FDA.reportPublic FDA data

MED-EL CORP.

Matched from indexed company URL: Med-El Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10667023003370917MED-EL CORP.1Y2026-01-012645 Meridian Pkwy Ste 100 DURHAM NC US 27713
30140008053014000805MED-ELITE INNOVATION1Y2020-04-2511101 FRANKLIN AVE SUITE100 Franklin Park IL US 60131

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
09008737461416SONNET Battery Pack Cover Standard Pro, White - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com
09008737461423SONNET Battery Pack Cover Standard Pro, Black - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com
09008737461485SONNET Battery Pack Cover Micro Pro, Anthracite - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com
09008737461492SONNET Battery Pack Cover Micro Pro, Ebony - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic Gray - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com
09008737461515SONNET Battery Pack Cover Micro Pro, Beige - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com
09008737461522SONNET Battery Pack Cover Micro Pro, White - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com
09008737461539SONNET Battery Pack Cover Micro Pro, Black - Audio Processor Battery Pack Cover1-888-633-3524implants.us@medel.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2157481865165127K082784JUMAO MANUAL WHEELCHAIRIOR2008-10-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IOR12008-10-07

PMA#

Vibrant Soundbridge System

2022-10-11

Med-el Elektromedizinische Gerate GmbHfuerstenweg 77aa-6020innsbruck, Tirol  PMA NumberP990052 Supplement NumberS026 Date Received07/14/2022 Decision Date10/11/2022 Product Code MPV  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supp...

MED-EL CONCERT (PIN) Cochlear Implant

2022-05-18

MED-EL CORP.furstenweg 77ainnsbruck 6020 PMA NumberP000025 Supplement NumberS123 Date Received01/26/2022 Decision Date05/18/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/componen...

MAESTRO System Software 9.0

2022-05-17

MED-EL CORP.furstenweg 77ainnsbruck 6020 PMA NumberP000025 Supplement NumberS124 Date Received02/17/2022 Decision Date05/17/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/componen...

134 records. Showing 1-40. Next

PMN#

Bonebridge

2019-03-07

MED-EL Elektromedizinische Geraete GmbH

GUDID#

80 records. Showing 1-40. Next