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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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