MAST Biosurgery USA, Inc

FDA Regulatory Profile

MAST Biosurgery USA, Inc appears in FDA public data with 1 recall, 4 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1076-2015, Class II) was initiated on August 26, 2014. Its most recent 510(k) clearance was granted on January 7, 2010.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1076-2015Class IIThe SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 August 26, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K090637CARDIO-WRAPJanuary 7, 2010
K063648SURGI-WRAP MAST TENDON SHEETMarch 7, 2007
K061473SURGI-WRAP MAST BIORESORBABLE SHEETSeptember 21, 2006
K050332SURGI-WRAP MAST BIORESORBABLE SHEETMay 27, 2005