Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518410

FEI Number

2518410

Entity Name

GULDEN OPHTHALMICS

City/State/Country

Elkins Park, PA, US

Establishment Address

225 CADWALADER AVE., Elkins Park, PA 19027, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GULDEN OPHTHALMICS INC (Owner Number: 2518410)

Owner / Operator Contact Address

225 CADWALADER AVE., --, Elkins Park, PA 19027, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2017-04-10
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2020-02-25
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2020-02-25
HIT	Tester, Color Vision	Ophthalmic	Class 1	886.1170	2004-02-05
HOQ	Grid, Amsler	Ophthalmic	Class 1	886.1330	1999-03-02
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-03-02
HOL	Screen, Tangent, Felt (Campimeter)	Ophthalmic	Class 1	886.1810	2017-04-10
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2023-06-28
HLE	Ruler, Nearpoint (Punctometer)	Ophthalmic	Class 1	886.1790	2004-06-28
HKD	Tape, Nystagmus	Ophthalmic	Class 1	886.1905	2023-06-28
HOR	Simulatan (Including Crossed Cylinder)	Ophthalmic	Class 1	886.1840	2023-06-28
HKW	Prism, Bar, Ophthalmic	Ophthalmic	Class 1	886.1650	1992-08-26
HMH	Rack, Skiascopic	Ophthalmic	Class 1	886.1750	1999-03-02
HPL	Device, Fixation, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1290	1999-03-02
HLS	Exophthalmometer	Ophthalmic	Class 1	886.1270	2004-06-28
HLP	Target, Fusion And Stereoscopic	Ophthalmic	Class 1	886.1880	1999-03-02
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	1993-11-10
HOW	Drum, Opticokinetic	Ophthalmic	Class 1	886.1200	2004-02-05
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2007-11-08
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1992-08-26
HKQ	Prism, Rotary, Ophthalmic	Ophthalmic	Class 1	886.1665	2017-04-10
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2023-06-28
HLO	Test, Spectacle Dissociation, Battery-Powered (Lancaster)	Ophthalmic	Class 1	886.1910	1995-03-21
HON	Perimeter, Manual	Ophthalmic	Class 1	886.1605	2023-06-28
NXR	Fixation, Vision Training, Binocular	Ophthalmic	Class 1	886.1290	2023-06-28
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2004-06-28
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2017-04-10
HMM	Distometer	Ophthalmic	Class 1	886.1190	2014-03-25
KYE	Inserter/Remover Contact Lens	Ophthalmic	Class 1	886.5420	2023-06-28
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2016-08-31
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	1999-03-02

Official Correspondent

SEAN COCKLEY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GULDEN OPHTHALMICS INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2007	Integrated Orbital Implants Inc	2	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518410. Last updated year: 2026. Please use registration number 2518410 when referencing this establishment in official correspondence.