Injector And Syringe, Angiographic
FDA product code DXT · Class II (moderate risk) · 21 CFR 870.1650 · Cardiovascular
210510(k) clearances
0PMA approvals
60recalls
Manufacturers
- Medrad, Inc. 32
- Osprey Medical, Inc. 15
- Acist Medical Systems, Inc. 12
- Coeur, Inc. 10
- Bayer Medical Care, Inc. 7
- Merit Medical Systems, Inc. 7
- Mallinckrodt Inc., Liebel-Flarsheim Business 7
- Nemoto Kyorindo Co., Ltd. 7
- Vertex Medical Corp. 7
- Mallinckrodt Group, Inc. 6
- Coeur Laboratories, Inc. 5
- Advanced Cardiovascular Systems, Inc. 4
- C.R. Bard, Inc. 4
- Shenzhen Boon Medical Supply Co., Ltd. 3
- B. Braun Medical, Inc. 3
- Life-Tech Intl., Inc. 3
- Cordis Corp. 2
- Invasatec 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- American Edwards Laboratories 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional | Fortis Biosolutions Company Limited | 05/14/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional | Shenzhen Maiwei Biotech Co., Ltd. | 04/16/2026SE |
| K251788 | Extension tubeDXT · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 03/05/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | Bayer Medical Care, Inc. | 02/13/2026SE |
| K244038 | High Pressure TubingDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 09/05/2025SE |
| K242143 | Angiography InjectorDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 12/23/2024SE |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)DXT · Traditional | Nemoto Kyorindo Co., Ltd. | 08/27/2024SE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/22/2024SE |
| K230668 | Disposable High-pressure Extension LinesDXT · Traditional | Precision Medical Plastics , Ltd. | 06/14/2024SE |
| K232388 | High Pressure TubingDXT · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 11/21/2023SE |
| K211564 | Sterile High-pressure Angiographic Syringes for Single-useDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 10/19/2021SE |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDXT · Special | Acist Medical Systems, Inc. | 12/17/2020SE |
| K201395 | Sterile High-pressure Angiographic Syringes for single-useDXT · Traditional | Youwo (Guangzhou) Medical Device Co., Ltd. | 10/28/2020SE |
| K192657 | Sterile High-pressure Angiographic Syringes for Single-useDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/07/2020SE |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationDXT · Traditional | Bayer Medical Care, Inc. | 12/13/2019SE |
| K193028 | MEDRAD Mark 7 Arterion Injection SystemDXT · Special | Bayer Medical Care, Inc. | 12/05/2019SE |
| K190102 | DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert…DXT · Traditional | Osprey Medical, Inc. | 10/17/2019SE |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…DXT · Traditional | Acist Medical Systems, Inc. | 07/18/2019SE |
| K183267 | DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System…DXT · Special | Osprey Medical, Inc. | 12/20/2018SE |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitDXT · Special | Bayer Medical Care, Inc. | 11/01/2018SE |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Special | Bayer Medical Care, Inc. | 11/01/2018SE |
| K181936 | DyeVert PLUS EZ Contrast Reduction SystemDXT · Special | Osprey Medical, Inc. | 10/25/2018SE |
| K182289 | Sterile High-pressure Angiographic Syringes for Single-useDXT · Special | Shenzhen Baoan Medical Supplies Co., Ltd. | 10/10/2018SE |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…DXT · Traditional | Bayer Medical Care, Inc. | 08/17/2018SE |
| K172694 | Sterile Disposable SyringesDXT · Traditional | Shenyang Mastech Medical Device Co., Ltd. | 07/06/2018SE |
| K171646 | ACISTCVi® Contrast Delivery SystemDXT · Traditional | Acist Medical Systems, Inc. | 02/16/2018SE |
