Data / Medical devices / Coronary Drug-Eluting Stent
Coronary Drug-Eluting Stent (NIQ): 16 FDA-registered makers in 6 countries
16 establishments in 6 countries are registered with the FDA to make Coronary Drug-Eluting Stent (product code NIQ, Class 3). 11 of them have a 510(k) clearance or PMA approval on file and 3 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
- NIQ
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Ireland | 3 |
| Israel | 2 |
| Switzerland | 1 |
| Singapore | 1 |
| Germany | 1 |
Makers of Coronary Drug-Eluting Stent
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 Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | CLONMEL Tipperary, Ireland | Exporter to the US, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Biotronik AG | BULACH Zurich, Switzerland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Medinol Ltd. | Jerusalem, Israel | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medinol Ltd. | TEL-AVIV Tel Aviv, Israel | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Ireland | GALWAY Galway(County), Ireland | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Medtronic Vascular | Santa Rosa, CA, United States | Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Biotronik Apm Pte. Ltd | Singapore South East, Singapore | Contract 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 | |
| Elixir Medical Corporation | Milpitas, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Minneapolis, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics US LLC | Los Angeles, 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.