BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GULDEN OPHTHALMICS

    Reg #: 2518410 · FEI: 2518410 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    200
    Establishment Types
    4
    Classifications
    35

    Registration Details

    Registration Name
    GULDEN OPHTHALMICS
    Registration Number
    2518410
    FEI Number
    2518410
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    225 CADWALADER AVE.
    City
    Elkins Park
    State
    PA
    ZIP
    19027
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972661

    Owner / Operator

    Firm Name
    GULDEN OPHTHALMICS INC
    Operator Number
    2518410
    Address
    225 CADWALADER AVE., --
    City
    Elkins Park
    State
    PA
    Postal Code
    19027
    Country
    US
    Correspondent
    SEAN T COCKLEY

    Products

    Device Name Product Code
    Tape, Measuring, Rulers And Calipers FTY
    Implant, Eye Sphere HPZ
    Conformer, Ophthalmic HQN
    Tester, Color Vision HIT
    Grid, Amsler HOQ
    Spud, Ophthalmic HNA
    Screen, Tangent, Felt (Campimeter) HOL
    Light, Examination, Medical, Battery Powered KYT
    Ruler, Nearpoint (Punctometer) HLE
    Tape, Nystagmus HKD
    Simulatan (Including Crossed Cylinder) HOR
    Prism, Bar, Ophthalmic HKW
    Rack, Skiascopic HMH
    Device, Fixation, Ac-Powered, Ophthalmic HPL
    Exophthalmometer HLS
    Target, Fusion And Stereoscopic HLP
    Chart, Visual Acuity HOX
    Drum, Opticokinetic HOW
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Prism, Rotary, Ophthalmic HKQ
    Pupillometer, Manual HLH
    Test, Spectacle Dissociation, Battery-Powered (Lancaster) HLO
    Perimeter, Manual HON
    Fixation, Vision Training, Binocular NXR
    Frame, Trial, Ophthalmic HPA
    Distometer HMM
    Inserter/Remover Contact Lens KYE
    Shield, Eye, Radiological IWS
    Magnifier, Hand-Held, Low-Vision HJF
    Clip, Lens, Trial, Ophthalmic HPB
    Needle, Ophthalmic Suturing HNM
    Lens, Maddox HKR
    Dispenser, Liquid Medication KYX
    Instrument, Measuring, Stereopsis HLC
    Retractor, Ophthalmic HNI

