GZL · Class II · 21 CFR 882.1330

FDA Product Code GZL: Electrode, Depth

Leading manufacturers include Alpha Omega Engineering , Ltd., Ad-Tech Medical Instrument Corp and Ad-Tech Medical Instrument Corporation.

58
Total
58
Cleared
175d
Avg days
1980
Since
58 devices
25–48 of 58
Cleared Jun 12, 2012
STERILE DISPOSABLES FOR MER
K120098
Alpha Omega Engineering , Ltd.
Neurology · 152d
Cleared Feb 09, 2011
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
K110010
Blackrock Microsystems, Inc.
Neurology · 37d
Cleared Feb 25, 2009
NAVIGATION PROBES
K082404
We Sense, Ltd.
Neurology · 188d
Cleared Dec 03, 2007
NEURONAV SYSTEM AND NEURONAV DRIVE
K071697
Alpha Omega , Ltd.
Neurology · 166d
Cleared Aug 03, 2007
NEUROPORT ELECTRODE
K070272
Cyberkinetics Neurotechnology Systems, Inc.
Neurology · 186d
Cleared Jul 25, 2007
MICROTARGETING GUIDELINE 4000
K071364
FHC, Inc.
Neurology · 70d
Cleared May 25, 2006
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K053358
Ad-Tech Medical Instrument Corp
Neurology · 174d
Cleared Apr 12, 2006
NEUROPROBES
K052527
Alpha Omega Engineering , Ltd.
Neurology · 212d
Cleared Sep 16, 2005
NEURODRIVE SYSTEM
K051830
Alpha Omega , Ltd.
Neurology · 72d
Cleared Mar 29, 2005
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
K042384
Cyberkinetics, Inc. (Cki)
Neurology · 209d
Cleared Mar 18, 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K042208
Inomed Medizintechnik GmbH
Neurology · 214d
Cleared Aug 20, 2004
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
K041409
Inomed GmbH
Neurology · 85d
Cleared Aug 16, 2004
MACRO-MICRO DEPTH ELECTRODE
K041604
Ad-Tech Medical Instrument Corp
Neurology · 63d
Cleared Aug 03, 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730
Pmt Corp.
Neurology · 249d
Cleared Nov 19, 2001
RECORDING AND STIMULATING ELECTRODE
K012850
Radionics, A Division of Tyco Healthcare Group LP
Neurology · 87d
Cleared Aug 04, 2000
MICROTARGETING ELECTRODE
K991522
FHC, Inc.
Neurology · 459d
Cleared Jan 24, 2000
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K993622
Alpha Omega , Ltd.
Neurology · 90d
Cleared Nov 02, 1999
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788
Ad-Tech Medical Instrument Corp
Neurology · 237d
Cleared Jun 09, 1999
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
K991077
Microrecording Systems Consultants, LLC
Neurology · 70d
Cleared Nov 20, 1998
NEUROMAP
K981820
Radionics, Inc.
Neurology · 182d
Cleared Jun 16, 1998
PALI-TRODE
K981015
Preferred Instruments
Neurology · 90d
Cleared Jun 10, 1998
AD-TECH'S SPINAL ELECTRODE
K973454
Ad-Tech Medical Instrument Corp
Neurology · 272d
Cleared Aug 18, 1997
GUIDELINE SYSTEM
K970943
Axon Instruments, Inc.
Neurology · 157d
Cleared May 09, 1997
AD-TECH'S DEPTH ELECTRODE
K964644
Ad-Tech Medical Instrument Corp
Neurology · 190d