Medical Device Manufacturer · GB , Hull

Smith & Nephew Medical, Ltd.

7 submissions · 7 cleared · Since 2016
7
Total
7
Cleared
0
Denied

Smith & Nephew Medical, Ltd. — FDA 510(k) Submissions

Smith & Nephew Medical, Ltd. has submitted 7 FDA 510(k) premarket notifications since 2016, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Negative Pressure Wound Therapy Powered Suction Pump, Dressing, Wound, Drug . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
K251826 · OMP Negative Pressure Wound... · General & Plastic Surgery
Sep 2025 90d
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
K243576 · OMP Negative Pressure Wound... · General & Plastic Surgery
Feb 2025 91d
Renasys Edge
K231939 · OMP Negative Pressure Wound... · General & Plastic Surgery
May 2024 329d
IODOSORB
K190730 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Dec 2019 274d
IODOFLEX
K190756 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Dec 2019 270d
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
K153209 · OMP Negative Pressure Wound... · General & Plastic Surgery
Aug 2016 273d
PICO Single Use Negative Pressure Wound Therapy System
K151436 · OMP Negative Pressure Wound... · General & Plastic Surgery
Jan 2016 245d
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