FDA applicant

Sigma

St. Louis, MO6 decisions1983–19970 recalls

FDA records 6 decisions for Sigma (St. Louis, MO) from 1983 to 1997: 6 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and KIT (Media And Components, Synthetic Cell And…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Sigma since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sigma 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 Medical Supplies Corp. 5 Sigma Intl. 3 Sigma Cell Culture Reagents 2 Sigma Scientific Services, LLC 1 Sigma Teleproducts, Inc. 1 Sigma Biomedics, Inc. 1 Sigma Vision, Inc. 1 Sigma Intl. General Medical Apparatus, Inc. 1 Sigma-Brillen 1

Sigma

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sigma”