Product Code: MCM


Products Classified as MCM

1659Implant, Cochlear

Total Product Life Cycle (TPLC) Devices

1659Implant, Cochlear

FDA Consensus Standards

Implant, Cochlear [32308]21 CFR Unclassified 🔎
Implant, Cochlear [31251]21 CFR Unclassified 🔎
Implant, Cochlear [38689]21 CFR Unclassified 🔎
Implant, Cochlear [32302]21 CFR Unclassified 🔎
Implant, Cochlear [29591]21 CFR Unclassified 🔎
Implant, Cochlear [33856]21 CFR Unclassified 🔎
Implant, Cochlear [38629]21 CFR Unclassified 🔎
Implant, Cochlear [36150]21 CFR Unclassified 🔎

Pre-market Approvals for MCM

P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEMCochlear Americas
P840024Nucleus 22 Cochlear Implant SystemCochlear Americas
P890027Nucleus 22 Cochlear Implant SystemCochlear Americas
P960058HiResolution Bionic Ear SystemADVANCED BIONICS
P000025MED-EL Cochlear Implant SystemMED-EL CORP.
P970051Nucleus 24 Cochlear Implant SystemCochlear Americas

Global Unique Device Identification Database

07630016871535Implant, Cochlear
07630016871528Implant, Cochlear
07630016871511Implant, Cochlear
07630016871504Implant, Cochlear
07630016871498Implant, Cochlear
07630016871481Implant, Cochlear
07630016871474Implant, Cochlear
07630016871467Implant, Cochlear
07630016871450Implant, Cochlear
07630016871443Implant, Cochlear
07630016871436Implant, Cochlear
07630016871429Implant, Cochlear
07630016871412Implant, Cochlear
07630016871405Implant, Cochlear
07630016871399Implant, Cochlear

Maude Adverse Events

NUCLEUS 22COCHLEAR LTD2020-03-31
NUCLEUS 22COCHLEAR LTD2020-03-31
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-31
CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-31
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-31
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-31
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-31
NUCLEUS 22COCHLEAR LTD2020-03-31
NUCLEUS 22COCHLEAR LTD2020-03-31
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-31
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-31
NucleusCOCHLEAR LTD2020-03-31
NucleusCOCHLEAR LTD2020-03-31
HIRES? ULTRA 3D IMPLANTADVANCED BIONICS, LLC2020-03-31
HIRES? ULTRA IMPLANTADVANCED BIONICS, LLC2020-03-31
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-30
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODECOCHLEAR LTD2020-03-30
NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-30
NUCLEUS 22COCHLEAR LTD2020-03-30
NUCLEUS 24 DOUBLE ARRAYCOCHLEAR LTD2020-03-30
NUCLEUS 22COCHLEAR LTD2020-03-30
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-30
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-30
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-30
CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-30
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-29
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-29
NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-29
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-29
NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-29
HIRES? ULTRA 3D IMPLANTADVANCED BIONICS, LLC2020-03-27
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEMMED-EL ELEKTROMEDIZINISCHE GERAETE GMBH2020-03-27
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODECOCHLEAR LTD2020-03-27
NUCLEUS 22COCHLEAR LTD2020-03-26
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODECOCHLEAR LTD2020-03-26
NUCLEUS 24COCHLEAR LTD2020-03-26
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-26
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-26
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODECOCHLEAR LTD2020-03-26
NUCLEUS 24COCHLEAR LTD2020-03-26
HIRES 90K? IMPLANTADVANCED BIONICS, LLC2020-03-26
HIRES 90K? ADVANTAGE IMPLANTADVANCED BIONICS, LLC2020-03-26
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