Poly Medicure Limited

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252677Polyshield Safety IV CathetersNovember 5, 2025
K232234Nouvo Safety SetMarch 15, 2024
K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaSeptember 21, 2023
K230616Polyguard and Polyshield Safety IV CathetersMay 5, 2023
K220312Polyfusion IV Administration SetsApril 12, 2023