234 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
FDA Enforcement
Class II
·Terminated·Steris Corporation·September 5, 2012
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·October 17, 2012
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
FDA Enforcement
Class II
·Ongoing·Steris Corporation·May 10, 2023
3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·April 9, 2014
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 19, 2014
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
FDA Enforcement
Class II
·Terminated·Steris Corporation·July 16, 2014
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 materials used in healthcare facilities.
FDA Enforcement
Class II
·Terminated·Steris Corporation·May 6, 2015
VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 8, 2014
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·May 4, 2016
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·March 20, 2024
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
FDA Enforcement
Class II
·Terminated·Steris Corporation·November 13, 2013
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
FDA Enforcement
Class II
·Ongoing·3M Healthcare Business·November 30, 2022