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Electrode, Cortical
FDA product code GYC · Class 2 · Neurology
5,659
Registered devices
115
Adverse events
6
Recalls
32
510(k) clearances
Devices with this code
CORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONZenith — CADWELL INDUSTRIES, INC.Subdural Electrode — Ad-Tech Medical Instrument CorporationSubdural Electrode — Ad-Tech Medical Instrument CorporationCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONSubdural Electrode — Ad-Tech Medical Instrument CorporationCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONSubdural Electrode — Ad-Tech Medical Instrument CorporationCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONSubdural Electrode — Ad-Tech Medical Instrument CorporationCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONSubdural Electrode — Ad-Tech Medical Instrument CorporationCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATIONCORTAC® — PMT CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-06-18 | Ad-Tech Medical Instrument Corporation | Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environ |
| 2013-03-18 | Integra Burlington MA, Inc. | If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the oute |
| 2012-12-18 | Ad-Tech Medical Instrument Corporation | The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces w |
| 2011-10-05 | CareFusion 209 Inc. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation |
| 2011-10-05 | CareFusion 209 Inc. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation |
| 2011-10-05 | CareFusion 209 Inc. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation |
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