FDA applicant

Sonitus Medical, Inc.

San Carlos, CA2 decisions2011–20115 recalls

FDA records 2 decisions for Sonitus Medical, Inc. (San Carlos, CA) in 2011: 2 510(k) clearances. All are in product code LXB (Hearing Aid, Bone Conduction). Its devices cite 7 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

2in 2011

2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

5in 2012

2011high 5 (2012) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Sonitus Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sonitus Medical, Inc.

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?

What has been recalled?