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Cortex, Inc.

FDA Regulatory Profile

Cortex, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 23, 2026.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)April 23, 2026
K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)March 13, 2026

FDA data resources