Soredex Palodex Group OY is one of 51 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Soredex Palodex Group OY - FDA 510(k) Cleared Devices
Recent clearances: SCANORA 3D, SCANORA 3D, DIGORA PCT/DIGIPOD
9
Total
9
Cleared
0
Denied
Soredex Palodex Group OY has 9 FDA 510(k) cleared medical devices. Based in Helsinki, FI.
Historical record: 9 cleared submissions from 2001 to 2011. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Soredex Palodex Group OY Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Intertek Testing Services as regulatory consultant.
FDA 510(k) Regulatory Record - Soredex Palodex Group OY
9 devices
Cleared
Jun 30, 2011
SCANORA 3D
Radiology
97d
Cleared
Dec 19, 2007
SCANORA 3D
Radiology
20d
Cleared
Mar 27, 2007
DIGORA PCT/DIGIPOD
Radiology
55d
Cleared
Dec 26, 2006
CRANEX NOVUS
Radiology
41d
Cleared
Dec 17, 2004
CRANEX D
Radiology
16d
Cleared
Jul 13, 2004
CRANEX BASEX D OR CRANEX EXCEL D
Radiology
147d
Cleared
Jun 15, 2004
DIGORA OPTIME (OR DIGORA ONTIME)
Radiology
54d
Cleared
Apr 29, 2004
MINRAY
Radiology
150d
Cleared
Aug 10, 2001
DIGORA PCT
Radiology
29d