Terumo America, Inc. - FDA 510(k) Cleared Devices
31
Total
31
Cleared
0
Denied
FDA 510(k) Regulatory Record - Terumo America, Inc. Gastroenterology & Urology ✕
11 devices
Cleared
Dec 18, 1980
CLIRANS TH13 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
105d
Cleared
Dec 18, 1980
CLIRANS TH10 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
72d
Cleared
Aug 12, 1980
CLIRANS TE10 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
85d
Cleared
Aug 12, 1980
CLIRANS TE15 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
85d
Cleared
Aug 12, 1980
CLIRANS TE07 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
85d
Cleared
Nov 13, 1979
COAXIAL DUAL FLOW CATHETER
Gastroenterology & Urology
109d
Cleared
Mar 17, 1978
AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
Gastroenterology & Urology
80d
Cleared
Sep 15, 1977
CLIRANS TH 15 HOLLOW FIBER DIALYZER
Gastroenterology & Urology
9d
Cleared
Sep 12, 1977
SAFEED DISP. PLASTIC CATHETER
Gastroenterology & Urology
69d
Cleared
Jul 15, 1977
AV FISTULA NEEDLE SET
Gastroenterology & Urology
10d
Cleared
Jul 11, 1977
UROGARD URINARY DRAINAGE BAG
Gastroenterology & Urology
6d