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. Chemistry ✕

15 devices

1-15 of 15

Cleared Mar 15, 1990

VENOJECT II BLOOD COLLECTION TUBES

Chemistry · 52d

Cleared Jul 01, 1988

TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT

Chemistry · 24d

Cleared Jun 07, 1988

TERUMO SENSIBEAD EIA PROGESTERONE KIT

Chemistry · 49d

Cleared Jan 09, 1987

TERUMO OVATION SPECTROPHOTOMETER

Chemistry · 71d

Cleared Dec 04, 1986

TERUMO SENSIBEAD EIA FSH KIT

Chemistry · 57d

Cleared Nov 13, 1986

TERUMO SENSIBEAD(TM) EIA HLH KIT

Chemistry · 36d

Cleared Jun 19, 1986

TERUMO SENSIBEAD EIA TSH KIT

Chemistry · 52d

Cleared Feb 13, 1986

TERUMO SENSIBEAD EIG HCG KIT

Chemistry · 84d

Cleared Jan 13, 1986

TERUMO SENSIBEAD EIA HPRL KIT

Chemistry · 47d

Cleared Dec 05, 1985

TERUMO SENSIBEAD EIA COLORIMETER

Chemistry · 50d

Cleared Jul 09, 1985

TERUMO SENSIBEAD EIA HGH KIT

Chemistry · 41d

Cleared Mar 04, 1985

TERUMO SENSIBEAD EIA TSH KIT

Chemistry · 32d

Cleared Sep 07, 1984

TERUMO SENSIBEAD EIA THYROID UPTAKE KIT

Chemistry · 58d

Cleared May 22, 1984

TERUMO SENSIBEAD THYROXINE EIA KIT

Chemistry · 34d

Cleared Mar 12, 1984

SENSIBEAD EIA DIGOXIN KIT

Chemistry · 26d