Medical Device Manufacturer · US , Mchenry , IL

Smith & Nephew, Inc. - FDA 510(k) Cleared Devices

532 submissions · 518 cleared · Since 1980

Recent clearances: Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981), AETOS Shoulder System - CONCELOC Glenoids, AETOS Shoulder System Meta Humeral Prosthesis Size 0

Official Website

532

Total

518

Cleared

1

Denied

FDA 510(k) Regulatory Record - Smith & Nephew, Inc. Ear, Nose, Throat ✕

5 devices

1-5 of 5

Cleared Jul 26, 2000

VOCOM SILICONE SYSTEM

Ear, Nose, Throat · 77d

Cleared Mar 01, 2000

VOCOM IMPLANT- 8MM

Ear, Nose, Throat · 13d

Cleared Mar 21, 1997

SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE

Ear, Nose, Throat · 58d

Cleared Feb 26, 1996

VENTILATION TUBES

Ear, Nose, Throat · 25d

Cleared Nov 18, 1994

OTOVIEW TELESCOPIC OTOSCOPES

Ear, Nose, Throat · 109d