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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 10 Results
Recall Date to: 10/25/2014 PMA Number: P960058
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Product Description
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FDA Recall
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Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 ... 2 12/21/2010 Advanced Bionics Corporation
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H ... 2 12/21/2010 Advanced Bionics Corporation
Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case.... 2 09/11/2009 Advanced Bionics LLC
HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd.... 2 02/03/2009 Advanced Bionics LLC
Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech pr... 2 02/03/2009 Advanced Bionics LLC
S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BI... 2 02/03/2009 Advanced Bionics LLC
S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONI... 2 02/03/2009 Advanced Bionics LLC
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a ... 2 04/11/2006 Advanced Bionics Corporation
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a ... 2 04/11/2006 Advanced Bionics Corporation
Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02 2 10/23/2004 Advanced Bionics
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