| K173450 | PRESS DUO elite, PRESS DUO elite AGDXT · Traditional | Nemoto Kyorindo Co., Ltd. | 02/07/2018SE |
| K170279 | Disposable High Pressure SyringeDXT · Traditional | Union Medical Shenzhen Co., Ltd. | 12/12/2017SE |
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…DXT · Traditional | Coeur, Inc. | 08/18/2017SE |
| K171698 | Smart SyringeDXT · Special | Osprey Medical, Inc. | 07/07/2017SE |
| K163084 | Merit Coronary Control SyringeDXT · Abbreviated | Merit Medical Systems, Inc. | 06/15/2017SE |
| K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemDXT · Special | Osprey Medical, Inc. | 05/26/2017SE |
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemDXT · Traditional | Osprey Medical, Inc. | 03/08/2017SE |
| K162088 | Ecomed Disposable Angiographic SyringesDXT · Traditional | Ecomed Solutions, LLC | 01/27/2017SE |
| K152906 | Disposable High Pressure Injector SyringeDXT · Traditional | Wuxi Yushou Medical Appliances Co., Ltd. | 11/22/2016SE |
| K160190 | Sunmed Control SyringesDXT · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 11/10/2016SE |
| K161471 | MR Syringe Dual Pack for Solaris InjectorsDXT · Traditional | Coeur, Inc. | 10/06/2016SE |
| K161505 | DyeVert NG Contrast Modulation SystemDXT · Special | Osprey Medical, Inc. | 08/03/2016SE |
| K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing SyringeDXT · Traditional | Merit Medical Systems, Inc. | 07/29/2016SESK |
| K152978 | DeRoyal Angiography KitsDXT · Traditional | Deroyal Industries, Inc. | 03/25/2016SESK |
| K153141 | DyeVert Contrast Modulation SystemDXT · Traditional | Osprey Medical, Inc. | 02/04/2016SE |
| K151960 | Sterile High-pressure Angiographic Syringes for Single-useDXT · Traditional | Shenzhen Baoan Medical Supplies Co., Ltd. | 01/07/2016SE |
| K150902 | 330psi Extension Y-Line with Dual Check ValveDXT · Traditional | Coeur, Inc. | 10/22/2015SE |
| K151300 | AVERT Contrast Modulation SystemDXT · Traditional | Osprey Medical, Inc. | 10/15/2015SE |
| K151746 | Dyevert Contrast Modulation SystemDXT · Traditional | Osprey Medical, Inc. | 10/09/2015SE |
| K152218 | AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast…DXT · Traditional | Osprey Medical | 09/21/2015SE |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe KitDXT · Traditional | Bayer Medical Care, Inc. | 08/14/2015SE |
| K142745 | 125mL CT SyringeDXT · Traditional | Coeur, Inc. | 04/01/2015SE |
| K150485 | AVERT Contrast Modulation SystemDXT · Special | Osprey Medical, Inc. | 03/26/2015SE |
| K142081 | Contrast Monitoring System Display, Contrast Monitoring System SyringesDXT · Traditional | Osprey Medical, Inc. | 12/12/2014SE |
| K140469 | MR Syringe Dual PackDXT · Traditional | Coeur, Inc. | 07/28/2014SE |
| K133189 | Dual Shot Alpha 7DXT · Special | Nemoto Kyorindo Co., Ltd. | 06/30/2014SE |
| K140425 | Contrast Modulation SystemDXT · Traditional | Osprey Medical, Inc. | 06/11/2014SE |
| K133600 | Coeur, Inc. Frontload for Optivantage Power InjectorDXT · Traditional | Coeur, Inc. | 04/30/2014SE |
| K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & Go SyringeDXT · Special | Medrad, Inc. / Bayer Medical Care, Inc. | 01/23/2014SE |
| K131478 | Contrast Conservation SystemDXT · Traditional | Osprey Medical, Inc. | 08/15/2013SE |
| K120892 | Disposable 330PSI Extension LinesDXT · Traditional | Coeur, Inc. | 06/10/2013SE |
| K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…DXT · Special | Medrad, Inc. | 12/15/2011SE |
| K113198 | Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 MLDXT · Special | Navilyst Medical, Inc. | 11/28/2011SE |
| K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…DXT · Special | Medrad, Inc. | 10/14/2011SE |
| K093830 | Medline Angiographic Control SyringeDXT · Traditional | Medline Industries, Inc. | 03/03/2011SE |
