Gn Hearing Care Corp

FDA Filings

This page includes the latest FDA filings for Gn Hearing Care Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2182204
• FEI Number: 2182204
• Name: GN Hearing Care Corporation
• Owner & Operator: GN Hearing A/S
• Contact Address: Lautrupbjerg 7 ; Ballerup DK-84 Region Hovedstaden 2750 DK
• Official Correspondent:
  • Lars Hagander
  • 45-45-752100-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 8001 E Bloomington Freeway ; BLOOMINGTON, MN 55420 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K181586 | KLW GN Hearing Care Corporation [GN Hearing A/S]	Tinnitus Sound Generator Module	2019-02-27
PMN K180495 | KLW GN Hearing Care Corporation [GN Hearing A/S]	Tinnitus Sound Generator Module	2019-02-27
LDG GN Hearing Care Corporation [GN Hearing A/S]	Generic Earmould; TRUFIT	2018-06-25
PMN K150171 | KLW GN Hearing Care Corporation [GN Hearing A/S]	Tinnitus Sound Generator Module	2015-11-03
PMN K110932 | KLW GN Hearing Care Corporation [GN Hearing A/S]	Tinnitus Sound Generator Module	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Vida	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Vea	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	USB FITTING DONGLE	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	UP	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	UP Smart	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Trust	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	TV STREAMER 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	TV LINK 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	TV 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	TV 2 UNITE	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	TV 2 STREAMER	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Sola	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Saxo	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	RS UNITE PHONE CLIP	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	RS UNITE MINI MIC	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	REMOTE CONTROL 3	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	REMOTE CONTROL 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	RC-2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Promise	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Preza	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	PHONE LINK 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	PHONE CLIP PLUS	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Magna	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	MYPAL PRO	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	MYPAL MICRO	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	MULTI MIC	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	MINI MIC	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	MICRO MIC	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Lively	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	LiNX	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	LiNX Quattro	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	LiNX 3D	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	LiNX 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Legend	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Kirkland Signature 6	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Kirkland Signature 5	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Future	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Forza	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Forte	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Flyte	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	First	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Enya	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	ENZO Q	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	ENZO 3D	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	ENZO 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Cala	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	COSTCO CLIP-ON MIC	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	C-1	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Boost Ultra	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Boost Plus	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Boost Max	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	BT BLUETOOTH BRIDGE-2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	BT AUDIO LINK	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	BLUETOOTH BRIDGE-2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Amaze	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	Ally	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	ASM AIRLINK 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	AIRLINK	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	AIRLINK 2	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	AGXR-Y	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	AGXR-T	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	AGXR-N	2011-11-22
OSM GN Hearing Care Corporation [GN Hearing A/S]	AGXR Q	2011-11-22
PMN K073636 | KLW GN Hearing Care Corporation [GN Hearing A/S]	Tinnitus Sound Generator Module	2008-06-23
LRB GN Hearing Care Corporation [GN Hearing A/S]	Generic Faceplate	1994-09-15
ESD GN Hearing Care Corporation [GN Hearing A/S]	Vivid	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Vivid Stratus	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Vea	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Trust	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Sola	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Saxo	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Promise	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Origin	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	LiNX 3D	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	LiNX 2	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Legend	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Forza	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Forte	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Flyte	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Enya	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Cala	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Bold	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	Ally	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	AGXR-Y	1989-05-31
ESD GN Hearing Care Corporation [GN Hearing A/S]	AGXR-T	1989-05-31

Related Finance Registrations

NCAGE Code	08QZ7	GN HEARING CARE CORPORATION!DBA RESOUND
NCAGE Code	4RRX2	GN HEARING CARE CORPORATION!DBA GN OTOMETRICS
CAGE Code	08QZ7	GN HEARING CARE CORPORATION RESOUND
CAGE Code	4RRX2	GN HEARING CARE CORPORATION GN OTOMETRICS
S.A.M. Registration	08QZ7 [173814856]	GN HEARING CARE CORPORATION RESOUND
DUNS	930930529	GN HEARING CARE CORPORATION