FDA applicant

Omega Mark-3 Pen Corp.

Mchenry, IL1 decision1978–19780 recalls

FDA records 1 decision for Omega Mark-3 Pen Corp. (Mchenry, IL) in 1978: 1 510(k) clearance. All are in product code FZZ (Marker, Skin). 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 and plastic surgery panel, where it files most

How often FDA has decided Omega Mark-3 Pen Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega Mark-3 Pen Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Omega Mark-3 Pen Corp. 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 Technologies, Inc. 1 Omega Critical Care Limited 1

Omega Mark-3 Pen Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Omega”