Baxter Healthcare Corporation
FDA 510(k) & PMA Approved Devices — 47 products
Total Devices47
Categories16
Latest FDA decision2026-08-07
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 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) | 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 |
No matching devices.
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