FDA applicant

Ascom Sweden AB

Goteborg, SE2 decisions2011–20181 recall

FDA records 2 decisions for Ascom Sweden AB (Goteborg, SE) from 2011 to 2018: 2 510(k) clearances. All are in product code MSX (System, Network And Communication…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Ascom (Sweden) 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 Ascom Sweden AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2015

2011high 1 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Ascom Sweden AB by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ascom Sweden AB’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 “Ascom”

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

Ascom Ums Srl Unipersonale 2 Ascom (Us), Inc. 1

Ascom Sweden AB

Which product codes does it file in?

Whose devices does it build on?

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 “Ascom”