FDA applicant

Qualimed Srl

Rome, IT2 decisions2014–20180 recalls

FDA records 2 decisions for Qualimed Srl (Rome, IT) from 2014 to 2018: 2 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 2 predicates, 0 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2018

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Qualimed Srl by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Qualimed Srl’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 “Qualimed”

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

Qualimed USA, LLC 1

Qualimed Srl

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Qualimed”