FDA applicant

Instrumentarium-Datex

Mchenry, IL2 decisions1980–19800 recalls

FDA records 2 decisions for Instrumentarium-Datex (Mchenry, IL) in 1980: 2 510(k) clearances. All are in product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). 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 Instrumentarium-Datex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Instrumentarium-Datex since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Instrumentarium-Datex’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 “Instrumentarium-Datex”

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

Instrumentarium Imaging, Inc. 24 Instrumentarium Corp. 20 Instrumentarium Dental, Palodex Group OY 5 Instrumentarium Corp. Imaging Division 3 Instrumentarium Dental, Inc. 1

Instrumentarium-Datex

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Instrumentarium-Datex”