Synapse Biomedical Inc

FDA Regulatory Profile

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
1
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1561-2022Class INeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.July 11, 2022
Z-1393-2022Class IIINeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name May 31, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K242704Synchrony (20-3000)June 5, 2025