vasx, Inc. 2 Neuro-Biometrix, Inc. 2 Neuro-Diagnostic Assoc. 2 Neuro Event Labs OY 1 Neuro-Fitness, LLC 1

Neuro-Eye Diagnostic Systems, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Neuro-Eye”