Data / Medical devices / Austria / Med-El Elektromedizinische Geraete, GMBH

Med-El Elektromedizinische Geraete, GMBH: FDA-registered device maker in INNSBRUCK Tirol, Austria, 8 510(k) clearances and 2 PMA approvals

Name: Med-El Elektromedizinische Geraete, GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Med-El Elektromedizinische Geraete, GMBH is registered with the FDA (registration 9710014) in INNSBRUCK Tirol, Austria. It lists 12 device types. The FDA files 8 510(k) clearances and 2 PMA approvals under its listings, the newest dated April 3, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Med-El Elektromedizinische Geraete, GMBH

FDA registration number: 9710014
FEI number: 3000249315
Address: Fuerstenweg 77a, INNSBRUCK Tirol, Austria, 6020
Owner or operator: MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH (9042031)
Roles: Manufacturer
First device listed: November 13, 2007
Registered through: 2026
Brand names listed: ADHEAR System, BONEBRIDGE, COMBI 40+ Cochlear Implant System, Maestro Cochlear Implant System, Medical Screwdriver (SD 2), Partial Prosthesis Sizer Kit, SoftGrip Forceps (Ms050207), SoftGrip Forceps 2 and more

Devices it lists

Device	Product code	Class	Role	Source
Active Implantable Bone Conduction Hearing System	PFO	2	Manufacturer	accessdata.fda.gov
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	PGQ	3	Manufacturer	accessdata.fda.gov
Forceps, Ent	KAE	1	Manufacturer	accessdata.fda.gov
Gauge, Measuring	JYJ	1	Manufacturer	accessdata.fda.gov
Hearing Aid, Bone Conduction	LXB	2	Manufacturer	accessdata.fda.gov
Implant, Cochlear	MCM	3	Manufacturer	accessdata.fda.gov
Implant, Hearing, Active, Middle Ear, Partially Implanted	MPV	3	Manufacturer	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Manufacturer	accessdata.fda.gov
Prosthesis, Partial Ossicular Replacement	ETB	2	Manufacturer	accessdata.fda.gov
Replacement, Ossicular Prosthesis, Total	ETA	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Ent	MMO	1	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 3, 2026	K260720	mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);	ETB	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH	accessdata.fda.gov
April 3, 2026	K260719	mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50	ETA	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH	accessdata.fda.gov
April 3, 2026	K260718	mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)	ETB	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH	accessdata.fda.gov
January 17, 2025	K241269	mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit	ETA	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH	accessdata.fda.gov
January 17, 2025	K241261	mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit	ETB	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH	accessdata.fda.gov
January 17, 2025	K241142	mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis	ETB	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH	accessdata.fda.gov
July 20, 2018	DEN170009	Bonebridge	PFO	Unknown	Med-El Elektromedizinische Geraete GmbH	accessdata.fda.gov
April 27, 2018	K172460	ADHEAR System	LXB	Substantially Equivalent	Med-El Elektromedizinische Geraete GmbH	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 20, 2001	P000025	COMBI 40+ COCHLEAR IMPLANT SYSTEM	MCM	130	October 9, 2026	accessdata.fda.gov
August 31, 2000	P990052	VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM	MPV	21	October 11, 2022	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 18, 2024	94531	Class II	Ongoing	Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant	A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.	accessdata.fda.gov
October 16, 2018	81683	Class II	Terminated	MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard;	Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.	accessdata.fda.gov
October 25, 2016	76503	Class II	Terminated	SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on t	Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.	accessdata.fda.gov

Compare with other makers

Updated October 9, 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.