Synaptive Medical Inc
Summary
- Total Recalls
- 5 (1 Class I)
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1955-2021 | Class II | Synaptive Trackable Suction Set Standard and Malleable | April 23, 2021 |
| Z-1759-2020 | Class II | Synaptive ImageDrive Clinical | February 26, 2020 |
| Z-1758-2020 | Class II | ClearCanvas RIS/PACS | February 26, 2020 |
| Z-0470-2019 | Class I | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: Bri | October 9, 2018 |
| Z-0480-2016 | Class II | Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide sys | December 4, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231986 | Modus IR | March 25, 2024 |
| K232981 | Synq Software Version 1.3 | October 11, 2023 |
| K200327 | Evry | April 29, 2020 |
| K183325 | Modus Nav | July 14, 2019 |
| K180394 | BrightMatter Plan 1.6.0 | March 9, 2018 |
| K160523 | BrightMatter Guide with BrightMatter Pointer | June 24, 2016 |
| K153281 | BrightMatter Guide with Surface Trace Registration | March 30, 2016 |
| K153284 | Synaptive ImageDrive Pro | March 29, 2016 |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | April 2, 2015 |
| K140337 | BRIGHTMATTER PLANNING SOFTWARE | June 2, 2014 |