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Advanced Bionics, LLC

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Sc recall (Z-2283-2026)Advanced Bionics, LLC2026-06-01
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catal recall (Z-1950-2026)Advanced Bionics, LLC2026-04-27
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/ recall (Z-1493-2026)Advanced Bionics, LLC2026-03-05
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 recall (Z-1813-2025)Advanced Bionics, LLC2025-05-22
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power t recall (Z-0486-2021)Advanced Bionics, LLC2020-11-25
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power t recall (Z-0487-2021)Advanced Bionics, LLC2020-11-25
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. recall (Z-1259-2020)Advanced Bionics, LLC2020-02-18
Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Ma recall (Z-2039-2009)Advanced Bionics LLC2009-09-11
HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fe recall (Z-0956-2009)Advanced Bionics LLC2009-02-03
Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with recall (Z-0957-2009)Advanced Bionics LLC2009-02-03
S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVAN recall (Z-0958-2009)Advanced Bionics LLC2009-02-03
S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) AD recall (Z-0959-2009)Advanced Bionics LLC2009-02-03

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