    Proprietary Names

    Orbital Sizer Kit Autoclavable Orbital Sizer Kit 10mm Eye Sphere (Sterile) 18mm Eye Sphere (Sterile) 16mm Eye Sphere (Sterile) Small Conformer (Sterile) Large Conformer with Holes (Sterile) 20mm Eye Sphere (Sterile) Medium Conformer (Sterile) Small Conformer with Holes (Sterile) Large Conformer (Sterile) Medium Conformer with Holes (Sterile) 12mm Eye Sphere (Sterile) 14mm Eye Sphere (Sterile) 22mm Eye Sphere (Sterile) Farnsworth Lantern Flashlight Ishihara 24 Plate C Daylight Glasses Ishihara 14 Plate Farnsworth Dichotomous D-15 Compact Magnetic Combined Farnsworth-Lanthony D-15 Circular Magnetic Farnsworth Dichotomous D-15 Combined Farnsworth-Lanthony D-15 Circular Magnetic Lanthony Desaturated D-15 Compact Magnetic Lanthony Desaturated D-15 HRR Pseudoisochromatic Plate Compact Magnetic Farnsworth Dichotomous D-15 Ishihara 38 Plate Lanthony Desaturated D-15 Amsler Grid Book Magnetic Amsler Grids (10pk) Ellis Magnetic Foreign Body Remover Dix Magnetic Foreign Body Remover Tangent Screen Gulden Penlight Lewerenz Accommodation Maddox OculoMotor Assessment Tool (OMAT) Large OculoMotor Assessment Tool (OMAT) R-50 Accommodation Rule Optokinetic Flag Jackson Crossed Cylinder: +/-0.25 & 0.50 Jackson Crossed Cylinder: +/- 0.75 & 10 Color Coded Flipper Set 4 Lens Flipper S-22 Magnetic Stick Prism Set LB-14 & LB-15 Large Prism Bar Set S-16 Prism Set Magnetic Vergence Facility Prism S-16 Universal Prism Set S-22 Universal Prism Set LB-14 Large Vertical Prism Bar Combination Horizontal / Vertical Prism Bar BV-15 Vertical Prism Bar S-4 Prism Set Magnetic Stick Prism LB-15 Large Horizontal Prism Bar B-16 Horizontal Prism Bar Vergence Facility Stick Prism S-16 Magnetic Stick Prism Set BV-15 & B-16 Prism Bar Set Stick Prism Yoked Prism Bar Holder Kit SS-8 Prism Set B-12 Prism Bar Vergence Facility Prism Magnetic Stick S-22 Prism Set MS-10 Prism Set Yoked Prism Bar Holder BV-15 & B-16 Prism Bar Case Set S-8 Prism Set Magnetic Vergence Facility Stick Prism Magnetic Prism Bishop Alignment Prism Set Single Prism Universal Prism Retinoscopy Rack with Compass Retinoscopy Rack Peds Pack Pediatric Fixation Sticks (3pk) Face Fixation Sticks (3pk) Flashing Butterfly Fixation Stick Fixation Sticks (4pk) Flashing Fixation Sticks (2pk) Color Fixation Sticks Pediatric Fixation Wand Luedde Exophthalmometer Fly Stereo Acuity Test Butterfly Stereo Acuity Test Fixi-Tic Pediatric Screening Kit Vision Therapy Kit Neumueller Card Sloan Letter Acuity Chart (3 meter) Adult Near Contrast Test Booklet LEA Symbols Acuity Chart (3 meter) Phoropter Roto Chart Eye Alignment Near Card Adult Screening Kit Accommodation Cards (5pk) Pediatric CPAC Eger Equivalent Near Card Wormington Card Sloan Letter Folding Chart (3 meter) Near Point Card (2pk) Modified Thorington Test Card Optokinetic Drum 10mm Eye Sphere (non-sterile) 22mm Eye Sphere (non-sterile) 18mm Eye Sphere (non-sterile) 14mm Eye Sphere (non-sterile) 20mm Eye Sphere (non-sterile) 12mm Eye Sphere (non-sterile) 16mm Eye Sphere (non-sterile) Eye Shield Adult (Bulk) Eye Shield Child (dz) Eye Shield Adult (dz) Dual Eye Shield Durette Plastic Goggles Orange Eye Shield Eye Shield Foam (12pk) Eye Patch Shield Eye Shield Child (Bulk) Dry Eye Lagophthalmos Kit Lasik Eye Guards (10pk) Maddox Phoria Measure Accurate Pupil Tester (APT) Digital PD Ruler Digital Pupilometer with Vertex Distance Red & Green Trial Lenses Reversed Red & Green Wrap-Around Glasses Child Red & Green Glasses Pediatric Frame #3 Reversed Red & Green Wrap-Around Glasses Adult Red & Green Spectacles Reversed Red & Green Adult Glasses Black Frame #2 Red & Green Wrap-Around Glasses Child Red & Green Pediatric Glasses (6pk) Red & Green Wrap-Around Glasses Adult LED Worth Four Dot Test Reversed Red & Green Glasses Pediatric Frame #4 LED Three Character Test Red & Green Black Frame Glasses (6pk) Red & Green Glasses Adult Black Frame #1 Automated Confrontation Test (ACV) Brock String Medium Conformer (non-sterile) Small Conformer (non-sterile) Small Conformer with Holes (non-sterile) Large Conformer (non-sterile) Small Symblepharon Ring (non-sterile) Medium Conformer with Holes (non-sterile) Medium Symblepharon Ring (non-sterile) Large Symblepharon Ring (non-sterile) Large Conformer with Holes (non-sterile) Universal Trial Frame Universal Lightweight Trial Frame Lens Holder without Scale Lens Holder with Scale Lens Holder Handle Child Trial Frame Lens Holder Kit 8 Well Lens Holder Kit 4 Well Premium Trial Frame Raff Level Trial Flipper Lens Holder Nose Bridge Pediatric Trial Frame Gulden Distometer Silicone Suction Cup (12pk) COX II External Laser Shield - Small COX II External Laser Shield - Extra Small COX II External Laser Shield - Medium Durette IV External Laser Shield Durette III External Laser Shield COX II External Laser Shield - Large Autoclavable Blepharoplasty Ocular Shield MagniTouch 3x LED Magnifier Clip-on Occluder Clip-on Spielmann Opto Clip (2pk) Clip-on Multiple Pinhole Occluder Aurosling Maddox Long 38mm Red & Green Maddox Maddox Short Double Maddox Combo Occluder Occluder & Maddox Maddox & Red Lens Opticare Eye Drop Dispenser (10pk) Magic Touch Eye Drop Applicator Opticare Eye Drop Dispenser Polarized Trial Lenses Occluder & Red Lens Polarized Wrap-Around Glasses Adult Red Lens Long Red Lens Short Polarized Wrap-Around Glasses Child Autoclavable Jaeger Lid Plate Plastic Desmarres Lid Plate Jaeger Lid Plate

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility