MedicalCommunications GmbH

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2673-2025Class IIAshvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2September 9, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K200132AshvinsFebruary 18, 2020