# Bionen S.A.S.

- Location (FDA's records): Carmel, IN
- FDA decisions: 1 (2010–2010): 1 510(k) clearance
- Product codes: IKT (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 1 (0 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
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)
- Dantec Medical, Inc.: 1 (https://510kreport.com/company/dantec-medical)
- Axon Systems, Inc.: 1 (https://510kreport.com/company/axon-systems)
- Spes Medica Srl: 1 (https://510kreport.com/company/spes-medica)
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)

## Firms that cite its devices most
- Bio Protech, Inc.: 1 (https://510kreport.com/company/bio-protech)

## Its most-cited devices
- K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle (2010), cited by 1

## Recent decisions
- K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle (Oct 7, 2010)

Source page: https://510kreport.com/company/bionen