Radionics, Inc. - FDA 510(k) Cleared Devices
56
Total
56
Cleared
0
Denied
34 devices
Cleared
Oct 23, 2000
NEUROMAP WITH NEURO 100
Neurology
47d
Cleared
Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Neurology
399d
Cleared
Jul 26, 2000
OPTICAL TRACKING SYSTEM (OTS)
Neurology
29d
Cleared
May 17, 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
Neurology
9d
Cleared
Mar 20, 2000
RADIONICS LUMBOPERITONEAL SHUNT
Neurology
70d
Cleared
Sep 21, 1999
RADIONICS MICROELECTRODE KIT
Neurology
152d
Cleared
Sep 10, 1999
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
Neurology
28d
Cleared
Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
Neurology
54d
Cleared
Apr 29, 1999
OPTICAL TRACKING SYSTEM (OTS)
Neurology
62d
Cleared
Apr 19, 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
Neurology
405d
Cleared
Dec 18, 1998
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL...
Neurology
21d
Cleared
Nov 20, 1998
NEUROMAP
Neurology
182d