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 & Plastic Surgery ✕
85 devices
Cleared
Feb 01, 2021
FAST-FIX FLEX
General & Plastic Surgery
75d
Cleared
Sep 04, 2019
Smith & Nephew DYONICS 25 Fluid Management System
General & Plastic Surgery
26d
Cleared
Sep 29, 2016
RENASYS GO
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
RENASYS
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
Cleared
May 16, 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
General & Plastic Surgery
296d
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