Cosman Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0687-2018Class IINitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-1July 5, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K101131FIDUCIAL MARKERSJune 17, 2010
K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4October 16, 2008
K082012COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CNOctober 14, 2008
K060799COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULAMay 2, 2006
K053415LESIONPOINT RF CANNULAApril 25, 2006
K050084COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINALMarch 17, 2005