Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 2001-02-20

EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870

Applicant Tuttnauer Co. , Ltd.

K number K003470

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FLE 2001-02-09

TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP

Applicant Tuttnauer U.S.A Co, Ltd.

K number K993856

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FLE 2001-01-02

CASTLE MODEL 233HC STEAM STERILIZER

Applicant Getinge/Castle, Inc.

K number K003441

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FLE 2000-03-17

STERIS AMSCO MILLENNIUM STEAM STERILIZER

Applicant STERIS Corporation

K number K000077

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FLE 2000-02-16

CASTLE SERIES 100HC STEAM STERILIZERS

Applicant Getinge/Castle, Inc.

K number K994314

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FLE 2000-01-10

MIDMARK M4*9 EASYCLAVE STEAM STERILIZER

Applicant Midmark Corp.

K number K992744

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FLE 1999-12-03

PRIMUS STEAM STERILIZERS

Applicant Primus Sterilizer Co., Inc.

K number K991575

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FLE 1999-04-19

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

Applicant Midmark Corp.

K number K990189

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FLE 1999-01-20

STERIS TEN SIXTEEN STEAM STERILIZER

Applicant STERIS Corporation

K number K982332

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FLE 1999-01-04

STATIM 5000 CASSETTE AUTOCLAVE

Applicant Scican

K number K983679

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FLE 1998-06-01

EAGLE CENTURY STEAM STERILIZER

Applicant Amsco Intl., Inc.

K number K964332

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FLE 1998-05-15

THE SYSTEM 2S STEAM STERILIZER

Applicant STERIS Corporation

K number K980014

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FLE 1998-03-03

PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE

Applicant Prestige Medical Corp.

K number K962903

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FLE 1998-02-10

CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)

Applicant Getinge/Castle, Inc.

K number K973225

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FLE 1997-11-12

CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)

Applicant Getinge/Castle, Inc.

K number K970907

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FLE 1997-11-12

TUTTNAUER PREVACUUM TABLE AUTOCLAVE

Applicant Tuttnauer U.S.A Co, Ltd.

K number K962282

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FLE 1997-10-29

TUTTNAUER TABLE-TOP AUTOCLAVE

Applicant Tuttnauer U.S.A Co, Ltd.

K number K973550

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FLE 1997-06-06

STERRADD STERILIZATION SYSTEM

Applicant Advanced Sterilization Products

K number K954142

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FLE 1997-03-04

STRYKER ENCORE STERILIZER

Applicant Stryker Corp.

K number K962755

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FLE 1997-02-28

DELTA

Applicant Pelton & Crane Co.

K number K945117

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FLE 1997-01-30

STERILEMAX

Applicant Barnstead/Thermolyne Corp.

K number K953938

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FLE 1997-01-13

STAT IM 5000 CASSETTE AUTOCLAVE

Applicant Scican

K number K962179

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FLE 1996-10-02

STERIMASTER AUTOCLAVE

Applicant Scican

K number K944036

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FLE 1996-08-15

ACCESS (POWERCLAVE)

Applicant Mdt Biologic Co.

K number K954736

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FLE 1996-06-27

EASTERCLAVE

Applicant Easter Services, Inc.

K number K961230

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FLE 1995-09-29

EASTERCLAVE

Applicant Easter Services, Inc.

K number K951557

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FLE 1995-08-08

BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER

Applicant Buxton Medical Servic Corp.

K number K951273

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FLE 1995-07-07

OCR II & OCM II

Applicant Chambermaid Products Co.

K number K942989

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FLE 1995-04-19

BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER

Applicant Barnard and Assoc.

K number K950341

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FLE 1994-11-30

MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

Applicant Midmark Corp.

K number K936181

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FLE 1994-05-09

PRIMUS PSS SERIES STERILIZERS

Applicant Primus Sterilizer Co., Inc.

K number K926185

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FLE 1994-04-15

SES-2012 AUTOMATIC STEAM STERILIZER

Applicant Porter Instrument Co., Inc.

K number K924596

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FLE 1993-10-15

MDT/HARVEY MC-8 AND MC-10

Applicant Mdt Corp., Inc.

K number K924955

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FLE 1993-07-08

TUTTNAUER LSI (AUTOMATIC)

Applicant Tuttnauer Co. , Ltd.

K number K920478

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FLE 1993-01-29

STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510

Applicant Dept. of the Army

K number K921613

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FLE 1992-08-04

STATIM CASSETT AUTOCLAVE, MODIFICATION

Applicant Scican

K number K915054

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FLE 1992-06-26

EAGLE 3000 SDS

Applicant Amsco Co.

K number K912471

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FLE 1992-04-21

DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY

Applicant Davis & Geck, Inc.

K number K920293

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FLE 1992-03-27

MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER

Applicant Mdt Biologic Co.

K number K910777

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FLE 1991-11-29

MAXIMA-10

Applicant Stirn Industries

K number K911206

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FLE 1991-10-28

STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)

Applicant Mdt Biologic Co.

