FDA applicant

Datex-Ohmeda, Inc., A General Electric Company

Madison1 decision2022–20221 recall

FDA records 1 decision for Datex-Ohmeda, Inc., A General Electric Company (Madison) in 2022: 1 original PMA approval. All are in product code QSF (Software Option For Anesthesia Gas Machine To…). 1 recall is linked to its devices, 1 Class I.

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 Datex-Ohmeda, Inc., A General Electric Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2024

2022high 1 (2024) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Datex-Ohmeda, Inc., A General Electric Company by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Datex-Ohmeda, Inc., A General Electric…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Datex-Ohmeda”

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

Datex-Ohmeda, Inc. 103 Datex Division Instrumentarium Corp. 55 Datex-Engstrom, Inc. 10 Datex Medical Instrumentation, Inc. 5 Datex-Ohmeda Inc., A Division of Instrumentarium C 2

Datex-Ohmeda, Inc., A General Electric Company

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Datex-Ohmeda”