FDA applicant

Instrumentarium Corp.

Milwaukee, WI20 decisions1983–20021 recall

FDA records 20 decisions for Instrumentarium Corp. (Milwaukee, WI) from 1983 to 2002: 20 510(k) clearances. Most are in product codes EHD (Unit, X-Ray, Extraoral With Timer) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 1 predicate, 1 of them its own earlier devices. 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, dental panel, where it files most

How often FDA has decided Instrumentarium Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Instrumentarium Corp. since 2007.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like 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 “Instrumentarium”

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

Instrumentarium Imaging, Inc. 24 Instrumentarium Dental, Palodex Group OY 5 Instrumentarium Corp. Imaging Division 3 Instrumentarium-Datex 2 Instrumentarium Dental, Inc. 1

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?

What has been recalled?

Other applicant names beginning “Instrumentarium”