ClearanceBrief
Product code MCM ยท Class 3

Implant, Cochlear

0510(k)s in 12 months (0 all time)
3recalls in 12 months (32 all time)
0recalls that name a 510(k)
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Top companies in MCM

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
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
Open, Classified
MCMNone listed
Jul 12, 2024MED-EL Elektromedizinische Gereate, Gmbh
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
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
Jul 20, 2015Cochlear Americas Inc.
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth o
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
Oct 3, 2011Cochlear Americas Inc.
Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to rest
Terminated
MCMNone 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
Nov 2, 2009Cochlear Americas Inc.
Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
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
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
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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