Medical Device Manufacturer · US , Mchenry , IL

Edwards Laboratories - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 1976

Total

Cleared

Denied

Edwards Laboratories has 11 FDA 510(k) cleared cardiovascular devices. Based in Mchenry, US.

Historical record: 11 cleared submissions from 1976 to 1980.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

Edwards Laboratories 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 - Edwards Laboratories

12 devices

1-12 of 12

Cleared Jul 28, 1980

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

K801552 · KRB

Cardiovascular · 20d

Cleared Apr 16, 1980

MODEL 100 SPECTRAVIEW

K800655 · DQC

Cardiovascular · 22d

Not Cleared Mar 17, 1980

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

K792441 · KRH

Cardiovascular · 109d

Cleared Dec 07, 1979

INTEGRAL DISPOSABLE HOLDER CARPENTIER

K792034 · DTJ

Cardiovascular · 58d

Cleared Feb 26, 1979

CARDIAC OUTPUT COMPUTER, MDEL 9520A

K790047 · DXG

Cardiovascular · 52d

Cleared Jan 15, 1979

DISPOSABLE HOLDER FOR BIOPROSTHESIS

K790022 · DTJ

Cardiovascular · 12d

Cleared Sep 15, 1978

AC ADAPTER:MODELS 9525,9526,9527

VENA CAVA UMBRELLA FILTER, MODEL 7321

K771046 · DTK

Cardiovascular · 12d

Cleared Aug 26, 1976

APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)

K760151 · DTK

Cardiovascular · 56d

Cleared Jul 19, 1976

FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)

K760152 · DTK

Cardiovascular · 18d

Cleared Jul 19, 1976

COMPUTER, THERMODILUTION CARDIAC (9520)

K760192 · DXG

Cardiovascular · 13d

Edwards Laboratories - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Edwards Laboratories

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