510(k) Report

FDA applicant

Unidex Group, Inc.

Des Plaines, IL2 decisions1996–19960 recalls

FDA records 2 decisions for Unidex Group, Inc. (Des Plaines, IL) in 1996: 2 510(k) clearances. Most are in product codes IXA (Cassette, Radiographic Film) and IXJ (Grid, Radiographic). 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, radiology panel, where it files most

How often FDA has decided Unidex Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unidex Group, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Unidex Group, 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?

  • IXACassette, Radiographic Film1decision
  • IXJGrid, Radiographic1decision

What has FDA decided for it lately?

  • K962336Radiographic Film CassettesUnidex Group, Inc. · 1996
  • K962338Radiographic GridUnidex Group, Inc. · 1996

All 2 as Unidex Group, Inc. →

Other applicant names beginning “Unidex”

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

Unidex, Inc. 1