FDA 510(k) Applications Submitted by LISA A EWING
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060401 |
02/15/2006 |
MEDRAD 3.0T ECOIL IMAGING SYSTEM |
MEDRAD, INC. |
| K051349 |
05/24/2005 |
3.0T PROSTATE IMAGING SYSTEM |
MEDRAD, INC. |
| K131517 |
05/28/2013 |
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING |
MEDRAD, INC. / BAYER MEDICAL CARE, INC. |
| K132928 |
09/18/2013 |
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE |
MEDRAD, INC. / BAYER MEDICAL CARE, INC. |
| K052827 |
10/05/2005 |
MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS |
MEDRAD, INC. |
| K053042 |
10/28/2005 |
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE |
MEDRAD, INC. |
| K063342 |
11/06/2006 |
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS |
MEDRAD, INC. |
| K173773 |
12/12/2017 |
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T |
Bayer Medical Care Inc. |
| K182273 |
08/22/2018 |
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T |
Bayer Medical Care Inc. |
| K143538 |
12/15/2014 |
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit |
BAYER MEDICAL CARE INC. |
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