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BEMER INT. AG

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1105-2021Class IIBemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX ProfeJanuary 13, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K223919B.Light Clear Evo and B.Light Restore EvoSeptember 23, 2023
K231368Bemer Therapy System EvoJune 9, 2023
K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetFebruary 4, 2021
K151834BEMER Classic Set, BEMER Pro-SetFebruary 22, 2017