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
FDA 510(k) Regulatory Record - NIKKISO CO., LTD. Gastroenterology & Urology ✕
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