FDA applicant

Cochlear Bone Anchored Systems AB

Centennial, CO2 decisions2008–20090 recalls

FDA records 2 decisions for Cochlear Bone Anchored Systems AB (Centennial, CO) from 2008 to 2009: 2 510(k) clearances. Most are in product codes LXB (Hearing Aid, Bone Conduction) and MAH (Hearing Aid, Bone Conduction, Implanted). Its devices cite 8 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, ear, nose and throat panel, where it files most

How often FDA has decided Cochlear Bone Anchored Systems AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Cochlear Bone Anchored Systems AB by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cochlear Bone Anchored Systems AB’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 “Cochlear”

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

Cochlear Americas 27 Cochlear 3 Cochlear Laboratories, Ltd. 1

Cochlear Bone Anchored Systems AB

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 “Cochlear”