Company · US
Dallen Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2017. Name variants (Inc, Corp, punctuation) are merged.
11510(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 |
|---|---|---|---|
| Nov 7, 2017 | K171473 | Compressyn Staple Dallen Medical, Inc. | JDR |
| May 7, 2015 | K150359 | Tensyn Plug Dallen Medical, Inc. | HTN |
| Feb 11, 2015 | K143092 | Tensyn Plug Dallen Medical, Inc. | HTN |
| Aug 21, 2014 | K141264 | TENSYN BAND, TENSYN FRACTURE PLATES Dallen Medical, Inc. | HTN |
| Jun 2, 2014 | K140358 | COMPRESSYN STAPLE Dallen Medical, Inc. | JDR |
| Feb 28, 2014 | K133858 | TENSYN BAND Dallen Medical, Inc. | HTN |
| Dec 30, 2013 | K132875 | COMPRESSYN STAPLE Dallen Medical, Inc. | JDR |
| Nov 15, 2013 | K131850 | TENSYN BAND Dallen Medical, Inc. | HTN |
| Jul 25, 2013 | K130431 | COMPRESSYN BAND Dallen Medical, Inc. | JDQ |
| Feb 7, 2013 | K122871 | COMPRESSYN STAPLE Dallen Medical, Inc. | JDR |
| Apr 1, 2011 | K101484 | COMPRESSYN BAND Dallen Medical | JDQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||