Baxter Healthcare Corporation - FDA 510(k) Cleared Devices
61
Total
60
Cleared
1
Denied
FDA 510(k) cleared devices by 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