| K092896 | Rempress and Angiography Contrast Delivery System RempressDXT · Traditional | Nemoto Kyorindo Co., Ltd. | 10/29/2010SE |
| K090487 | Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125…DXT · Traditional | Coeur, Inc. | 10/19/2009SE |
| K090621 | Flowcardia Flowmater Injector, Model Inj 100DXT · Traditional | Flowcardia, Inc. | 06/19/2009SE |
| K082439 | Disposable Angiographic Syringe, Model(S) CT-200-NE, CT-200-MA, CT-200+200-MA…DXT · Traditional | Shandong Weigao Medical Polymer Co., Ltd. | 03/23/2009SE |
| K083523 | Monarch Compak Inflation Syringe and Universal Fluid Dispensing SyringeDXT · Special | Merit Medical Systems, Inc. | 02/04/2009SE |
| K082212 | Syringe with Handi-FilDXT · Special | Mallinckrodt Inc., Liebel-Flarsheim Business | 01/22/2009SE |
| K082905 | Medrad Stellant CT Injector System with P3T CardiacDXT · Traditional | Medrad, Inc. | 01/12/2009SE |
| K073592 | Optistar Elite Injection SystemDXT · Traditional | Mallinckrodt Inc., Liebel-Flarsheim Business | 05/07/2008SE |
| K072696 | Ant Angiographic Syringes, Model(S) 100101,102,103,100201,202,203,204,100301,200101,201,2…DXT · Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 05/02/2008SE |
| K072886 | Medrad Stellant CT Injector System with P3TDXT · Traditional | Medrad, Inc. | 12/21/2007SE |
| K071691 | Dual Shot AlphaDXT · Special | Nemoto Kyorindo Co., Ltd. | 12/19/2007SE |
| K070798 | Adapters for CT, Angiographic, And/Or MRI Power InjectorsDXT · Traditional | Coeur, Inc. | 10/04/2007SE |
| K061976 | CKIS-004A Injector Synchronization OptionDXT · Traditional | Toshiba America Medical Systems, In.C | 09/27/2006SE |
| K062168 | Contrast Delivery System - Dual Shot AlphaDXT · Traditional | Nemoto Kyorindo Co., Ltd. | 08/18/2006SE |
| K052744 | C2000 Automated Manifold KitDXT · Special | Acist Medical Systems, Inc. | 12/16/2005SE |
| K051799 | Disposable Ct/Mr Syringes for Nemoto InjectorsDXT · Traditional | Coeur, Inc. | 11/02/2005SE |
| K052633 | Dual Shot - Contrast Delivery SystemDXT · Traditional | Nemoto Kyorindo Co., Ltd. | 10/17/2005SE |
| K050456 | Medrad Avanta Fluid Management Injection SystemDXT · Traditional | Medrad, Inc. | 06/17/2005SE |
| K042784 | Medrad Spectris Solaris Ep MR Injector SystemDXT · Special | Medrad, Inc. | 12/10/2004SE |
| K042744 | Optiv Antage DH Power Injection SystemDXT · Special | Mallinckrodt Inc., Liebel-Flarsheim Business | 11/30/2004SE |
| K040298 | Acist Antiographic Injection System Contrast Management Disposable KitsDXT · Special | Acist Medical Systems, Inc. | 03/15/2004SE |
| K033881 | Medrad Stellant CT Injector System with Imaging System Interface ModuleDXT · Special | Medrad, Inc. | 03/02/2004SE |
| K032920 | The Coeur Injector Adaptor/Pressure Jacket, Model C859-6003DXT · Traditional | Coeur Medical | 12/16/2003SE |
| K033247 | Medrad Spectris Solaris MR Injector SystemDXT · Special | Medrad, Inc. | 11/05/2003SE |
| K031483 | Medrad Manual Syringe LoaderDXT · Traditional | Medrad, Inc. | 08/01/2003SE |
| K031339 | OptibolusDXT · Special | Mallinckrodt Inc., Liebel-Flarsheim Business | 07/11/2003SE |
| K020892 | Acist Gentoo Contrast Injection SystemDXT · Abbreviated | Acist Medical Systems | 01/27/2003SE |
| K023183 | Medrad Stellant CT Injector SystemDXT · Special | Medrad, Inc. | 01/10/2003SE |
| K022116 | Elph Injection SystemDXT · Special | Mallinckrodt Inc., Liebel-Flarsheim Business | 07/26/2002SE |
| K020333 | Atrion Medical QL Fluid Dispensing SyringeDXT · Traditional | Atrion Medical Products, Inc. | 04/25/2002SE |
| K013815 | Medrad Qwik-Fit SyringeDXT · Special | Medrad, Inc. | 12/13/2001SE |
| K012950 | Modification to: Medrad Spectris Solaris MR Injector SystemDXT · Special | Medrad, Inc. | 10/04/2001SE |
