FDA Device Intelligence
HomeDevice types › OEQ

Angiography/Angioplasty Kit

FDA product code OEQ · Class 2 · Cardiovascular

27,023
Registered devices
494
Adverse events
89
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-17Windstone Medical Packaging, Inc.Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HC
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie
2026-04-02Merit Medical Systems, Inc.catheter may experience resistance when being advanced over the guidewire
2026-04-02Merit Medical Systems, Inc.catheter may experience resistance when being advanced over the guidewire
2026-04-02Merit Medical Systems, Inc.catheter may experience resistance when being advanced over the guidewire
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-19Medline Industries, LPDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market
2026-02-27Medline Industries, LPFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
2026-02-27Medline Industries, LPUnapproved design changes to the products outside of the 510(k) clearance.
2026-02-27Medline Industries, LPFirm 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.