Home / Companies / NIKKISO CO., LTD.

NIKKISO CO., LTD.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 SerMay 15, 2025
K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)May 15, 2025
K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 SerMay 15, 2025
K231589Blood Tubing Lines for Hemodialysis AV06C-EJuly 28, 2023
K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeJune 16, 2023
K152938DBB-06 Hemodialysis Delivery SystemMarch 18, 2016
K091978DBB-06 HEMODIALYSIS DELIVERY SYSTEMMarch 25, 2010
K082719NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-PMarch 30, 2009
K061519MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEMSeptember 28, 2007
K953996NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERSMarch 19, 1997
K803068NIKKISO ND-14 PARALLEL FLOW DIALYZERMarch 4, 1981