Synapse Biomedical Inc
FDA Regulatory Profile
Synapse Biomedical Inc appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 1 510(k) clearance, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1561-2022, Class I) was initiated on July 11, 2022. Its most recent 510(k) clearance was granted on June 5, 2025.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1561-2022 | Class I | NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021. | July 11, 2022 |
| Z-1393-2022 | Class III | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name | May 31, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242704 | Synchrony (20-3000) | June 5, 2025 |