BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Smith & Nephew, Inc.

    Reg #: 3010034780 · FEI: 3010034780 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    49
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    Smith & Nephew, Inc.
    Registration Number
    3010034780
    FEI Number
    3010034780
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2225 Cedars Rd Ste A
    City
    Lawrenceville
    State
    GA
    ZIP
    30043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102001

    Owner / Operator

    Firm Name
    SMITH & NEPHEW, INC.
    Operator Number
    9002406
    Address
    150 Minuteman Road
    City
    Andover
    State
    MA
    Postal Code
    01810
    Country
    US
    Correspondent
    Beth - Zis

    Products

    Device Name Product Code
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Drape, Adhesive, Aerosol KGT
    Dressing, Wound And Burn, Occlusive MGP
    Bandage, Liquid KMF
    Mesh, Surgical, Polymeric FTL
    Dressing, Wound, Drug FRO
    Dressing, Wound, Hydrophilic NAC
    Bandage, Liquid, Skin Protectant NEC
    Lavage, Jet FQH
    Beads, Hydrophilic, For Wound Exudate Absorption KOZ
    Bag, Drainage, With Adhesive, Ostomy FON
    Drain, Tee (Water Trap) BYH
    Accessories, Catheter KGZ
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Gauze / Sponge,Nonresorbable For External Use NAB
    Solvent, Adhesive Tape KOX
    Dressing, Wound, Occlusive NAD
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    Renasys Gel Adhesive SOLOSITE Conformable SOLOSITE Gel Renasys EZ PLUS Renasys Adhesive Gel Patch Renasys EZ CicaNet No-Sting Skin Prep Renasys F/-AB Abdominal Wound Dressing Kit ALLEVYN Modification to VersaTile 1 Wound V NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM EXU-DRY CONFORMANT 2 SKIN PREP VERSAJET SYSTEMS VersaJet II Hydrosurgery System Renasys Go Negative Pressure RENASYS AB Abdominial Kit with Soft Port No-Sting Skin-Prep Secura No-Sting Skin-Prep IODOSORB GEL VISCOPASTE URI-KLEEN DETERGENT BANISH II LIQUID DEODORANT Tincture Benzoin RENASYS Touch Renasys -F Foam Dressing Kit Versatile 1 EZcare Wound Vacuum Sys VersaJet Hydrosurgery System AQUALERT DERMIVEX RENASYS Foam & gauze NPWT Wound Dressing Kits with Softport Flexigel PROFORE Wound Contact Layer DRYNET TRICOTEX IODOFLEX PADS UNISOLVE ADHESIVE REMOVER REMOVE Versatil 1 Wound Vacuum System REPLICARE REPLICARE Thin REPLICARE Ultra NPWT TRANSPARENT ADHESIVE DRESSING Replicare Ultra CovRSite PRIMAFIX PLUS BlueSky Vista Wound Vacuum System

    Establishment Types

    Repack or Relabel Medical Device