510(k) Report

FDA applicant

Arlanda Medicinska Instrument Co. AB

191 47 Sollentuna, SE1 decision1997–19970 recalls

FDA records 1 decision for Arlanda Medicinska Instrument Co. AB (191 47 Sollentuna, SE) in 1997: 1 510(k) clearance. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). 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, radiology panel, where it files most

How often FDA has decided Arlanda Medicinska Instrument Co. AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arlanda Medicinska Instrument Co. AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arlanda Medicinska Instrument Co. AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic1decision

What has FDA decided for it lately?

  • K955668Intracavity Needle Guide KitArlanda Medicinska Instrument Co. AB · 1997

The one decision as Arlanda Medicinska Instrument Co. AB →