12 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
FDA Enforcement
Class II
·Ongoing·Vantive US Healthcare LLC·November 5, 2025
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·September 3, 2025
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·September 3, 2025
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·September 3, 2025