Renal Systems, Inc. - FDA 510(k) Cleared Devices
35
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Renal Systems, Inc. Gastroenterology & Urology ✕
34 devices
Cleared
Jan 05, 1998
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
Gastroenterology & Urology
319d
Cleared
Jun 09, 1987
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
Gastroenterology & Urology
399d
Cleared
Nov 05, 1985
RENALFO HEMOFILTER CAVHD
Gastroenterology & Urology
36d
Cleared
May 23, 1985
RENAFLO HEMOCONCENTRATOR
Gastroenterology & Urology
164d
Cleared
Jan 07, 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
Gastroenterology & Urology
88d
Cleared
Jan 07, 1985
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
Gastroenterology & Urology
76d
Cleared
Jul 06, 1984
RENATRON
Gastroenterology & Urology
29d
Cleared
May 22, 1984
CONCENTRATE CONDUCTIVITY METER
Gastroenterology & Urology
36d
Cleared
May 02, 1984
RENAPAK CONCENTRATE MIXING SYS.
Gastroenterology & Urology
106d
Cleared
Feb 21, 1984
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT
Gastroenterology & Urology
20d
Cleared
Feb 21, 1984
HEMASITE ACCESSORIES MODIFICATION
Gastroenterology & Urology
20d
Cleared
Feb 04, 1984
RENAFLO AVF SET FOR HEMODIALYSIS
Gastroenterology & Urology
45d