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Gulden Ophthalmics

United States·US-MF-000008608

Last updated September 17, 2026

About

Over 80 years of experience have earned Gulden Ophthalmics a place as an undisputed thought leader and respected industry expert in ophthalmic instruments and devices.

From the manufacturer's own website. Source

Information

Country: United States
Address: 225, Cadwalader Avenue, Elkins Park, United States
Website: www.guldenophthalmics.com
LinkedIn: linkedin.com/company/gulden-ophthalmics
Facebook: facebook.com/pages/category/Company/Gulden-Ophthalmics-335150849939078
Email: [email protected]
Phone: 215-884-8105
PRRC Contact: Steven McLaughlin
EUDAMED SRN: US-MF-000008608
FDA FEI Number: 2518410
DUNS Number: —

Catalogue (222)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Magnetic Prism - 12 Diopter	11201-12	EUDAMED	Class I	Active
Magnetic Prism - 6 Diopter	11201-6	EUDAMED	Class I	Active
Stick Prism - 6 Diopter	11104-6	EUDAMED	Class I	Active
LB-15 Large Horizontal Prism Bar	11112	EUDAMED	Class I	Active
Flashing Fixation Sticks (2pk)	1	FDA UDI	Class I	Active
Ellis Magnetic Foreign Body Remover	1	FDA UDI	Class I	Active
Medium Conformer with Holes (non-sterile)	14168	FDA UDI	Class II	Active
12mm Eye Sphere (non-sterile)	14151	FDA UDI	Class II	Active
Symblepharon Ring - 24mm	14347	FDA UDI	Class II	Unknown
Medium Sterile Eye Conformer (PMMA)	14265	FDA UDI	Class II	Active
Tangent Screen	1	FDA UDI	Class I	Active
12mm Sterile Orbital Implant (PMMA)	14251	FDA UDI	Class II	Active
Orbital Implant Sizer Kit	1	FDA UDI	Class I	Active
Symblepharon Ring - 20mm	14345	FDA UDI	Class II	Unknown
Opto Clip (2 pk)	1	FDA UDI	Class I	Active
Small Sterile Eye Conformer (PMMA)	14264	FDA UDI	Class II	Active
16mm Eye Sphere (non-sterile)	14153	FDA UDI	Class II	Active
Schioetz Tonometer - Allen Wrench Modification	13110	FDA UDI	Class II	Unknown
22mm Sterile Orbital Implant (PMMA)	14256	FDA UDI	Class II	Active
Dix Magnetic Foreign Body Remover	1	FDA UDI	Class I	Active
Medium Conformer (non-sterile)	14165	FDA UDI	Class II	Active
10mm Sterile Orbital Implant (PMMA)	14250	FDA UDI	Class II	Active
Clip-on Multiple Pinhole Occluder	1	FDA UDI	Class I	Active
22mm Eye Sphere (non-sterile)	14156	FDA UDI	Class II	Active
Brock String	1	FDA UDI	Class I	Active
Silicone Eye Sphere - 22mm	14356	FDA UDI	Class II	Unknown
Schioetz Tonometer	13107	FDA UDI	Class II	Unknown
18mm Sterile Orbital Implant (PMMA)	14254	FDA UDI	Class II	Active
10mm Eye Sphere (non-sterile)	14150	FDA UDI	Class II	Active
Face Fixation Sticks (3pk)	1	FDA UDI	Class I	Active
Flashing Butterfly Fixation Stick	1	FDA UDI	Class I	Active
10mm Eye Sphere (non-sterile)	14150	FDA UDI	Class II	Active
Jaeger Lid Plate	1	FDA UDI	Class I	Active
Small Conformer (non-sterile)	14164	FDA UDI	Class II	Active
16mm Sterile Orbital Implant (PMMA)	14253	FDA UDI	Class II	Active
Small Sterile Eye Conformer with Holes (PMMA)	14267	FDA UDI	Class II	Active
Retinoscopy Rack	1	FDA UDI	Class I	Active
Silicone Suction Cup (10pk)	2	FDA UDI	Class I	Active
16mm Eye Sphere (non-sterile)	14153	FDA UDI	Class II	Active
Silicone Eye Sphere - 14mm	14352	FDA UDI	Class II	Unknown
20mm Eye Sphere (non-sterile)	14155	FDA UDI	Class II	Active
18mm Eye Sphere (non-sterile)	14154	FDA UDI	Class II	Active
Clip-on Occluder	1	FDA UDI	Class I	Active
Silicone Eye Sphere - 20mm	14355	FDA UDI	Class II	Unknown
20mm Eye Sphere (non-sterile)	14155	FDA UDI	Class II	Active
Pediatric Fixation Sticks (3pk)	1	EUDAMEDFDA UDI	Class I	Active
Pediatric Fixation Wand	1	FDA UDI	Class I	Active
Fixation Sticks (4pk)	1	FDA UDI	Class I	Active
Silicone Eye Sphere - 18mm	14354	FDA UDI	Class II	Unknown
Color Fixation Sticks	1	EUDAMEDFDA UDI	Class I	Active

Related Companies

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Authorities

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FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 29, 2002	Z-0531-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0538-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0534-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0537-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0533-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0535-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0530-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0536-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0528-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0539-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0529-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0532-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0540-03	—	terminated	lack of sterility assurance