Sirtex Medical US Holdings, Inc.

FDA Regulatory Profile

Sirtex Medical US Holdings, Inc. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest 510(k)
Oct 23, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K202392SIR-Spheres Microspheres Activity Calculator (SMAC)Oct 23, 2020