Soredex Palodex Group OY: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Soredex Palodex Group OY” (first 2001, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 5 | 5 |
| EHD | Unit, X-Ray, Extraoral With Timer | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 1 | 1 |
Review panels
- Radiology (9)
Most recent Soredex Palodex Group OY 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110839 | SCANORA 3D | OAS | 2011-06-30 | 97 |
| K073350 | SCANORA 3D | MUH | 2007-12-19 | 20 |
| K070304 | DIGORA PCT/DIGIPOD | MUH | 2007-03-27 | 55 |
| K063459 | CRANEX NOVUS | MUH | 2006-12-26 | 41 |
| K043307 | CRANEX D | EHD | 2004-12-17 | 16 |
| K040382 | CRANEX BASEX D OR CRANEX EXCEL D | EHD | 2004-07-13 | 147 |
| K041050 | DIGORA OPTIME (OR DIGORA ONTIME) | MUH | 2004-06-15 | 54 |
| K033755 | MINRAY | EHD | 2004-04-29 | 150 |
| K012170 | DIGORA PCT | MUH | 2001-08-10 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Soredex Palodex Group OY.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Soredex, Inc. (1 510(k)s)
- Soredex Medical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Soredex Palodex Group OY?
FDA lists 9 510(k) clearances under the applicant name “Soredex Palodex Group OY” (first 2001, latest 2011), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Soredex Palodex Group OY?
The median time from FDA receipt to decision across 510(k)s cleared under the name Soredex Palodex Group OY is 54 days.
Which FDA product codes appear under Soredex Palodex Group OY?
The most frequent FDA product codes under this applicant name are MUH (System, X-Ray, Extraoral Source, Digital, 5); EHD (Unit, X-Ray, Extraoral With Timer, 3); OAS (X-Ray, Tomography, Computed, Dental, 1).
Next steps
- See all 9 Soredex Palodex Group OY clearances with predicates and recalls
- Run predicate analysis for product code MUH, Soredex Palodex Group OY's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.