Medical Device Manufacturer · US , Mchenry , IL

American Sterilizer Co. - FDA 510(k) Cleared Devices

36 submissions · 35 cleared · Since 1977

36

Total

35

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Sterilizer Co. General Hospital ✕

13 devices

1-12 of 13

Cleared Feb 07, 1994

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER

General Hospital · 299d

Cleared Sep 29, 1993

CHEMDI-VHP CHEMICAL INDICATOR

General Hospital · 499d

Cleared Nov 25, 1985

General Hospital · 371d

Cleared Jun 17, 1985

BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH

General Hospital · 154d

Cleared Apr 24, 1985

BLUE SEAL II STERILIZATION POUCH

General Hospital · 21d

Cleared Mar 21, 1985

DART DAILY AIR REMOVAL TEST

General Hospital · 121d

Cleared Sep 13, 1984

CENTURIAN HYDRAULIC STRETCHER

General Hospital · 9d

Cleared Apr 13, 1984

General Hospital · 25d

Cleared Jan 09, 1983

General Hospital · 10d

Cleared Nov 08, 1982

CHEMDI STEAM & GAS STERILIZATION INDICA

General Hospital · 20d

Cleared Aug 13, 1980

General Hospital · 57d

Cleared Oct 24, 1978

STERILIZER, EAGLE 2000

General Hospital · 22d