Sterilizer, Steam
FDA product code FLE · 180 cleared devices
Class 2
General Hospital
- Regulation
- 21 CFR 880.6880
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-01-26 – 2026-06-24
FLE
2026-06-24
FLE
2026-02-26
Enbio PRO
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FLE
2026-01-22
Getinge GSS67N Series Steam Sterilizer
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FLE
2025-12-30
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
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FLE
2025-08-14
Cassette Autoclave (ACA5)
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FLE
2025-06-06
Steam Sterilizer (2545D)
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FLE
2025-03-07
FRONT-LINE Field Sterilizer (FL135)
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FLE
2024-04-04
Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
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FLE
2024-02-08
Lexa MINI (RIS-303, RIS-305)
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FLE
2023-12-19
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
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FLE
2023-11-27
T-Top 10 & T-Top T-Top 11
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FLE
2023-09-13
AMSCO 600 Steam Sterilizer
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FLE
2023-06-21
Sturdy Autoclave Super Microm
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FLE
2023-05-05
Lexa MINI (RIS-303, RIS-305)
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FLE
2023-02-10
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
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FLE
2023-02-02
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
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FLE
2022-12-16
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
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FLE
2022-10-12
MOST-T Autoclave
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FLE
2022-09-20
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
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FLE
2022-08-19
Lexa PLUS RIS-311
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FLE
2022-08-01
Consolidated HC Steam Sterilizer
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FLE
2022-05-18
GSS610N21 Series Steam Sterilizer
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FLE
2022-03-31
STATIM 6000B Vacuum Autoclave
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FLE
2022-03-02
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135
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FLE
2022-02-22
Enbio S
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FLE
2022-01-04
T-Edge 10, T-Edge 11
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FLE
2021-10-29
Enbio S
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FLE
2021-10-28
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
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FLE
2021-08-25
AMSCO 600 Medium Steam Sterilizer
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FLE
2021-07-01
Bravo G4 Chamber Autoclave
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FLE
2021-03-01
Getinge GSS610N Series Steam Sterilizer
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FLE
2020-11-06
Amsco 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); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)
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FLE
2020-06-19
STATClave G4 Chamber Autoclave
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FLE
2019-11-01
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
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FLE
2019-10-31
Belimed Steam Sterilizer MST-H TOP 5000
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FLE
2019-07-26
STATCLAVE G4 Chamber Autoclave
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FLE
2019-07-08
Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
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FLE
2019-03-27
AMSCO 600 Steam Sterilizer
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FLE
2018-07-26
Saniclave 250
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FLE
2018-05-30
MN-111
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FLE
2018-03-09
Amsco Evolution Medium Steam Sterilizer
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FLE
2018-03-02
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
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FLE
2018-02-23
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000
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FLE
2018-02-22
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
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FLE
2018-02-22
Amsco Evolution Medium Steam Sterilizer
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FLE
2018-01-30
Getinge GSS67N Series Steam Sterilizer
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FLE
2017-08-31
Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
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FLE
2017-05-12
Belimed Steam Sterilizer MST-H TOP 5000
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FLE
2017-02-23
Family of Steam sterilizers B17 B22 Series
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FLE
2016-03-04
Family of Steam Sterilizers B 28 series
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FLE
2013-09-23
BELIMED STEAM STERILIZER MST-V
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FLE
2013-05-23
SANICLAVE 102, MODEL RS-SC-102
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FLE
2013-05-22
GETINGE 800HC- SERIES STEAM STERILIZER
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FLE
2013-05-09
SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
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FLE
2013-03-12
GETINGE 400HC-E / SERIES STEAM STERILIZER
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FLE
2012-07-10
STATIM 2000 G4 CASSETTE
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FLE
2012-05-31
GETINGE 700HC-E SERIES STEAM STERILIZER
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FLE
2012-05-08
SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
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FLE
2012-05-08
AMSCO CHIMERON MEDIUM STEAM STERLILZER
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FLE
2012-01-11
SANICLAVE 200
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FLE
2011-12-16
AMSCO CHIMERON MEDIUM STEAM STERILIZER
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FLE
2011-12-08
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
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FLE
2011-09-20
AMSCO CHIMERON SMALL STEAM STERILIZER
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FLE
2011-03-16
GETINGE 400HC/500HC SERIES STEAM STERILIZER
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FLE
2011-03-15
BELIMED STEAM STERILIZER MST-V
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FLE
2010-08-27
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
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FLE
2010-04-02
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
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FLE
2009-11-04
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
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FLE
2009-09-23
BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2
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FLE
2009-09-17
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
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FLE
2009-08-20
TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE
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FLE
2009-07-07
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
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FLE
2009-06-29
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
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FLE
2009-05-21
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M
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FLE
2009-05-15
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
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FLE
2008-12-30
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
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FLE
2007-12-19
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
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FLE
2007-10-05
BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
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FLE
2007-06-29
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
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FLE
2007-04-05
GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
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FLE
2007-02-02
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
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FLE
2006-11-21
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
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FLE
2006-09-05
IMAX 9.5 STERILIZERS
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FLE
2006-03-08
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
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FLE
2004-12-10
CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
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FLE
2004-08-12
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
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FLE
2004-02-02
BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8
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FLE
2003-10-01
CLS-2000 UNIT
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FLE
2003-05-12
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
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FLE
2003-03-26
AMSCO CENTURY STEAM STERILIZER
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FLE
2003-03-03
MIDMARK M9 ULTRACLAVE STEAM STERILIZER
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FLE
2003-02-07
W & H LISA STEAM STERILIZER
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FLE
2002-08-08
QUANTIM 16 AUTOCLAVE
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FLE
2002-07-25
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
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FLE
2002-06-26
BELIMED STEAM STERILIZER, MODEL TOP 5000
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FLE
2002-05-17
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
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FLE
2002-03-20
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
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FLE
2002-02-22
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33
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FLE
2001-09-05
CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
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FLE
2001-05-31
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
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