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Poly Medicure Limited

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2026-04-01
TypeNumberDevice NameCodeDateActions
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)FOZ2026-04-01 View
510(k) K252677 Polyshield Safety IV CathetersFOZ2025-11-05 View
510(k) K232234 Nouvo Safety SetFOZ2024-03-15 View
510(k) K231401 Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaFOZ2023-09-21 View
510(k) K230616 Polyguard and Polyshield Safety IV CathetersFOZ2023-05-05 View
510(k) K220312 Polyfusion IV Administration SetsFPA2023-04-12 View
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