| K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing SyringeDXT · Special | Merit Medical Systems, Inc. | 08/22/2001SE |
| K011991 | Modification to Medrad Spectris MR InjectorDXT · Special | Medrad, Inc. | 08/21/2001SE |
| K010390 | Acist Angiographic Injection System, Model R2000-CMSDXT · Special | Acist Medical Systems, Inc. | 03/09/2001SE |
| K001663 | Front-Load Polypropylene SyringeDXT · Traditional | Medrad, Inc. | 11/16/2000SE |
| K991103 | Modification to Acist CL 100HDXT · Traditional | Acist Medical Systems | 05/31/2000SE |
| K984231 | Angiographic Contrast Management System, Model Part a and Part BDXT · Traditional | Invasatec | 05/31/2000SE |
| K000013 | Acist Angiographic Injection System, Model R-2000DXT · Special | Acist Medical Systems | 03/28/2000SE |
| K983826 | 3S Injector-Ct Contrast Delivery SystemDXT · Traditional | Unimachs Corp. | 03/23/2000SE |
| K993774 | Acist Angiographic Injection System, Model CL1OOHDXT · Special | Acist Medical Systems | 12/07/1999SE |
| K984088 | Optistar MR Injector SystemDXT · Traditional | Mallinckrodt Inc., Liebel-Flarsheim Business | 12/06/1999SE |
| K993728 | Medrad Envision CT Injector SystemDXT · Special | Medrad, Inc. | 11/26/1999SE |
| K991557 | Medrad Vistron CT Injector SystemDXT · Special | Medrad, Inc. | 07/21/1999SE |
| K984418 | Universal Adjustable T-Rail Table BracketDXT · Traditional | Medrad, Inc. | 03/11/1999SE |
| K982814 | Medrad Vistron CT Injector SystemDXT · Special | Medrad, Inc. | 10/09/1998SE |
| K973334 | Oz Power SyringeDXT · Traditional | Cardiovascular Innovations | 04/03/1998SE |
| K963982 | Acist Angiographic InjectorDXT · Traditional | Invasatec | 12/05/1997SE |
| K973230 | Monarch (in 2125)/INTELLISYSTEM (in 1125)DXT · Traditional | Merit Medical Systems, Inc. | 11/25/1997SE |
| K971712 | Coeur 130 ML Angiographic SyringeDXT · Traditional | Coeur Laboratories, Inc. | 10/08/1997SE |
| K963071 | Angiomat IllumenaDXT · Traditional | Mallinckrodt Inc., Liebel-Flarsheim Business | 09/23/1997SE |
| K964642 | Medrad Disposable SyringesDXT · Traditional | Medrad, Inc. | 04/29/1997SE |
| K962141 | Volume Control Syringe Model VCD-SYR-10DXT · Traditional | B.Braun Medical, Inc. | 03/19/1997SE |
| K955685 | RNS Sterile, Disposable CT Biopsy TrayDXT · Traditional | Contour Fabricators of Florida, Inc. | 10/04/1996SE |
| K960674 | Contrast Injection LinesDXT · Traditional | B.Braun Medical, Inc. | 09/19/1996SE |
| K960965 | Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211DXT · Traditional | Coeur Laboratories, Inc. | 09/12/1996SE |
| K960430 | Control SyringeDXT · Traditional | Scientific Device Manufacturer, LLC | 08/06/1996SE |
| K955684 | RNS Sterile, Disposable Angiographic TrayDXT · Traditional | Contour Fabricators of Florida, Inc. | 05/02/1996SESK |
| K955381 | B. Braum Angiographic/Angioplasty KitDXT · Traditional | B.Braun Medical, Inc. | 02/21/1996SE |
| K935668 | Medrad Spectris MR InjectorDXT · Traditional | Medrad, Inc. | 09/25/1995SE |
| K951802 | Scimed Encore Advantage Kit and the Essentials KitDXT · Traditional | Scimed Life Systems, Inc. | 07/21/1995SE |
| K934086 | Medrad Envision CT Injector and Qwik Fit SyringeDXT · Traditional | Medrad, Inc. | 06/15/1995SE |
| K942381 | Low Pressure Injection Tubing, Coiled Line, Extension TubingDXT · Traditional | Apogee, Inc. | 03/17/1995SE |
| K944875 | Angiomat 3000, 6000, CT InjectorDXT · Traditional | Lievel-Flarsheim Co. | 01/04/1995SE |
| K933846 | Angiography Syringe KitsDXT · Traditional | Angiodynamics, Div. E-Z-Em, Inc. | 12/13/1994SE |
| K933908 | Medrad CT Custom Convenience KitDXT · Traditional | Medrad, Inc. | 02/25/1994SE |
| K932083 | XDCS-100DXT · Traditional | Microwave Medical Systems, Inc. | 12/16/1993SE |
| K923117 | Cavernosometry Module for MenuetDXT · Traditional | Dantec Medical, Inc. | 02/22/1993SE |
