Medical Device Manufacturer · US , Melbourne , FL

Image-Guided Neurologics, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1999
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Image-Guided Neurologics, Inc. Neurology
20 devices
1-20 of 20
Cleared Apr 21, 2005
NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
K050772 · HAW
Neurology · 27d
Cleared Feb 07, 2005
NAVIGUS NEXDRIVE, MODEL MI-3000
K043091 · HAW
Neurology · 90d
Cleared Oct 04, 2004
NAVIGUS PASSIVE PROBE, MODEL NP-1000
K040334 · HAW
Neurology · 236d
Cleared Jun 03, 2004
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
K040834 · HAW
Neurology · 64d
Cleared Mar 02, 2004
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
K033619 · HAW
Neurology · 105d
Cleared Aug 21, 2003
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · HBL
Neurology · 64d
Cleared Mar 12, 2003
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
K024201 · HAW
Neurology · 82d
Cleared Feb 25, 2003
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K023949 · HAW
Neurology · 90d
Cleared Sep 25, 2002
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 &...
K022100 · HAW
Neurology · 89d
Cleared Oct 22, 2001
NAVIGUS II MR
K012719 · HAW
Neurology · 69d
Cleared Oct 01, 2001
NAVIGUS II TRAJECTORY GUIDE
K012366 · HAW
Neurology · 67d
Cleared Aug 03, 2001
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K011971 · HAW
Neurology · 39d
Cleared Oct 25, 2000
BURR HOLE COVER, MODEL XX
K001096 · GXR
Neurology · 204d
Cleared Oct 18, 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330 · GWG
Neurology · 78d
Cleared Jun 07, 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · HAW
Neurology · 56d
Cleared Apr 20, 2000
CRANIAL DRILL
K000195 · HBB
Neurology · 90d
Cleared Oct 25, 1999
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
K992796 · HCA
Neurology · 67d
Cleared Aug 27, 1999
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
K992304 · HAW
Neurology · 50d
Cleared Aug 12, 1999
REMOTE INTRODUCER, MODEL PI-1000
K990907 · HAW
Neurology · 147d
Cleared Feb 12, 1999
TRAJECTORY GUIDE, MODEL # TGX-XXX
K983539 · HAW
Neurology · 126d
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