Biom'up

FDA Regulatory Profile

Biom'up appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1110-2017, Class II) was initiated on December 2, 2016. Its most recent 510(k) clearance was granted on March 2, 2012.

Summary

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

Known Names

biom'up, biomup

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