FDA applicant
Leonhard Lang GmbH
FDA records 19 decisions for Leonhard Lang GmbH (Stillwater, MN) from 1999 to 2014: 19 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and MKJ (Automated External Defibrillators (Non-Wearable)). Its devices cite 33 predicates, 17 of them its own earlier devices. 7 recalls are linked to its devices, 3 Class I.
FDA’s records also spell it “Leonhard Lang Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Leonhard Lang GmbH’s devices, and how often a recall has named them.
FDA decisions per year
3in 2014
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Leonhard Lang GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report