FDA applicant
Cardiox Corp.
FDA records 1 decision for Cardiox Corp. (Columbus, OH) in 2013: 1 510(k) clearance. All are in product code DXG (Computer, Diagnostic, Pre-Programmed…). 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 Cardiox Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2013high 1 (2013) · low 0 (2014)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Cardiox Corp.’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