Laurimed LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
8
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1527-2014Class IIIPolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filteApril 7, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderMarch 9, 2017
K161101PolypVac Microdebrider (3.3mm and 4.0mm)June 22, 2016
K133133LAURIMED POLYPVAC MICRODEBRIDERDecember 23, 2013
K091818LAURIMED SPINAL INJECTION SYSTEMSeptember 23, 2009
K090815PERCUTANEOUS DISCECTOMY SYSTEMMay 21, 2009
K083909SPINAL INJECTION SYSTEMMarch 18, 2009
K082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002August 28, 2008
K080140LAURIMED SPINAL INJECTION SYSTEMMay 9, 2008