Direx Systems Corp.

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K111947	DUET MAGNA	LNS	2012-03-01	View
510(k)	K102765	PRONEX	IYE	2010-12-07	View
510(k)	K072529	TRACKPORT	IYE	2007-10-26	View
510(k)	K071701	TRACKLEAF-10	IYE	2007-07-23	View
510(k)	K063482	CROSSPLAN / ACCUSOFT-XL V.4.04	MUJ	2006-12-14	View
510(k)	K062147	INTEGRA SL	LNS	2006-10-20	View
510(k)	K062032	ACCUSOFT, ACCUSOFT XL	MUJ	2006-10-05	View
510(k)	K061873	VERT-X	OXO	2006-08-18	View
510(k)	K061713	MAGIS1;MAGIS2	IYE	2006-07-21	View
510(k)	K052212	MIGUE	IYE	2006-03-10	View
510(k)	K053640	INTEGRA	LNS	2006-03-01	View
510(k)	K052705	DART-12	IYE	2006-02-21	View
510(k)	K043409	ACCUCHANGER	IYE	2005-05-05	View
510(k)	K050091	TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)	LNS	2005-03-16	View
510(k)	K041213	3DSCOPE	OXO	2004-07-22	View
510(k)	K041582	MODIFICATION TO TRIPTER X-1 COMPACT DUET	LNS	2004-07-07	View
510(k)	K040474	ACCUSOFT	MUJ	2004-06-23	View
510(k)	K040470	TRIPTER X-1 COMPACT	LNS	2004-04-28	View
510(k)	K040553	MODIFICATION TO ACCULEAF	IXI	2004-04-01	View
510(k)	K032171	ACCUSOFT	IYE	2003-12-15	View