Medical Device Manufacturer · US , Elkton , MD

Terumo Medical Corp. - FDA 510(k) Cleared Devices

143 submissions · 143 cleared · Since 1980
143
Total
143
Cleared
0
Denied

FDA 510(k) Regulatory Record - Terumo Medical Corp. Gastroenterology & Urology

18 devices
1-18 of 18
Cleared Nov 20, 2001
CLIRANS E-SERIES DIALYZER
K013550 · KDI
Gastroenterology & Urology · 27d
Cleared Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · KDI
Gastroenterology & Urology · 90d
Cleared Jan 30, 1998
CAPIOX HEMOCONCENTRATOR
K973516 · KDI
Gastroenterology & Urology · 135d
Cleared Dec 19, 1997
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · FJI
Gastroenterology & Urology · 296d
Cleared Aug 15, 1997
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K971937 · OCY
Gastroenterology & Urology · 80d
Cleared Mar 06, 1995
CLIRANS WET PACK HOLLOW FIBER DIALYZER
K930503 · FJI
Gastroenterology & Urology · 763d
Cleared Oct 02, 1992
RADIFOCUS GUIDE WIRE M
K923607 · KOD
Gastroenterology & Urology · 78d
Cleared Aug 07, 1991
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
K910558 · FJK
Gastroenterology & Urology · 180d
Cleared Jun 22, 1989
TERUMO AV FISTULA NEEDLE SET
K891062 · FIE
Gastroenterology & Urology · 113d
Cleared Jun 09, 1989
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477 · FJI
Gastroenterology & Urology · 85d
Cleared Dec 13, 1985
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280 · FJI
Gastroenterology & Urology · 51d
Cleared Dec 08, 1983
CLIRANS MODEL TAF 15 HOLLOW FIBER
K833503 · KOC
Gastroenterology & Urology · 64d
Cleared Aug 26, 1983
CLIRANS TAF06 HOLLOW FIBER DIALYZER
K832252 · KOC
Gastroenterology & Urology · 46d
Cleared Jun 03, 1983
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &
K831482 · KOC
Gastroenterology & Urology · 25d
Cleared Jul 08, 1982
CLIRANS HOLLOW FIBER DIALYZERS
K820524 · FJI
Gastroenterology & Urology · 132d
Cleared Jun 23, 1982
HOLLOW FIBER DIALYZERS
K820743 · FJI
Gastroenterology & Urology · 96d
Cleared Apr 16, 1982
COAXIAL DUAL FLOW CATHETER
K820859 · LBW
Gastroenterology & Urology · 18d
Cleared Sep 29, 1981
CLIRANS TE12 HOLLOW FIBER DIALYZER
K812498 · KOC
Gastroenterology & Urology · 29d
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