Laurimed, LLC
Medical device manufacturer in Redwood City, CA.
8510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderERL · Traditional | 03/09/2017SE |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm)ERL · Special | 06/22/2016SE |
| K133133 | Laurimed Polypvac MicrodebriderERL · Traditional | 12/23/2013SE |
| K091818 | Laurimed Spinal Injection SystemBSP · Special | 09/23/2009SE |
| K090815 | Percutaneous Discectomy SystemHRX · Traditional | 05/21/2009SE |
| K083909 | Spinal Injection SystemBSP · Traditional | 03/18/2009SE |
| K082194 | Laurimed Percutaneous Discectomy System, Model FG-000002HRX · Traditional | 08/28/2008SE |
| K080140 | Laurimed Spinal Injection SystemBSP · Traditional | 05/09/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1527-2014 Class III | PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1…The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component… | 04/07/2014Terminated |