Radionics, Inc. - FDA 510(k) Cleared Devices
56
Total
56
Cleared
0
Denied
56 devices
Cleared
Sep 29, 1998
XKNIFE-4
Radiology
190d
Cleared
Aug 05, 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
Neurology
30d
Cleared
Jul 01, 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
Neurology
90d
Cleared
May 18, 1998
ATLASPLAN
Neurology
90d
Cleared
Apr 03, 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
Physical Medicine
57d
Cleared
Mar 16, 1998
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
Neurology
40d
Cleared
Oct 29, 1997
COSMAN COAGULATOR (CC-1) SYSTEM
General & Plastic Surgery
57d
Cleared
Aug 18, 1997
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE...
Neurology
455d
Cleared
Jul 24, 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
Neurology
87d
Cleared
Jun 04, 1997
RADIONICS BURR HOLE VALVE
Neurology
110d
Cleared
Mar 12, 1997
RFG-3CF
Neurology
78d
Cleared
Jan 31, 1997
RADIONICS CONTOUR FLEX PLUS VALVE
Neurology
88d
Cleared
Nov 21, 1996
RADIONICS SLUIJTER-MEHTA CANNULA
Neurology
76d
Cleared
Nov 08, 1996
PACE-1A CARDIAC STIMULATOR
Cardiovascular
63d
Cleared
Oct 23, 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
Neurology
83d
Cleared
Aug 07, 1996
COSGROVE DEPTH ELECTRODE KIT(CDEK)
Neurology
85d
Cleared
Jan 26, 1996
CONTOUR FLEX VALVES (REGULAR & SMALL)
Neurology
134d
Cleared
Feb 08, 1995
GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH...
Radiology
509d
Cleared
Apr 21, 1994
TITANIUM BIPOLAR FORCEPS
General & Plastic Surgery
78d
Cleared
Dec 13, 1993
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
Radiology
507d
Cleared
Nov 19, 1993
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
Neurology
331d
Cleared
Nov 19, 1993
V/P AND L/P CATHETER PASSERS
Neurology
71d
Cleared
Apr 21, 1993
OJEMANN CORTICAL STIMULATOR
Neurology
243d
Cleared
Apr 07, 1993
LCM-2-LINAC COUCH-MOUNT SYSTEM
Radiology
205d
Cleared
Nov 09, 1992
RFG-DGP DISPOSABLE GROUNDING PADS
General & Plastic Surgery
111d