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Baxter Healthcare Corporation

FDA 510(k) & PMA Approved Devices — 48 products

Total Devices48
Categories17
Latest Approval2025-12-16
TypeNumberDevice NameCodeDate
510(k) K251745 Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) DXQ 2025-12-16 View
510(k) K251636 Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) FRN 2025-07-28 View
510(k) K251640 SIGMA Spectrum Infusion Pump with Master Drug Library FRN 2025-07-28 View
510(k) K243529 Solution Administration Sets FPA 2025-03-14 View
510(k) K242339 Intravascular Extension Sets and Accessories FPA 2025-02-28 View
510(k) K242390 Novum IQ Syringe Pump (40800BAXUS) FRN 2024-09-05 View
510(k) K241564 Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS MQV 2024-08-02 View
510(k) K230665 Dose IQ Safety Software PHC 2024-03-29 View
510(k) K211122 Novum IQ Large Volume Pump FRN 2024-03-29 View
510(k) K232467 CleanCart A, CleanCart C, AK 98 Hemodialysis Machine KDI 2023-09-14 View
PMA P210036 Agent, absorbable hemostatic, non-collagen based LMG 2023-05-19 View
510(k) K230041 Spectrum IQ Infusion System with Dose IQ Safety Software FRN 2023-03-31 View
510(k) K230022 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library FRN 2023-03-31 View
510(k) K223175 lntravascular Administration Sets with Stopcock and Manifold FMG 2023-03-10 View
510(k) K220558 Blood Administration Sets BRZ 2022-11-17 View
510(k) K212262 PCA Syringe Sets FPA 2022-10-03 View
510(k) K222048 Spectrum IQ Infusion System with Dose IQ Safety Software FRN 2022-09-06 View
510(k) K211125 Novum IQ Syringe Pump FRN 2022-08-30 View
510(k) K211124 Dose IQ Safety Software PHC 2022-08-30 View
510(k) K220417 Spectrum IQ Infusion System with Dose IQ Safety Software FRN 2022-04-29 View
510(k) K212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set KDI 2022-04-01 View
510(k) K214016 15L Cycler Drainage Bag KDJ 2022-03-18 View
510(k) K213639 Revaclear 500, Revaclear 400, Revaclear 300 KDI 2022-01-24 View
510(k) K211649 PCEA Syringe Set PWH 2021-11-23 View
510(k) K211035 U9000 Plus Ultrafilter FIP 2021-10-19 View
510(k) K203609 Intravascular Administration Sets FPA 2021-09-30 View
510(k) K210430 Intravascular Extension Set FPA 2021-06-18 View
510(k) K210335 Blood Administration Set BRZ 2021-06-10 View
510(k) K201867 Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System FKX 2020-11-19 View
510(k) DEN190042 Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer QAX 2020-08-28 View
510(k) K192366 Intravascular Extension Sets and Accessories FPA 2020-07-20 View
510(k) K201464 Altapore MIS MQV 2020-06-30 View
510(k) K200640 ALTAPORE SHAPE MQV 2020-05-08 View
510(k) K193482 PrisMax System Version 3 KDI 2020-03-13 View
510(k) K192363 Altapore MQV 2020-01-09 View
510(k) K191513 Altapore Shape MQV 2019-10-19 View
510(k) K180739 Clearlink System Solution Set FPA 2019-05-28 View
510(k) K181225 ALTAPORE MQV 2018-08-31 View
510(k) K181306 Actifuse Flow MQV 2018-08-17 View
510(k) K173084 Spectrum IQ Infusion System, Dose IQ Safety Software FRN 2018-05-11 View
510(k) K171671 Prismaflex System 8.10 KDI 2018-02-23 View
PMA P100030 Sealant, polymerizing NBE 2017-12-21 View
510(k) K172544 IV Fat Emulsion Administration Sets FPA 2017-09-22 View
510(k) K161808 Solution Set with 1.2 Micron Air Eliminating Filter FPA 2017-06-21 View
510(k) K162887 PrismaSATE KPO 2017-01-06 View
510(k) K160007 Paclitaxel Sets FPA 2016-12-19 View
510(k) K161323 Solution Set for Epidural Use FPA 2016-11-30 View
PMA P950034 Barrier, absorbable, adhesion MCN 2016-11-14 View
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