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
Enobio Dx — NEUROELECTRICS BARCELONA SLBlackrock NeuroPort Biopotential Signal Processing System — BLACKROCK MICROSYSTEMS, LLCR-40 — LIFELINES LIMITEDSEP 6 Channel Fiber Optic Cable Long (Power) — INTELLIGENT HEARING SYSTEMS CORP.NExT-AS — EB NEURO SPAeego amplifier — eemagine Medical Imaging Solutions GmbHSEP 1 Channel Fiber Optic Cable Long (Power) — INTELLIGENT HEARING SYSTEMS CORP.Enobio Dx — NEUROELECTRICS BARCELONA SLBlackrock NeuroPort Biopotential Signal Processing System — BLACKROCK MICROSYSTEMS, LLCSEP 4 Channel Fiber Optic Cable Long (Power) — INTELLIGENT HEARING SYSTEMS CORP.ATLAS-HS-36-CHET-A9 — NEURALYNX, INC.eego amplifier — eemagine Medical Imaging Solutions GmbHNeurotravel LIGHT — EB NEURO SPAR-40 (24) — LIFELINES LIMITEDBE PLUS PRO LIGHT — EB NEURO SPANExT Station Advanced — EB NEURO SPAENOBIO — NEUROELECTRICS BARCELONA SLClavis — NATUS MANUFACTURING LIMITEDg.HIamp — g.tec medical engineering GmbHAlpine BioMed — Alpine Biomed ApSNeMus 2 — EB NEURO SPABE Micro — EB NEURO SPAEnobio Dx — NEUROELECTRICS BARCELONA SLg.Nautilus PRO — 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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