Baxter Healthcare Corp - FDA 510(k) Cleared Devices
505
Total
496
Cleared
0
Denied
87 devices
Cleared
Jul 25, 2019
PrisMax System Version 2
Gastroenterology & Urology
108d
Cleared
May 03, 2017
PrisMax Control Unit
Gastroenterology & Urology
138d
Cleared
Mar 30, 2011
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS...
Gastroenterology & Urology
177d
Cleared
Aug 07, 2009
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X...
Gastroenterology & Urology
217d
Cleared
Sep 11, 2006
RENALSOFT
Gastroenterology & Urology
102d
Cleared
Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS...
Gastroenterology & Urology
62d
Cleared
Aug 27, 2004
ACCUSOL DIALYSIS SOLUTION
Gastroenterology & Urology
91d
Cleared
Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q,...
Gastroenterology & Urology
174d
Cleared
Jun 17, 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
Gastroenterology & Urology
158d
Cleared
Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
Gastroenterology & Urology
28d
Cleared
Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
Gastroenterology & Urology
28d
Cleared
Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
Gastroenterology & Urology
113d
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