Data / Medical devices / Stent, Iliac
Stent, Iliac (NIO): 21 FDA-registered makers in 7 countries
21 establishments in 7 countries are registered with the FDA to make Stent, Iliac (product code NIO, Class 3). 14 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NIO
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Ireland | 4 |
| Germany | 2 |
| Switzerland | 1 |
| Netherlands | 1 |
| Mexico | 1 |
| Japan | 1 |
Makers of Stent, Iliac
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 |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer, Specification developer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 0 | 2 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer, Manufacturer for export | 0 | 2 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | CLONMEL Tipperary, Ireland | Exporter to the US, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Angiomed GMBH & Co. Medizintechnik KG | KARLSRUHE Baden-Wurttemberg, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Biotronik AG | BULACH Zurich, Switzerland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific International BV, European Dist. Ctr. | KERKRADE Limburg, Netherlands | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cook Ireland Ltd | LIMERICK Limerick(County), Ireland | Complaint file establishment, Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Cardinal Health Mexico 244 S de RL de CV | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Manufacturer for export, Specification developer | 0 | 1 | 3 | 0 | api.fda.gov | |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clearstream Technologies Ltd. | Wexford, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CORTRONIK GmbH | Rostock-Warnemuende Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Minneapolis, MN, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norman Noble, Inc. | Highland Heights, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics Radiation Technologies, LLC | San Diego, CA, United States | Contract sterilizer, Manufacturer for export | 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.