Medical Device Manufacturer · US , Mchenry , IL

Terumo America, Inc. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 1976

Total

Cleared

Denied

Terumo America, Inc. has 31 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 31 cleared submissions from 1976 to 1981.

Browse the FDA 510(k) cleared devices submitted by Terumo America, Inc. Filter by specialty or product code using the sidebar.

Terumo America, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Terumo America, Inc.

31 devices

1-12 of 31

TERUMO HOLLOW FIBER OXYGENATOR

K802970 · DTZ

Cardiovascular · 62d

Cleared Dec 18, 1980

CLIRANS TH13 HOLLOW FIBER DIALYZER

K802122 · FJI

Gastroenterology & Urology · 105d

Cleared Dec 18, 1980

CLIRANS TH10 HOLLOW FIBER DIALYZER

K802441 · FJI

Gastroenterology & Urology · 72d

Cleared Aug 12, 1980

CLIRANS TE10 HOLLOW FIBER DIALYZER

K801192 · FJI

Gastroenterology & Urology · 85d

Cleared Aug 12, 1980

CLIRANS TE15 HOLLOW FIBER DIALYZER

K801193 · KDJ

Gastroenterology & Urology · 85d

Cleared Aug 12, 1980

CLIRANS TE07 HOLLOW FIBER DIALYZER

K801194 · FJI

Gastroenterology & Urology · 85d

Cleared Nov 13, 1979

COAXIAL DUAL FLOW CATHETER

K791411 · KOC

Gastroenterology & Urology · 109d

Cleared Jul 30, 1979

SURFLO INJECTION PLUG

K791173 · FPA

General Hospital · 35d

AVF SET FOR SINGLE NEEDLE HEMODIALYSIS

K772362 · FIE

Gastroenterology & Urology · 80d

Terumo America, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Terumo America, Inc.

Filters