# Gulden Ophthalmics

- Location (FDA's records): Elkins Park, PA
- FDA decisions: 1 (1997–1997): 1 510(k) clearance
- Product codes: HPZ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Storz Instrument Co.: 1 (https://510kreport.com/company/storz-instrument)

## Firms that cite its devices most
- Becker & Associates Consulting, Inc.: 1 (https://510kreport.com/company/becker-associates-consulting)
- Product and Educational Services, LLC: 1 (https://510kreport.com/company/product-and-educational-services)

## Its most-cited devices
- K972661: Eye Sphere, Conformers (1997), cited by 2

## Recent decisions
- K972661: Eye Sphere, Conformers (Oct 3, 1997)

Source page: https://510kreport.com/company/gulden-ophthalmics