FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

66 results for "Radionics, Inc."
1–24 of 66
Search insights Median review: 82d Cleared: 100% Top manufacturer: Radionics, Inc. Lead specialty: Neurology
Cleared Jun 10, 2011
CUSA NXT EXTENDED LENGTH TIP
K102258 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 304d
Cleared Apr 22, 2010
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
K100096 · IYE
Integra Radionics, Inc.
Radiology · 99d
Cleared Apr 08, 2010
XKNIFE 5
K100417 · MUJ
Integra Radionics, Inc.
Radiology · 51d
Cleared May 08, 2009
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR...
K090864 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 39d
Cleared Mar 02, 2009
RADIONICS XKNIFE HDRT SYSTEM
K083414 · MUJ
Integra Radionics, Inc.
Radiology · 104d
Cleared Aug 13, 2008
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
K081459 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 82d
Cleared Oct 16, 2007
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
K072454 · IYE
Integra Radionics, Inc.
Radiology · 46d
Cleared Aug 17, 2007
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP
K071669 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 59d
Cleared Dec 21, 2006
INTEGRA RADIONICS IMAGEFUSION 3
K063230 · MUJ
Integra Radionics, Inc.
Radiology · 57d
Cleared Jul 25, 2006
INTEGRA RADIONICS XKNIFE RT 4
K061893 · MUJ
Integra Radionics, Inc.
Radiology · 22d
Cleared Apr 04, 2003
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K030697 · GEI
Radionics, Inc.
General & Plastic Surgery · 29d
Cleared Oct 23, 2000
NEUROMAP WITH NEURO 100
K002773 · GWF
Radionics, Inc.
Neurology · 47d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · HRX
Radionics, Inc.
Orthopedic · 137d
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · JXG
Radionics, Inc.
Neurology · 399d
Cleared Jul 26, 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · HAW
Radionics, Inc.
Neurology · 29d
Cleared Jun 28, 2000
XPLAN 2.1
K001700 · MUJ
Radionics, Inc.
Radiology · 23d
Cleared May 17, 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · HAW
Radionics, Inc.
Neurology · 9d
Cleared Mar 20, 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057 · JXG
Radionics, Inc.
Neurology · 70d
Cleared Dec 15, 1999
CONFORMAX MMLC VR1
K993594 · IYE
Radionics, Inc.
Radiology · 51d
Cleared Sep 21, 1999
RADIONICS MICROELECTRODE KIT
K991399 · GXI
Radionics, Inc.
Neurology · 152d
Cleared Sep 10, 1999
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
K992721 · HAW
Radionics, Inc.
Neurology · 28d
Cleared Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · JXG
Radionics, Inc.
Neurology · 54d
Cleared Aug 30, 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237 · MUJ
Radionics, Inc.
Radiology · 140d
Cleared Jul 30, 1999
TLC PEDIATRIC FRAME, MODEL TLC-SYS
K991523 · IYE
Radionics, Inc.
Radiology · 88d