Medical Device Manufacturer · US , Mchenry , IL

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

530 submissions · 517 cleared · Since 1980

Recent clearances: AETOS Shoulder System - CONCELOC Glenoids, AETOS Shoulder System Meta Humeral Prosthesis Size 0, AETOS Shoulder System Stemless Humeral Prosthesis

Official Website

530

Total

517

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smith & Nephew, Inc. Neurology ✕

14 devices

1-14 of 14

Cleared Jul 16, 2009

SMITH & NEPHEW RF CANNULATE

Neurology · 101d

Cleared Feb 20, 2009

PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0

Neurology · 79d

Cleared Oct 29, 2008

PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1

Neurology · 79d

Cleared Jul 18, 2008

PIGALILEO 4TH GENERATION SYSTEM

Neurology · 109d

Cleared Jul 20, 2007

MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

Neurology · 72d

Cleared Nov 21, 2006

SMITH & NEPHEW RF CANNULAE

Neurology · 28d

Cleared Sep 10, 2004

SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS

Neurology · 329d

Cleared Mar 16, 2004

SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

Neurology · 83d

Cleared Dec 09, 2002

SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS

Neurology · 192d

Cleared Oct 17, 2002

SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS

Neurology · 136d

Cleared Aug 19, 2002

SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS

Neurology · 24d

Cleared Feb 08, 2002

SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS

Neurology · 161d

Cleared Jan 30, 1984

HYPAL ADHESIVE TAPE

Neurology · 150d

Cleared Mar 31, 1982

TENSOPLAST SKIN TRACTION KIT

Neurology · 23d