Premier North America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233862NUNA LUX (NUNL528)March 1, 2024
K232656BLU TOTALE (Model: ENEOB852)November 14, 2023
K220735Avologi Gel Primer (Model: Av25)September 15, 2023
K214100LuminiceFebruary 24, 2022
K213841ENEO TOTALE (Model: ENEOT947)January 6, 2022
K181659Avologi ENEOJuly 26, 2018