# Synapse Biomedical, Inc.

- Location (FDA's records): Oberline, OH
- FDA decisions: 2 (2023–2025): 1 510(k) clearance and 1 original PMA approval
- Product codes: GZI (1), OIR (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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
- Bioness, Inc.: 1 (https://510kreport.com/company/bioness)
- Med Labs, Inc.: 1 (https://510kreport.com/company/med-labs)

## Recent decisions
- K242704: Synchrony (20-3000) (Jun 5, 2025)
- P200018: NeuRX Diaphragm Pacing System (DPS) (Mar 31, 2023)

Source page: https://510kreport.com/company/synapse-biomedical