Company
Advanced Bionics, LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
35recalls (3 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2026 | Advanced Bionics, LLC Brand Name: HiResolution" Bionic Ear System
Product Name: HiRes Ultra 3D CI HiFocus Mid Scala
Model/Catalog Number: CI-1601-04
Software Version: N/A
Product Description: The HiResolution Bionic Ear Sy Open, Classified |
MCM | None listed |
| Apr 27, 2026 | Advanced Bionics, LLC Brand Name: HiResolution" Bionic Ear System
Product Name: M Zn-Air Battery Pak
Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501- Open, Classified |
MCM | None listed |
| Mar 5, 2026 | Advanced Bionics, LLC Brand Name: HiResolution Bionic Ear System
Product Name: Sky CI M90 Sound Processor
Model/Catalog Number: CI-5295-150 Open, Classified |
MCM | None listed |
| May 22, 2025 | Advanced Bionics, LLC HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 Open, Classified |
MCM | None listed |
| Nov 25, 2020 | Advanced Bionics, LLC AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada C Terminated |
MCM | None listed |
| Nov 25, 2020 | Advanced Bionics, LLC AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada C Terminated |
MCM | None listed |
| Feb 18, 2020 | Advanced Bionics, LLC HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant. Terminated |
MCM | None listed |
| Feb 17, 2020 | Advanced Bionics, LLC AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via el Terminated |
MCM | None listed |
| Feb 17, 2020 | Advanced Bionics, LLC AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural d Terminated |
MCM | None listed |
| Apr 4, 2019 | Advanced Bionics, LLC SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by heal Terminated |
MCM | None listed |
| Feb 6, 2019 | Advanced Bionics, LLC Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. Terminated |
MCM | None listed |
| Feb 6, 2019 | Advanced Bionics, LLC Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150. Terminated |
MCM | None listed |
| Feb 6, 2019 | Advanced Bionics, LLC Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150. Terminated |
MCM | None listed |
| Oct 22, 2012 | Advanced Bionics Corporation HiRes 90K devices with Helix Electrodes Model CI 1400-02H
The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hea Terminated |
MCM | None listed |
| Apr 19, 2012 | Advanced Bionics Corporation OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305
The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk Terminated |
LGW | None listed |
| Dec 21, 2010 | Advanced Bionics Corporation Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H
The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful h Terminated |
MCM | None listed |
| Dec 21, 2010 | Advanced Bionics Corporation Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01
Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to p Terminated |
MCM | None listed |
| Sep 11, 2009 | Advanced Bionics LLC Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case.
Cochlear implant intended to restore a level of auditory sensation to patients with profound senso Terminated |
MCM | None listed |
| Feb 3, 2009 | Advanced Bionics LLC S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with s Terminated |
MCM | None listed |
| Feb 3, 2009 | Advanced Bionics LLC S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with spe Terminated |
MCM | None listed |
| Feb 3, 2009 | Advanced Bionics LLC Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion M Terminated |
MCM | None listed |
| Feb 3, 2009 | Advanced Bionics LLC HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufa Terminated |
MCM | None listed |
| Oct 31, 2008 | Advanced Bionics Corp Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhe Terminated |
LGW | None listed |
| Feb 27, 2008 | Advanced Bionics Corp Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342 Terminated |
LGW | None listed |
| Feb 27, 2008 | Advanced Bionics Corp Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342 Terminated |
LGW | None listed |
| Oct 12, 2007 | Advanced Bionics Corp Precision Implantable Pulse Generator (IPG), Model Number SC-110 Terminated |
LGW | None listed |
| Mar 31, 2007 | Advanced Bionics Corp The Precision Implantable Pulse Generator, Model Number SC-1110 Terminated |
LGW | None listed |
| Jan 10, 2007 | Advanced Bionics Corporation Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70. Terminated |
LGW | None listed |
| Apr 11, 2006 | Advanced Bionics Corporation The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H. Terminated |
MCM | None listed |
| Apr 11, 2006 | Advanced Bionics Corporation The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-01 Terminated |
MCM | None listed |
| Jan 15, 2005 | Advanced Bionics Corporation Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System Terminated |
LGW | None listed |
| Oct 23, 2004 | Advanced Bionics Advanced Bionics implantable cochlear stimulator HiRes 90,
Models
CI-1400-01
CI-1400-02 Terminated |
MCM | None listed |
| Oct 23, 2004 | Advanced Bionics Advanced Bionics implantable cochlear stimulator CLARION CII
Models
AB-5100H-11A
AB-5100h-12A Terminated |
MCM | None listed |
| Oct 23, 2004 | Advanced Bionics Advanced Bionics implantable cochlear stimulator CLARION 1.2
Models
AB-5100L
AB-5100R
AB-5100ML/R (For Export Only)
AB-5100H
AB-5100H-01A Terminated |
MCM | None listed |
| Aug 10, 2004 | Advanced Bionics Corporation Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. Terminated |
MCM | None listed |