| K924116 | Medrad MCT, MCT Plus Injector/Medrad Front LoadDXT · Traditional | Medrad, Inc. | 01/21/1993SE |
| K913624 | Medrad Mct-Plus InjectorDXT · Traditional | Medrad, Inc. | 07/30/1992SE |
| K920135 | Medroyal Angiographic Control SyringeDXT · Traditional | Medroyal, Inc. | 07/24/1992SE |
| K912944 | CT 8000 Digital Injection SystemDXT · Traditional | Mallinckrodt Group, Inc. | 02/04/1992SE |
| K910594 | Trac-Wright System, Model TW2DXT · Traditional | Dow Corning Wright | 09/23/1991SE |
| K905819 | Medrad Varible Infusion InjectorDXT · Traditional | Medrad, Inc. | 09/16/1991SE |
| K911166 | Diagnostic Ultrasound/Uro-Gyn Ud 511DXT · Traditional | Diagnostic Ultrasound Corp. | 08/15/1991SE |
| K911549 | Injector Fill TubeDXT · Traditional | The R Group | 07/18/1991SE |
| K910873 | BD Angiographic Syringe W/A Rotating TipDXT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/29/1991SE |
| K904994 | Closed System Flush SetDXT · Traditional | Argon Medical Corp. | 01/15/1991SE |
| K902377 | Angeflator(Tm)DXT · Traditional | Angeion Corp. | 12/13/1990SE |
| K904212 | High-Pressure Connector TubeDXT · Traditional | Mallinckrodt Medical | 12/03/1990SE |
| K902475 | Cardio-Pak Angiography Custom PacksDXT · Traditional | Cardio-Pak | 12/03/1990SE |
| K903494 | Maintenace Flow - Accesory Device for CavropumpDXT · Traditional | Life-Tech Intl., Inc. | 10/17/1990SE |
| K903495 | Liquid DetectorDXT · Traditional | Life-Tech Intl., Inc. | 10/05/1990SE |
| K903390 | Medrad Mark V-Plus InjectorDXT · Traditional | Medrad, Inc. | 09/26/1990SE |
| K902221 | Modified Angiographic Injector and SyringeDXT · Traditional | Mallinckrodt Group, Inc. | 08/08/1990SE |
| K901382 | Isoflo(Tm) High Pressure Injection LinesDXT · Traditional | Healthdyne Cardiovascular, Inc. | 07/19/1990SE |
| K900034 | Angio-MaxDXT · Traditional | Accumed Systems, Inc. | 05/22/1990SE |
| K896415 | Usci Presto Disposable Inflation DeviceDXT · Traditional | C.R. Bard, Inc. | 01/19/1990SE |
| K895318 | B-D Angiographic Control SyringeDXT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/19/1990SE |
| K890292 | PCA-10, 10CC Disp. Angiography Control SyringeDXT · Traditional | Coeur Laboratories, Inc. | 06/22/1989SE |
| K890208 | High Pressure Connecting SetsDXT · Traditional | E-Z-Em, Inc. | 05/19/1989SE |
| K884913 | Merit Intelliflator(Tm) & Merit Monitor(Tm)DXT · Traditional | Merit Medical Systems, Inc. | 04/18/1989SE |
| K890898 | Model 611101 Contrast Injection DeviceDXT · Traditional | Medtronic Versaflex, Inc. | 04/12/1989SE |
| K883769 | Excel Inflate-AidDXT · Traditional | Medical Profiles, Inc. | 12/01/1988SE |
| K883452 | Acs Indeflator P/T 20DXT · Traditional | Advanced Cardiovascular Systems, Inc. | 10/14/1988SE |
| K882329 | L-F Coiled Extension TubingDXT · Traditional | Mallinckrodt Group, Inc. | 09/02/1988SE |
| K881521 | Modified Servo SyringeDXT · Traditional | Engineering, Inc. | 05/31/1988SE |
| K880877 | Contrast Injection DeviceDXT · Traditional | Med-West, Inc. | 05/31/1988SE |
| K880987 | Injector Handle with SyringeDXT · Traditional | Applied Vascular Devices, Inc. | 05/13/1988SE |
| K880493 | Medrad Microprocessor CT Injection SystemDXT · Traditional | Medrad, Inc. | 04/28/1988SE |
| K880310 | Angio Drape Pack ACP-010FMDXT · Traditional | Arrow Intl., Inc. | 04/22/1988SE |
| K875324 | Modified Schneider Shiley Inflation SyringesDXT · Traditional | Schneider-Shilley (Usa) | 03/25/1988SE |
| K873410 | Disposable Angiographic, Control SyringeDXT · Traditional | Blood Gas Supply Co. | 03/25/1988SE |
| K875196 | Disposable Coronary Control Syringe 12CCDXT · Traditional | Merit Medical Systems, Inc. | 02/11/1988SE |
| K873955 | Namic Angiographic SyringeDXT · Traditional | North American Instrument Corp. | 02/05/1988SE |
