510(k) Report

FDA applicant

Leon H. Lang Co.

Archenweg, 56, AT1 decision1986–19860 recalls

FDA records 1 decision for Leon H. Lang Co. (Archenweg, 56, AT) in 1986: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). 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 Leon H. Lang Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leon H. Lang Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Leon”

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