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Osprey Medical, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories1
Latest FDA decision2019-10-17
TypeNumberDevice NameCodeDateActions
510(k) K190102 DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction SystemDXT2019-10-17 View
510(k) K183267 DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction SystemDXT2018-12-20 View
510(k) K181936 DyeVert PLUS EZ Contrast Reduction SystemDXT2018-10-25 View
510(k) K171698 Smart SyringeDXT2017-07-07 View
510(k) K171217 DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemDXT2017-05-26 View
510(k) K163054 DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemDXT2017-03-08 View
510(k) K161505 DyeVert NG Contrast Modulation SystemDXT2016-08-03 View
510(k) K153141 DyeVert Contrast Modulation SystemDXT2016-02-04 View