114 results
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Sources: EU EUDAMED, US FDA
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Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024
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
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
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
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.
FDA Enforcement
Class II
·Terminated·Steris Corporation·July 2, 2014
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2016
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 8, 2014
Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 23, 2016
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
FDA Enforcement
Class II
·Terminated·Steris Corporation·July 3, 2013
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.
FDA Enforcement
Class II
·Terminated·Steris Corporation·October 2, 2013
ALYON Surgical Lighting System
FDA Enforcement
Class II
·Ongoing·Steris Corporation·June 24, 2026
HarmonyAIR A-Series Surgical Lighting System
FDA Enforcement
Class II
·Ongoing·Steris Corporation·June 24, 2026
HarmonyAIR A-Series Surgical Lighting System
FDA Enforcement
Class II
·Ongoing·Steris Corporation·June 24, 2026
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
FDA Enforcement
Class II
·Ongoing·Steris Corporation·February 18, 2026
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
FDA Enforcement
Class II
·Ongoing·Steris Corporation·December 17, 2025
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.
FDA Enforcement
Class II
·Ongoing·Steris Corporation·December 17, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
FDA Enforcement
Class II
·Ongoing·Steris Corporation·August 6, 2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
FDA Enforcement
Class II
·Ongoing·Steris Corporation·August 6, 2025
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
FDA Enforcement
Class II
·Ongoing·Steris Corporation·August 14, 2024