BEMER INT. AG

FDA Regulatory Profile

BEMER INT. AG appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1105-2021, Class II) was initiated on January 13, 2021. Its most recent 510(k) clearance was granted on September 23, 2023.

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