Medical Device Manufacturer · US , Mchenry , IL

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

535 submissions · 521 cleared · Since 1980

Recent clearances: Tendon Anchor, Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue, LANDMARK Total Knee System

View 535 510(k) Devices ↓ Official Website

535

Total

521

Cleared

1

Denied

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

86 devices

1-12 of 86

Cleared Oct 27, 2026

General & Plastic Surgery · 29d

Cleared Feb 01, 2021

General & Plastic Surgery · 75d

Cleared Sep 04, 2019

Smith & Nephew DYONICS 25 Fluid Management System

General & Plastic Surgery · 26d

Cleared Sep 29, 2016

General & Plastic Surgery · 423d

Cleared Aug 31, 2016

RENASYS-G Gauze Dressing Kits with Soft Port

General & Plastic Surgery · 30d

Cleared Jul 23, 2015

RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal...

General & Plastic Surgery · 265d

Cleared Jul 16, 2015

RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device

General & Plastic Surgery · 59d

Cleared Apr 29, 2015

General & Plastic Surgery · 196d

Cleared Dec 05, 2013

TFCC FAST-FIX KIT

General & Plastic Surgery · 153d

Cleared Oct 30, 2013

SMITH & NEPHEW ULTRATAPE

General & Plastic Surgery · 93d

Cleared Oct 23, 2013

RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE

General & Plastic Surgery · 78d

Cleared Oct 18, 2012

SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA...

General & Plastic Surgery · 114d

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