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Sources: EU EUDAMED, US FDA
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Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Enforcement
Class I
·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 [323], MD BD Pyxis SupplyStation V9 [317], Security Module [139698-01], BD Knowledge Portal for Medication Technologies [136607-01], STOCKSTN V10.X WRD/WL SCANNERS [132-53-02], PRS STOCKSTN V10.X WRD/WL SCANNERS [132-53-01], STOCKSTN V10.X WIRED SCANNER [132-52-02], PRS STOCKSTN V10.X WIRED SCANNER [132-52-01], BD Pyxis CII Safe ES Desktop PC [1156-00], BD Pyxis SupplyStation Panel PC V11 [1132-00], BD Pyxis SupplyRoller V11 [1127-00], Dell 640 Server [1128-00], BD Pyxis SupplyStation System V11 [1123-00], BD Pyxis CII Safe ES 10885403512605 [1116-00], BD Pyxis Enterprise Server 10885403518348, 10885403520341 [1115-00], BD Pyxis SupplyRoller V10 [1101-00], BD Pyxis CIISafe V9.X SGL IM BIO 10885403512520 [111-221], BD Pyxis CIISafe V7.X DBL INTG MAIN BIO, SOLID DO [111-194], BD Pyxis CIISafe V8.X Desktop PC, Bio [107-245-01], BD Pyxis SupplyStation V10 [347], BD Pyxis CII Safe V9.X DESKTOP PC [107-252-01], BD Pyxis CII Safe V7.X DBL INTG MAIN BIO CLEAR DO [111-191], BD Pyxis CII Safe V7.XSGL INTG MAIN BIO SOLID DO [111-198], BD Pyxis CII SafeV8.XDBL INTG MAIN BIO SOLID DO [111-202-01], BD Pyxis CII SafeV8.XSGL INTG MAIN BIO SOLID DO [111-206-01], BD Pyxis CII Safe V9.X DBL IM BIO SLD DOORS [111-215], BD Pyxis CII Safe V9.X SGL IM BIO CLR DOORS [111-216], BD Pyxis CII Safe V9.X DBL IM BIO CLR DOORS [111-219], Supply itParActive RF V11 (Supply Kanban) [138566-01]
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·July 2, 2025