FDA applicant

Sigma Biomedics, Inc.

Prospect Heights, IL1 decision2006–20060 recalls

FDA records 1 decision for Sigma Biomedics, Inc. (Prospect Heights, IL) in 2006: 1 510(k) clearance. All are in product code MUH (System, X-Ray, Extraoral Source, Digital). 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, dental panel, where it files most

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

FDA decisions per year

No FDA decision for Sigma Biomedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sigma Biomedics, 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 “Sigma”

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

Sigma Chemical Co. 231 Sigma Diagnostics, Inc. 164 Sigma Medical, Inc. 13 Sigma 6 Sigma Medical Supplies Corp. 5 Sigma Intl. 3 Sigma Cell Culture Reagents 2 Sigma Scientific Services, LLC 1 Sigma Teleproducts, Inc. 1 Sigma Vision, Inc. 1 Sigma Intl. General Medical Apparatus, Inc. 1 Sigma-Brillen 1

Sigma Biomedics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sigma”