Baxter Healthcare Corporation - FDA 510(k) Cleared Devices

Cleared Sep 14, 2023

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

K232467 · KDI

Gastroenterology & Urology · 30d

Cleared Apr 01, 2022

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

K212216 · KDI

Gastroenterology & Urology · 259d

Cleared Mar 18, 2022

15L Cycler Drainage Bag

K214016 · KDJ

Gastroenterology & Urology · 86d

Cleared Jan 24, 2022

Revaclear 500, Revaclear 400, Revaclear 300

K213639 · KDI

Gastroenterology & Urology · 67d

Cleared Oct 19, 2021

U9000 Plus Ultrafilter

K211035 · FIP

Gastroenterology & Urology · 195d

Cleared Nov 19, 2020

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with...

K201867 · FKX

Gastroenterology & Urology · 135d

Not Cleared Aug 28, 2020

Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

DEN190042 · QAX

Gastroenterology & Urology · 347d

Cleared Mar 13, 2020

PrisMax System Version 3

K193482 · KDI

Gastroenterology & Urology · 87d

Cleared Feb 23, 2018

Prismaflex System 8.10

K171671 · KDI

Gastroenterology & Urology · 262d

Cleared Jan 06, 2017

PrismaSATE

K162887 · KPO

Gastroenterology & Urology · 81d

Cleared Oct 29, 2015

FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with...

K152129 · KDJ

Gastroenterology & Urology · 90d

Cleared Feb 20, 2009

XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210

K083778 · KDI

Gastroenterology & Urology · 63d