| K873173 | Medrad MRI Injection SystemDXT · Traditional | Medrad, Inc. | 02/05/1988SE |
| K873597 | Tubing, PolyethyleneDXT · Traditional | Coeur Laboratories, Inc. | 11/12/1987SE |
| K872981 | Acs Indeflator Plus (Modification #2)DXT · Traditional | Advanced Cardiovascular Systems, Inc. | 10/20/1987SE |
| K873687 | Angiomat CT InjectorDXT · Traditional | Mallinckrodt Group, Inc. | 10/09/1987SE |
| K872472 | Schneider-Shiley Biflator Balloon Inflation DeviceDXT · Traditional | Angiomedics, Inc. | 09/14/1987SE |
| K871129 | CavropumpDXT · Traditional | Life-Tech Intl., Inc. | 08/28/1987SE |
| K863596 | Chin-Fogarty Inflation DeviceDXT · Traditional | American Edwards Laboratories | 11/20/1986SE |
| K863537 | Cordis Reusable Inflation Device for AngioplastyDXT · Traditional | Cordis Corp. | 10/31/1986SE |
| K863037 | Usci (R) Disposable Inflation DeviceDXT · Traditional | C.R. Bard, Inc. | 09/23/1986SE |
| K862547 | Mechanical Inflation DeviceDXT · Traditional | American Edwards Laboratories | 09/03/1986SE |
| K860204 | Angiomat 6000DXT · Traditional | Mallinckrodt Group, Inc. | 05/02/1986SE |
| K860842 | AngiojectDXT · Traditional | Target Therapeutics | 04/23/1986SE |
| K850861 | Roentgenography Set & Pressure Monitoring LineDXT · Traditional | Medical Components, Inc. | 02/18/1986SE |
| K854310 | Acs Indeflator (Modification)DXT · Traditional | Advanced Cardiovascular Systems, Inc. | 12/04/1985SE |
| K841092 | High Pressure Flex. Connecting TubingDXT · Traditional | Tronomed, Inc. | 07/24/1985SE |
| K851402 | Leveen Inflator Disposable Inflation SyringeDXT · Traditional | Medi-Tech, Inc. | 06/10/1985SE |
| K844045 | Advanced Cardiovascular Systems AngiojectDXT · Traditional | Advanced Cardiovascular Systems, Inc. | 11/13/1984SE |
| K841493 | Model 1000 Apc-Angioplasty PressureDXT · Traditional | E.A. Fischione Instrument Mfg. | 06/11/1984SE |
| K840281 | Angiographic Drape PacksDXT · Traditional | Medrad, Inc. | 04/17/1984SE |
| K833645 | Contrast Media Inject. Set CMSDXT · Traditional | Gish Biomedical, Inc. | 04/17/1984SE |
| K834107 | Angioplasty Inflation Device & CartrDXT · Traditional | Cordis Corp. | 01/13/1984SE |
| K833138 | Digital Injector SysDXT · Traditional | Sybron Corp. | 11/14/1983SE |
| K830754 | Blood Pressure Monitoring Kits,WalrusDXT · Traditional | Medical Parameters, Inc. | 08/12/1983SE |
| K830609 | Inflation DeviceDXT · Traditional | Interventional Medical, Inc. | 03/24/1983SE |
| K823920 | Coeurlock Sterile Dispos. AngiographicDXT · Traditional | Coeur Laboratories, Inc. | 02/18/1983SE |
| K823340 | Clear Vinyl Monitoring ConnectorDXT · Traditional | Vertex Medical Corp. | 12/30/1982SE |
| K823256 | Ultra-Asept Angiographic Syringe/SpareDXT · Traditional | Vertex Medical Corp. | 12/30/1982SE |
| K823254 | Reusable Metal StopcockDXT · Traditional | Vertex Medical Corp. | 12/30/1982SE |
| K823253 | Vertex Monitoring CatheterDXT · Traditional | Vertex Medical Corp. | 12/30/1982SE |
| K823238 | Injection Fill TubeDXT · Traditional | Vetrex Medical Corp. | 12/30/1982SE |
| K823192 | Tuohy-Borst Adapter W/Side ArmDXT · Traditional | Vertex Medical Corp. | 12/30/1982SE |
| K823191 | Disposable Plastic StopcockDXT · Traditional | Vertex Medical Corp. | 12/30/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3147-2026 | MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog…Some devices may not have been properly sterilized due to a manufacturing sterilization issue. | Bayer Medical Care, Inc. | 07/31/2026Open, Classified |
| Z-2296-2026 Class II | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the…Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta… | Bayer Medical Care, Inc. | 04/24/2026Open, Classified |
