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Injector And Syringe, Angiographic

FDA product code DXT · Class 2 · Cardiovascular

1,743
Registered devices
3,329
Adverse events
70
Recalls
211
510(k) clearances

Devices with this code

Medical Imaging Solutions International — Shenzhen Boon Medical Supply Co., Ltd.DeRoyal — DEROYAL INDUSTRIES, INC.Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.FastLoad™ CTA Dual Syringe Pack with spikes — Bracco Injeneering SAMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Merit Medical® — Merit Medical Systems, Inc.MEDRAD® Stellant Sterile Disposable Syringe — BAYER MEDICAL CARE INC.Monarch® — Merit Medical Systems, Inc.MEDRAD® Mark 7 Arterion Injection System — Bayer Medical Care Inc.Monarch® — Merit Medical Systems, Inc.CVi® Cable — ACIST MEDICAL SYSTEMS, INC.Coeur Nemoto — COEUR, INC.Merit Maestro® — Merit Medical Systems, Inc.NAMIC — NAVILYST MEDICAL, INC.DeRoyal — DEROYAL INDUSTRIES, INC.CVi® Cable — ACIST MEDICAL SYSTEMS, INC.Disposable High Pressure Injector Syringe — WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.CVi® Cable — ACIST MEDICAL SYSTEMS, INC.Merit Medical® — Merit Medical Systems, Inc.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Merit Medical® — Merit Medical Systems, Inc.CABLE,START SWITCH,25FT,4PIN,UDI,BATCH — BAYER MEDICAL CARE INC.Antmed — ShenZhen Antmed Co., Ltd

Recent recalls

DateFirmReason
2026-07-31Bayer Medical Care, Inc.Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
2026-04-24Bayer Medical Care, Inc.Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result i
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2024-08-30Merit Medical Systems, Inc.Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
2024-08-30Merit Medical Systems, Inc.Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.