# Opko Health, Inc.

- Location (FDA's records): Miami, FL
- FDA decisions: 2 (2008–2021): 1 510(k) clearance and 1 original PMA approval
- Product codes: OBO (1), QRF (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ophthalmic Technologies, Inc.: 1 (https://510kreport.com/company/ophthalmic-technologies)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)

## Firms that cite its devices most
- Optos Plc.: 1 (https://510kreport.com/company/optos)

## Its most-cited devices
- K080460: Spectral Oct/Slo (2008), cited by 1

## Recent decisions
- P190022: 4Kscore Test (Dec 7, 2021)
- K080460: Spectral Oct/Slo (Nov 14, 2008)

Source page: https://510kreport.com/company/opko-health