NIKKISO CO., LTD. - FDA 510(k) Cleared Devices

Cleared May 15, 2025

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

K242155 · KDI

Gastroenterology & Urology · 296d

Cleared May 15, 2025

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...

K242176 · KOC

Gastroenterology & Urology · 295d

Cleared May 15, 2025

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...

K242479 · KOC

Gastroenterology & Urology · 267d

Cleared Jul 28, 2023

Blood Tubing Lines for Hemodialysis AV06C-E

K231589 · KOC

Gastroenterology & Urology · 57d

Cleared Jun 16, 2023

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines...

K230514 · KOC

Gastroenterology & Urology · 112d

Cleared Mar 18, 2016

DBB-06 Hemodialysis Delivery System

K152938 · KDI

Gastroenterology & Urology · 165d

Cleared Mar 25, 2010

DBB-06 HEMODIALYSIS DELIVERY SYSTEM

K091978 · KDI

Gastroenterology & Urology · 267d

Cleared Mar 30, 2009

NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P,...

K082719 · KOC

Gastroenterology & Urology · 194d

Cleared Sep 28, 2007

MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM

K061519 · KDI

Gastroenterology & Urology · 484d

Cleared Mar 19, 1997

NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS

K953996 · KDI

Gastroenterology & Urology · 573d

Cleared Mar 04, 1981

NIKKISO ND-14 PARALLEL FLOW DIALYZER

K803068 · FJG

Gastroenterology & Urology · 90d