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STERIS Corporation

205 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
AMSCO 700 Steam Sterilizer (K261055)STERIS Corporation2026-06-24
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K251666)STERIS Corporation2026-04-08
Celerity 5 HP Biological Indicator (LCB052) (K260766)STERIS Corporation2026-04-08
Celerity™ 20 HP Biological Indicator (K252680)STERIS Corporation2025-09-24
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048)STERIS Corporation2025-05-02
VERIFY STEAM Integrating Indicator (K243876)STERIS Corporation2025-04-25
PADLOCK CLIP EFTR Kit (00713229) (K250842)STERIS Corporation2025-04-18
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K250044)STERIS Corporation2025-02-06
Celerity Incubator (K250061)STERIS Corporation2025-02-06
Chemical Indicator for enspire CLCSPS (LCC015) (K243475)STERIS Corporation2024-12-04
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433)STERIS Corporation2024-12-02
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (K243075)STERIS Corporation2024-11-08
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K242742)STERIS Corporation2024-10-11
PADLOCK CLIP EFTR Kit (00713229) (K240274)STERIS Corporation2024-09-17
Celerity Chemical Indicator for enspire 3000 CLCSPS (K240032)STERIS Corporation2024-04-17
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (K240352)STERIS Corporation2024-03-06
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K240098)STERIS Corporation2024-02-09
ConFirm 20 Minute Incubator (K233681)STERIS Corporation2023-12-15
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE (K233682)STERIS Corporation2023-12-15
enspire 300 Series Automated Endoscope Reprocessor (K232918)STERIS Corporation2023-10-03
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (K232914)STERIS Corporation2023-10-03
VERIFY Spore Test Strip for S40 Sterilant Concentrate (K231746)STERIS Corporation2023-09-11
Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator (K231490)STERIS Corporation2023-08-07
V-PRO maX 2 Low Temperature Sterilization System (K223476)STERIS Corporation2023-08-07
Vis-U-All Low Temperature Sterilization Pouches (K231500)STERIS Corporation2023-08-07
PRO-LITE Sterilization Tray (K231501)STERIS Corporation2023-08-07
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 (K231878)STERIS Corporation2023-07-25
enspire 300 Series Automated Endoscope Reprocessor System (K230560)STERIS Corporation2023-07-21
Revital-Ox PAA High Level Disinfectant Chemical Indicator (K230558)STERIS Corporation2023-07-17
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (K230930)STERIS Corporation2023-06-30
Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack (K223717)STERIS Corporation2023-06-15
Celerity Incubator (K223715)STERIS Corporation2023-06-15
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K230582)STERIS Corporation2023-03-28
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 (K223466)STERIS Corporation2023-02-17
truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 (K223369)STERIS Corporation2022-12-02
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (K222615)STERIS Corporation2022-09-28
truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 (K222272)STERIS Corporation2022-08-18
Celerity Incubator (K213881)STERIS Corporation2022-07-21
EndoGator Endoscopy Irrigation Tubing (K220395)STERIS Corporation2022-03-11
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K220361)STERIS Corporation2022-03-10
CELERITY HP Chemical Indicator (K213262)STERIS Corporation2022-01-07
Uretero1 Ureteroscope System (K211347)STERIS Corporation2021-11-23
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers (K212424)STERIS Corporation2021-10-28
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) (K212860)STERIS Corporation2021-10-07
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (K211607)STERIS Corporation2021-09-07
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (K210342)STERIS Corporation2021-09-03
AMSCO 600 Medium Steam Sterilizer (K211500)STERIS Corporation2021-08-25
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate (K210737)STERIS Corporation2021-05-12
BioGuard EUS Air/Water and Suction Valves (K202104)STERIS Corporation2021-01-14
Celerity 20 Steam Biological Indicator for IUSS (K202721)STERIS Corporation2021-01-08
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector (K203199)STERIS Corporation2020-12-01
BioShield biopsy valve EUS - Linear (K202583)STERIS Corporation2020-11-06
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) (K203061)STERIS Corporation2020-11-06
STERIS Patient Warming System (K200446)STERIS Corporation2020-06-13
VERIFY Assert Self-Contained Biological Indicator (K200126)STERIS Corporation2020-05-22
Reliance Endoscope Processing System (K200989)STERIS Corporation2020-05-14
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K200577)STERIS Corporation2020-04-03
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile (K191715)STERIS Corporation2020-01-27
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (K192929)STERIS Corporation2019-12-10
Padlock Clip defect closure system, Padlock Pro-Select defect closure device (K192722)STERIS Corporation2019-10-24
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (K191343)STERIS Corporation2019-09-05
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label (K192020)STERIS Corporation2019-09-05
RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K190081)STERIS Corporation2019-08-21
Celerity HP Incubator (K190297)STERIS Corporation2019-05-14
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems (K190917)STERIS Corporation2019-05-09
Avulsion Forceps (K183428)STERIS Corporation2019-04-16
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System (K190103)STERIS Corporation2019-04-05
AMSCO 600 Steam Sterilizer (K183410)STERIS Corporation2019-03-27
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183401)STERIS Corporation2019-03-01
PRO-LITE Sterilization Tray (K183402)STERIS Corporation2019-03-01
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (K182827)STERIS Corporation2019-01-31
VERIFY VH202 Indicator Tape (K183293)STERIS Corporation2019-01-04
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (K182568)STERIS Corporation2019-01-03
PRO-LITE Sterilization Tray (K183301)STERIS Corporation2019-01-03
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack (K183294)STERIS Corporation2019-01-03
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183297)STERIS Corporation2019-01-03
Acu-sInQ Complete Endoscope Cleaning Aid System (K181865)STERIS Corporation2018-12-14
CelerityTM 10 STEAM Chemical Indicator (K182724)STERIS Corporation2018-12-10
CELERITY 20 Steam Biological Indicator (K181686)STERIS Corporation2018-07-24
CELERITY 20 HP Biological Indicator (K181429)STERIS Corporation2018-06-13
VERIFY Assert Self-Contained Biological Indicator (K181442)STERIS Corporation2018-06-13
VERIFY Spore Test Strip for S40 Sterilant (K180553)STERIS Corporation2018-05-29
Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device (K180689)STERIS Corporation2018-04-12
Amsco Evolution Medium Steam Sterilizer (K173481)STERIS Corporation2018-03-09
System 1 endo Liquid Chemical Sterilant Processing System (K173256)STERIS Corporation2018-03-02
VERIFY Chemical Indicator for S40 Sterilant (K173428)STERIS Corporation2018-03-02
CELERITY 20 HP Challenge Pack (K173488)STERIS Corporation2018-03-01
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K173633)STERIS Corporation2018-02-28
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 (K173493)STERIS Corporation2018-02-23
Amsco Evolution Medium Steam Sterilizer (K173485)STERIS Corporation2018-02-22
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) (K173490)STERIS Corporation2018-02-22
CELERITY 20 Steam Process Challenge Device for Gravity Cycles (K173629)STERIS Corporation2018-02-21
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (K173626)STERIS Corporation2018-02-21
CELERITY 20 Steam Biological Indicator (K173634)STERIS Corporation2018-02-12
CELERITY 20 Steam Incubator (K173670)STERIS Corporation2018-02-12
PRO-LITE Sterilization Trays (K172755)STERIS Corporation2018-02-09
CELERITY 20 HP Biological Indicator (K172752)STERIS Corporation2018-02-09
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K172749)STERIS Corporation2018-02-09
VERIFY VH2O2 Indicator Tape (K172753)STERIS Corporation2018-02-09
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label (K172746)STERIS Corporation2018-02-09
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