Data / Medical devices / Implant, Cochlear

Implant, Cochlear (MCM): 18 FDA-registered makers in 9 countries

Name: FDA-registered makers of Implant, Cochlear
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in 9 countries are registered with the FDA to make Implant, Cochlear (product code MCM, Class 3). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 21 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: MCM
Device class: 3
Medical specialty: Unknown
Implant: Yes

Makers by country

Country	Makers
China	5
Australia	3
United States	2
Mexico	2
Switzerland	2
Malaysia	1
Austria	1
Germany	1
Sweden	1

Makers of Implant, Cochlear

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	PMA approvals	Recall events	Source
Cochlear Ltd.	LANE COVE New South Wales, Australia	Manufacturer	3	0	api.fda.gov
Cochlear Americas Warehouse	Centennial, CO, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	3	0	api.fda.gov
Cochlear Limited - Brisbane	Newstead Queensland, Australia	Manufacturer	3	0	api.fda.gov
Cochlear Ltd	Macquarie University New South Wales, Australia	Manufacturer, Specification developer	3	0	api.fda.gov
Advanced Bionics LLC	Valencia, CA, United States	Manufacturer	1	14	api.fda.gov
Advanced Bionics North American Operations Center S.A. de C.V.	Mexicali Baja California, Mexico	Manufacturer	1	0	api.fda.gov
Cochlear Malaysia Sdn Bhd	Kuala Lumpur, Malaysia	Complaint file establishment, Exporter to the US, Manufacturer	1	0	api.fda.gov
Med-El Elektromedizinische Geraete, GMBH	INNSBRUCK Tirol, Austria	Manufacturer	1	1	api.fda.gov
Christian Diener GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0	0	api.fda.gov
Frueh Verpackungstechnik AG	Fehraltorf Zurich, Switzerland	Contract manufacturer	0	0	api.fda.gov
Greatbatch Medical S. de R.L. de C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0	0	api.fda.gov
In-Tech Electronics Ltd	Dongguan Guangdong, China	Contract manufacturer	0	0	api.fda.gov
Jabil Circuit (Shanghai) Ltd.	Shanghai, China	Contract manufacturer	0	0	api.fda.gov
Mehow Innovative (huizhou) Ltd.	Huizhou Guangdong, China	Contract manufacturer	0	0	api.fda.gov
Mehow Innovative Ltd	Shenzhen Guangdong, China	Contract manufacturer	0	0	api.fda.gov
STOKVIS Nordic	Norrkoping Ostergotland, Sweden	Contract manufacturer	0	0	api.fda.gov
Wyon AG	Appenzell Steinegg Appenzell Innerrhoden, Switzerland	Contract manufacturer	0	0	api.fda.gov
Zhong Shan First City Leather Products Co., Ltd.	Zhongshan City Guangdong, China	Contract manufacturer	0	0	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.