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Arcoma AB

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1332-2022Class IIOmnera 400A Digital Radiographic SystemMay 5, 2021
Z-1331-2022Class IIOmnera 400T Digital Radiographic SystemMay 5, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K1406830180 INTUITION, 0072 PRECISIONJune 3, 2014
K073632INTUITION, MODEL 0170January 10, 2008