FDA 510(k) Applications Submitted by MELANIE HESS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060036 |
01/05/2006 |
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER |
SMITHS MEDICAL MD, INC. |
| K190102 |
01/22/2019 |
DyeVertÖ Plus Contrast Reduction System, DyeTectÖ Contrast Monitoring System, DyeVertÖ Plus EZ Contrast Reduction System |
Osprey Medical Inc. |
| K150485 |
02/24/2015 |
AVERT Contrast Modulation System |
Osprey Medical, Inc. |
| K171217 |
04/26/2017 |
DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System |
Osprey Medical, Inc. |
| K151300 |
05/15/2015 |
AVERT Contrast Modulation System |
OSPREY MEDICAL, INC. |
| K161505 |
06/01/2016 |
DyeVert NG Contrast Modulation System |
OSPREY MEDICAL, INC. |
| K171698 |
06/08/2017 |
Smart Syringe |
Osprey Medical, Inc. |
| K051568 |
06/14/2005 |
CADD-MS 3 AMBULATORY INFUSION PUMP |
SMITHS MEDICAL MD, INC. |
| K151746 |
06/29/2015 |
Dyevert Contrast Modulation System |
OSPREY MEDICAL, INC. |
| K142081 |
07/31/2014 |
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES |
OSPREY MEDICAL, INC. |
| K152218 |
08/07/2015 |
AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System |
Osprey Medical |
| K062592 |
09/01/2006 |
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE |
SMITHS MEDICAL MD, INC. |
| K153141 |
10/30/2015 |
DyeVert Contrast Modulation System |
OSPREY MEDICAL, INC. |
| K163054 |
11/01/2016 |
DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System |
OSPREY MEDICAL, INC. |
| K183267 |
11/23/2018 |
DyeVertÖ NG Contrast Reduction System, DyeVertÖ PLUS EZ Contrast Reduction System, DyeTectÖ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVertÖ PLUS EZ Contrast Reduction System |
Osprey Medical, Inc. |
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