510(k) Report

FDA applicant

Traatek, Inc.

Redwood City, CA1 decision2002–20020 recalls

FDA records 1 decision for Traatek, Inc. (Redwood City, CA) in 2002: 1 510(k) clearance. All are in product code HBA (Neurosurgical Paddie). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Traatek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Traatek, 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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