Sofregen Medical, Inc.

FDA Regulatory Profile

Sofregen Medical, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 3, 2024.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K240919Silk Voice (SMI-04)May 3, 2024
K180631Silk VoiceNovember 8, 2018
K172545SERI ContourSeptember 22, 2017