FDA applicant

Sigma Intl.

Medina, NY3 decisions1994–200418 recalls

FDA records 3 decisions for Sigma Intl. (Medina, NY) from 1994 to 2004: 3 510(k) clearances. All are in product code FRN (Pump, Infusion). Its devices cite 4 predicates, 0 of them its own earlier devices. 18 recalls are linked to its devices, 3 Class I.

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 Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sigma Intl. since 2007.

Recalls per year

1in 2021

2007high 6 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sigma Intl. 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 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 Intl.

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?

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Other applicant names beginning “Sigma”