Company ยท US
Dfine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2010. Name variants (Inc, Corp, punctuation) are merged.
5510(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 |
|---|---|---|---|
| Aug 11, 2010 | K091310 | ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 Dfine, Inc. | GEI |
| Dec 30, 2009 | K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) Dfine, Inc. | NDN |
| Oct 5, 2007 | K072496 | MODIFICATION TO SPACE CPSXL BONE CEMENT Dfine, Inc. | NDN |
| Jun 29, 2007 | K070351 | SPACE 360 DELIVERY SYSTEM Dfine, Inc. | NDN |
| Aug 30, 2006 | K061531 | SPACE CPSXL BONE CEMENT Dfine, Inc. | NDN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||