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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)
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Top companies in FLE

DateFirm and productCodeLinked 510(k)
Aug 18, 2026Fort Defiance Industries, LLC
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Open, Classified
FLEK141009
Aug 3, 2023Scican 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
FLEK192910
Aug 3, 2023Scican 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
FLEK190062
Aug 19, 2021Fort Defiance Industries, LLC
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Open, Classified
FLEK141009
Oct 22, 2019Steris Corporation
Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Terminated
FLEK082435
K091731 +1
Oct 22, 2019Steris 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
FLEK964332
Apr 18, 2019Skytron, 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
FLEK132439
Dec 26, 2018Steris Corporation
ATLAS Loading Car
Terminated
FLEK082435
K091136
May 24, 2018Fort 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
FLEK141009
Nov 4, 2015Steris Corporation
AMSCO 400 and AMSCO C Small Steam Sterilizers
Terminated
FLEK111223
Apr 30, 2015Steris 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
FLEK111223
K112055
Dec 11, 2013Steris 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
FLEK082435
K091136
Mar 6, 2013Steris Corporation
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Terminated
FLEK111223
K112403
May 11, 2012Steris 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
FLEK082435
K091136
Jan 11, 2012Midmark 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
FLEK936181
Sep 17, 2008Steris 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
FLEK964332
Aug 23, 2007Steris Corp
Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).
Terminated
FLEK010865
Apr 1, 2003Midmark Corp
Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers.
Terminated
FLENone listed

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