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Baxter Healthcare Corporation

FDA 510(k) & PMA Approved Devices — 47 products

Total Devices47
Categories16
Latest FDA decision2026-08-07
TypeNumberDevice NameCodeDateActions
510(k) K211124 Dose IQ Safety SoftwarePHC2022-08-30 View
510(k) K220417 Spectrum IQ Infusion System with Dose IQ Safety SoftwareFRN2022-04-29 View
510(k) K212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setKDI2022-04-01 View
510(k) K214016 15L Cycler Drainage BagKDJ2022-03-18 View
510(k) K213639 Revaclear 500, Revaclear 400, Revaclear 300KDI2022-01-24 View
510(k) K211649 PCEA Syringe SetPWH2021-11-23 View
510(k) K211035 U9000 Plus UltrafilterFIP2021-10-19 View
510(k) K203609 Intravascular Administration SetsFPA2021-09-30 View
510(k) K210430 Intravascular Extension SetFPA2021-06-18 View
510(k) K210335 Blood Administration SetBRZ2021-06-10 View
510(k) K201867 Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemFKX2020-11-19 View
510(k) K192366 Intravascular Extension Sets and AccessoriesFPA2020-07-20 View
510(k) K201464 Altapore MISMQV2020-06-30 View
510(k) K200640 ALTAPORE SHAPEMQV2020-05-08 View
510(k) K193482 PrisMax System Version 3KDI2020-03-13 View
510(k) K192363 AltaporeMQV2020-01-09 View
510(k) K191513 Altapore ShapeMQV2019-10-19 View
510(k) K180739 Clearlink System Solution SetFPA2019-05-28 View
510(k) K181225 ALTAPOREMQV2018-08-31 View
510(k) K181306 Actifuse FlowMQV2018-08-17 View

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