Xoft, Inc. - FDA 510(k) Cleared Devices
Recent clearances: AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E, AXXENT FLEXISHIELD MINI, AXXENT SURFACE APPLICATOR, MODEL 710257
6
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Xoft, Inc. Radiology ✕
6 devices
Cleared
Jul 16, 2009
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
Radiology
106d
Cleared
Jun 23, 2009
AXXENT FLEXISHIELD MINI
Radiology
125d
Cleared
Feb 11, 2009
AXXENT SURFACE APPLICATOR, MODEL 710257
Radiology
57d
Cleared
May 09, 2008
AXXENT VAGINAL APPLICATOR
Radiology
235d
Cleared
Feb 29, 2008
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Radiology
161d
Cleared
Dec 22, 2005
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Radiology
265d