2 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 4, 2019
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011