Medical Device Manufacturer · US , Mchenry , IL

American Sterilizer Co.

36 submissions · 35 cleared · Since 1977
36
Total
35
Cleared
0
Denied

American Sterilizer Co. — FDA 510(k) Submissions

American Sterilizer Co. has submitted 36 FDA 510(k) premarket notifications since 1977, of which 35 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Indicator, Physical/chemical Sterilization Process, Wrap, Sterilization, Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment, Light, Surgical, Ceiling Mounted, Indicator, Biological Sterilization Process . Use the specialty filter in the sidebar to narrow results.

36 devices
1–25 of 36
AMSCO SQ240 SURGICAL LIGHT
K943288 · FSY Light, Surgical, Ceiling... · General & Plastic Surgery
Oct 1994 101d
THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
K931872 · FLF Sterilizer,... · General Hospital
Feb 1994 299d
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · JOJ Indicator,... · General Hospital
Sep 1993 499d
QUANTUM 3080 SURGICAL TABLE
K930493 · FQO Table, Operating-room,... · General & Plastic Surgery
Jun 1993 141d
ORTHOVISION TABLE
K905816 · JEB Table, Surgical With... · General & Plastic Surgery
Mar 1991 68d
AMSCO QUANTUM LIGHT
K896674 · FSY Light, Surgical, Ceiling... · General & Plastic Surgery
Jan 1990 37d
EAGLE DS
K895164 · ECG Sterilizer, Boiling Water · Dental
Nov 1989 87d
GENERAL SURGICAL TABLE AND ACCESSORIES
K882660 · FQO Table, Operating-room,... · General & Plastic Surgery
Jul 1988 27d
GEMINI SURGICAL LIGHT
K880198 · FSS Light, Surgical, Floor... · General & Plastic Surgery
Feb 1988 26d
RADIOGRAPHIC - LEG SECTION
K864846 · KQS Table, Cystometric,... · Gastroenterology & Urology
Dec 1986 14d
CHEMSPOR
K844479 · FRC Indicator, Biological... · General Hospital
Nov 1985 371d
AMSCO URO-ENDO MOBILE TABLE
K852127 · KQS Table, Cystometric,... · Gastroenterology & Urology
Aug 1985 85d
BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH
K850144 · FRC Indicator, Biological... · General Hospital
Jun 1985 154d
BLUE SEAL II STERILIZATION POUCH
K851340 · FRG Wrap, Sterilization · General Hospital
Apr 1985 21d
DART DAILY AIR REMOVAL TEST
K844512 · JOJ Indicator,... · General Hospital
Mar 1985 121d
SPORDEX CULTURE MEDIA
K850143 · JSC Culture Media, General... · Microbiology
Mar 1985 50d
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · GEC Brush, Scrub, Operating-room · General & Plastic Surgery
Dec 1984 33d
CENTURIAN HYDRAULIC STRETCHER
K843439 · FPO Stretcher, Wheeled · General Hospital
Sep 1984 9d
MINOR SURGICAL LIGHT MODEL 180
K841360 · FTD Lamp, Surgical · General & Plastic Surgery
Apr 1984 22d
VANTAGE E
K841156 · FRG Wrap, Sterilization · General Hospital
Apr 1984 25d
HALL ARTHROTOME
K832816 · General & Plastic Surgery
Nov 1983 101d
AMSCO ORTHOGRAPHIC 2 TABLE
K823772 · BWN Table And Attachments,... · General & Plastic Surgery
Jan 1983 31d
EAGLE STERISET
K823902 · FRG Wrap, Sterilization · General Hospital
Jan 1983 10d
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · JOJ Indicator,... · General Hospital
Nov 1982 20d
AMSCO ENDOSCOPY TABLE
K821749 · GDC Table, Operating-room,... · General & Plastic Surgery
Jul 1982 24d
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