Natus Medical Denmark ApS

TAASTRUP Hovedstaden, DK

Natus Medical Denmark ApS appears in FDA device records in TAASTRUP Hovedstaden, DK. FDA records list 15 510(k) clearances between 2004-03-31 and 2025-02-14, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 15
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Natus Medical Denmark ApS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Gn Otometrics A/S510(k), enforcement report, recall

510(k) clearance history

FDA records hold 15 510(k) clearances for Natus Medical Denmark ApS between 2004 and 2025. The busiest year on record is 2006, with 2. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Natus Medical Denmark ApS, by decision year
Year	Clearances
2004	1
2006	2
2008	1
2009	2
2011	1
2012	2
2013	1
2014	1
2015	2
2016	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K242198	ICS Dizcovery (1091)	GWN	Substantially Equivalent	2025-02-14
K161707	Madsen Zodiac	ETY	Substantially Equivalent	2016-09-01
K151504	ICS Impulse	GWN	Substantially Equivalent	2015-11-16
K143670	ICS CHARTR EP 200 WITH VEMP	GWJ	Substantially Equivalent	2015-10-23
K132957	MADSEN ACCUSCREEN TYPE 1077	GWJ	Substantially Equivalent	2014-02-27
K122550	ICS IMPULSE	GWN	Substantially Equivalent	2013-02-01
K122028	AURICAL HIT	ETW	Substantially Equivalent	2012-10-23
K122067	TYPE 1077 ACCUSCREEN	GWJ	Substantially Equivalent	2012-09-27
K110286	GN OTOMETRICS TYPE 1053 FREEFIT	ETW	Substantially Equivalent	2011-04-28
K092373	ICS CHARTR EP 200	GWJ	Substantially Equivalent	2009-09-03
K083399	ICS CHARTR EP 200	GWJ	Substantially Equivalent	2009-02-20
K081234	GN OTOMETRICS INSERT EARPHONES	EWO	Substantially Equivalent	2008-07-14
K061791	FOCUS VNG/ENG TYPE 1068	GWN	Substantially Equivalent	2006-07-11
K061104	SPEECHLINK 100 TYPE 1053	ETW	Substantially Equivalent	2006-05-03
K033645	OTOFLEX 100 TYE 1012	ETY	Substantially Equivalent	2004-03-31

Registered establishments

FDA registered establishments for Natus Medical Denmark ApS, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9612197	3002807554	Natus Medical Denmark ApS	Hoerskaetten 9, TAASTRUP Hovedstaden DK-2630 DK	2026	ERA ESD ETT ETW ETY EWO FOK GWJ GWN HKI and 4 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2553-2019	Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.	The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.	Class II	2019-08-01	Open, Classified
Z-0170-2020	The ICS CHARTR EP 200	There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.	Class II	2019-05-28	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Natus Medical Denmark ApS edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain