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 Orthopedic ✕

7 devices

1-7 of 7

Cleared Oct 31, 1986

XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES

Orthopedic · 17d

Cleared Oct 03, 1986

ARTHROSCOPIC IRRIGATION PUMP

Orthopedic · 17d

Cleared Sep 25, 1986

AMERICAN EDWARDS 4.0 MM ARTHROSCOPE

Orthopedic · 10d

Cleared Aug 22, 1985

AMERICAN EDWARDS LABORATORIES FLEXISCOPE

Orthopedic · 55d

Cleared Jun 28, 1985

AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE

Orthopedic · 81d

Cleared Aug 18, 1984

AMERICAN EDWARDS LABS FLEXISCOPE

Orthopedic · 121d

Cleared Aug 17, 1984

AMER. EDWARDS LAB FLEXISCOPE OBTURATOR

Orthopedic · 65d