Home › Device types › OMA
Amplitude-Integrated Electroencephalograph
FDA product code OMA · Class 2 · Neurology
77
Registered devices
4
Adverse events
3
Recalls
16
510(k) clearances
Devices with this code
Component Neuromonitoring System — NATUS NEUROLOGY INCORPORATEDComponent Neuromonitoring System — MOBERG RESEARCH INCComponent Neuromonitoring System — MOBERG RESEARCH INCNatus — XLTEKneo — eemagine Medical Imaging Solutions GmbHComponent Neuromonitoring System — MOBERG RESEARCH INCComponent Neuromonitoring System — MOBERG RESEARCH INCNatus — XLTEKXltek — XLTEKComponent Neuromonitoring System — NATUS NEUROLOGY INCORPORATEDXltek — XLTEKPersyst 12 EEG Review and Analysis Software — Persyst Development CorpNA — NIHON KOHDEN CORPORATIONNatus — XLTEKComponent Monitoring System — MOBERG RESEARCH INCComponent Neuromonitoring System — NATUS NEUROLOGY INCORPORATEDXltek — XLTEKXltek — XLTEKComponent Neuromonitoring System — MOBERG RESEARCH INCComponent Neuromonitoring System — NATUS NEUROLOGY INCORPORATEDComponent Neuromonitoring System — MOBERG RESEARCH INCencevis — AIT Austrian Institute of Technology GmbHNeuroMatch — LVIS CORPORATIONComponent Neuromonitoring System — MOBERG RESEARCH INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-07 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates |
| 2023-02-20 | Moberg Research, Inc. | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. D |
| 2020-03-05 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest |
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