Smith & Nephew Medical Ltd
HULL East Riding of Yorkshire, GB
Smith & Nephew Medical Ltd appears in FDA device records in HULL East Riding of Yorkshire, GB. FDA records list 32 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 32 510(k) clearances for Smith & Nephew Medical Ltd between 1989 and 2026. The busiest year on record is 2019, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 3 |
| 2016 | 4 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 6 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260646 | RENASYS EDGE (66803126) | OMP | Substantially Equivalent | |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | OMP | Substantially Equivalent | |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port | OMP | Substantially Equivalent | |
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | KGN | Substantially Equivalent | |
| K231939 | Renasys Edge | OMP | Substantially Equivalent | |
| K223526 | 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 | FRO | Substantially Equivalent | |
| K220964 | VERSAJET Hydrosurgery System (III) | FQH | Substantially Equivalent | |
| K213853 | RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large | OMP | Substantially Equivalent | |
| K223041 | Renasys Edge (66803126) | OMP | Substantially Equivalent | |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing | OMP | Substantially Equivalent | |
| K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | QFC | Substantially Equivalent | |
| K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack | OMP | Substantially Equivalent | |
| K190756 | IODOFLEX | FRO | Substantially Equivalent | |
| K190730 | IODOSORB | FRO | Substantially Equivalent | |
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K181822 | RENASYS Touch; RENASYS Y-Connector | OMP | Substantially Equivalent | |
| K182323 | PICO 7Y Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K181204 | RENASYS Y-Connector; RENASYS TOUCH | OMP | Substantially Equivalent | |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K180618 | PICO Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K180614 | PICO Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K172005 | PICO 7 Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K172521 | PICO Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K172519 | PICO Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K163387 | PICO Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K153723 | ACTICOAT Surgical Dressing | FRO | Substantially Equivalent | |
| K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply | OMP | Substantially Equivalent | |
| K161289 | DURAFIBER Ag | FRO | Substantially Equivalent | |
| K151436 | PICO Single Use Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K891444 | PERRY* STERILE X-AM* GLOVES | LYY | Substantially Equivalent | |
| K892353 | PERRY* NON-STERILE X-AM* GLOVES | LYY | Substantially Equivalent | |
| K891712 | PERRY* LATEX FLOOR GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043484 | 3002808194 | Smith & Nephew Medical Ltd | 101 Hessle Road, HULL East Riding of Yorkshire HU3 2BN GB | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FONBag, Drainage, With Adhesive, Ostomy
- FQMBandage, Elastic
- KMFBandage, Liquid
- NECBandage, Liquid, Skin Protectant
- KOZBeads, Hydrophilic, For Wound Exudate Absorption
- PUIDrape, Surgical, Exempt
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- NABGauze / Sponge,Nonresorbable For External Use
- LYYLatex Patient Examination Glove
- FQHLavage, Jet
- FTLMesh, Surgical, Polymeric
- KMIMonitor, Bed Patient
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- FMPProtector, Skin Pressure
- KOXSolvent, Adhesive Tape
- KGXTape And Bandage, Adhesive
- MZRTopical Approximation System
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0516-2025 | 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 fluids, wound exudate and infectious materials. | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. | Class II | Open, Classified | |
| Z-1597-2024 | 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 | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump | Class II | Open, Classified | |
| Z-1596-2024 | 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 | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain