Medical Device Manufacturer · US , Lexington , KY

Nipro Medical Corporation - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 2005
33
Total
33
Cleared
0
Denied

FDA 510(k) cleared devices by Nipro Medical Corporation Gastroenterology & Urology ✕

14 devices
1-12 of 14
Cleared Mar 19, 2026
ELISIO™-H
K260533 · KDI
Gastroenterology & Urology · 30d
Cleared Jul 19, 2019
Surdial DX Hemodialysis System
K182940 · KDI
Gastroenterology & Urology · 269d
Cleared Feb 08, 2017
FB-U Hemodialyzer
K160444 · KDI
Gastroenterology & Urology · 357d
Cleared Apr 14, 2014
ELISIO-H HEMODIALYZER
K140191 · KDI
Gastroenterology & Urology · 77d
Cleared Dec 20, 2013
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
K131935 · KDI
Gastroenterology & Urology · 176d
Cleared Dec 19, 2013
ELISIO-H HEMODIALYZER
K131381 · KDI
Gastroenterology & Urology · 219d
Cleared Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
K122952 · FJI
Gastroenterology & Urology · 435d
Cleared May 07, 2013
PUREFLUX-H HEMODIALYZER
K122343 · KDI
Gastroenterology & Urology · 277d
Cleared May 01, 2013
ELISIO-H AND ELISIO-M HEMODIALYZERS
K122347 · KDI
Gastroenterology & Urology · 271d
Cleared Sep 28, 2012
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · FJK
Gastroenterology & Urology · 385d
Cleared Mar 17, 2010
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K100520 · FIE
Gastroenterology & Urology · 22d
Cleared Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K072988 · FIB
Gastroenterology & Urology · 121d
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