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Smith & Nephew Medical, Ltd.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories2
Latest Approval2025-09-11
TypeNumberDevice NameCodeDate
510(k) K251826 RENASYS WOUND+ Dressing Kit with AIRLOCK Technology OMP 2025-09-11 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 Port OMP 2025-02-18 View
510(k) K231939 Renasys Edge OMP 2024-05-24 View
510(k) K190756 IODOFLEX FRO 2019-12-20 View
510(k) K190730 IODOSORB FRO 2019-12-20 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 Supply OMP 2016-08-04 View
510(k) K151436 PICO Single Use Negative Pressure Wound Therapy System OMP 2016-01-28 View