Palodex Group OY
Palodex Group OY holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2024, with 5 FDA device recalls on record.
Top product codes for Palodex Group OY
FDA recalls by Palodex Group OY
- Z-2413-2024 — 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 operated and used by qualified healthcare professionals.
- Z-0842-2020 — Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
- Z-0839-2020 — Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
- Z-0841-2020 — KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
- Z-0840-2020 — Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Palodex Group OY
- K241249 — Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
- K230505 — Orthopantomograph OP 3D LX
- K180947 — Orthopantomograph OP 3D
- K173646 — FS Ergo
- K163423 — Orthopantomograph OP300
- K162799 — Cliniview
- K170813 — ORTHOPANTOMOGRAPH OP 3D
- K133544 — OP300
- K130297 — SCANORA 3DX
- K122018 — OP300
Data sourced from openFDA. This site is unofficial and independent of the FDA.