Arcoma AB

FDA Regulatory Profile

Arcoma AB appears in FDA public data with 2 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1332-2022, Class II) was initiated on May 5, 2021. Its most recent 510(k) clearance was granted on June 3, 2014.

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