Quantum Inc

FDA Regulatory Profile

Quantum Inc appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (F-0146-2021, Class I) was initiated on November 6, 2020. Its most recent 510(k) clearance was granted on May 30, 2013.

Summary

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

Known Names

quantum, quantum surgical, quantum co

Recent Recalls

NumberClassProductDate
F-0146-2021Class IQuantum Health branded Elderberry liquid herbal extract dietary supplement is packaged in 2oz glass November 6, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K122663ORAMOISTMay 30, 2013