Product Code: FLE


Products Classified as FLE

2539Sterilizer, SteamSteam Sterilizer.

Total Product Life Cycle (TPLC) Devices

2539Sterilizer, SteamSteam Sterilizer.

FDA Consensus Standards

Sterilizer, Steam [31812]21 CFR §880.6880 🔎
Sterilizer, Steam [38433]21 CFR §880.6880 🔎
Sterilizer, Steam [38432]21 CFR §880.6880 🔎

Pre-market Notifications for FLE

K212424AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation
K211500AMSCO 600 Medium Steam SterilizerSteris Corporation
K210326Bravo G4 Chamber AutoclaveSciCan Ltd.
K210279Enbio SEnbio Group AG
K203061Amsco Evolution Medium Steam Sterilizer (Models HC-900 And HC-1200),Evolution Automated Loading And Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 And HC-1500),Evolution Automated Loading And Unloading System (ALUS); ASTERIS Corporation
K201927Getinge GSS610N Series Steam SterilizerMaquet GmbH
K192910STATClave G4 Chamber AutoclaveSciCan Ltd.
K191896Belimed Steam Sterilizer MST-H TOP 5000Belimed AG
K190062STATCLAVE G4 Chamber AutoclaveSciCan Ltd.
K183410AMSCO 600 Steam SterilizerSTERIS Corporation
K181993STURDY Autoclave Super Microm (models SA-260MA And SA-260MA-R)Sturdy Industrial Co., Ltd
K181456Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 And 69180 AutoclavesTuttnauer Ltd.
K180272Saniclave 250REVOLUTIONARY SCIENCE
K173481Amsco Evolution Medium Steam SterilizerSTERIS Corporation
K173493Amsco Evolution Floorloader Steam Sterilizer HC-2000 And HC-3000STERIS Corporation

Global Unique Device Identification Database

00729011064035Sterilizer, Steam
00724995151959Sterilizer, steam
00724995151942Sterilizer, steam
00724995151935Sterilizer, steam
00724995151928Sterilizer, steam
00724995151843Sterilizer, steam
00724995151836Sterilizer, steam
00724995151829Sterilizer, steam
00724995151812Sterilizer, steam
00724995151805Sterilizer, steam
00724995151799Sterilizer, steam
00724995151782Sterilizer, steam
00724995151775Sterilizer, steam
00724995151768Sterilizer, steam
00724995151751Sterilizer, steam

Maude Adverse Events

66" EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2020-03-13
48" CENTURY STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2020-03-13
AMSCO 400 STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2020-03-12
400-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2020-03-12
EVOLUTION LOADING CARSTERIS MEXICO, S. DE R.L. DE C.V.2020-03-04
54" EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2020-03-04
16" CENTURY STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2020-03-04
700-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2020-03-04
FILTER RETENTION PLATEAESCULAP AG2020-03-03
54" EVOLUTION STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2020-02-12
AMSCO CENTURY STERILIZER V116STERIS CORPORATION2020-01-31
800-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2020-01-23
EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2020-01-22
AMSCO 600 STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2020-01-22
EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2020-01-15
EAGLE 3000 STERILZIERSTERIS MEXICO, S. DE R.L. DE C.V.2020-01-15
EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2020-01-15
EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2020-01-08
STERILIZER, STEAMSTERIS CORPORATION2019-11-14
STERILIZER, STEAMSTERIS CORPORATION2019-11-14
STERILIZER, STEAMSTERIS CORPORATION2019-11-14
STERILIZER, STEAMSTERIS CORPORATION2019-11-14
EAGLE 3000STERIS CORPORATION2019-11-13
STERILIZER, STEAMSTERIS CORPORATION2019-11-12
500-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-10-31
700-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-10-28
AMSCO CENTURYSTERIS MEXICO, S. DE R.L. DE C.V.2019-10-15
42" EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2019-10-11
EVOLUTION STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-10-09
EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2019-10-02
AMSCO 400 STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-10-02
CENTURY STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-09-25
122STERILIZER, STEAMGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-09-24
42" EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2019-09-20
533HCMCGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-09-20
533HCMCGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-09-16
60" CENTURY STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-09-11
66" EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2019-09-11
20" MILLENNIUM STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-09-05
AMSCO C STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-08-21
800-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-08-21
500-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-08-09
133HCGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-08-08
AMSCO 400 STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-08-07
AMSCO 400 STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-07-31
66" EVOLUTION TRANSFER CARRIAGESTERIS MEXICO, S. DE R.L. DE C.V.2019-07-25
800-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-07-16
500-SERIES2019-07-11
AMSCO 400 STERILIZERSTERIS MEXICO, S. DE R.L. DE C.V.2019-07-10
500-SERIESGETINGE IC PRODUCTION POLAND SP. Z O.O.2019-07-10

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