5 results
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18ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.
FDA Enforcement
Class III
·Terminated·Steris Corporation·July 16, 2014
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
FDA Enforcement
Class III
·Terminated·Steris Corporation·September 12, 2012
AMSCO 400 and AMSCO C Small Steam Sterilizers
FDA Enforcement
Class III
·Terminated·Steris Corporation·November 11, 2015
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
FDA Enforcement
Class III
·Terminated·Steris Corporation·November 25, 2020
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
FDA Enforcement
Class III
·Terminated·Steris Corporation Hopkins Facility·September 21, 2022