Electrode, Cortical
Regulation 882.1310
0510(k)s in 12 months (32 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in GYC
| Company | 510(k)s | Recalls |
|---|---|---|
| Ad-Tech Medical Instrument Corp | 7 | 2 |
| CareFusion 209 Inc. | 0 | 3 |
| Radionics, Inc. | 3 | 0 |
| Pmt Corp. | 2 | 0 |
| Blackrock Microsystems | 1 | 0 |
| Blackrock Neuromed | 1 | 0 |
| Cardinal Health, Inc. | 1 | 0 |
| Chatten Associates, Inc. | 1 | 0 |
| Cortec GmbH | 1 | 0 |
| Dixi Medical | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes Terminated |
GYC | K053363 |
| Apr 1, 2013 | Integra Burlington MA, Inc. Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2.
Intended for intraoperative cortical stimulation mapping procedures. Terminated |
GYC | K924226 |
| Mar 2, 2013 | Ad-Tech Medical Instrument Corporation Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation Terminated |
GYC | K053363 |
| Jan 26, 2012 | CareFusion 209 Inc. Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F.
Product Usage:
The SSU Amplifier is used with the Cortical Sti Terminated |
GYC | K072964 |
| Jan 26, 2012 | CareFusion 209 Inc. Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558
Product Usage:
The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping p Terminated |
GYC | K072964 |
| Jan 26, 2012 | CareFusion 209 Inc. NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600
Product Usage:
The SSU Amplifier is used with the Cortical Stimulator Control unit which is used Terminated |
GYC | K072964 |
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