5 results
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34ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
FDA Enforcement
Class II
·Terminated·Isopure Corp·January 29, 2020
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022