Sophysa - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
4 devices
Cleared
Apr 10, 2026
Pressio 3 Multi-parameter Neuromonitoring System
Neurology
267d
Cleared
Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
Neurology
270d
Cleared
Jun 20, 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar...
Neurology
267d
Cleared
Feb 02, 2023
Polaris Valve Electronic Reading Instrument
Neurology
175d