FDA applicant

Omega Silicone, Inc.

Santa Barbara, CA5 decisions1987–19870 recalls

FDA records 5 decisions for Omega Silicone, Inc. (Santa Barbara, CA) in 1987: 5 510(k) clearances. Most are in product codes FWP (Prosthesis, Chin, Internal) and LFB (Button, Nasal Septal). 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 Silicone, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega Silicone, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Omega Silicone, 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 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 Silicone, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Omega”