| Z-1713-2026 Class I | NAMIC Angiographic Control Syringe, labeled as follows: 1.…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1712-2026 Class I | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1843-2026 Class II | Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-1833-2026 Class II | Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-1831-2026 Class II | Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2)…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-1830-2026 Class II | Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-0062-2025 Class II | Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Merit Medical Systems, Inc. | 08/30/2024Open, Classified |
| Z-0061-2025 Class II | Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Merit Medical Systems, Inc. | 08/30/2024Open, Classified |
| Z-0060-2025 Class II | Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Merit Medical Systems, Inc. | 08/30/2024Open, Classified |
| Z-0059-2025 Class II | Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Merit Medical Systems, Inc. | 08/30/2024Open, Classified |
| Z-0058-2025 Class II | Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Merit Medical Systems, Inc. | 08/30/2024Open, Classified |
| Z-0057-2025 Class II | Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe…Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Merit Medical Systems, Inc. | 08/30/2024Open, Classified |
| Z-0069-2025 Class II | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/BInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-0067-2025 Class II | IntelliSystem Inflation Device, REF: IN1525/DInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-0066-2025 Class II | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/AInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-0064-2025 Class II | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C…Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may… | Merit Medical Systems, Inc. | 08/19/2024Open, Classified |
| Z-3032-2024 Class II | Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-0135-2024 Class II | 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management…Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | B. Braun Medical, Inc. | 09/26/2023Open, Classified |
| Z-0131-2024 Class II | 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | B. Braun Medical, Inc. | 09/26/2023Open, Classified |
| Z-0199-2022 Class II | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made…Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go… | Bayer Medical Care, Inc. | 09/14/2021Terminated |
| Z-1529-2021 Class II | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product…The firm received a complaint regarding particulate found in the packaging foam that could contaminate the… | LeMaitre Vascular, Inc. | 04/06/2021Terminated |
| Z-0483-2021 Class II | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe…Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the… | Bayer Medical Care, Inc. | 10/05/2020Terminated |
| Z-0745-2019 Class II | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with…If the head mount knob is not properly tightened and the operator directly uses the injector head to move… | Bayer Medical Care, Inc. | 12/14/2018Terminated |
| Z-0654-2019 Class II | Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the…Insufficient seal on the sterile barrier of the device, compromising the sterility of the device | Bracco Injeneering S.A. | 11/12/2018Terminated |
| Z-2768-2016 Class II | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System…CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit… | Bayer Healthcare | 08/02/2016Terminated |
| Z-2244-2016 Class II | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD…Bayer Healthcare is initiating this recall due to complaints that were received from customer sites… | Bayer Healthcare | 06/09/2016Terminated |
