# Oneness Biotech Co., Ltd.

- Location (FDA's records): Taipei, TW
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: FRO (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stemcyte, Inc.: 1 (https://510kreport.com/company/stemcyte)
- Valeant Pharmaceuticals: 1 (https://510kreport.com/company/valeant-pharmaceuticals)

## Its most-cited devices
- K251093: Bonvadis® (2025), cited by 1

## Recent decisions
- K261638: Bonvadis® (Jun 17, 2026)
- K251093: Bonvadis® (Jun 9, 2025)

Source page: https://510kreport.com/company/oneness-biotech