Direx Systems Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K111947DUET MAGNAMarch 1, 2012
K102765PRONEXDecember 7, 2010
K072529TRACKPORTOctober 26, 2007
K071701TRACKLEAF-10July 23, 2007
K063482CROSSPLAN / ACCUSOFT-XL V.4.04December 14, 2006
K062147INTEGRA SLOctober 20, 2006
K062032ACCUSOFT, ACCUSOFT XLOctober 5, 2006
K061873VERT-XAugust 18, 2006
K061713MAGIS1;MAGIS2July 21, 2006
K052212MIGUEMarch 10, 2006
K053640INTEGRAMarch 1, 2006
K052705DART-12February 21, 2006
K043409ACCUCHANGERMay 5, 2005
K050091TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)March 16, 2005
K0412133DSCOPEJuly 22, 2004
K041582MODIFICATION TO TRIPTER X-1 COMPACT DUETJuly 7, 2004
K040474ACCUSOFTJune 23, 2004
K040470TRIPTER X-1 COMPACTApril 28, 2004
K040553MODIFICATION TO ACCULEAFApril 1, 2004
K032171ACCUSOFTDecember 15, 2003