| Z-0744-2016 Class II | ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU…Reports related to ingress of air into the manifold. | Acist Medical Systems | 12/21/2015Terminated |
| Z-2775-2015 Class II | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software…Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case… | Bayer Healthcare | 08/04/2015Terminated |
| Z-1686-2015 Class II | MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific…The root cause investigation showed that the under-volume hazard can occur when the unit has been configured… | Medrad Inc dba Bayer R&I | 09/20/2013Terminated |
| Z-1145-2013 Class II | ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be…ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated… | Acist Medical Systems | 03/15/2013Terminated |
| Z-0870-2013 Class II | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac…The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath… | Medrad Inc | 11/05/2012Terminated |
| Z-1123-2012 | Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | Mallinckrodt Inc | 02/10/2012Terminated |
| Z-1122-2012 | Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | Mallinckrodt Inc | 02/10/2012Terminated |
| Z-1121-2012 | Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | Mallinckrodt Inc | 02/10/2012Terminated |
| Z-1120-2012 | Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | Mallinckrodt Inc | 02/10/2012Terminated |
| Z-1119-2012 | Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | Mallinckrodt Inc | 02/10/2012Terminated |
| Z-1118-2012 | Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt…The machine used to package the product was missing a tool, which could prevent the packaging from sealing… | Mallinckrodt Inc | 02/10/2012Terminated |
| Z-0815-2012 | Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt…The firm received complaints from their customers stating that they found open seals on two of their… | Mallinckrodt Inc | 12/20/2011Terminated |
| Z-0147-2012 | Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865.…Packaging may exhibit open seals - sterility compromised | Medrad Inc | 10/24/2011Terminated |
| Z-2866-2011 | MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500…Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection… | Medrad Inc | 06/02/2011Terminated |
| Z-1954-2010 | Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPKKits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause… | Medrad Inc | 05/24/2010Terminated |
| Z-0367-2011 | MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes…Some kits have a hole in the packaging which could compromise the sterility of the components. | Medrad Inc | 05/17/2010Terminated |
| Z-2081-2012 Class II | The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10…A report was received from a Japanese distributor regarding a complaint from a hospital customer stating… | Mallinckrodt Inc | 02/01/2010Terminated |
| Z-1199-2010 | Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT)…The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging. | Medrad Inc | 01/06/2010Terminated |
| Z-0516-2010 | Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220Potential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |
| Z-0515-2010 | Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with…Potential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |
| Z-0514-2010 | Merit Advance Angiographic Needle label reading in part: MAJESTIK SERIES ANGIOGRAPHIC…Potential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |
| Z-0513-2010 | Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for…Potential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |