BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ETHICON, LLC.

    Reg #: 2648650 · FEI: 2648650 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    44
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    ETHICON, LLC.
    Registration Number
    2648650
    FEI Number
    2648650
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Highway 183 Km. 8.3
    City
    San Lorenzo
    State
    PR
    ZIP
    00754
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180829
    PMA Number
    P880047

    Owner / Operator

    Firm Name
    ETHICON INC.
    Operator Number
    2210968
    Address
    1000 US Highway 202 S.
    City
    Raritan
    State
    NJ
    Postal Code
    08869
    Country
    US
    Correspondent
    Reynaldo Librojo

    Products

    Device Name Product Code
    Mesh, Surgical, Polymeric FTL
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Cutaneous Tissue Adhesive With Mesh OMD
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Needle, Cerclage, Gynecological HDH
    Electrode, Pacemaker, Temporary LDF
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Silk GAP
    Suture, Absorbable, Natural GAL
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Barrier, Absorbable, Adhesion MCN
    Instrument, Surgical, Disposable KDC
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Agent, Absorbable Hemostatic, Non-Collagen Based LMG

    Proprietary Names

    PROLENE Polypropylene Mesh PROLENE Hernia System STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device DERMABOND Prineo Skin Closure System (60mm) and DERMABOND Prineo Skin Closure System (22cm) ETHILON Blue Suture DERMABOND PRINEO Skin Closure System (42mm) MERSILENE WHITE WOVEN Polyester Fiber Ligature MERSILENE Tape MERSILENE WHITE WOVEN Polyester Fiber Strip Temporary Cardiac Pacing Wire Surgical Stainless Steel Suture PRONOVA Poly (Hexafluoropropylene - VDF) Suture PERMA-HAND/Mersilk Suture/Silk Suture ETHILON Nylon Suture NUROLON ETHIBOND ETHIBOND EXCEL SURGICAL GUT SUTURE (Plain and Chromic) MERSILENE, MERSUTURE DERMABOND ProPen DERMABOND Mini Topical Skin Adhesive DERMABOND ADVANCED Topical Skin Adhesive STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices GYNEMESH Prolene Soft Mesh INTERCEED GYNECARE INTERCEED Absorbable Adhesion Barrier PROLENE Polypropylene Nonabsorbable Suture PROLENE Soft Polypropylene Mesh Mersilene Tape Nylon Tape ETHIBOND EXCEL VALVE LOOP SUTURE STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device DERMABOND™ PRINEO™ Skin Closure System (22cm) SURGICEL Fibrillar Absorbable Hemostat SURGICEL Nu-Knit Absorbable Hemostat SURGICEL Absorbable Hemostat SURGICEL Powder Absorbable Hemostatic Powder SURGICEL Endoscopic Applicator SURGICEL Snow Absorbable Hemostat

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only