Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Spes Medica Srl with 9 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Nov 10, 2022: Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip an….
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.
| Nov 10, 2022 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridK211954 · GYC | 510(k) clearances |
| Dec 1, 2021 | AC Cream - Conductive pasteK212326 · GYB | 510(k) clearances |
| Apr 8, 2021 | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 Class II · The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. | Device recalls |
| Apr 8, 2021 | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous Class II · The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. | Device recalls |
| Apr 8, 2021 | Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.Class II · The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. | Device recalls |
| Apr 8, 2021 | SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 Class II · The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. | Device recalls |
| Apr 8, 2021 | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuouClass II · The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. | Device recalls |
| Jan 17, 2020 | SAC2 - Electrode CreamK192606 · GYB | 510(k) clearances |
| Nov 22, 2019 | Spes Medica Subdermal Needle ElectrodesK192603 · GXZ | 510(k) clearances |
| Jul 19, 2019 | Tech Dots - Adhesive and conductive gelK190050 · GYB | 510(k) clearances |
| Nov 21, 2014 | STIM PROBEK133348 · ETN | 510(k) clearances |
| Jun 11, 2012 | DISPOSABLE ADHESIVE SURFACE ELECTRODEK120494 · GXY | 510(k) clearances |
| Aug 24, 2010 | LARYNGEAL SURFACE ELECTRODEK093373 · ETN | 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
