ClearanceBrief
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

CodeDeviceRecords
MCMImplant, Cochlear27
LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief8

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jun 1, 2026Advanced 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
MCMNone listed
Apr 27, 2026Advanced 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
MCMNone listed
Mar 5, 2026Advanced Bionics, LLC
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Open, Classified
MCMNone listed
May 22, 2025Advanced Bionics, LLC
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Open, Classified
MCMNone listed
Nov 25, 2020Advanced 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
MCMNone listed
Nov 25, 2020Advanced 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
MCMNone listed
Feb 18, 2020Advanced Bionics, LLC
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Terminated
MCMNone listed
Feb 17, 2020Advanced 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
MCMNone listed
Feb 17, 2020Advanced 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
MCMNone listed
Apr 4, 2019Advanced 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
MCMNone listed
Feb 6, 2019Advanced Bionics, LLC
Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Terminated
MCMNone listed
Feb 6, 2019Advanced 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
MCMNone listed
Feb 6, 2019Advanced 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
MCMNone listed
Oct 22, 2012Advanced 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
MCMNone listed
Apr 19, 2012Advanced 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
LGWNone listed
Dec 21, 2010Advanced 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
MCMNone listed
Dec 21, 2010Advanced 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
MCMNone listed
Sep 11, 2009Advanced 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
MCMNone listed
Feb 3, 2009Advanced 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
MCMNone listed
Feb 3, 2009Advanced 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
MCMNone listed
Feb 3, 2009Advanced 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
MCMNone listed
Feb 3, 2009Advanced 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
MCMNone listed
Oct 31, 2008Advanced 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
LGWNone listed
Feb 27, 2008Advanced 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
LGWNone listed
Feb 27, 2008Advanced 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
LGWNone listed
Oct 12, 2007Advanced Bionics Corp
Precision Implantable Pulse Generator (IPG), Model Number SC-110
Terminated
LGWNone listed
Mar 31, 2007Advanced Bionics Corp
The Precision Implantable Pulse Generator, Model Number SC-1110
Terminated
LGWNone listed
Jan 10, 2007Advanced 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
LGWNone listed
Apr 11, 2006Advanced 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
MCMNone listed
Apr 11, 2006Advanced 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
MCMNone listed
Jan 15, 2005Advanced Bionics Corporation
Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
Terminated
LGWNone listed
Oct 23, 2004Advanced Bionics
Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02
Terminated
MCMNone listed
Oct 23, 2004Advanced Bionics
Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A
Terminated
MCMNone listed
Oct 23, 2004Advanced 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
MCMNone listed
Aug 10, 2004Advanced Bionics Corporation
Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
Terminated
MCMNone listed
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