Company · FI
Palodex Group OY
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2024. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2024 | K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) Palodex Group OY, FI | OAS |
| Jun 9, 2023 | K230505 | Orthopantomograph OP 3D LX Palodex Group OY, FI | OAS |
| Jun 7, 2018 | K180947 | Orthopantomograph OP 3D Palodex Group OY, FI | OAS |
| Dec 19, 2017 | K173646 | FS Ergo Palodex Group OY, FI | MUH |
| Aug 31, 2017 | K163423 | Orthopantomograph OP300 Palodex Group OY, FI | OAS |
| Apr 25, 2017 | K162799 | Cliniview Palodex Group OY, FI | LLZ |
| Apr 7, 2017 | K170813 | ORTHOPANTOMOGRAPH OP 3D Palodex Group OY, FI | OAS |
| Mar 26, 2014 | K133544 | OP300 Palodex Group OY, FI | OAS |
| May 29, 2013 | K130297 | SCANORA 3DX Palodex Group OY, FI | OAS |
| Dec 10, 2012 | K122018 | OP300 Palodex Group OY, FI | OAS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2024 | Palodex Group Oy Orthopantomograph OP300 dental computed tomography x-ray system.
The X-ray device produces conventional 2D X-ray images and Xray
projection images for the reconstruction of a 3D view. The device is o Open, Classified |
OAS | K163423 |
| Jan 7, 2020 | Palodex Group Oy Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |
| Jan 7, 2020 | Palodex Group Oy KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |
| Jan 7, 2020 | Palodex Group Oy Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |
| Jan 7, 2020 | Palodex Group Oy Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |