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JB CERVELLO 32

BLACKROCK NEUROMED, LLC · Model 7512 · UDI-DI 00850154007048

GWLGWQOLVGWK Prescription
10
510(k) clearances
5
Adverse events
4
Recalls
25
Facilities

Description

JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be switched to Bipolar, to be used with CERVELLO 32 Series Headboxes

Recalls

DateFirmReason
2016-08-10Blackrock Microsystems, LLCBlackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient
2016-08-10Blackrock Microsystems, LLCBlackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient
2013-02-27Natus Neurology IncorporatedNatus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overhea
2010-03-26I2s Micro Implantable Systems LlcComponent of cranial array may not allow sufficient tightening to maintain inserter position.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.