Baxter Healthcare Corporation - FDA 510(k) Cleared Devices
Recent clearances: Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs), Spectrum IQ Infusion System with Dose IQ Safety Software (3570009), SIGMA Spectrum Infusion Pump with Master Drug Library
61
Total
60
Cleared
1
Denied
FDA 510(k) Regulatory Record - Baxter Healthcare Corporation Gastroenterology & Urology ✕
14 devices
Cleared
Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
Gastroenterology & Urology
30d
Cleared
Apr 01, 2022
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
Gastroenterology & Urology
259d
Cleared
Mar 18, 2022
15L Cycler Drainage Bag
Gastroenterology & Urology
86d
Cleared
Jan 24, 2022
Revaclear 500, Revaclear 400, Revaclear 300
Gastroenterology & Urology
67d
Cleared
Oct 19, 2021
U9000 Plus Ultrafilter
Gastroenterology & Urology
195d
Cleared
Nov 19, 2020
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...
Gastroenterology & Urology
135d
Not Cleared
Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Gastroenterology & Urology
347d
Cleared
Mar 13, 2020
PrisMax System Version 3
Gastroenterology & Urology
87d
Cleared
Feb 23, 2018
Prismaflex System 8.10
Gastroenterology & Urology
262d
Cleared
Jan 06, 2017
PrismaSATE
Gastroenterology & Urology
81d
Cleared
Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with...
Gastroenterology & Urology
90d
Cleared
Feb 20, 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
Gastroenterology & Urology
63d
Cleared
Oct 19, 2006
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
Gastroenterology & Urology
90d
Cleared
May 24, 2006
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
Gastroenterology & Urology
155d