Tepha Incorporated

FDA Regulatory Profile

Tepha Incorporated appears in FDA public data with 1 recall, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0948-2017, Class II) was initiated on November 21, 2016.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Known Names

tepha incorporated, tepha, incorporated

Recent Recalls

NumberClassProductDate
Z-0948-2017Class IIGalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioreNovember 21, 2016