Data / Medical devices / Stent, Carotid
Stent, Carotid (NIM): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make Stent, Carotid (product code NIM, Class 3). 10 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 15 recall events (2 Class I). FDA data exported November 2, 2026.
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- Product code
- NIM
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Israel | 2 |
| Ireland | 1 |
| Mexico | 1 |
| Germany | 1 |
| Costa Rica | 1 |
Makers of Stent, Carotid
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Manufacturer | 0 | 2 | 3 | 0 | api.fda.gov | |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 0 | 1 | 2 | 1 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Contego Medical, Inc | Raleigh, NC, United States | Complaint file establishment, Specification developer | 0 | 1 | 2 | 0 | api.fda.gov | |
| Cardinal Health Mexico 244 S de RL de CV | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 0 | 1 | 2 | 1 | api.fda.gov | |
| Inspiremd, Ltd. | Tel Aviv, Israel | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Admedes GMBH | PFORZHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maruho Relucent, Inc | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Murray, Inc. | Lake Zurich, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroVention Costa Rica S.R.L. | . Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resonetics, LLC | Or Akiva Central, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.