2 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
FDA Enforcement
Class II
·Terminated·Rockwell Medical, Inc·May 23, 2018
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 23, 2025