FDA applicant

Koros USA, Inc.

Moorepark, CA4 decisions2007–20130 recalls

FDA records 4 decisions for Koros USA, Inc. (Moorepark, CA) from 2007 to 2013: 4 510(k) clearances. Most are in product codes GZT (Retractor, Self-Retaining, For Neurosurgery) and PDQ (Neurosurgical Nerve Locator). 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2013

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Koros USA, Inc.’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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Koros USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?