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)
Top companies in MEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Steris Corporation | 0 | 11 |
| Getinge Disinfection | 0 | 8 |
| Maquet Cardiovascular Us Sales, Llc | 0 | 5 |
| Getinge Usa Sales Inc | 0 | 3 |
| Getinge USA Inc | 0 | 1 |
| Getinge/Castle, Inc. | 0 | 1 |
| Getinge Group Logistics America, LLC | 0 | 1 |
| Hamo USA, Inc. | 1 | 0 |
| Natus Medical Incorporated | 0 | 1 |
| Olympic Medical Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Steris 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 |
MEC | None listed |
| Dec 11, 2025 | Steris 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 |
MEC | None listed |
| Oct 1, 2025 | Getinge Disinfection Ab Getinge 88-Series Washer- Disinfector. Model Number: 88-5. Open, Classified |
MEC | None listed |
| May 5, 2025 | Getinge Disinfection Ab Washer Disinfector Aquadis 56; Model Number: 56M Open, Classified |
MEC | None listed |
| May 5, 2025 | Getinge Disinfection Ab Washer Disinfector Aquadis 56; Model Number: 56A Open, Classified |
MEC | None listed |
| May 17, 2023 | Steris Corporation Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 Open, Classified |
MEC | None listed |
| Apr 22, 2022 | Steris Corporation Reliance Synergy Washer/Disinfector Terminated |
MEC | None listed |
| Apr 13, 2022 | Getinge 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 |
MEC | None listed |
| Apr 13, 2022 | Getinge 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 |
MEC | None listed |
| Apr 1, 2022 | Getinge Usa Sales Inc Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. Open, Classified |
MEC | None listed |
| Dec 21, 2020 | Getinge 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 |
MEC | None listed |
| Dec 11, 2020 | Steris 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 |
MEC | None listed |
| Feb 18, 2020 | Maquet 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 |
MEC | None listed |
| Jan 16, 2020 | Maquet 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 |
MEC | None listed |
| Jan 16, 2020 | Maquet 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 |
MEC | None listed |
| May 20, 2019 | Maquet 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 |
MEC | None listed |
| May 20, 2019 | Maquet 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 |
MEC | None listed |
| Dec 20, 2018 | Steris Corporation AMSCO 5000 Series Washer/Disinfector Model # 5052 Terminated |
MEC | None listed |
| Dec 20, 2018 | Steris Corporation AMSCO 3000 Series Washer/Disinfector Model # 3052 Terminated |
MEC | None listed |
| May 23, 2018 | Steris 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 |
MEC | None listed |
| Mar 2, 2018 | Getinge 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 |
MEC | None listed |
| Mar 2, 2018 | Getinge 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 |
MEC | None listed |
| Jun 2, 2017 | Natus 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 |
MEC | K081094 |
| Aug 25, 2015 | Getinge 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 |
MEC | None listed |
| Dec 23, 2014 | Getinge 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 |
MEC | None listed |
| Jul 10, 2014 | Steris 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 |
MEC | None listed |
| Oct 17, 2013 | Getinge 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 |
MEC | None listed |
| Aug 1, 2012 | Steris 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 |
MEC | None listed |
| Jul 26, 2012 | Getinge 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 |
MEC | None listed |
| Sep 1, 2011 | Steris 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 |
MEC | None listed |
| Jun 5, 2003 | Getinge/Castle, Inc. Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden. Terminated |
MEC | K920413 |
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