NIKKISO CO., LTD. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
NIKKISO CO., LTD. - FDA 510(k) Cleared Devices
Recent clearances: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO), BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U), BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
11
Total
11
Cleared
0
Denied
NIKKISO CO., LTD. has 11 FDA 510(k) cleared gastroenterology & urology devices. Based in Mchenry, US.
Latest FDA clearance: May 2025. Active since 1981.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Mic International and Healthcare Innovation Catalysts, Inc..
FDA 510(k) Regulatory Record - NIKKISO CO., LTD.
11 devices
Cleared
May 15, 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
Gastroenterology & Urology
296d
Cleared
May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
Gastroenterology & Urology
295d
Cleared
May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
Gastroenterology & Urology
267d
Cleared
Jul 28, 2023
Blood Tubing Lines for Hemodialysis AV06C-E
Gastroenterology & Urology
57d
Cleared
Jun 16, 2023
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines...
Gastroenterology & Urology
112d
Cleared
Mar 18, 2016
DBB-06 Hemodialysis Delivery System
Gastroenterology & Urology
165d
Cleared
Mar 25, 2010
DBB-06 HEMODIALYSIS DELIVERY SYSTEM
Gastroenterology & Urology
267d
Cleared
Mar 30, 2009
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P,...
Gastroenterology & Urology
194d
Cleared
Sep 28, 2007
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
Gastroenterology & Urology
484d
Cleared
Mar 19, 1997
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
Gastroenterology & Urology
573d
Cleared
Mar 04, 1981
NIKKISO ND-14 PARALLEL FLOW DIALYZER
Gastroenterology & Urology
90d