FDA applicant

Omega Surgical Instruments, Inc.

Fenton, MI3 decisions1993–19940 recalls

FDA records 3 decisions for Omega Surgical Instruments, Inc. (Fenton, MI) from 1993 to 1994: 3 510(k) clearances. Most are in product codes GFA (Blade, Saw, General & Plastic Surgery, Surgical) and HTY (Pin, Fixation, Smooth). 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 Surgical Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega Surgical Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Omega Surgical Instruments, 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”

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 Medical Corp. 2 Omega Point Systems, LLC 1 Omega Mark-3 Pen Corp. 1 Omega Technologies, Inc. 1 Omega Critical Care Limited 1

Omega Surgical Instruments, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Omega”