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Smith & Nephew Medical, Ltd.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest FDA decision2026-05-27
TypeNumberDevice NameCodeDateActions
510(k) K260646 RENASYS EDGE (66803126)OMP2026-05-27 View
510(k) K251826 RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP2025-09-11 View
510(k) K243576 RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft PortOMP2025-02-18 View
510(k) K231939 Renasys EdgeOMP2024-05-24 View
510(k) K190756 IODOFLEXFRO2019-12-20 View
510(k) K190730 IODOSORBFRO2019-12-20 View
510(k) K153209 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power SupplyOMP2016-08-04 View
510(k) K151436 PICO Single Use Negative Pressure Wound Therapy SystemOMP2016-01-28 View
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