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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2026 | K253970 | Wovyn Depth Electrode Sensomedical Labs, Ltd., IL | GZL |
| Nov 5, 2025 | K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth El Beijing Sinovation Medical Technology Co., Ltd., CN | GZL |
| Mar 30, 2025 | K250601 | Neuro Omega System; NeuroSmart System Alpha Omega Engineering , Ltd., IL | GZL |
| May 18, 2023 | K223276 | Anchor Bolts as Accessories to Depth Electrodes Ad-Tech Medical Instrument Corporation | GZL |
| May 18, 2023 | K223269 | Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation | GZL |
| Apr 18, 2023 | K213170 | SENSOSEEG Depth Electrodes Sensomedical Labs, Ltd., IL | GZL |
| Dec 6, 2022 | K222706 | iCE-SG2 Subcutaneous Electrode Kit Ice Neurosystems, Inc. | GZL |
| Oct 20, 2022 | K222404 | Evo® sEEG System Neuroone Medical Technologies Corp. | GZL |
| Sep 16, 2022 | K220553 | Neuro Omega System, NeuroSmart System Alpha Omega Engineering , Ltd., IL | GZL |
| Nov 18, 2021 | K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes Dixi Medical, FR | GZL |
| Sep 1, 2021 | K211367 | Evo sEEG System Neuroone Medical Technologies Corp. | GZL |
| Mar 8, 2021 | K201678 | iCE-SG Subcutaneous Electrode Arrays Ice Neurosystems, Inc. | GZL |
| Jan 2, 2020 | K191739 | Sterile LeadConfirm Alpha Omega Engineering , Ltd., IL | GZL |
| Dec 20, 2018 | K183123 | microTargeting Guideline 4000 5.0 System FHC, Inc. | GZL |
| Aug 9, 2018 | K181544 | Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation | GZL |
| Feb 27, 2018 | K172042 | NeuroNav System, NeuroSmart System Alpha Omega Engineering , Ltd., IL | GZL |
| Dec 22, 2017 | K171581 | Neuro Omega System Alpha Omega Engineering , Ltd., IL | GZL |
| Nov 24, 2017 | K170959 | DIXI Medical Microdeep Depth Electrode Dixi Medical, FR | GZL |
| Jun 15, 2017 | K162459 | AccuPoint Electrode Microprobes For Life Science, Inc. Dba Neuron | GZL |
| Apr 12, 2017 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation | GZL |
| Jul 14, 2016 | K151790 | PMT Platinum Depthalon Depth Electrode Pmt Corporation | GZL |
| Mar 4, 2016 | K152547 | DNAP Electrode Ad-Tech Medical Instrument Corporation | GZL |
| Dec 12, 2014 | K140680 | LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM Alpine Biomed Aps, DK | GZL |
| Apr 5, 2013 | K123796 | NEURO OMEGA SYSTEM Alpha Omega Engineering , Ltd., IL | GZL |
| Jun 12, 2012 | K120098 | STERILE DISPOSABLES FOR MER Alpha Omega Engineering , Ltd., IL | GZL |
| Feb 9, 2011 | K110010 | NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM Blackrock Microsystems, Inc. | GZL |
| Feb 25, 2009 | K082404 | NAVIGATION PROBES We Sense, Ltd., IL | GZL |
| Dec 3, 2007 | K071697 | NEURONAV SYSTEM AND NEURONAV DRIVE Alpha Omega , Ltd., IL | GZL |
| Aug 3, 2007 | K070272 | NEUROPORT ELECTRODE Cyberkinetics Neurotechnology Systems, Inc. | GZL |
| Jul 25, 2007 | K071364 | MICROTARGETING GUIDELINE 4000 FHC, Inc. | GZL |
| May 25, 2006 | K053358 | DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES Ad-Tech Medical Instrument Corp | GZL |
| Apr 12, 2006 | K052527 | NEUROPROBES Alpha Omega Engineering , Ltd., IL | GZL |
| Sep 16, 2005 | K051830 | NEURODRIVE SYSTEM Alpha Omega , Ltd., IL | GZL |
| Mar 29, 2005 | K042384 | NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM Cyberkinetics, Inc. (Cki) | GZL |
| Mar 18, 2005 | K042208 | ISIS MER SYSTEM/ELEKTA MER SYSTEM Inomed Medizintechnik GmbH, DE | GZL |
| Aug 20, 2004 | K041409 | MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 Inomed GmbH, SE | GZL |
| Aug 16, 2004 | K041604 | MACRO-MICRO DEPTH ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Aug 3, 2004 | K033730 | PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES Pmt Corp. | GZL |
| Mar 24, 2004 | K033173 | MICRO TARGETING ELECTRODE FHC, Inc. | GZL |
| Nov 19, 2001 | K012850 | RECORDING AND STIMULATING ELECTRODE Radionics, A Division of Tyco Healthcare Group LP | GZL |
| Aug 4, 2000 | K991522 | MICROTARGETING ELECTRODE FHC, Inc. | GZL |
| Jan 24, 2000 | K993622 | NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY Alpha Omega , Ltd., IL | GZL |
| Nov 2, 1999 | K990788 | AD-TECH'S FORAMEN OVALE ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Jun 9, 1999 | K991077 | MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) Microrecording Systems Consultants, LLC | GZL |
| Nov 20, 1998 | K981820 | NEUROMAP Radionics, Inc. | GZL |
| Jun 16, 1998 | K981015 | PALI-TRODE Preferred Instruments | GZL |
| Jun 10, 1998 | K973454 | AD-TECH'S SPINAL ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Aug 18, 1997 | K970943 | GUIDELINE SYSTEM Axon Instruments, Inc. | GZL |
| May 9, 1997 | K964644 | AD-TECH'S DEPTH ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Apr 29, 1997 | K970418 | PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) Pmt Corp. | GZL |
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