FDA 510(k) Applications Submitted by DIREX SYSTEMS CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K040470 02/24/2004 TRIPTER X-1 COMPACT DIREX SYSTEMS CORP.
K040553 03/02/2004 MODIFICATION TO ACCULEAF DIREX SYSTEMS CORP.
K021338 04/26/2002 ACCULEAF DIREX SYSTEMS CORP.
K041213 05/10/2004 3DSCOPE DIREX SYSTEMS CORP.
K041582 06/14/2004 MODIFICATION TO TRIPTER X-1 COMPACT DUET DIREX SYSTEMS CORP.
K061713 06/19/2006 MAGIS1;MAGIS2 DIREX SYSTEMS CORP.
K071701 06/21/2007 TRACKLEAF-10 DIREX SYSTEMS CORP.
K061873 07/03/2006 VERT-X DIREX SYSTEMS CORP.
K111947 07/08/2011 DUET MAGNA DIREX SYSTEMS CORP.
K032171 07/16/2003 ACCUSOFT DIREX SYSTEMS CORP.
K062032 07/18/2006 ACCUSOFT, ACCUSOFT XL DIREX SYSTEMS CORP.
K062147 07/27/2006 INTEGRA SL DIREX SYSTEMS CORP.
K052212 08/15/2005 MIGUE DIREX SYSTEMS CORP.
K072529 09/07/2007 TRACKPORT DIREX SYSTEMS CORP.
K102765 09/24/2010 PRONEX DIREX SYSTEMS CORP.
K052705 09/28/2005 DART-12 DIREX SYSTEMS CORP.
K023535 10/21/2002 TRIPTER X-1 COMPACT DUET DIREX SYSTEMS CORP.
K063482 11/17/2006 CROSSPLAN / ACCUSOFT-XL V.4.04 DIREX SYSTEMS CORP.
K053640 12/30/2005 INTEGRA DIREX SYSTEMS CORP.
K050091 01/14/2005 TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) DIREX SYSTEMS CORP.
K040474 02/24/2004 ACCUSOFT DIREX SYSTEMS CORP.
K043409 12/10/2004 ACCUCHANGER DIREX SYSTEMS CORP.


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