Home › Device types › GWL
Amplifier, Physiological Signal
FDA product code GWL · Class 2 · Neurology
230
Registered devices
5
Adverse events
4
Recalls
53
510(k) clearances
Devices with this code
SEP 2 Channel Fiber Optic Cable Long (Power) — INTELLIGENT HEARING SYSTEMS CORP.g.HIamp — g.tec medical engineering GmbHCERVELLO 64 — BLACKROCK NEUROMED, LLCNomad PMU800 Portable Recorder (USB) — Neurotronics, LLCBE PLUS PRO ADVANCED — EB NEURO SPAR-40 (24) — LIFELINES LIMITEDeego amplifier — eemagine Medical Imaging Solutions GmbHTrackit T4A — LIFELINES LIMITEDBlackrock NeuroPort Biopotential Signal Processing System — BLACKROCK MICROSYSTEMS, LLCBlackrock NeuroPort Biopotential Signal Processing System — BLACKROCK MICROSYSTEMS, LLCBE PLUS LTM PLUG-IN HEADBOX, 64-CHANNELS — EB NEURO SPATrackit T4 — LIFELINES LIMITEDEnobio Dx — NEUROELECTRICS BARCELONA SLBE PLUS LTM Battery Pack — EB NEURO SPAg.Nautilus PRO — g.tec medical engineering GmbHg.HIamp — g.tec medical engineering GmbHBlackrock NeuroPort Biopotential Signal Processing System — BLACKROCK MICROSYSTEMS, LLCNeuroPlex E128 — BLACKROCK MICROSYSTEMS, LLCApollo — CADWELL INDUSTRIES, INC.g.Nautilus PRO — g.tec medical engineering GmbHTrackit T4 — LIFELINES LIMITEDBE PLUS PRO [LIGHT] — EB NEURO SPADigital NeuroPort Biopotential Signal Processing System — BLACKROCK MICROSYSTEMS, LLCg.HIamp — g.tec medical engineering GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-08-10 | Blackrock Microsystems, LLC | Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Ampli |
| 2016-08-10 | Blackrock Microsystems, LLC | Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Ampli |
| 2013-02-27 | Natus Neurology Incorporated | Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off |
| 2010-03-26 | I2s Micro Implantable Systems Llc | Component of cranial array may not allow sufficient tightening to maintain inserter position. |
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