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Fresenius Medical Care North America, Design Cente

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K123630FRESENIUS LIBERTY CYCLERSeptember 9, 2013
K121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)January 17, 2013
K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSJune 15, 2012
K120505FRESENIUS 2008T HEMODIALYSIS MACHINEMarch 6, 2012
K101715FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573December 21, 2010