Smith & Nephew Medical Limited - FDA 510(k) Cleared Devices
Recent clearances: BIOBRANE Temporary Wound Dressing, ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, VERSAJET Hydrosurgery System (III)
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smith & Nephew Medical Limited General & Plastic Surgery ✕
20 devices
Cleared
Dec 17, 2024
BIOBRANE Temporary Wound Dressing
General & Plastic Surgery
147d
Cleared
Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite...
General & Plastic Surgery
268d
Cleared
May 16, 2023
VERSAJET Hydrosurgery System (III)
General & Plastic Surgery
410d
Cleared
Nov 22, 2022
Renasys Edge (66803126)
General & Plastic Surgery
54d
Cleared
Jan 14, 2022
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film...
General & Plastic Surgery
479d
Cleared
Jan 05, 2022
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use...
General & Plastic Surgery
250d
Cleared
Oct 30, 2020
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use...
General & Plastic Surgery
88d
Cleared
Dec 05, 2019
PICO 14 Single Use Negative Pressure Wound Therapy System
General & Plastic Surgery
157d
Cleared
Mar 21, 2019
RENASYS Touch
General & Plastic Surgery
255d
Cleared
Jan 18, 2019
PICO 7Y Single Use Negative Pressure Wound Therapy System
General & Plastic Surgery
144d
Cleared
Jan 10, 2019
RENASYS Y-Connector
General & Plastic Surgery
248d
Cleared
Aug 21, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
General & Plastic Surgery
158d