FDA applicant

Datex-Engstrom, Inc.

Tewksbury, MA10 decisions1996–19988 recalls

FDA records 10 decisions for Datex-Engstrom, Inc. (Tewksbury, MA) from 1996 to 1998: 10 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). 8 recalls are linked to its devices.

FDA’s records also spell it “Datex Engstrom AB”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Datex-Engstrom, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Datex-Engstrom, Inc. since 2007.

Recalls per year

3in 2008

2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Datex-Engstrom, 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 “Datex-Engstrom”

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 Medical Instrumentation, Inc. 5 Datex-Ohmeda Inc., A Division of Instrumentarium C 2 Datex-Ohmeda, Inc., A General Electric Company 1

Datex-Engstrom, 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-Engstrom”