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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 2020 | K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer Andersen Sterilizers, Inc. | FLF |
| Oct 31, 2017 | K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer Andersen Sterilizers, Inc. | FLF |
| Nov 18, 2015 | K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer Andersen Sterilizers, Inc. | FLF |
| Jan 8, 2015 | K142034 | 3M STERI-VAC STERILIZER/AERATOR 3M Company | FLF |
| Dec 2, 2009 | K090636 | TSO3 OZONE STERILIZER, MODEL 125L Tso3, Inc. | FLF |
| Jul 26, 2006 | K051595 | TSO3 OZONE STERILIZER, MODEL 125L Tso3, Inc. | FLF |
| Aug 26, 2003 | K020875 | TSO3 OZONE STERILIZER, MODEL 125L Technologies of Sterilization With Oxone, Tso3, Inc. | FLF |
| Jun 25, 2003 | K014013 | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM H & W Technology, LLC | FLF |
| Apr 3, 2003 | K023290 | STERRAD 50 & STERRAD 100S STERILIZERS Advanced Sterilization Products | FLF |
| Dec 22, 1994 | K923442 | ABTOX PLAZLYTE PROCESS MONITOR Abtox, Inc. | FLF |
| Dec 22, 1994 | K905119 | PLAZLYTE(TM) Abtox, Inc. | FLF |
| Dec 2, 1994 | K941748 | STERI-VAC GAS STERILIZER MODEL 8XL 3M Health Care, Ltd. | FLF |
| Feb 7, 1994 | K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER American Sterilizer Co. | FLF |
| Oct 1, 1993 | K915682 | STERRAD 100 STERILIZATION SYSTEM Johnson & Johnson Medical, Inc. | FLF |
| Mar 31, 1993 | K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION Mdt Corp., Inc. | FLF |
| Sep 6, 1991 | K910649 | MDT/CASTLE 10/90 LOAD STATION Mdt Biologic Co. | FLF |
| Mar 7, 1991 | K901146 | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT Joslyn Valve Corp. | FLF |
| Jul 19, 1990 | K902036 | STERI-VAC GAS STERILIZER MODEL 5XL 3M Company | FLF |
| Jan 27, 1989 | K873200 | KARLSON OZONE STERILIZER MODEL 100B Life Enhancement Technologies, LLC | FLF |
| Nov 1, 1985 | K852115 | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER Ars Enterprises, Inc. | FLF |
| Dec 29, 1983 | K833457 | ETHYLENE OXIDE GAS STERILIZA SYS II Ben Venue Laboratories, Inc. | FLF |
| Oct 19, 1983 | K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA Amsco Co. | FLF |
| Jul 28, 1982 | K821842 | GAS STERILIZATION EQUIPMENT Getinge International, Inc. | FLF |
| Apr 15, 1982 | K820783 | CASTLE MICROCOMPUTER STERILIZER CONTROL Sybron Corp. | FLF |
| Nov 2, 1981 | K812867 | STERI-VAC #400C GAS STERILIZER 3M Company | FLF |
| Jan 29, 1980 | K792660 | 1500 EO EXHAUST HOOD Castle Co. | FLF |
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