Panels › General Hospital › Product code FLE · Class 2
Sterilizer, Steam
Regulation 880.6880
4510(k)s in 12 months (185 all time)
1recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in FLE
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 23 | 10 |
| Tuttnauer , Ltd. | 18 | 0 |
| Scican | 13 | 2 |
| Midmark Corp. | 9 | 1 |
| Fort Defiance Industries, Inc. | 3 | 3 |
| Getinge/Castle, Inc. | 6 | 0 |
| Primus Sterilizer Co., Inc. | 6 | 0 |
| Castle Co. | 5 | 0 |
| Getinge Sourcing, LLC | 5 | 0 |
| Sauter AG | 5 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2026 | Fort Defiance Industries, LLC Fort Defiance Industries (FDI), Automated Field Steam Sterilizer
REF: P2131 Open, Classified |
FLE | K141009 |
| Aug 3, 2023 | Scican Ltd. STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Model: G4 622303 Open, Classified |
FLE | K192910 |
| Aug 3, 2023 | Scican Ltd. STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Model: G4 621103 Open, Classified |
FLE | K190062 |
| Aug 19, 2021 | Fort Defiance Industries, LLC P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 Open, Classified |
FLE | K141009 |
| Oct 22, 2019 | Steris Corporation Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam Terminated |
FLE | K082435 K091731 +1 |
| Oct 22, 2019 | Steris Corporation Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two Terminated |
FLE | K964332 |
| Apr 18, 2019 | Skytron, Div. The KMW Group, Inc Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam
Product Usage:
The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorpor Terminated |
FLE | K132439 |
| Dec 26, 2018 | Steris Corporation ATLAS Loading Car Terminated |
FLE | K082435 K091136 |
| May 24, 2018 | Fort Defiance Industries, LLC FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641
Product Usage:
The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for ste Terminated |
FLE | K141009 |
| Nov 4, 2015 | Steris Corporation AMSCO 400 and AMSCO C Small Steam Sterilizers Terminated |
FLE | K111223 |
| Apr 30, 2015 | Steris Corporation AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation.
AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer.
Designed for sterilization of heat and moisture-stable Terminated |
FLE | K111223 K112055 |
| Dec 11, 2013 | Steris Corporation AMSCO Evolution steam sterilizer Transfer Carriage.
Product Usage:
Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units. Terminated |
FLE | K082435 K091136 |
| Mar 6, 2013 | Steris Corporation AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Terminated |
FLE | K111223 K112403 |
| May 11, 2012 | Steris Corporation The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two Terminated |
FLE | K082435 K091136 |
| Jan 11, 2012 | Midmark Corportation Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380.
Sterilize reusable equipment that is heat and moisture stable. Terminated |
FLE | K936181 |
| Sep 17, 2008 | Steris Corp Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat Terminated |
FLE | K964332 |
| Aug 23, 2007 | Steris Corp Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm). Terminated |
FLE | K010865 |
| Apr 1, 2003 | Midmark Corp Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers. Terminated |
FLE | None listed |
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