Company ยท US
Laurimed, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2017. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 2017 | K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider Laurimed, LLC | ERL |
| Jun 22, 2016 | K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) Laurimed, LLC | ERL |
| Dec 23, 2013 | K133133 | LAURIMED POLYPVAC MICRODEBRIDER Laurimed, LLC | ERL |
| Sep 23, 2009 | K091818 | LAURIMED SPINAL INJECTION SYSTEM Laurimed, LLC | BSP |
| May 21, 2009 | K090815 | PERCUTANEOUS DISCECTOMY SYSTEM Laurimed, LLC | HRX |
| Mar 18, 2009 | K083909 | SPINAL INJECTION SYSTEM Laurimed, LLC | BSP |
| Aug 28, 2008 | K082194 | LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 Laurimed, LLC | HRX |
| May 9, 2008 | K080140 | LAURIMED SPINAL INJECTION SYSTEM Laurimed, LLC | BSP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2014 | Laurimed LLC PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which acces Terminated |
ERL | K133133 |