Spes Medica
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1971-2021 | Class II | Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraopera | April 8, 2021 |
| Z-1967-2021 | Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE | April 8, 2021 |
| Z-1968-2021 | Class II | SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on pol | April 8, 2021 |
| Z-1969-2021 | Class II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE34 | April 8, 2021 |
| Z-1970-2021 | Class II | SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on pol | April 8, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid | November 10, 2022 |
| K212326 | AC Cream - Conductive paste | December 1, 2021 |
| K192606 | SAC2 - Electrode Cream | January 17, 2020 |
| K192603 | Spes Medica Subdermal Needle Electrodes | November 22, 2019 |
| K190050 | Tech Dots - Adhesive and conductive gel | July 19, 2019 |
| K133348 | STIM PROBE | November 21, 2014 |
| K120494 | DISPOSABLE ADHESIVE SURFACE ELECTRODE | June 11, 2012 |
| K093373 | LARYNGEAL SURFACE ELECTRODE | August 24, 2010 |
| K091410 | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, | August 11, 2009 |