Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
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
532
Total
518
Cleared
1
Denied
FDA 510(k) Regulatory Record - Smith & Nephew, Inc. General Hospital ✕
14 devices
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
THEATRE GOWNS
General Hospital
18d
Cleared
Jul 28, 1987
OPSITE SPECIALITY DRAPES
General Hospital
15d