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 General Hospital ✕

7 devices

1-7 of 7

Cleared Apr 17, 1987

HOMEPRO II VOLUMETRIC INFUSION PUMP

General Hospital · 73d

Cleared Feb 27, 1987

MEDTRAC VP VOLUMETRIC INFUSION PUMP

General Hospital · 67d

Cleared Feb 12, 1986

RATEMINDER III INFUSION DEVICE

General Hospital · 61d

Cleared Feb 15, 1985

HOME PRO VOLUMETRIC INFUSION PUMP

General Hospital · 318d

Cleared Oct 19, 1984

MODULAR VOLUMETRIC INFUSION PUMP SYS

General Hospital · 60d

Cleared Jul 13, 1984

ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232

General Hospital · 64d

Cleared Jul 31, 1981

VOLUMETRIC INFUSION PUMP

General Hospital · 11d