Panels › General Hospital › Product code FLF · Class 2
Sterilizer, Ethylene-Oxide Gas
Regulation 880.6860
0510(k)s in 12 months (26 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in FLF
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Sterilization Products | 1 | 5 |
| 3M Company | 3 | 0 |
| 3M Company - Health Care Business | 0 | 3 |
| Andersen Sterilizers, Inc. | 3 | 0 |
| Abtox, Inc. | 2 | 0 |
| Tso3, Inc. | 2 | 0 |
| 3M Health Care, Ltd. | 1 | 0 |
| American Sterilizer Co. | 1 | 0 |
| Amsco Co. | 1 | 0 |
| Ars Enterprises, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2016 | 3M Company - Health Care Business 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. Terminated |
FLF | K902036 K941748 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 100S, Product Code 10113.
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive re Terminated |
FLF | K023290 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 50, Product Code 10114.
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reus Terminated |
FLF | K023290 |
| Apr 2, 2014 | 3M Company - Health Care Business 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL
The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas ster Terminated |
FLF | K812867 K902036 +1 |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD 100S Sterilization System, Product Code: 10101
The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorg Terminated |
FLF | K023290 |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD 50 Sterilization System, Product Code: 10050
The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms Terminated |
FLF | K023290 |
| Oct 9, 2012 | 3M Company - Health Care Business 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL.
3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerato Terminated |
FLF | K902036 K941748 |
| Jun 15, 2009 | Advanced Sterilization Products STERRAD 50 Sterilization System Product Code 10050
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devi Terminated |
FLF | K023290 K981625 |
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