510(k) Report

FDA applicant

Tdk Corp.

272 01, Japan, JP6 decisions1984–19880 recalls

FDA records 6 decisions for Tdk Corp. (272 01, Japan, JP) from 1984 to 1988: 6 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and DRS (Transducer, Blood-Pressure, Extravascular). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Tdk Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tdk Corp.’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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