BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ELMED, INC.

    Reg #: 1412854 · FEI: 1412854 · Expires 2026
    View on FDA
    Products
    83
    Proprietary Names
    37
    Establishment Types
    3
    Classifications
    83

    Registration Details

    Registration Name
    ELMED, INC.
    Registration Number
    1412854
    FEI Number
    1412854
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    35 N Brandon Dr
    City
    Glendale Heights
    State
    IL
    ZIP
    60139
    Country
    US

    Regulatory Submissions

    510(k) Number
    K921770

    Owner / Operator

    Firm Name
    ELMED, INC.
    Operator Number
    1412854
    Address
    35 N BRANDON DRIVE., --
    City
    Glendale Heights
    State
    IL
    Postal Code
    60139
    Country
    US

    Products

    Device Name Product Code
    Probe, Lachrymal HNL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Table And Attachments, Operating-Room BWN
    Laryngoscope, Rigid CCW
    Elevator HTE
    Forceps, Rongeur, Surgical EMH
    Pliers, Surgical HTC
    Rongeur HTX
    Snare, Surgical GAE
    Punch, Biopsy, Surgical EME
    Caliper, Ophthalmic HOE
    Speculum, Rectal FFQ
    Chair, Examination And Treatment FRK
    Retractor, Vaginal HDL
    Scissors, General, Surgical LRW
    Laparoscope, General & Plastic Surgery GCJ
    Clamp, Cannula FKC
    Microscope, Surgical EPT
    Vectorcardiograph DYC
    Forceps, Biopsy, Gynecological HFB
    Hemostat, Surgical EMD
    Scissors, Medical, Disposable JOK
    Chisel, Bone, Surgical EML
    Hammer, Surgical FZY
    Stool, Anesthesia BRX
    Dilator, Cervical, Fixed Size HDQ
    Accessories, Arthroscopic NBH
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Instrument, Ligature Passing And Knot Tying HCF
    Curette, Uterine HCY
    Camera, Still, Endoscopic FXM
    Instruments, Dental Hand DZN
    Instrument, Ent Manual Surgical LRC
    Cannula, Ventricular HCD
    Knife, Surgical EMF
    Instrument, Surgical, Non-Powered HAO
    Basin, Emesis FNY
    Speculum, Ent EPY
    Stainless Steel Instrument, Shunt System Implantation PIY
    Forceps, Ophthalmic HNR
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Accessories, Cleaning Brushes, For Endoscope MNL
    Table, Operating-Room, Electrical GDC
    Applier, Surgical, Clip GDO
    Clamp, Surgical, General & Plastic Surgery GDJ
    Laparoscopic Accessories, Gynecologic NWV
    Scissors, Ophthalmic HNF
    Saw HSO
    Source, Carrier, Fiberoptic Light EQH
    Endoscope, Rigid GCM
    Brush, Biopsy, General & Plastic Surgery GEE
    Unit, Electrosurgical And Coagulation, With Accessories BWA
    Headlamp, Operating, Battery-Operated HPP
    Apparatus, Suturing, Stomach And Intestinal FHM
    Unit, Examining/Treatment, Ent ETF
    Otoscope ERA
    Hook, Surgical, General & Plastic Surgery GDG
    Hook, Fibroid, Gynecological HDE
    Loupe, Diagnostic/Surgical FSP
    Orthopedic Manual Surgical Instrument LXH
    Speculum, Vaginal, Metal HDF
    Specula, Ophthalmic HNC
    Hysteroscope Accessories NWW
    Forceps, Surgical, Gynecological HCZ
    Burr, Orthopedic HTT
    Curette, Surgical, General Use FZS
    Instruments, Surgical, Cardiovascular DWS
    Mallet, Surgical, General & Plastic Surgery GFJ
    Tray, Surgical LRP
    Cannula, Manipulator/Injector, Uterine LKF
    Stimulator, Nerve ETN
    Forceps, General & Plastic Surgery GEN
    Chisel (Osteotome) KDG
    Chair, Surgical, Ac-Powered GBB
    Forceps, Biopsy, Non-Electric FCL
    Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat IMJ
    Cannula, Surgical, General & Plastic Surgery GEA
    Hook, Ophthalmic HNQ
    Laparoscope, Gynecologic (And Accessories) HET
    Scissors, Wire Cutting, Ent, Sterile JYA
    Instrument, Manual, Surgical, General Use MDM
    Retractor GAD
    File HTP

    Proprietary Names

    ESU 100 MEDI-MATIC RIGID LARYNGOSCOPE ELMED RONGEUR FORCEPS ELMED SPECULUM ELMED SCISSORS ELMED Laparoscopic Instruments and Accessories SEILER ESU 120 M/M DIGITAL ORTHOPAEDIC INSTRUMENTS MANUAL ENT INSTRUMENT VENTRICULAR CANNULA Shunt Guide LBC 50-P ACCESSORIES FOR ENDOSCOPES ENDOSCOPIC ACCESSORIES CLIP APPLIER LAPAROSCOPIC INSTRUMENTS DUAL ELMED-SINGLE ENDOSCOPE RIGID GENERAL INSTRUMENTS ELEKTROTOM/ESU ELMED HEADLIGHTS F1 EXAMINATION CHAIR ESU 70 SERIES SYSTEM ELMED MALLET ELMED INSTRUMENT TRAY COHEN CANNULA Stimulating Instrument ELMED FORCEPS BIOPSY FORCEPS ULTRATHERM MARTIN SUPER AUTOMATIC ELMED MANUAL GENERAL INSTRUMENTS RETRACT ROBOT

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)