Flosonics Medical (R/A 1929803 ONTARIO CORP.)

FDA Regulatory Profile

Flosonics Medical (R/A 1929803 ONTARIO CORP.) appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2517-2025, Class III) was initiated on August 7, 2025. Its most recent 510(k) clearance was granted on March 24, 2020.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2517-2025Class IIIFloPatch FP120, REF: FP120-FOT01-005August 7, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K200337FloPatch (FP120)March 24, 2020
K191388FloPatch (FP110)June 21, 2019