Medical Device Manufacturer · US , Round Lake , IL

Baxter Healthcare Corporation - FDA 510(k) Cleared Devices

61 submissions · 60 cleared · Since 2004

61

Total

60

Cleared

1

Denied

FDA 510(k) Regulatory Record - Baxter Healthcare Corporation General Hospital ✕

38 devices

1-12 of 38

Cleared Jul 28, 2025

Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

General Hospital · 60d

Cleared Jul 28, 2025

SIGMA Spectrum Infusion Pump with Master Drug Library

General Hospital · 60d

Cleared Mar 14, 2025

Solution Administration Sets

General Hospital · 120d

Cleared Feb 28, 2025

Intravascular Extension Sets and Accessories

General Hospital · 205d

Cleared Sep 05, 2024

Novum IQ Syringe Pump (40800BAXUS)

General Hospital · 24d

Cleared Mar 29, 2024

Novum IQ Large Volume Pump

General Hospital · 1079d

Cleared Mar 29, 2024

Dose IQ Safety Software

General Hospital · 385d

Cleared Mar 31, 2023

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

General Hospital · 86d

Cleared Mar 31, 2023

Spectrum IQ Infusion System with Dose IQ Safety Software

General Hospital · 84d

Cleared Mar 10, 2023

lntravascular Administration Sets with Stopcock and Manifold

General Hospital · 150d

Cleared Nov 17, 2022

Blood Administration Sets

General Hospital · 262d

Cleared Oct 03, 2022

PCA Syringe Sets

General Hospital · 440d

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