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)
Top companies in GZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Ad-Tech Medical Instrument Corp | 13 | 8 |
| Dixi Medical | 2 | 9 |
| Alpha Omega Engineering , Ltd. | 8 | 1 |
| FHC, Inc. | 4 | 5 |
| Alpha Omega , Ltd. | 3 | 0 |
| Pmt Corp. | 3 | 0 |
| Progress Mankind Technology | 3 | 0 |
| Cyberkinetics Neurotechnology Systems, Inc. | 1 | 1 |
| Ice Neurosystems, Inc. | 2 | 0 |
| Neuroone Medical Technologies Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | K163355 |
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | K163355 |
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | K163355 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Dec 9, 2021 | DIXI 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 |
GZL | K170959 |
| Jun 17, 2020 | FHC, 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 |
GZL | K183123 |
| Jun 18, 2019 | Ad-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 |
GZL | K181544 |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Skull Anchor Bolts Terminated |
GZL | K181544 |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes Terminated |
GZL | K163355 |
| May 6, 2019 | Alpha 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 |
GZL | K123796 K171581 |
| Apr 16, 2019 | Ad-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 |
GZL | K163355 |
| Oct 21, 2014 | Ad-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 |
GZL | K944061 |
| Mar 16, 2010 | FHC, Inc. FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software,
Catalog # MT-GL4K.
Intended to assist in functional neurological procedures. Terminated |
GZL | K071364 |
| Jul 7, 2009 | Cyberkinetics Neurotechnology Systems, Inc. Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468. Terminated |
GZL | K042384 |
| Dec 18, 2008 | FHC, 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 |
GZL | K991522 |
| Dec 18, 2008 | FHC, 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 |
GZL | K991522 |
| Dec 18, 2008 | FHC, 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 |
GZL | K991522 |
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