Company
INSPIREMD Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (6 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NIM | Stent, Carotid | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 10mmx40mm
Model/Catalog Number: CND1040 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 10mmx30mm
Model/Catalog Number: CND1030 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm
Model/Catalog Number: CND0940 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 9mx30mm
Model/Catalog Number: CND0930 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm
Model/Catalog Number: CND0840 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm
Model/Catalog Number: CND0830 Open, Classified |
NIM | None listed |