Omnia SRL

FDA Regulatory Profile

Omnia SRL appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1518-2021, Class II) was initiated on March 30, 2021. Its most recent 510(k) clearance was granted on April 6, 2018.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1518-2021Class IIOmnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section March 30, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K180630PTFE SURGICAL SUTUREApril 6, 2018
K132464PTFE SURGICAL SUTUREFebruary 12, 2014
K110724SURGICAL PROCEDURE PACKSJune 23, 2011