BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLEXBAR MACHINE CORP.

    Reg #: 2424366 · FEI: 2424366 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    51
    Establishment Types
    5
    Classifications
    26

    Registration Details

    Registration Name
    FLEXBAR MACHINE CORP.
    Registration Number
    2424366
    FEI Number
    2424366
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    250 GIBBS RD.
    City
    ISLANDIA
    State
    NY
    ZIP
    11749
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102663

    Owner / Operator

    Firm Name
    FLEXBAR MACHINE CORP., dba Mediflex
    Operator Number
    2424366
    Address
    250 GIBBS RD., --
    City
    Islandia
    State
    NY
    Postal Code
    11749
    Country
    US
    Correspondent
    Keith P Donaldson

    Products

    Device Name Product Code
    Resectoscope, Working Element FDC
    Resectoscope FJL
    Electrode, Electrosurgical, Active, Urological FAS
    Retractor GAD
    Catheter, Cholangiography GBZ
    Laparoscope, General & Plastic Surgery GCJ
    Instrument, Ligature Passing And Knot Tying HCF
    Retainer, Surgical GCZ
    Table And Attachments, Operating-Room BWN
    Guide, Surgical, Instrument FZX
    Orthopedic Manual Surgical Instrument LXH
    Retractor, Self-Retaining FFO
    Pneumoperitoneum Needle FHO
    Retractor, Fiberoptic FDG
    Neurological Stereotaxic Instrument HAW
    Cannula And Trocar, Suprapubic, Non-Disposable FBM
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Support, Patient Position CCX
    Laparoscopic Accessories, Gynecologic NWV
    Gag, Mouth KBN
    Clamp HXD
    Tray, Surgical LRP
    Retractor, Self-Retaining, For Neurosurgery GZT
    Applier, Surgical, Clip GDO
    Tray, Surgical, Instrument FSM

    Proprietary Names

    Mediflex Reusable Electrodes LaproFlex DnyaTrac Retractor Frame Slide-Lock Graspers Micro-Grip Mediflex Knot Pushers Mediflex Needle Holders Skin Hooks Mediflex Cholangiography Catheter Mediflex Laparoscopic Tissue Retrieval Bag Mediflex Multi-Pupose Knot Pusher Mediflex Suture Grasper Closure Device SafePass Suture Grasper Device Surgeon's Sturgeon Mediflex FlexArm Mediflex StrongArm Mediflex Suture Passer Guide Bookler Table Mounted Retractor System FlexGuard Retractor Blade Cushion Lapro-Flex Universal Roundbar Retractor Mini-Bookler Retractor System Nathanson Liver Retractor Hooks Mediflex Laparoscopic Needle Holder Verres Needle Mediflex Retractor, Fiberoptic SUGITA HEADFRAME ADAPTER Mediflex Portland Trocars and Flexible Retractors Mediflex Container System Mediflex Cutting Edge Handle with Ratchet Mediflex Deluxe Laparoscopic Instruments Mediflex 3.5mm Laparoscopic Instruments Mediflex Airway Assist Mediflex One Piece Needle Holder Mediflex Clip Applier Mediflex Modular Needle Holder Mediflex Scope Warmer Mouth Guard with Hex Post CLAMP Freehand Mediflex Sterilization Trays Davida Neurological Retractor System The Cutting Edge Mediflex Lap-Rack GREENBERG INSTRUMENT HOLDER Lap-Rack The Cutting Edge Scissor Handles ZipGrip Scissor Handles The Cutting Edge Disposable Scissor Tips The Cutting Edge Scissor System ZipClip Dispoable Scissor Tips

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)