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Smith & Nephew Medical Limited

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242146BIOBRANE Temporary Wound Dressing; BIOBRANE GloveDecember 17, 2024
K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYAugust 18, 2023
K220964VERSAJET Hydrosurgery System (III)May 16, 2023
K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing LargeFebruary 10, 2023
K223041Renasys Edge (66803126)November 22, 2022
K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingJanuary 14, 2022
K203716PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound ThDecember 14, 2021
K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure WoundOctober 30, 2020
K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemDecember 5, 2019
K181822RENASYS Touch; RENASYS Y-ConnectorMarch 21, 2019
K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemJanuary 18, 2019
K181204RENASYS Y-Connector; RENASYS TOUCHJanuary 10, 2019
K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemAugust 21, 2018
K180618PICO Single Use Negative Pressure Wound Therapy SystemApril 20, 2018
K180614PICO Single Use Negative Pressure Wound Therapy SystemApril 6, 2018
K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemFebruary 2, 2018
K172521PICO Single Use Negative Pressure Wound Therapy SystemSeptember 20, 2017
K172519PICO Single Use Negative Pressure Wound Therapy SystemSeptember 15, 2017
K163387PICO Single Use Negative Pressure Wound Therapy SystemApril 18, 2017
K153723ACTICOAT Surgical DressingSeptember 14, 2016