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Panels › Neurology › Product code GZL · Class 2

Electrode, Depth

Regulation 882.1330

2510(k)s in 12 months (58 all time)
0recalls in 12 months (24 all time)
24recalls that name a 510(k)
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Top companies in GZL

Company510(k)sRecalls
Ad-Tech Medical Instrument Corp138
Dixi Medical29
Alpha Omega Engineering , Ltd.81
FHC, Inc.45
Alpha Omega , Ltd.30
Pmt Corp.30
Progress Mankind Technology30
Cyberkinetics Neurotechnology Systems, Inc.11
Ice Neurosystems, Inc.20
Neuroone Medical Technologies Corp.20
DateFirm and productCodeLinked 510(k)
Oct 24, 2024Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Completed
GZLK163355
Oct 24, 2024Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Completed
GZLK163355
Oct 24, 2024Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Completed
GZLK163355
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Dec 9, 2021DIXI MEDICAL USA
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat
Terminated
GZLK170959
Jun 17, 2020FHC, Inc.
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instr
Terminated
GZLK183123
Jun 18, 2019Ad-Tech Medical Instrument Corporation
LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor b
Terminated
GZLK181544
Jun 18, 2019Ad-Tech Medical Instrument Corporation
Skull Anchor Bolts
Terminated
GZLK181544
Jun 18, 2019Ad-Tech Medical Instrument Corporation
Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
Terminated
GZLK163355
May 6, 2019Alpha Omega Engineering
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Terminated
GZLK123796
K171581
Apr 16, 2019Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyle
Terminated
GZLK163355
Oct 21, 2014Ad-Tech Medical Instrument Corporation
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Ele
Terminated
GZLK944061
Mar 16, 2010FHC, Inc.
FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.
Terminated
GZLK071364
Jul 7, 2009Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
Terminated
GZLK042384
Dec 18, 2008FHC, Inc.
FC400SP microTargeting StimPilot Single Procedure Kit Distributed by Medtronic Inc., Minneapolis, MN Ref: FHC4000SP Intended for use in intra-operative recording of single unit neuronal activity or
Terminated
GZLK991522
Dec 18, 2008FHC, Inc.
FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc., Minneapolis, MN REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each)
Terminated
GZLK991522
Dec 18, 2008FHC, Inc.
FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
Terminated
GZLK991522

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