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Isotis NV

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061880ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCAugust 15, 2007
K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYMarch 29, 2006
K060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYMarch 27, 2006
K031813OSSATURA DENTALAugust 20, 2004
K041344OPEN BORE SYRINGEJuly 16, 2004
K030131OSSATURA BCP BONE VOID FILLERMay 20, 2003
K010840SYNPLUGApril 20, 2001
K000587SHUTTLE STOPMay 4, 2000