Home › Device types › OEQ
Angiography/Angioplasty Kit
FDA product code OEQ · Class 2 · Cardiovascular
27,488
Registered devices
528
Adverse events
90
Recalls
0
510(k) clearances
Devices with this code
basixCOMPAK™ — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMerit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-02 | Medline Industries, LP | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaki |
| 2026-06-17 | Windstone Medical Packaging, Inc. | Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices |
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie |
| 2026-04-02 | Merit Medical Systems, Inc. | catheter may experience resistance when being advanced over the guidewire |
| 2026-04-02 | Merit Medical Systems, Inc. | catheter may experience resistance when being advanced over the guidewire |
| 2026-04-02 | Merit Medical Systems, Inc. | catheter may experience resistance when being advanced over the guidewire |
| 2026-03-24 | Medline Industries, LP | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market |
| 2026-02-27 | Medline Industries, LP | Unapproved design changes to the products outside of the 510(k) clearance. |
| 2026-02-27 | Medline Industries, LP | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. |
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