Data / Medical devices / Israel / Inspiremd, Ltd.
Inspiremd, Ltd.: FDA-registered device maker in Tel Aviv, Israel, 1 PMA approval
Inspiremd, Ltd. is registered with the FDA (registration 3031658894) in Tel Aviv, Israel. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated June 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031658894
- Address
- 4 Menorat HaMaor Street, Tel Aviv, Israel, 6744832
- Owner or operator
- InspireMD, Ltd. (10093698)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 25, 2025
- Registered through
- 2026
- Brand names listed
- CGuard Prime Carotid Stent System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stent, Carotid | NIM | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 23, 2025 | P240029 | CGuard Prime Carotid Stent System | NIM | 2 | March 16, 2026 | accessdata.fda.gov |
Compare with other makers
Updated March 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.