510(k) Report

FDA applicant

Omni Mfg., Inc.

Eaton Park, FL1 decision1993–19930 recalls

FDA records 1 decision for Omni Mfg., Inc. (Eaton Park, FL) in 1993: 1 510(k) clearance. All are in product code NAB (Gauze / Sponge,Nonresorbable For External Use). 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 Omni Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omni Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • NABGauze / Sponge,Nonresorbable For External Use1decision

What has FDA decided for it lately?

  • K931610Omnisorb II, Nonwoven Sponge, Sterile and NonOmni Mfg., Inc. · 1993

The one decision as Omni Mfg., Inc. →

Other applicant names beginning “Omni”

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

Omni Life Science, Inc. 21Omni Intl., Inc. 12Omni Hearing Systems 7Omni Therm, Inc. 5Omni-Tract Surgical, Div. Minn. Scientific, Inc. 4Omni Surgical, L.P. 2Omni-Guide Holdings, Inc. 2Omni Sales Corp. 2Omni Medical Designs 1Omni-Flow, Inc. 1Omni Surgical, LLC Dba Spine360 1Omni Surgical, LP Dba Spine360 1