Company ยท US
Getinge Disinfection Ab
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1995. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |