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Osprey Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ ContrOctober 17, 2019
K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ ContrastDecember 20, 2018
K181936DyeVert PLUS EZ Contrast Reduction SystemOctober 25, 2018
K171698Smart SyringeJuly 7, 2017
K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemMay 26, 2017
K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemMarch 8, 2017
K161505DyeVert NG Contrast Modulation SystemAugust 3, 2016
K153141DyeVert Contrast Modulation SystemFebruary 4, 2016
K151300AVERT Contrast Modulation SystemOctober 15, 2015
K151746Dyevert Contrast Modulation SystemOctober 9, 2015
K152218AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation SystemSeptember 21, 2015
K150485AVERT Contrast Modulation SystemMarch 26, 2015
K142081CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGESDecember 12, 2014
K140425CONTRAST MODULATION SYSTEMJune 11, 2014
K131478CONTRAST CONSERVATION SYSTEMAugust 15, 2013