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Poly Medicure Limited FDA Approvals
0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)510(k)Apr 1, 2026General Hospital |
| Polyshield Safety IV Catheters510(k)Nov 5, 2025General Hospital |
| Nouvo Safety Set510(k)Mar 15, 2024General Hospital |
| Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva510(k)Sep 21, 2023General Hospital |
| Polyguard and Polyshield Safety IV Catheters510(k)May 5, 2023General Hospital |
| Polyfusion IV Administration Sets510(k)Apr 12, 2023General Hospital |