Getinge USA, Inc.
Medical device manufacturer in Rochester, NY.
4510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K050664 | Spor-Test Pa Biological Indicator KitFRC · Special | 04/07/2005SE |
| K032723 | Biosign STEAM-24 Biological IndicatorFRC · Special | 10/01/2003SE |
| K031647 | Biosign Ssi Biological Test Pack with Instant Readout IntegratorJOJ · Traditional | 07/29/2003SE |
| K031259 | Model 833HC Vacuum/Gravity Steam SterilizerFLE · Special | 05/12/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1994-2013 Class II | Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and…AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This… | 08/02/2013Terminated |
| Z-2079-2012 Class II | Getinge brand --- large capacity, floor loading jet spray, washers for mechanical…Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated… | 05/25/2012Terminated |