ClearanceBrief
Company ยท GB

Smith & Nephew Medical Limited

FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2026. Name variants (Inc, Corp, punctuation) are merged.

32510(k) clearances (2 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
OMPNegative Pressure Wound Therapy Powered Suction Pump25
FRODressing, Wound, Drug5
LYYLatex Patient Examination Glove3
FQHLavage, Jet1
KGNWound Dressing With Animal-Derived Material(S)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 11, 2026K261338RENASYS DYNAFLOW Kit (66807741)
Smith & Nephew Medical, Ltd., GB
OMP
May 27, 2026K260646RENASYS EDGE (66803126)
Smith & Nephew Medical, Ltd., GB
OMP
Sep 11, 2025K251826RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
Smith & Nephew Medical, Ltd., GB
OMP
Feb 18, 2025K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Tec
Smith & Nephew Medical, Ltd., GB
OMP
Dec 17, 2024K242146BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
Smith & Nephew Medical Limited, GB
KGN
May 24, 2024K231939Renasys Edge
Smith & Nephew Medical, Ltd., GB
OMP
Aug 18, 2023K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum
Smith & Nephew Medical Limited, GB
FRO
May 16, 2023K220964VERSAJET Hydrosurgery System (III)
Smith & Nephew Medical Limited, GB
FQH
Nov 22, 2022K223041Renasys Edge (66803126)
Smith & Nephew Medical Limited, GB
OMP
Jan 14, 2022K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
Smith & Nephew Medical Limited, GB
OMP
Jan 5, 2022K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PIC
Smith Nephew Medical Limited, GB
OMP
Oct 30, 2020K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PIC
Smith & Nephew Medical Limited, GB
OMP
Dec 20, 2019K190756IODOFLEX
Smith & Nephew Medical, Ltd., GB
FRO
Dec 20, 2019K190730IODOSORB
Smith & Nephew Medical, Ltd., GB
FRO
Dec 5, 2019K191760PICO 14 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Mar 21, 2019K181822RENASYS Touch; RENASYS Y-Connector
Smith & Nephew Medical Limited, GB
OMP
Jan 18, 2019K182323PICO 7Y Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Jan 10, 2019K181204RENASYS Y-Connector; RENASYS TOUCH
Smith & Nephew Medical Limited, GB
OMP
Aug 21, 2018K180698PICO 7 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Apr 20, 2018K180618PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Apr 6, 2018K180614PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Feb 2, 2018K172005PICO 7 Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Sep 20, 2017K172521PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Sep 15, 2017K172519PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Apr 18, 2017K163387PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited, GB
OMP
Sep 14, 2016K153723ACTICOAT Surgical Dressing
Smith & Nephew Medical Limited, GB
FRO
Aug 4, 2016K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y
Smith & Nephew Medical, Ltd., GB
OMP
Aug 3, 2016K161289DURAFIBER Ag
Smith & Nephew Medical Limited, GB
FRO
Jan 28, 2016K151436PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical, Ltd., GB
OMP
Sep 19, 1989K891444PERRY* STERILE X-AM* GLOVES
Smith & Nephew Medical
LYY
May 25, 1989K892353PERRY* NON-STERILE X-AM* GLOVES
Smith & Nephew Medical
LYY
Apr 27, 1989K891712PERRY* LATEX FLOOR GLOVES
Smith & Nephew Medical
LYY

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 22, 2024Smith & Nephew Medical, Ltd.
RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body
Open, Classified		 OMPK223041
Apr 18, 2024Smith & Nephew Medical, Ltd.
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Open, Classified		 OMPK223041
Apr 18, 2024Smith & Nephew Medical, Ltd.
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Open, Classified		 OMPK223041
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