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Injector And Syringe, Angiographic

FDA product code DXT · Class 2 · Cardiovascular

1,731
Registered devices
3,315
Adverse events
69
Recalls
210
510(k) clearances

Devices with this code

MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT — BAYER MEDICAL CARE INC.Coeur — COEUR, INC.ACIST CVi® Contrast Delivery System — ACIST MEDICAL SYSTEMS, INC.Quick Fill Disposable Syringe Fill Tube — BAYER MEDICAL CARE INC.Merit Medical® — Merit Medical Systems, Inc.Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.KYPHON ELEMENT™ Balloon Kyphoplasty System — MEDTRONIC SOFAMOR DANEK, INC.Blue Diamond™ — Merit Medical Systems, Inc.Steriatrics — Shenzhen Boon Medical Supply Co., Ltd.A2000 Multi-use Syringe Kit — ACIST MEDICAL SYSTEMS, INC.AngioTouch® Kit — ACIST MEDICAL SYSTEMS, INC.MEDRAD® Stellant CT Injection System — BAYER MEDICAL CARE INC.MEDRAD® Stellant FLEX Syringe Kit — BAYER MEDICAL CARE INC.MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT — BAYER MEDICAL CARE INC.Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.DeRoyal — DEROYAL INDUSTRIES, INC.LF — Liebel-Flarsheim Company LLCNAMIC — NAVILYST MEDICAL, INC.Medical Imaging Solutions Intl. — MEDICAL IMAGING SOLUTIONS INTERNATIONAL COMPANYGuerbet — Shenzhen Boon Medical Supply Co., Ltd.LF — Liebel-Flarsheim Company LLCDeRoyal — DEROYAL INDUSTRIES, INC.Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.DeRoyal — DEROYAL INDUSTRIES, INC.

Recent recalls

DateFirmReason
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LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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.
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.