FDA applicant
Xavant Technology (Pty), Ltd.
FDA records 7 decisions for Xavant Technology (Pty), Ltd. (Pretoria, Gauteng, ZA) from 2007 to 2022: 7 510(k) clearances. Most are in product codes BXN (Stimulator, Nerve, Battery-Powered) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 13 predicates, 6 of them its own earlier devices. 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 Xavant Technology (Pty), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Xavant Technology (Pty), Ltd.’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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