Bioness, Inc. - FDA 510(k) Cleared Devices
13
Total
13
Cleared
0
Denied
FDA 510(k) cleared devices by Bioness, Inc. Neurology ✕
13 devices
Cleared
Feb 23, 2022
StimRouter Neuromodulation System
Neurology
244d
Cleared
Mar 27, 2020
StimRouter Neuromodulation System
Neurology
29d
Cleared
Mar 04, 2020
L100 Go System
Neurology
30d
Cleared
Oct 31, 2019
StimRouter Neuromodulation System
Neurology
295d
Cleared
Sep 12, 2019
L360 Thigh System
Neurology
90d
Cleared
Mar 14, 2019
L300 Go System
Neurology
31d
Cleared
Mar 09, 2018
L300 Go System
Neurology
98d
Cleared
Jan 27, 2017
L300 Go System
Neurology
151d
Cleared
Feb 20, 2015
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician...
Neurology
175d
Cleared
May 01, 2013
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT...
Neurology
159d
Cleared
Dec 27, 2012
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100
Neurology
107d
Cleared
Apr 20, 2012
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300...
Neurology
30d
Cleared
Apr 29, 2011
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
Neurology
165d