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Advanced Bionics Corporation

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear Syst recall (Z-0117-2013)Advanced Bionics Corporation2012-10-22
OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Sp recall (Z-1441-2012)Advanced Bionics Corporation2012-04-19
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI- recall (Z-0795-2011)Advanced Bionics Corporation2010-12-21
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI- recall (Z-0796-2011)Advanced Bionics Corporation2010-12-21
Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation Sys recall (Z-0299-2007)Advanced Bionics Corporation2007-01-10
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthru recall (Z-0758-06)Advanced Bionics Corporation2006-04-11
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthru recall (Z-0759-06)Advanced Bionics Corporation2006-04-11
Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System recall (Z-0396-05)Advanced Bionics Corporation2005-01-15
Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. recall (Z-1332-04)Advanced Bionics Corporation2004-08-10

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Every clearance here is in the API, with alerts when new ones post.