Fresenius Medical Care

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K2315345008X Hemodialysis SystemFebruary 2, 2024
K141997CRIT-LINE IV SYSTEMApril 1, 2015
K111639FRESENIUS 2008T HEMODIALYSIS MACHINEOctober 21, 2011
K030497FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIESMay 20, 2003
K023162FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETSMarch 20, 2003
K022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOROctober 30, 2002
K994267FRESENIUS 2008KMarch 16, 2000