FDA applicant

Trudell Medical Intl.

London, CA12 decisions2002–20130 recalls

FDA records 12 decisions for Trudell Medical Intl. (London, CA) from 2002 to 2013: 12 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and NVP (Holding Chambers, Direct Patient Interface). Its devices cite 5 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, anesthesiology panel, where it files most

How often FDA has decided Trudell Medical Intl.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2013

2007high 3 (2013) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Trudell Medical Intl.’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 “Trudell”

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

Trudell Medical International 9 Trudell Medical Int'L 3 Trudell Medical 3

Trudell Medical Intl.

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?

Other applicant names beginning “Trudell”