INSPIREMD Inc

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2326-2026Class IIBrand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840May 1, 2026
Z-2330-2026Class IICGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040May 1, 2026
Z-2325-2026Class IIBrand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830May 1, 2026
Z-2327-2026Class IICGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930May 1, 2026
Z-2328-2026Class IIBrand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940May 1, 2026
Z-2329-2026Class IICGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030May 1, 2026