Novus Scientific Ab

FDA Regulatory Profile

Novus Scientific Ab appears in FDA public data with 1 recall, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2603-2016, Class II) was initiated on July 19, 2016. Its most recent 510(k) clearance was granted on March 26, 2020.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2603-2016Class IITIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030July 19, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshMarch 26, 2020
K163005TIGR Matrix Surgical MeshJuly 27, 2017