Direx Systems Corp.

Medical device manufacturer in Canton, MA.

22510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K111947Duet MagnaLNS · Traditional 03/01/2012SE
K102765PronexIYE · Traditional 12/07/2010SE
K072529TrackportIYE · Traditional 10/26/2007SE
K071701TRACKLEAF-10IYE · Special 07/23/2007SE
K063482Crossplan / Accusoft-Xl V.4.04MUJ · Special 12/14/2006SE
K062147Integra SLLNS · Special 10/20/2006SE
K062032Accusoft, Accusoft XLMUJ · Traditional 10/05/2006SE
K061873Vert-XOXO · Traditional 08/18/2006SE
K061713MAGIS1;MAGIS2IYE · Special 07/21/2006SE
K052212MigueIYE · Traditional 03/10/2006SE
K053640IntegraLNS · Traditional 03/01/2006SE
K052705DART-12IYE · Traditional 02/21/2006SE
K043409AccuchangerIYE · Traditional 05/05/2005SE
K050091TRIPTER-X1 Compact Duet SP (Separated Pulse)LNS · Special 03/16/2005SE
K0412133DSCOPEOXO · Special 07/22/2004SE
K041582Modification to Tripter X-1 Compact DuetLNS · Special 07/07/2004SE
K040474AccusoftMUJ · Traditional 06/23/2004SE
K040470Tripter X-1 CompactLNS · Special 04/28/2004SE
K040553Modification to AcculeafIXI · Special 04/01/2004SE
K032171AccusoftIYE · Traditional 12/15/2003SE
K023535Tripter X-1 Compact DuetLNS · Special 01/17/2003SE
K021338AcculeafIYE · Traditional 01/07/2003SE