Is this your brand? Sign in to claim ownership.

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 5 of 5

Device	Model / Reference	Registries	Class	Status
14mm Eye Sphere (non-sterile)	14152	FDA UDI	Class II	Active
12mm Eye Sphere (non-sterile)	14151	FDA UDI	Class II	Active
Silicone Suction Cup (12 pk)	1	FDA UDI	Class I	Unknown
Medium Sterile Eye Conformer with Holes (PMMA)	14268	FDA UDI	Class II	Active
Large Conformer (non-sterile)	14166	FDA UDI	Class II	Active
14mm Sterile Orbital Implant (PMMA)	14252	FDA UDI	Class II	Active
Silicone Eye Sphere - 12mm	14351	FDA UDI	Class II	Unknown
Large Sterile Eye Conformer (PMMA)	14266	FDA UDI	Class II	Active
Luedde Exophthalmometer	1	FDA UDI	Class I	Active
Peds Pack	1	FDA UDI	Class I	Active
22mm Eye Sphere (non-sterile)	14156	FDA UDI	Class II	Active
Large Sterile Eye Conformer with Holes (PMMA)	14269	FDA UDI	Class II	Active
Large Conformer with Holes (non-sterile)	14169	FDA UDI	Class II	Active
Symblepharon Ring - 22mm	14346	FDA UDI	Class II	Unknown
20mm Sterile Orbital Implant (PMMA)	14255	FDA UDI	Class II	Active
Clip-on Spielmann	1	FDA UDI	Class I	Active
Silicone Eye Sphere - 16mm	14353	FDA UDI	Class II	Unknown
14mm Eye Sphere (non-sterile)	14152	FDA UDI	Class II	Active
18mm Eye Sphere (non-sterile)	14154	FDA UDI	Class II	Active
Small Conformer with Holes (non-sterile)	14167	FDA UDI	Class II	Active
Retinoscopy Rack with Compass	1	FDA UDI	Class I	Active
Eye Sphere, Conformers	K972661	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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