Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 13, 2026, FDA's public records list Laurimed with 8 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Mar 9, 2017: 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider.
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.
| Date | Record | Source |
|---|---|---|
| Mar 9, 2017 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderK163247 · ERL | 510(k) clearances |
| Jun 22, 2016 | PolypVac Microdebrider (3.3mm and 4.0mm)K161101 · ERL | 510(k) clearances |
| Apr 7, 2014 | PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of poClass III · The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the dev | Device recalls |
| Dec 23, 2013 | LAURIMED POLYPVAC MICRODEBRIDERK133133 · ERL | 510(k) clearances |
| Sep 23, 2009 | LAURIMED SPINAL INJECTION SYSTEMK091818 · BSP | 510(k) clearances |
| May 21, 2009 | PERCUTANEOUS DISCECTOMY SYSTEMK090815 · HRX | 510(k) clearances |
| Mar 18, 2009 | SPINAL INJECTION SYSTEMK083909 · BSP | 510(k) clearances |
| Aug 28, 2008 | LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002K082194 · HRX | 510(k) clearances |
| May 9, 2008 | LAURIMED SPINAL INJECTION SYSTEMK080140 · BSP | 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