Advanced Bionics, LLC

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
0
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1493-2026Class IIBrand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog November 27, 2025
Z-1813-2025Class IIHiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607March 5, 2025
Z-0487-2021Class IIIAB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the followiSeptember 26, 2020
Z-0486-2021Class IIIAB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the followiSeptember 26, 2020
Z-2032-2020Class IIAB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The dFebruary 17, 2020
Z-2033-2020Class IIAB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intenFebruary 17, 2020
Z-1441-2020Class IIISoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)076300168532April 4, 2019
Z-1259-2020Class IIIHiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. CochleaMarch 18, 2019
Z-1085-2019Class IINa¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.February 6, 2019
Z-1083-2019Class IINa¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and VelFebruary 6, 2019
Z-1084-2019Class IINa¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and VelFebruary 6, 2019