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VANTIVE US HEALTHCARE LLC

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Withou recall (Z-1224-2026)VANTIVE US HEALTHCARE LLC2026-02-02
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Withou recall (Z-1225-2026)VANTIVE US HEALTHCARE LLC2026-02-02
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialys recall (Z-1226-2026)VANTIVE US HEALTHCARE LLC2026-02-02
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Seal recall (Z-1227-2026)VANTIVE US HEALTHCARE LLC2026-02-02
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Seal recall (Z-1228-2026)VANTIVE US HEALTHCARE LLC2026-02-02
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Se recall (Z-1229-2026)VANTIVE US HEALTHCARE LLC2026-02-02
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Se recall (Z-1230-2026)VANTIVE US HEALTHCARE LLC2026-02-02
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without S recall (Z-1231-2026)VANTIVE US HEALTHCARE LLC2026-02-02
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 softw recall (Z-0409-2026)Vantive US Healthcare LLC2025-10-29
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 recall (Z-2437-2025)VANTIVE US HEALTHCARE LLC2025-08-26
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 recall (Z-2438-2025)VANTIVE US HEALTHCARE LLC2025-08-26
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 95 recall (Z-2439-2025)VANTIVE US HEALTHCARE LLC2025-08-26

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Every clearance here is in the API, with alerts when new ones post.