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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Ohlson Vital Stain Enhancement Filter	12135	EUDAMED	Class I	Active
Occluder White	12117	EUDAMED	Class I	Active
Stick Prism - 14 Diopter	11104-14	EUDAMED	Class I	Active
Single Prism - 5 Diopter	11101-5	EUDAMED	Class I	Active
Magnetic Stick Prism - 15 Diopter	11204-15	EUDAMED	Class I	Active
Magnetic Prism - 14 Diopter	11201-14	EUDAMED	Class I	Active
LED Worth Four Dot Test	15304	EUDAMED	Class I	Active
Reverse Red & Green Adult Black Frame #2	19002	EUDAMED	Class I	Active
Lens Holder with Scale	15143	EUDAMED	Class I	Active
Stick Prism - 18 Diopter	11104-18	EUDAMED	Class I	Active
Single Prism - 16 Diopter	11101-16	EUDAMED	Class I	Active
Maddox Long	12113	EUDAMED	Class I	Active
Brock String	15133	EUDAMED	Class I	Active
Polarized Wrap-Around Glasses, Adult	15200	EUDAMED	Class I	Active
Magnetic Prism - 1 Diopter	11201-1	EUDAMED	Class I	Active
Eye Shield, Adult (dz)	14203	EUDAMED	Class I	Active
Occluder & Maddox	12122	EUDAMED	Class I	Active
LED Three Character Test	15305	EUDAMED	Class I	Active
Maddox Phoria Measure	12136	EUDAMED	Class I	Active
Single Prism - 6 Diopter	11101-6	EUDAMED	Class I	Active
MS-10 Prism Set	11310	EUDAMED	Class I	Active
Red & Green Adult Black Frame #1	19001	EUDAMED	Class I	Active
Single Prism - 30 Diopter	11101-30	EUDAMED	Class I	Active
Magnetic Stick Prism - 25 Diopter	11204-25	EUDAMED	Class I	Active
Magnetic Prism - 9 Diopter	11201-9	EUDAMED	Class I	Active
Compact Magnetic Lanthony Desaturated D-15	15107	EUDAMED	Class I	Active
Occluder Black	12112	EUDAMED	Class I	Active
Stick Prism - 16 Diopter	11104-16	EUDAMED	Class I	Active
BV-15 & B-16 Prism Bar Case Set	11L14	EUDAMED	Class I	Active
Magnetic Stick Prism - 18 Diopter	11204-18	EUDAMED	Class I	Active
Reverse Red & Green Pediatric Frame #4	19004	EUDAMED	Class I	Active
Single Prism - 25 Diopter	11101-25	EUDAMED	Class I	Active
Stick Prism - 12 Diopter	11104-12	EUDAMED	Class I	Active
Eye Shield, Adult (Bulk)	14100	EUDAMED	Class I	Active
Stick Prism - 1/2 Diopter	11104-1/2	EUDAMED	Class I	Active
Magnetic Prism - 8 Diopter	11201-8	EUDAMED	Class I	Active
Single Prism - 1/2 Diopter	11101-1/2	EUDAMED	Class I	Active
Magnetic Stick Prism - 45 Diopter	11204-45	EUDAMED	Class I	Active
Lens Holder Kit 4 Well	15144	EUDAMED	Class I	Active
Stick Prism - 4 Diopter	11104-4	EUDAMED	Class I	Active
Flipper 6 Holder	11122	EUDAMED	Class I	Active
Magnetic Stick Prism - 8 Diopter	11204-8	EUDAMED	Class I	Active
Stick Prism - 7 Diopter	11104-7	EUDAMED	Class I	Active
Magnetic Prism - 4 Diopter	11201-4	EUDAMED	Class I	Active
Magnetic Prism - 40 Diopter	11201-40	EUDAMED	Class I	Active
Single Prism - 45 Diopter	11101-45	EUDAMED	Class I	Active
S-16 Prism Set	11L16	EUDAMED	Class I	Active
Magnetic Stick Prism - 6 Diopter	11204-6	EUDAMED	Class I	Active
Circular Magnetic Lanthony Desaturated D-15	15110	EUDAMED	Class I	Active
S-8 Prism Set	11308	EUDAMED	Class I	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