FDA applicant
Novocure, GmbH
FDA records 3 decisions for Novocure, GmbH (Baar) from 2011 to 2026: 3 original PMA approvals. Most are in product codes NZK (Stimulator, Low Electric Field, Tumor Treatment) and SDA (Electrical Tumor Treatment Fields For…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Novocure, GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2011high 1 (2011) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Novocure, 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