FDA applicant

Datex Division Instrumentarium Corp.

Helsinki, Finland, FI55 decisions1982–19970 recalls

FDA records 55 decisions for Datex Division Instrumentarium Corp. (Helsinki, Finland, FI) from 1982 to 1997: 55 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and DQA (Oximeter). 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 Datex Division Instrumentarium Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Datex Division Instrumentarium Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Datex Division Instrumentarium Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Datex”

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

Datex-Ohmeda, Inc. 103 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 1

Datex Division Instrumentarium Corp.

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 “Datex”