Company ยท US
Owandy
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2014. Name variants (Inc, Corp, punctuation) are merged.
7510(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 |
|---|---|---|---|
| Apr 28, 2014 | K133271 | OPTEO, VIDEOGRAPH HD Owandy | MUH |
| Jun 14, 2013 | K130443 | I-MAX TOUCH 3D Owandy | OAS |
| Oct 18, 2010 | K093105 | VISTEO Owandy | EHD |
| Jun 2, 2009 | K083057 | I-MAX TOUCH Owandy | MUH |
| Apr 5, 2007 | K070505 | KRYSTAL-X WIFI Owandy | MUH |
| Nov 14, 2006 | K062403 | IMAX CEPH DIGITAL X-RAY SENSOR Owandy | MUH |
| Jun 9, 2006 | K053172 | UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) Owandy Sas | MUH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||