FDA applicant

Tecnimed S.R.L.

Great Neck, NY4 decisions2004–20170 recalls

FDA records 4 decisions for Tecnimed S.R.L. (Great Neck, NY) from 2004 to 2017: 4 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 2 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, general hospital panel, where it files most

How often FDA has decided Tecnimed S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tecnimed S.R.L.’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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Tecnimed S.R.L.

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?