FDA applicant

Omega Results

Dallas, TX1 decision1997–19970 recalls

FDA records 1 decision for Omega Results (Dallas, TX) in 1997: 1 510(k) clearance. All are in product code OLZ (Automatic Event Detection Software For…). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Omega Results since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Omega”

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

Omega Medical Electronics 21 Omega Medical Imaging, Inc. 15 Omega-Med Intl., Inc. 9 Omega Laboratories, Inc. 9 Omega Medical Diagnostics 5 Omega Silicone, Inc. 5 Omega Universal Technologies, Ltd. 3 Omega Surgical Instruments, Inc. 3 Omega Medical Corp. 2 Omega Point Systems, LLC 1 Omega Mark-3 Pen Corp. 1 Omega Technologies, Inc. 1

Omega Results

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Omega”