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Sources: EU EUDAMED, US FDA
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Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items must be further processed through terminal sterilization before use in any surgical procedure.
FDA Enforcement
Class II
·Terminated·Getinge Group Logistics America, LLC·February 24, 2021
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
FDA Enforcement
Class II
·Terminated·Getinge USA Inc·August 1, 2012
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection·October 23, 2013
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection Ab·April 25, 2018
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection Ab·April 25, 2018
Washer Disinfector Aquadis 56; Model Number: 56A
FDA Enforcement
Class II
·Ongoing·Getinge Disinfection Ab·May 14, 2025
Washer Disinfector Aquadis 56; Model Number: 56M
FDA Enforcement
Class II
·Ongoing·Getinge Disinfection Ab·May 14, 2025
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection Ab·December 31, 2014
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class III
·Terminated·Getinge Disinfection Ab·August 26, 2015
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
FDA Enforcement
Class II
·Ongoing·Getinge Disinfection Ab·October 8, 2025
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
FDA Enforcement
Class III
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 4, 2020
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
FDA Enforcement
Class III
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 4, 2020
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·March 18, 2020
Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·June 15, 2022
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·June 15, 2022