Smith & Nephew Medical, Ltd.
Smith & Nephew Medical, Ltd. holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2026, with 3 FDA device recalls on record.
Top product codes for Smith & Nephew Medical, Ltd.
FDA recalls by Smith & Nephew Medical, Ltd.
- Z-0516-2025 — RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
- Z-1596-2024 — RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
- Z-1597-2024 — RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Smith & Nephew Medical, Ltd.
- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K260646 — RENASYS EDGE (66803126)
- K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
- K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port +1 more
- K231939 — Renasys Edge
- K190730 — IODOSORB
- K190756 — IODOFLEX
- 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
- K151436 — PICO Single Use Negative Pressure Wound Therapy System
Data sourced from openFDA. This site is unofficial and independent of the FDA.