BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Teleflex Medical LLC

    Reg #: 1221601 · FEI: 1221601 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    48
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    Teleflex Medical LLC
    Registration Number
    1221601
    FEI Number
    1221601
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    375 FORBES BLVD.
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K001434

    Owner / Operator

    Firm Name
    Teleflex
    Operator Number
    9062981
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Suture, Absorbable, Synthetic GAN
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Nonabsorbable, Silk GAP
    Suture Kit OVN
    Suture, Nonabsorbable GAO
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Guide, Surgical, Instrument FZX
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Suture, Absorbable, Natural GAL

    Proprietary Names

    NEXTSTITCH POLYETHYLENE SYNTHETIC NONABSORBABL Cottony II, Silky II Polydek Tevdek II MONODEK POLYSORB SYNTHETIC ABSORBABLE SUTUR Force Fiber SAPH IOOP APH IOOP DEKNATEL SAPHLOOP BONDEK BONDEK SYNTHETIC ABSO Deknatel®, Deklene®, Deklene® Maxx™, Capio Polydek Deklene Tevdek Deklene Maxx Cottony Deknatel MULTIPLE POLYAMIDE SYNTH E SUTURES OrthoTape COTTONY II, Silky II, Polydek, MULTIPLE SURGICAL INSTRUMENT GUIDES PILLING Paratrooper Plantar Plate Repair System Force Fiber® Suture Bondek Monodek MULTIPLE STERILE ABSORABLE SUTURES OPTHAMEND Deknatel®, Tevdek®, Capio, LSI, Niceloop, Polydek®, NextStich®, silky, Cottony MULTIPLE STAINLESS STEE and Monofiliment Sutures Stainless Steel, Multifiloment, Polyglycolytic Acid Absorbable Sutr Bondek Plus POLYPROPYLENE SYNTHETIC NONABSORBAB ORTHODEK Nonabsorb Polypropylene Synthetic Suture S-FIBRE BightForceTM ULTRABRAID Force Fiber Fusion MINITAPE POLYPROP, POLYETHYLE NYLON AND SILK

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device