Medical Device Manufacturer · US , Walker , MI

American Edwards Laboratories - FDA 510(k) Cleared Devices

89 submissions · 88 cleared · Since 1980

89

Total

88

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Edwards Laboratories Cardiovascular ✕

53 devices

1-12 of 53

Cleared Dec 03, 1987

EDSLAB (R) OCCLUSION BALLOON CATHETER

Cardiovascular · 94d

Cleared Sep 30, 1987

TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30

Cardiovascular · 90d

Cleared Sep 15, 1987

THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2

Cardiovascular · 81d

Cleared Jan 06, 1987

SHEAR FORCE GAUGE

Cardiovascular · 63d

Cleared Jan 02, 1987

VEIN VALVE CUTTER

Cardiovascular · 169d

Cleared Nov 20, 1986

CHIN-FOGARTY INFLATION DEVICE

Cardiovascular · 66d

Cleared Nov 20, 1986

MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS

Cardiovascular · 28d

Cleared Sep 03, 1986

MECHANICAL INFLATION DEVICE

Cardiovascular · 62d

Cleared Jan 15, 1985

RIGHT VENTRICULAR EJECTION FRACTION-

Cardiovascular · 235d

Cleared Jan 14, 1985

SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER

Cardiovascular · 286d

Cleared Nov 01, 1984

PERICARDIAL PATCH

Cardiovascular · 372d

Cleared Oct 18, 1984

AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE

Cardiovascular · 115d

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