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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
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
K242479BLOOD 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