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 Hospital ✕

14 devices

1-14 of 14

Cleared Jul 15, 2015

The VersaJet II Hydrosurgery System

General Hospital · 258d

Cleared Aug 01, 2011

VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES,...

General Hospital · 118d

Cleared Nov 22, 2010

SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428

General Hospital · 116d

Cleared Jul 02, 2009

SMITH & NEPHEW INSTRUMENT TRAYS

General Hospital · 29d

Cleared Mar 18, 2009

SMITH & NEPHEW INSTRUMENT TRAYS

General Hospital · 16d

Cleared Feb 26, 2007

CAPTION APPLICATOR

General Hospital · 96d

Cleared Feb 14, 2006

LEVELERT II FLUID LEVEL SENSOR

General Hospital · 27d

Cleared Aug 23, 2004

SMITH & NEPHEW GRAFT DELIVERY SYSTEM

General Hospital · 32d

Cleared Apr 17, 2002

MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS

General Hospital · 23d

Cleared Mar 09, 1998

SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS

General Hospital · 59d

Cleared May 01, 1995

HYPO(R) SAFETY CARTRIDGE SYRINGE

General Hospital · 497d

Cleared Jul 19, 1991

PERRY NATURAL POWDER FREE GLOVES

General Hospital · 24d

Cleared Jul 31, 1987

General Hospital · 18d

Cleared Jul 28, 1987

OPSITE SPECIALITY DRAPES

General Hospital · 15d