Medical Device Manufacturer · US , Mchenry , IL

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

31 submissions · 31 cleared · Since 1976

Recent clearances: PLASMA FLEX, TERUMO HOLLOW FIBER OXYGENATOR, CLIRANS TH13 HOLLOW FIBER DIALYZER

31

Total

31

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared Jul 30, 1979

SURFLO INJECTION PLUG

General Hospital · 35d

Cleared Sep 28, 1977

HICALIQ IVH BAG

General Hospital · 58d

Cleared Sep 20, 1977

BLOOD FILTER, W/SET

General Hospital · 50d

Cleared Aug 26, 1977

INFUSION ACCELERATOR

General Hospital · 22d

Cleared Jul 26, 1977

TERUFUSION BLOOD ADMIN. SET

General Hospital · 21d

Cleared Jul 14, 1977

DISP. HYPODERMIC NEEDLE

General Hospital · 9d

Cleared Jul 14, 1977

SURFLO WINGED INFUSION SET

General Hospital · 9d

Cleared Jul 14, 1977

HYPODERMIC SYRINGE

General Hospital · 9d

Cleared Jul 14, 1977

TERUFUSION DONOR SET

General Hospital · 9d

Cleared Mar 16, 1977

CATHETER, SURFLO, I.V.

General Hospital · 9d

Cleared Dec 09, 1976

THERMO FINER CORETEMP

General Hospital · 38d