FDA applicant

Sigma Medical, Inc.

Indianapolis, IN13 decisions1985–19850 recalls

FDA records 13 decisions for Sigma Medical, Inc. (Indianapolis, IN) in 1985: 13 510(k) clearances. All are in product code CAI (Circuit, Breathing (W Connector, Adaptor, Y…). 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, anesthesiology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sigma Medical, 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 6 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 Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sigma”