Nipro Medical Corporation - FDA 510(k) Cleared Devices
Recent clearances: ELISIO™-HX, PRESSONE™, ELISIO™-H
35
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nipro Medical Corporation Gastroenterology & Urology ✕
15 devices
Cleared
CT
Jul 28, 2026
ELISIO™-HX
Gastroenterology & Urology
90d
Cleared
Mar 19, 2026
ELISIO™-H
Gastroenterology & Urology
30d
Cleared
Jul 19, 2019
Surdial DX Hemodialysis System
Gastroenterology & Urology
269d
Cleared
Feb 08, 2017
FB-U Hemodialyzer
Gastroenterology & Urology
357d
Cleared
Apr 14, 2014
ELISIO-H HEMODIALYZER
Gastroenterology & Urology
77d
Cleared
Dec 20, 2013
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
Gastroenterology & Urology
176d
Cleared
Dec 19, 2013
ELISIO-H HEMODIALYZER
Gastroenterology & Urology
219d
Cleared
Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
Gastroenterology & Urology
435d
Cleared
May 07, 2013
PUREFLUX-H HEMODIALYZER
Gastroenterology & Urology
277d
Cleared
May 01, 2013
ELISIO-H AND ELISIO-M HEMODIALYZERS
Gastroenterology & Urology
271d
Cleared
Sep 28, 2012
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
Gastroenterology & Urology
385d
Cleared
Mar 17, 2010
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
Gastroenterology & Urology
22d
Cleared
Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
Gastroenterology & Urology
121d
Cleared
Sep 07, 2007
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
Gastroenterology & Urology
136d
Cleared
Feb 28, 2006
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
Gastroenterology & Urology
54d