Poly Medicure Limited
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories2
Latest Approval2026-04-01
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252513 | 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) | FOZ | 2026-04-01 | View |
| 510(k) | K252677 | Polyshield Safety IV Catheters | FOZ | 2025-11-05 | View |
| 510(k) | K232234 | Nouvo Safety Set | FOZ | 2024-03-15 | View |
| 510(k) | K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | FOZ | 2023-09-21 | View |
| 510(k) | K230616 | Polyguard and Polyshield Safety IV Catheters | FOZ | 2023-05-05 | View |
| 510(k) | K220312 | Polyfusion IV Administration Sets | FPA | 2023-04-12 | View |
No matching devices.