Medical Device Manufacturer · US , Memphis , TN

Smith & Nephew - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2015

Recent clearances: EVOS Pelvic and Acetabular System, EVOS Patella Plates, Footprint Mini PK, 3.5mm Suture Anchor

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17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smith & Nephew General & Plastic Surgery ✕

6 devices

1-6 of 6

Cleared Sep 06, 2022

Smith+Nephew INTELLIO Tablet

General & Plastic Surgery · 67d

Cleared May 13, 2021

Tablet Application

General & Plastic Surgery · 157d

Cleared Jul 17, 2020

S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO,...

General & Plastic Surgery · 74d

Cleared Feb 27, 2020

INTELLIO Tablet Application

General & Plastic Surgery · 142d

Cleared May 21, 2019

Smith & Nephew Tablet Application

General & Plastic Surgery · 95d

Cleared Jun 02, 2016

LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head,...

General & Plastic Surgery · 168d