Home › Device types › NIO
Stent, Iliac
FDA product code NIO · Class 3 · Unknown
781
Registered devices
7,195
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
Epic™ Vascular — BOSTON SCIENTIFIC CORPORATIONAstron — Biotronik AGAbsolute Pro — ABBOTT VASCULAR INC.Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.Omnilink Elite — ABBOTT VASCULAR INC.Zilver 518 — COOK IRELAND LTDEpic™ Vascular — BOSTON SCIENTIFIC CORPORATIONS.M.A.R.T. RADIANZ — Cordis US Corp.E-Luminexx® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.E-Luminexx® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Epic™ Vascular — BOSTON SCIENTIFIC CORPORATIONASSURANT® COBALT — MEDTRONIC, INC.Epic™ Vascular — BOSTON SCIENTIFIC CORPORATIONZilver 518 — COOK IRELAND LTDEpic™ Vascular — BOSTON SCIENTIFIC CORPORATIONEpic™ Vascular — BOSTON SCIENTIFIC CORPORATIONCordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.Zilver 518 — COOK IRELAND LTDProtégé™ GPS™ — EV3, INCAbsolute Pro — ABBOTT VASCULAR INC.Astron — Biotronik AGLifeStar® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.E-Luminexx® Vascular & Biliary Stent — Bard Peripheral Vascular, Inc.Zilver 635 — COOK IRELAND LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-04 | Cordis US Corp | product mix-up; Vascular stent labeled as one size but contains a different size. |
| 2025-03-04 | Cordis US Corp | product mix-up; Vascular stent labeled as one size but contains a different size. |
| 2019-11-14 | Cardinal Health Inc. | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Co |
| 2015-12-22 | Cook Medical Incorporated | Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate du |
| 2012-01-31 | Cordis Corporation | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches. |
| 2012-01-05 | Cook Ireland Ltd. | Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-1 |
| 2008-03-10 | Cordis Corporation | Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not |
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