FDA applicant

Omega-Med Intl., Inc.

Mchenry, IL9 decisions1981–19840 recalls

FDA records 9 decisions for Omega-Med Intl., Inc. (Mchenry, IL) from 1981 to 1984: 9 510(k) clearances. Most are in product codes KDC (Instrument, Surgical, Disposable) and IPF (Stimulator, Muscle, Powered). 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-Med Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega-Med Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Omega-Med Intl., 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 “Omega-Med”

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 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 Critical Care Limited 1

Omega-Med Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Omega-Med”