FDA applicant
Simbionix, Ltd.
FDA records 3 decisions for Simbionix, Ltd. (Chalotte, NC) from 2010 to 2013: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 5 predicates, 2 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 Simbionix, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2010high 1 (2010) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Simbionix, Ltd.’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