ClearanceBrief
Panels › General Hospital › Product code MEC · Class 2

Disinfector, Medical Devices

Regulation 880.6992

0510(k)s in 12 months (2 all time)
2recalls in 12 months (31 all time)
2recalls that name a 510(k)
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Top companies in MEC

DateFirm and productCodeLinked 510(k)
Dec 11, 2025Steris Corporation
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 soil
Open, Classified
MECNone listed
Dec 11, 2025Steris Corporation
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 soile
Open, Classified
MECNone listed
Oct 1, 2025Getinge Disinfection Ab
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Open, Classified
MECNone listed
May 5, 2025Getinge Disinfection Ab
Washer Disinfector Aquadis 56; Model Number: 56M
Open, Classified
MECNone listed
May 5, 2025Getinge Disinfection Ab
Washer Disinfector Aquadis 56; Model Number: 56A
Open, Classified
MECNone listed
May 17, 2023Steris Corporation
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Open, Classified
MECNone listed
Apr 22, 2022Steris Corporation
Reliance Synergy Washer/Disinfector
Terminated
MECNone listed
Apr 13, 2022Getinge Usa Sales Inc
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
Open, Classified
MECNone listed
Apr 13, 2022Getinge Usa Sales Inc
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
Open, Classified
MECNone listed
Apr 1, 2022Getinge Usa Sales Inc
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Open, Classified
MECNone listed
Dec 21, 2020Getinge Group Logistics America, LLC
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 a
Terminated
MECNone listed
Dec 11, 2020Steris Corporation
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urina
Terminated
MECNone listed
Feb 18, 2020Maquet Cardiovascular Us Sales, Llc
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Terminated
MECNone listed
Jan 16, 2020Maquet Cardiovascular Us Sales, Llc
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 h
Terminated
MECNone listed
Jan 16, 2020Maquet Cardiovascular Us Sales, Llc
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 h
Terminated
MECNone listed
May 20, 2019Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories w
Terminated
MECNone listed
May 20, 2019Maquet Cardiovascular Us Sales, Llc
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laborat
Terminated
MECNone listed
Dec 20, 2018Steris Corporation
AMSCO 5000 Series Washer/Disinfector Model # 5052
Terminated
MECNone listed
Dec 20, 2018Steris Corporation
AMSCO 3000 Series Washer/Disinfector Model # 3052
Terminated
MECNone listed
May 23, 2018Steris Corporation
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level di
Terminated
MECNone listed
Mar 2, 2018Getinge Disinfection Ab
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 co
Terminated
MECNone listed
Mar 2, 2018Getinge Disinfection Ab
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loadi
Terminated
MECNone listed
Jun 2, 2017Natus Medical Incorporated
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and vir
Terminated
MECK081094
Aug 25, 2015Getinge Disinfection Ab
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, a
Terminated
MECNone listed
Dec 23, 2014Getinge Disinfection Ab
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 lab
Terminated
MECNone listed
Jul 10, 2014Steris Corporation
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 bedpan
Terminated
MECNone listed
Oct 17, 2013Getinge Disinfection
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
Terminated
MECNone listed
Aug 1, 2012Steris Corporation
The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellane
Terminated
MECNone listed
Jul 26, 2012Getinge USA Inc
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, s
Terminated
MECNone listed
Sep 1, 2011Steris Corporation
Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensil
Terminated
MECNone listed
Jun 5, 2003Getinge/Castle, Inc.
Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
Terminated
MECK920413

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