Company ยท US
Direx Systems Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2012. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 2012 | K111947 | DUET MAGNA Direx Systems Corp. | LNS |
| Dec 7, 2010 | K102765 | PRONEX Direx Systems Corp. | IYE |
| Oct 26, 2007 | K072529 | TRACKPORT Direx Systems Corp. | IYE |
| Jul 23, 2007 | K071701 | TRACKLEAF-10 Direx Systems Corp. | IYE |
| Dec 14, 2006 | K063482 | CROSSPLAN / ACCUSOFT-XL V.4.04 Direx Systems Corp. | MUJ |
| Oct 20, 2006 | K062147 | INTEGRA SL Direx Systems Corp. | LNS |
| Oct 5, 2006 | K062032 | ACCUSOFT, ACCUSOFT XL Direx Systems Corp. | MUJ |
| Aug 18, 2006 | K061873 | VERT-X Direx Systems Corp. | OXO |
| Jul 21, 2006 | K061713 | MAGIS1;MAGIS2 Direx Systems Corp. | IYE |
| Mar 10, 2006 | K052212 | MIGUE Direx Systems Corp. | IYE |
| Mar 1, 2006 | K053640 | INTEGRA Direx Systems Corp. | LNS |
| Feb 21, 2006 | K052705 | DART-12 Direx Systems Corp. | IYE |
| May 5, 2005 | K043409 | ACCUCHANGER Direx Systems Corp. | IYE |
| Mar 16, 2005 | K050091 | TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) Direx Systems Corp. | LNS |
| Jul 22, 2004 | K041213 | 3DSCOPE Direx Systems Corp. | OXO |
| Jul 7, 2004 | K041582 | MODIFICATION TO TRIPTER X-1 COMPACT DUET Direx Systems Corp. | LNS |
| Jun 23, 2004 | K040474 | ACCUSOFT Direx Systems Corp. | MUJ |
| Apr 28, 2004 | K040470 | TRIPTER X-1 COMPACT Direx Systems Corp. | LNS |
| Apr 1, 2004 | K040553 | MODIFICATION TO ACCULEAF Direx Systems Corp. | IXI |
| Dec 15, 2003 | K032171 | ACCUSOFT Direx Systems Corp. | IYE |
| Jan 17, 2003 | K023535 | TRIPTER X-1 COMPACT DUET Direx Systems Corp. | LNS |
| Jan 7, 2003 | K021338 | ACCULEAF Direx Systems Corp. | IYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||