Poly Medicure Limited - FDA 510(k) Cleared Devices
Recent clearances: Polywin Safety (14G x 51mm, Polyshield Safety IV Catheters, Nouvo Safety Set
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Poly Medicure Limited General Hospital ✕
6 devices
Cleared
Apr 01, 2026
Polywin Safety (14G x 51mm
General Hospital
233d
Cleared
Nov 05, 2025
Polyshield Safety IV Catheters
General Hospital
72d
Cleared
Mar 15, 2024
Nouvo Safety Set
General Hospital
232d
Cleared
Sep 21, 2023
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
General Hospital
129d
Cleared
May 05, 2023
Polyguard and Polyshield Safety IV Catheters
General Hospital
60d
Cleared
Apr 12, 2023
Polyfusion IV Administration Sets
General Hospital
434d