Unicare Biomedical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K151344Cytoflex Tefguard Ti-Enforced MembraneNovember 19, 2015
K092567MODIFICATION TO UNIGRAFTNovember 25, 2009
K090612BENACELJuly 24, 2009
K090083CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090March 23, 2009
K080532BENACEL, MODELS C-001, C-002 AND C-005November 12, 2008
K021511CYTOFLEX MESHAugust 6, 2002
K020720OSSIFORMMay 7, 2002
K012144CYTOFLEXOctober 1, 2001
K003457UNIGRAFTJanuary 9, 2001
K993784UNIGRAFTJanuary 27, 2000
K982699UNIGRAFEOctober 20, 1998