K number K910778

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FLE 1991-08-26

MODEL #M9 ULTRACLAVE STEAM STERILIZER

Applicant Midmark Corp.

K number K911322

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FLE 1991-08-26

KAVOKLAVE STEAM AUTOCLAVE

Applicant Kavo America

K number K910789

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FLE 1991-05-03

STATIM CASSETTE AUTOCLAVE

Applicant Scican

K number K910241

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FLE 1990-12-14

HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE

Applicant Harvard Apparatus, Inc.

K number K903614

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FLE 1990-11-30

JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT

Applicant Joslyn Valve Corp.

K number K901147

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FLE 1990-11-23

MAC LAVE STEAM STERILIZER

Applicant Merchants Export Development Corp.

K number K895275

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FLE 1990-11-07

HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)

Applicant Harvard Apparatus, Inc.

K number K903613

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FLE 1990-10-01

RACK-IT (R)

Applicant Vengo Industries, Inc.

K number K903096

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FLE 1990-07-27

MODEL #M8 ELECTRONIC STERILIZER

Applicant Midmark Corp.

K number K900432

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FLE 1990-02-22

STEAM STERILIZER (AUTOCLAVE), DENTAL

Applicant Porter Instrument Co., Inc.

K number K895638

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FLE 1989-12-11

PRESSURE STEAM STERILIZERS

Applicant Scientific Device Laboratory, Inc.

K number K895848

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FLE 1989-08-21

MITEK STERILIZATION TRAY

Applicant Mitek Surgical Products, Inc.

K number K893886

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FLE 1989-08-07

RESUBMITTED STC SERIES 8600 AUTOCLAVE

Applicant Sterilizer Technologies Corp.

K number K890359

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FLE 1989-03-29

MULTI-PURPOSE CONTROL SYSTEM

Applicant Colliers Sterilizer Sales & Service Co., Inc.

K number K885140

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FLE 1988-08-12

REBUILDING STERILIZERS

Applicant Mdt Corp., Inc.

K number K882713

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FLE 1988-06-24

MODEL 172-P AND 172-N ROTARY SPRAY ARM

Applicant Boling Precision Components Co.

K number K882465

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FLE 1988-01-27

STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON

Applicant Pharmetics, Inc.

K number K874644

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FLE 1987-04-17

MODIFIED CASTLE POWERCLAVE

Applicant Castle Co.

K number K870975

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FLE 1986-10-22

STARCRAFT ELITE AUTOCLAVE

Applicant Starcraft Medical Corp.

K number K862495

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FLE 1985-09-27

ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000

Applicant Ars Enterprises, Inc.

K number K852114

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FLE 1985-09-27

ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81

Applicant Ars Enterprises, Inc.

K number K852113

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FLE 1985-08-05

ELECTRICALLY HEATED STERILIZER STEAM STERILIZER

Applicant Takizawa Medical Instruments Manufacturer

K number K844649

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FLE 1985-06-04

TUTTNAUER PRE-VACUUM AUTOCLAVE

Applicant Tuttnauer Co. , Ltd.

K number K850264

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FLE 1984-07-26

STERELIS SEALING EQUIPMENT

Applicant Sterelis Corp.

K number K842631

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FLE 1984-07-18

STEAM STERILIZER

Applicant Ars Enterprises, Inc.

K number K831356

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FLE 1984-03-19

ETHYLENE OXIDE DETECTOR GLD-1-07

Applicant Calnor of EL Paseo, Inc.

K number K834152

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FLE 1984-01-11

AMERICAN GOLD SERIES AUTOCLAVE

Applicant Tuttnauer Co. , Ltd.

K number K833837

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FLE 1983-07-27

PORTABLE AUTOCLAVES

Applicant Arnold & Sons

K number K830931

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FLE 1983-02-23

NON-PRESSURE AUTOCLAVE FOR STERILIZATION

Applicant Interdent, Inc.

K number K823457

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FLE 1982-06-22

STEAM STERILIZATION EQUIPMENT

Applicant Getinge International, Inc.

K number K821591

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FLE 1980-06-20

RITTER STERILIZER

Applicant Sybron Corp.

K number K801309

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FLE 1980-01-28

STERILIZING CASE CAT. NO. 65199

Applicant Edward Weck, Inc.

K number K800080

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FLE 1979-12-27

CONTAINER SYSTEM

Applicant Aesculap Instruments Corp.

K number K792558

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FLE 1978-10-24

STERILIZER, EAGLE 2000

Applicant American Sterilizer Co.

K number K781684

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FLE 1977-08-02

STERILIZERS, 3100 SERIES TRIM LINE

Applicant Castle Co.

K number K771229

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FLE 1977-05-20

STERILIZER, SERIES 3000, MODIFICATION TO

Applicant Castle Co.

K number K770682

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FLE 1977-04-29

STEAM STERILIZER, 3000

Applicant Castle Co.

K number K770536

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FLE 1977-04-05

STERILIZER, STEAM, CASTLE 3000

Applicant Castle Co.

K number K770372

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FLE 1977-01-26

CRADLING SYSTEM

Applicant Medin Corp.

K number K761032

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