Data / Medical devices / United Kingdom / Smith & Nephew Medical Ltd
Smith & Nephew Medical Ltd: FDA-registered device maker in HULL East Riding of Yorkshire, United Kingdom, 29 510(k) clearances
Smith & Nephew Medical Ltd is registered with the FDA (registration 8043484) in HULL East Riding of Yorkshire, United Kingdom. It lists 20 device types. The FDA files 29 510(k) clearances under its listings, the newest dated September 11, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8043484
- FEI number
- 3002808194
- Address
- 101 Hessle Road, HULL East Riding of Yorkshire, United Kingdom, HU3 2BN
- Owner or operator
- SMITH AND NEPHEW MEDICAL LTD. (9001952)
- Roles
- Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- December 17, 1990
- Registered through
- 2027
- Brand names listed
- ACTICOAT, ACTICOAT 7, ACTICOAT EXFIX, ACTICOAT FLEX, ACTICOAT FLEX 3, ACTICOAT FLEX 7, ACTICOAT Moisture Control, ACTICOAT Post Op and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2026 | K261338 | RENASYS DYNAFLOW Kit (66807741) | OMP | Substantially Equivalent | Smith & Nephew Medical, Ltd. | accessdata.fda.gov |
| May 27, 2026 | K260646 | RENASYS EDGE (66803126) | OMP | Substantially Equivalent | Smith & Nephew Medical, Ltd. | accessdata.fda.gov |
| September 11, 2025 | K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | OMP | Substantially Equivalent | Smith & Nephew Medical, Ltd. | accessdata.fda.gov |
| February 18, 2025 | 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 | Smith & Nephew Medical, Ltd. | accessdata.fda.gov |
| December 17, 2024 | K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | KGN | Substantially Equivalent | Smith & Nephew Medical Limited | accessdata.fda.gov |
| May 24, 2024 | K231939 | Renasys Edge | OMP | Substantially Equivalent | Smith & Nephew Medical, Ltd. | accessdata.fda.gov |
| August 18, 2023 | 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 | Smith & Nephew Medical Limited | accessdata.fda.gov |
| February 10, 2023 | K213853 | RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large | OMP | Substantially Equivalent | Smith and Nephew Medical Limited | accessdata.fda.gov |
| November 22, 2022 | K223041 | Renasys Edge (66803126) | OMP | Substantially Equivalent | Smith & Nephew Medical Limited | accessdata.fda.gov |
| January 14, 2022 | K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing | OMP | Substantially Equivalent | Smith & Nephew Medical Limited | accessdata.fda.gov |
| January 5, 2022 | K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs | OMP | Substantially Equivalent | Smith Nephew Medical Limited | accessdata.fda.gov |
| December 14, 2021 | 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 | Smith and Nephew Medical Limited | accessdata.fda.gov |
| December 20, 2019 | K190756 | IODOFLEX | FRO | Substantially Equivalent | Smith & Nephew Medical, Ltd. | accessdata.fda.gov |
| December 20, 2019 | K190730 | IODOSORB | FRO | Substantially Equivalent | Smith & Nephew Medical, Ltd. | accessdata.fda.gov |
| March 21, 2019 | K181822 | RENASYS Touch; RENASYS Y-Connector | OMP | Substantially Equivalent | Smith & Nephew Medical Limited | accessdata.fda.gov |
| September 29, 2016 | K152163 | RENASYS GO | OMP | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 14, 2016 | K153723 | ACTICOAT Surgical Dressing | FRO | Substantially Equivalent | Smith & Nephew Medical Limited | accessdata.fda.gov |
| August 31, 2016 | K162129 | RENASYS-G Gauze Dressing Kits with Soft Port | OMP | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 3, 2016 | K161289 | DURAFIBER Ag | FRO | Substantially Equivalent | Smith & Nephew Medical Limited | accessdata.fda.gov |
| July 23, 2015 | K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device | OMP | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 15, 2015 | K143115 | The VersaJet II Hydrosurgery System | FQH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 29, 2015 | K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters | OMP | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 22, 2009 | K083113 | ACTICOAT FLEX 7 DRESSING | FRO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 3, 2007 | K063835 | ALLEVYN AG DRESSING | FRO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 21, 2005 | K050030 | ACTICOAT MOISTURE CONTROL DRESSING | FRO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 6, 2000 | K001519 | ACTICOAT 7 DRESSING | FRO | Substantially Equivalent | Westaim Biomedical, Inc. | accessdata.fda.gov |
| June 7, 2000 | K992221 | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | FRO | Substantially Equivalent | Westaim Biomedical, Inc. | accessdata.fda.gov |
| April 28, 1994 | K940414 | IODOFLEX PASTE | KMF | Substantially Equivalent for Some Indications | Oclassen Pharmaceuticals, Inc. | accessdata.fda.gov |
| November 8, 1984 | K842967 | AQUAPHOR R GAUZE | FRO | Substantially Equivalent | Beiersdorf, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 2, 2024 | 95558 | Class II | Ongoing | 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 | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. | accessdata.fda.gov |
| March 11, 2024 | 94248 | Class II | Ongoing | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Lavage, Jet
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Dressing, Wound, Drug
- All makers of Mesh, Surgical, Polymeric
- All makers of Gauze / Sponge,Nonresorbable For External Use
Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.