Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Sophysa SA with 13 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Apr 10, 2026: Pressio 3 Multi-parameter Neuromonitoring System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 10, 2026 | Pressio 3 Multi-parameter Neuromonitoring SystemK252241 · GWM | 510(k) clearances |
| Nov 28, 2025 | Sophy Mini Monopressure Valve (SM1)K250636 · JXG | 510(k) clearances |
| Nov 17, 2025 | The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure MonitorClass II · Customer complaints of Pressio monitor rebooting. | Device recalls |
| Jun 20, 2025 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersK242974 · JXG | 510(k) clearances |
| Feb 2, 2023 | Polaris Valve Electronic Reading InstrumentK222422 · JXG | 510(k) clearances |
| Apr 17, 2017 | Pressio 2 ICP Monitoring SystemK162108 · GWM | 510(k) clearances |
| Apr 2, 2015 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONXK141227 · JXG | 510(k) clearances |
| Jan 22, 2010 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICEK091328 · JXG | 510(k) clearances |
| Aug 11, 2009 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400K090342 · JXG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
