Panels › Cardiovascular › Product code DXT · Class 2
Injector And Syringe, Angiographic
Regulation 870.1650
7510(k)s in 12 months (211 all time)
8recalls in 12 months (70 all time)
58recalls that name a 510(k)
Top companies in DXT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 2026 | K262043 | MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging B Bayer Medical Care, Inc. | DXT |
| May 14, 2026 | K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injec Fortis Biosolutions Company Limited, TW | DXT |
| May 13, 2026 | K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Ca Acist Medical Systems, Inc. | DXT |
| May 13, 2026 | K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Ma Acist Medical Systems, Inc. | DXT |
| Apr 16, 2026 | K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube Shenzhen Maiwei Biotech Co., Ltd., CN | DXT |
| Mar 5, 2026 | K251788 | Extension tube Zhuhai DR Medical Instruments Co., Ltd., CN | DXT |
| Feb 13, 2026 | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) Bayer Medical Care, Inc. | DXT |
| Sep 5, 2025 | K244038 | High Pressure Tubing Shandong Int Medical Instruments Co., Ltd., CN | DXT |
| Dec 23, 2024 | K242143 | Angiography Injector Shandong Int Medical Instruments Co., Ltd., CN | DXT |
| Aug 27, 2024 | K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) Nemoto Kyorindo Co., Ltd., JP | DXT |
| Aug 22, 2024 | K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories Shenzhen Boon Medical Supply Co., Ltd., CN | DXT |
| Jun 14, 2024 | K230668 | Disposable High-pressure Extension Lines Precision Medical Plastics , Ltd., CN | DXT |
| Nov 21, 2023 | K232388 | High Pressure Tubing Ningbo Dizegens Medical Science Co.,Ltd, CN | DXT |
| Oct 19, 2021 | K211564 | Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Boon Medical Supply Co., Ltd., CN | DXT |
| Dec 17, 2020 | K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System Acist Medical Systems, Inc. | DXT |
| Oct 28, 2020 | K201395 | Sterile High-pressure Angiographic Syringes for single-use Youwo (Guangzhou) Medical Device Co., Ltd., CN | DXT |
| Aug 7, 2020 | K192657 | Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Boon Medical Supply Co., Ltd., CN | DXT |
| Dec 13, 2019 | K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation Bayer Medical Care, Inc. | DXT |
| Dec 5, 2019 | K193028 | MEDRAD Mark 7 Arterion Injection System Bayer Medical Care, Inc. | DXT |
| Oct 17, 2019 | K190102 | DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System Osprey Medical, Inc. | DXT |
| Jul 18, 2019 | K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, An Acist Medical Systems, Inc. | DXT |
| Dec 20, 2018 | K183267 | DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposab Osprey Medical, Inc. | DXT |
| Nov 1, 2018 | K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit Bayer Medical Care, Inc. | DXT |
| Nov 1, 2018 | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant C Bayer Medical Care, Inc. | DXT |
| Oct 25, 2018 | K181936 | DyeVert PLUS EZ Contrast Reduction System Osprey Medical, Inc. | DXT |
| Oct 10, 2018 | K182289 | Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Baoan Medical Supplies Co., Ltd., CN | DXT |
| Aug 17, 2018 | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant C Bayer Medical Care, Inc. | DXT |
| Jul 6, 2018 | K172694 | Sterile Disposable Syringes Shenyang Mastech Medical Device Co., Ltd., CN | DXT |
| Feb 16, 2018 | K171646 | ACISTCVi® Contrast Delivery System Acist Medical Systems, Inc. | DXT |
| Feb 7, 2018 | K173450 | PRESS DUO elite, PRESS DUO elite AG Nemoto Kyorindo Co., Ltd., JP | DXT |
| Dec 12, 2017 | K170279 | Disposable High Pressure Syringe Union Medical Shenzhen Co., Ltd., CN | DXT |
| Aug 18, 2017 | K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Coeur, Inc. | DXT |
| Jul 7, 2017 | K171698 | Smart Syringe Osprey Medical, Inc. | DXT |
| Jun 15, 2017 | K163084 | Merit Coronary Control Syringe Merit Medical Systems, Inc. | DXT |
| May 26, 2017 | K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System Osprey Medical, Inc. | DXT |
| Mar 8, 2017 | K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System Osprey Medical, Inc. | DXT |
| Jan 27, 2017 | K162088 | Ecomed Disposable Angiographic Syringes Ecomed Solutions, LLC | DXT |
| Nov 22, 2016 | K152906 | Disposable High Pressure Injector Syringe Wuxi Yushou Medical Appliances Co., Ltd., CN | DXT |
| Nov 10, 2016 | K160190 | Sunmed Control Syringes Sunny Medical Device (Shenzhen) Co., Ltd. | DXT |
| Oct 6, 2016 | K161471 | MR Syringe Dual Pack for Solaris Injectors Coeur, Inc. | DXT |
| Aug 3, 2016 | K161505 | DyeVert NG Contrast Modulation System Osprey Medical, Inc. | DXT |
| Jul 29, 2016 | K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Merit Medical Systems, Inc. | DXT |
| Mar 25, 2016 | K152978 | DeRoyal Angiography Kits Deroyal Industries, Inc. | DXT |
| Feb 4, 2016 | K153141 | DyeVert Contrast Modulation System Osprey Medical, Inc. | DXT |
| Jan 7, 2016 | K151960 | Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Baoan Medical Supplies Co., Ltd., CN | DXT |
| Oct 22, 2015 | K150902 | 330psi Extension Y-Line with Dual Check Valve Coeur, Inc. | DXT |
| Oct 15, 2015 | K151300 | AVERT Contrast Modulation System Osprey Medical, Inc. | DXT |
| Oct 9, 2015 | K151746 | Dyevert Contrast Modulation System Osprey Medical, Inc. | DXT |
| Sep 21, 2015 | K152218 | AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System Osprey Medical | DXT |
| Aug 14, 2015 | K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit Bayer Medical Care, Inc. | DXT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.