510(k) Report

FDA applicant

Omni Medical Designs

Livonia, MI1 decision1990–19900 recalls

FDA records 1 decision for Omni Medical Designs (Livonia, MI) in 1990: 1 510(k) clearance. All are in product code HBO (Clip, Scalp). 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, neurology panel, where it files most

How often FDA has decided Omni Medical Designs’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omni Medical Designs since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Omni Medical Designs 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?

  • HBOClip, Scalp1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K896723Clip Gun with Raney Type Scalp ClipsOmni Medical Designs · 19901cites it

What has FDA decided for it lately?

  • K896723Clip Gun with Raney Type Scalp ClipsOmni Medical Designs · 1990

The one decision as Omni Medical Designs →

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 Mfg., Inc. 1Omni-Flow, Inc. 1Omni Surgical, LLC Dba Spine360 1Omni Surgical, LP Dba Spine360 1