Soredex Palodex Group Oy
Helsinki, FI
Soredex Palodex Group OY appears in FDA device records in Helsinki, FI. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Soredex Palodex Group Oy between 2001 and 2011. The busiest year on record is 2004, with 4. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2004 | 4 |
| 2006 | 1 |
| 2007 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110839 | SCANORA 3D | OAS | Substantially Equivalent | |
| K073350 | SCANORA 3D | MUH | Substantially Equivalent | |
| K070304 | DIGORA PCT/DIGIPOD | MUH | Substantially Equivalent | |
| K063459 | CRANEX NOVUS | MUH | Substantially Equivalent | |
| K043307 | CRANEX D | EHD | Substantially Equivalent | |
| K040382 | CRANEX BASEX D OR CRANEX EXCEL D | EHD | Substantially Equivalent | |
| K041050 | DIGORA OPTIME (OR DIGORA ONTIME) | MUH | Substantially Equivalent | |
| K033755 | MINRAY | EHD | Substantially Equivalent | |
| K012170 | DIGORA PCT | MUH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain