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 |
|---|---|---|---|
| Apr 1, 2015 | K142745 | 125mL CT Syringe Coeur, Inc. | DXT |
| Mar 26, 2015 | K150485 | AVERT Contrast Modulation System Osprey Medical, Inc. | DXT |
| Dec 12, 2014 | K142081 | CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES Osprey Medical, Inc. | DXT |
| Jul 28, 2014 | K140469 | MR SYRINGE DUAL PACK Coeur, Inc. | DXT |
| Jun 30, 2014 | K133189 | DUAL SHOT ALPHA 7 Nemoto Kyorindo Co., Ltd., JP | DXT |
| Jun 11, 2014 | K140425 | CONTRAST MODULATION SYSTEM Osprey Medical, Inc. | DXT |
| Apr 30, 2014 | K133600 | COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR Coeur, Inc. | DXT |
| Jan 23, 2014 | K132928 | MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE Medrad, Inc. / Bayer Medical Care, Inc. | DXT |
| Aug 15, 2013 | K131478 | CONTRAST CONSERVATION SYSTEM Osprey Medical, Inc. | DXT |
| Jun 10, 2013 | K120892 | DISPOSABLE 330PSI EXTENSION LINES Coeur, Inc. | DXT |
| Dec 15, 2011 | K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE Medrad, Inc. | DXT |
| Nov 28, 2011 | K113198 | NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML Navilyst Medical, Inc. | DXT |
| Oct 14, 2011 | K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE Medrad, Inc. | DXT |
| Mar 3, 2011 | K093830 | MEDLINE ANGIOGRAPHIC CONTROL SYRINGE Medline Industries, Inc. | DXT |
| Oct 29, 2010 | K092896 | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS Nemoto Kyorindo Co., Ltd., JP | DXT |
| Oct 19, 2009 | K090487 | DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 Coeur, Inc. | DXT |
| Jun 19, 2009 | K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 Flowcardia, Inc. | DXT |
| Mar 23, 2009 | K082439 | DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT Shandong Weigao Medical Polymer Co., Ltd., CN | DXT |
| Feb 4, 2009 | K083523 | MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc. | DXT |
| Jan 22, 2009 | K082212 | SYRINGE WITH HANDI-FIL Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Jan 12, 2009 | K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC Medrad, Inc. | DXT |
| May 7, 2008 | K073592 | OPTISTAR ELITE INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| May 2, 2008 | K072696 | ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 Shenzhen Ant Hi-Tech Industrial Co., Ltd., CN | DXT |
| Dec 21, 2007 | K072886 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T Medrad, Inc. | DXT |
| Dec 19, 2007 | K071691 | DUAL SHOT ALPHA Nemoto Kyorindo Co., Ltd. | DXT |
| Oct 4, 2007 | K070798 | ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS Coeur, Inc. | DXT |
| Sep 27, 2006 | K061976 | CKIS-004A INJECTOR SYNCHRONIZATION OPTION Toshiba America Medical Systems, In.C | DXT |
| Aug 18, 2006 | K062168 | CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA Nemoto Kyorindo Co., Ltd., JP | DXT |
| Dec 16, 2005 | K052744 | C2000 AUTOMATED MANIFOLD KIT Acist Medical Systems, Inc. | DXT |
| Nov 2, 2005 | K051799 | DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS Coeur, Inc. | DXT |
| Oct 17, 2005 | K052633 | DUAL SHOT - CONTRAST DELIVERY SYSTEM Nemoto Kyorindo Co., Ltd., JP | DXT |
| Jun 17, 2005 | K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Medrad, Inc. | DXT |
| Dec 10, 2004 | K042784 | MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM Medrad, Inc. | DXT |
| Nov 30, 2004 | K042744 | OPTIV ANTAGE DH POWER INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Mar 15, 2004 | K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS Acist Medical Systems, Inc. | DXT |
| Mar 2, 2004 | K033881 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE Medrad, Inc. | DXT |
| Dec 16, 2003 | K032920 | THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 Coeur Medical | DXT |
| Nov 5, 2003 | K033247 | MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM Medrad, Inc. | DXT |
| Aug 1, 2003 | K031483 | MEDRAD MANUAL SYRINGE LOADER Medrad, Inc. | DXT |
| Jul 11, 2003 | K031339 | OPTIBOLUS Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Jan 27, 2003 | K020892 | ACIST GENTOO CONTRAST INJECTION SYSTEM Acist Medical Systems | DXT |
| Jan 10, 2003 | K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc. | DXT |
| Jul 26, 2002 | K022116 | ELPH INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business | DXT |
| Apr 25, 2002 | K020333 | ATRION MEDICAL QL FLUID DISPENSING SYRINGE Atrion Medical Products, Inc. | DXT |
| Dec 13, 2001 | K013815 | MEDRAD QWIK-FIT SYRINGE Medrad, Inc. | DXT |
| Oct 4, 2001 | K012950 | MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM Medrad, Inc. | DXT |
| Aug 22, 2001 | K011811 | MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc. | DXT |
| Aug 21, 2001 | K011991 | MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR Medrad, Inc. | DXT |
| Mar 9, 2001 | K010390 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS Acist Medical Systems, Inc. | DXT |
| Nov 16, 2000 | K001663 | FRONT-LOAD POLYPROPYLENE SYRINGE Medrad, Inc. | DXT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.