FDA applicant

Datex Medical Instrumentation, Inc.

Tewksbury, MA5 decisions1991–19971 recall

FDA records 5 decisions for Datex Medical Instrumentation, Inc. (Tewksbury, MA) from 1991 to 1997: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and CBS (Analyzer, Gas, Halothane, Gaseous-Phase…). 1 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 Medical Instrumentation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Datex Medical Instrumentation, Inc. since 2007.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Datex Medical Instrumentation, Inc.’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”

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-Ohmeda Inc., A Division of Instrumentarium C 2 Datex-Ohmeda, Inc., A General Electric Company 1

Datex Medical Instrumentation, 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?

What has been recalled?

Other applicant names beginning “Datex”