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Biom'up

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1110-2017Class IIRENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.December 2, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K103081COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANEMarch 2, 2012
K103087COVAMAX RESORBABLE COLLAGEN MEMBRANEAugust 26, 2011