FDA applicant

Ascom Ums Srl Unipersonale

Scandicci (Fi), IT2 decisions2018–20260 recalls

FDA records 2 decisions for Ascom Ums Srl Unipersonale (Scandicci (Fi), IT) from 2018 to 2026: 2 510(k) clearances. All are in product code MSX (System, Network And Communication…). Its devices cite 3 predicates, 1 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Ascom Ums Srl Unipersonale’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Ascom Ums Srl Unipersonale by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ascom Ums Srl Unipersonale’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 “Ascom”

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

Ascom Sweden AB 2 Ascom (Us), Inc. 1

Ascom Ums Srl Unipersonale

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ascom”