Stimulator, Electrical, Evoked Response
Regulation 882.1870
3510(k)s in 12 months (141 all time)
2recalls in 12 months (17 all time)
17recalls that name a 510(k)
Top companies in GWF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Cadwell Industries Inc Brand Name: IOMAX
Product Name: IOMAX Cortical Module
Model/Catalog Number: 190296-200
UDI-DI code: 00840067100653
Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low Open, Classified |
GWF | K162199 |
| Jul 23, 2026 | Alphatec Spine, Inc. SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System Open, Classified |
GWF | K252842 |
| Apr 18, 2025 | Medtronic Xomed, Inc. NIM Vital Nerve Monitoring System:
CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;
CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;
PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;
PATIENT IN Open, Classified |
GWF | K200759 |
| Jul 24, 2024 | Medtronic Xomed, Inc. NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3.
NIM Vital Nerve Integrity Monitor with below product descriptions. Open, Classified |
GWF | K200759 |
| Jul 12, 2024 | Cadwell Industries Inc Cascade IOMAX Cortical Module, REF: 190296-200 Open, Classified |
GWF | K162199 |
| May 22, 2024 | Cadwell Industries Inc Cascade IOMAX Cortical Module, REF: 190296-200 Open, Classified |
GWF | K162199 |
| Jun 2, 2022 | Medtronic Xomed, Inc. NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Open, Classified |
GWF | K200759 |
| Jun 2, 2022 | Medtronic Xomed, Inc. NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 Open, Classified |
GWF | K200759 |
| May 22, 2017 | Nexstim PLC NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1.
The Nexstim Navigated Brain Stimulation System (NBS System) is Open, Classified |
GWF | K112881 |
| May 22, 2017 | Nexstim PLC Nexstim eXima NBS System Software version 2.2 or higher.
The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to i Open, Classified |
GWF | K091457 |
| Feb 17, 2016 | Nihon Kohden America Inc MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG) Terminated |
GWF | K051178 |
| Feb 9, 2015 | Natus Medical Incorporated EPWorks software used in the Xltek Protektor Stimulator
Product Usage:
Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, s Terminated |
GWF | K040358 |
| May 25, 2013 | Alpine Biomed Aps Natus neurology Dantec KEYPOINT.NET 2.20.
Catalog/Part Numbers:
9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102,
9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA,
9033A071 Terminated |
GWF | K944547 |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse).
LABELING:
Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtr Terminated |
GWF | K083124 |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro).
LABELING:
Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtr Terminated |
GWF | K083124 |
| Sep 10, 2012 | Medtronic Xomed, Inc. Interfaces subject to recall:
Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response)
LABELING:
Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtron Terminated |
GWF | K083124 |
| Nov 28, 2006 | Nihon Kohden America Inc Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System) Terminated |
GWF | K991899 |
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