FDA applicant

Uroan 21

Palma De Mallorca, ES1 decision2006–20060 recalls

FDA records 1 decision for Uroan 21 (Palma De Mallorca, ES) in 2006: 1 510(k) clearance. All are in product code LIL (Monitor, Penile Tumescence). Its devices cite 1 predicate, 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

How often FDA has decided Uroan 21’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Uroan 21 since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Uroan 21 by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Uroan”

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

Uroan Xxi Electromedicina 1

Uroan 21

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Uroan”