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Baxter Healthcare Corporation FDA Approvals

0 new drug approvals and 27 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)510(k)Dec 16, 2025Cardiovascular
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)510(k)Jul 28, 2025General Hospital
SIGMA Spectrum Infusion Pump with Master Drug Library510(k)Jul 28, 2025General Hospital
Solution Administration Sets510(k)Mar 14, 2025General Hospital
Intravascular Extension Sets and Accessories510(k)Feb 28, 2025General Hospital
Novum IQ Syringe Pump (40800BAXUS)510(k)Sep 5, 2024General Hospital
Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS510(k)Aug 2, 2024Orthopedic
Dose IQ Safety Software510(k)Mar 29, 2024General Hospital
Novum IQ Large Volume Pump510(k)Mar 29, 2024General Hospital
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine510(k)Sep 14, 2023Gastroenterology, Urology
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library510(k)Mar 31, 2023General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software510(k)Mar 31, 2023General Hospital
lntravascular Administration Sets with Stopcock and Manifold510(k)Mar 10, 2023General Hospital
Blood Administration Sets510(k)Nov 17, 2022General Hospital
PCA Syringe Sets510(k)Oct 3, 2022General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software510(k)Sep 6, 2022General Hospital
Dose IQ Safety Software510(k)Aug 30, 2022General Hospital
Novum IQ Syringe Pump510(k)Aug 30, 2022General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software510(k)Apr 29, 2022General Hospital
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set510(k)Apr 1, 2022Gastroenterology, Urology
15L Cycler Drainage Bag510(k)Mar 18, 2022Gastroenterology, Urology
Revaclear 500, Revaclear 400, Revaclear 300510(k)Jan 24, 2022Gastroenterology, Urology
PCEA Syringe Set510(k)Nov 23, 2021General Hospital
U9000 Plus Ultrafilter510(k)Oct 19, 2021Gastroenterology, Urology
Intravascular Administration Sets510(k)Sep 30, 2021General Hospital
Intravascular Extension Set510(k)Jun 18, 2021General Hospital
Blood Administration Set510(k)Jun 10, 2021General Hospital

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