American Sterilizer Co.
Mchenry, IL, US
American Sterilizer Co. appears in FDA device records in Mchenry, IL. FDA records list 36 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 36
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 36 510(k) clearances for American Sterilizer Co. between 1977 and 1994. The busiest year on record is 1978, with 6. The most recent is 1994, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 6 |
| 1979 | 1 |
| 1980 | 3 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 6 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943288 | AMSCO SQ240 SURGICAL LIGHT | FSY | Substantially Equivalent | |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | FLF | Substantially Equivalent | |
| K922485 | CHEMDI-VHP CHEMICAL INDICATOR | JOJ | Substantially Equivalent | |
| K930493 | QUANTUM 3080 SURGICAL TABLE | FQO | Substantially Equivalent | |
| K905816 | ORTHOVISION TABLE | JEB | Substantially Equivalent | |
| K896674 | AMSCO QUANTUM LIGHT | FSY | Substantially Equivalent | |
| K895164 | EAGLE DS | ECG | Substantially Equivalent | |
| K882660 | GENERAL SURGICAL TABLE AND ACCESSORIES | FQO | Substantially Equivalent | |
| K880198 | GEMINI SURGICAL LIGHT | FSS | Substantially Equivalent | |
| K864846 | RADIOGRAPHIC - LEG SECTION | KQS | Substantially Equivalent | |
| K844479 | CHEMSPOR | FRC | Substantially Equivalent for Some Indications | |
| K852127 | AMSCO URO-ENDO MOBILE TABLE | KQS | Substantially Equivalent | |
| K850144 | BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH | FRC | Substantially Equivalent | |
| K851340 | BLUE SEAL II STERILIZATION POUCH | FRG | Substantially Equivalent | |
| K844512 | DART DAILY AIR REMOVAL TEST | JOJ | Substantially Equivalent | |
| K850143 | SPORDEX CULTURE MEDIA | JSC | Substantially Equivalent | |
| K844411 | SCRUB MATE DRY STERILE SCRUB BRUSH | GEC | Substantially Equivalent | |
| K843439 | CENTURIAN HYDRAULIC STRETCHER | FPO | Substantially Equivalent | |
| K841360 | MINOR SURGICAL LIGHT MODEL 180 | FTD | Substantially Equivalent | |
| K841156 | VANTAGE E | FRG | Substantially Equivalent | |
| K832816 | HALL ARTHROTOME | Substantially Equivalent | ||
| K823772 | AMSCO ORTHOGRAPHIC 2 TABLE | BWN | Substantially Equivalent | |
| K823902 | EAGLE STERISET | FRG | Substantially Equivalent | |
| K823074 | CHEMDI STEAM & GAS STERILIZATION INDICA | JOJ | Substantially Equivalent | |
| K821749 | AMSCO ENDOSCOPY TABLE | GDC | Substantially Equivalent | |
| K801063 | HALL ARTERIAL OSCILLATOR | DWX | Substantially Equivalent | |
| K801428 | CHEMDI | JOJ | Substantially Equivalent | |
| K800275 | CEBOTOME DRILL | HSZ | Substantially Equivalent | |
| K792028 | OTOTOME BUR | EQJ | Substantially Equivalent | |
| K781979 | SURGAIRTOME TWO | HSZ | Substantially Equivalent | |
| K781698 | EXAMINER 10 | HJE | Substantially Equivalent | |
| K781699 | EAGLE PAC/VISIBLE SEAL | KCT | Substantially Equivalent | |
| K781684 | STERILIZER, EAGLE 2000 | FLE | Substantially Equivalent | |
| K781581 | SURGICAL LIGHT 22 SERIES | FQP | Substantially Equivalent | |
| K772324 | WIREDRIVER | HSZ | Substantially Equivalent | |
| K771915 | MICRO OSCILLATING SAW | HTZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GECBrush, Scrub, Operating-Room
- EQJBur, Ear, Nose And Throat
- JSCCulture Media, General Nutrient Broth
- FRCIndicator, Biological Sterilization Process
- JOJIndicator, Physical/Chemical Sterilization Process
- HTZInstrument, Cutting, Orthopedic
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- HJELamp, Fluorescein, Ac-Powered
- FQPLamp, Operating-Room
- FTDLamp, Surgical
- FSYLight, Surgical, Ceiling Mounted
- FSSLight, Surgical, Floor Standing
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- ECGSterilizer, Boiling Water
- FLFSterilizer, Ethylene-Oxide Gas
- FLESterilizer, Steam
- FPOStretcher, Wheeled
- DWXStripper, Artery, Intraluminal
- BWNTable And Attachments, Operating-Room
- KQSTable, Cystometric, Non-Electric And Accessories
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- JEBTable, Surgical With Orthopedic Accessories, Manual
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain