Company ยท FI
Instrumentarium Dental, Palodex Group OY
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2014. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2014 | K133231 | DIGORA OPTIME Instrumentarium Dental, Palodex Group OY, FI | MUH |
| Oct 6, 2010 | K093683 | ORTHOPANTOMOGRAPH OP300 Instrumentarium Dental, Palodex Group OY, FI | MUH |
| Nov 20, 2009 | K092591 | ORTHOPANTOMOGRAPH OP30 Instrumentarium Dental, Palodex Group OY, FI | MUH |
| Sep 2, 2008 | K081925 | SNAPSHOT Instrumentarium Dental, Palodex Group OY, FI | MUH |
| Jul 2, 2007 | K063837 | SIGMA M Instrumentarium Dental, Palodex Group OY, FI | MUH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2014 | Instrumentarium Dental, PaloDEx Group Oy The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOC Terminated |
EHD | K022630 |