Nipro Medical Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nipro Medical Corporation - FDA 510(k) Cleared Devices
Recent clearances: ELISIO™-HX, PRESSONE™, ELISIO™-H
35
Total
35
Cleared
0
Denied
Nipro Medical Corporation has 35 FDA 510(k) cleared medical devices. Based in Lexington, US.
Latest FDA clearance: Jul 2026. Active since 2005. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Nipro Medical Corporation Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Nipro Medical Corporation
35 devices
Cleared
CT
Jul 28, 2026
ELISIO™-HX
Gastroenterology & Urology
90d
Cleared
Mar 24, 2026
PRESSONE™
General Hospital
183d
Cleared
Mar 19, 2026
ELISIO™-H
Gastroenterology & Urology
30d
Cleared
May 25, 2023
Nipro SafeTouch Needle
General Hospital
246d
Cleared
Apr 15, 2022
aboNT SYRINGE
General Hospital
234d
Cleared
Oct 24, 2019
Cronus HP PTA Balloon Catheter
Cardiovascular
289d
Cleared
Oct 09, 2019
Nipro Syringe
General Hospital
141d
Cleared
Jul 19, 2019
Surdial DX Hemodialysis System
Gastroenterology & Urology
269d
Cleared
Mar 30, 2018
Nipro Syringe
General Hospital
183d
Cleared
Mar 08, 2017
Nipro SafeTouch IV Catheter
General Hospital
264d
Cleared
Feb 08, 2017
FB-U Hemodialyzer
Gastroenterology & Urology
357d
Cleared
Jan 14, 2016
Cronus HP - High Pressure Peripheral Balloon Catheter
Cardiovascular
260d