510(k) Report

FDA applicant

Tdk Electronics Corporation of America

Port Washington, NY1 decision1997–19970 recalls

FDA records 1 decision for Tdk Electronics Corporation of America (Port Washington, NY) in 1997: 1 510(k) clearance. All are in product code LMB (Device, Digital Image Storage, Radiological). 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, radiology panel, where it files most

How often FDA has decided Tdk Electronics Corporation of America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tdk Electronics Corporation of America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tdk Electronics Corporation of America by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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