Sonova Ag

FDA Filings

This page includes the latest FDA filings for Sonova Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004929038
FEI Number3004929038
NameMario Castano
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address444 Commerce Street
Aurora, IL 60504 US
Establishment TypeManufacture Medical Device



Registration Number3005085999
FEI Number3005085999
NameMario Castano
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4520 Weaver Parkway
Warrenville, IL 60555 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3006312495
FEI Number3006312495
NameSonova Operations Center Vietnam Co., Ltd
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address#29A, VSIP ST NO.8, VIETNAM SINGAPORE INDUSTRIAL PARK THUAN AN TOWN
BINH DUONG PROVINCE Binh Duong, +84 VN
Establishment TypeManufacture Medical Device



Registration Number3008848788
FEI Number3008848788
NameSonova USA Inc.
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address444 Commerce Street
Aurora, IL 60504 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Sonova AG
Relate3.1 Platinum 312 Dir 063-6391-012024-04-01
Sonova AG
Relate3.1 Platinum 312 NW O 063-6390-012024-04-01
Sonova AG
Relate3.1 Platinum 10 NW O 063-6389-012024-04-01
Sonova AG
Stride V9-UP 050-6836-R82024-02-05
Sonova AG
Stride V9-UP 050-6836-P82024-02-05
Sonova AG
Stride V9-UP 050-6836-P72024-02-05
Sonova AG
Stride V9-UP 050-6836-P62024-02-05
Sonova AG
Stride V9-UP 050-6836-P42024-02-05
Sonova AG
Stride V7-UP 050-6835-R82024-02-05
Sonova AG
Stride V7-UP 050-6835-P82024-02-05
Sonova AG
Stride V7-UP 050-6835-P72024-02-05
Sonova AG
Stride V7-UP 050-6835-P62024-02-05
Sonova AG
Stride V7-UP 050-6835-P42024-02-05
Sonova AG
Stride V-UP FLEX:TRIAL 050-6837-P62024-02-05
Sonova AG
Stride V9-UP 050-6836-P22024-02-05
Sonova AG
Stride V7-UP 050-6835-P22024-02-05
Sonova AG
GEERS 3 088-0027-000312024-02-02
Sonova AG
Boots Hearingcare 3 088-0025-000312024-02-02
Sonova AG
myAudioNova 3 088-0020-000312024-02-02
Sonova AG
GEERS 3 088-0027-000302024-02-02
Sonova AG
Boots Hearingcare 3 088-0025-000302024-02-02
Sonova AG
myAudioNova 3 088-0020-000302024-02-02
Sonova AG
Boots Hearingcare 2 088-0025-000232024-02-02
Sonova AG
myAudioNova 2 088-0020-000232024-02-02
Sonova AG
Boots Hearingcare 2 088-0025-000222024-02-02
Sonova AG
myAudioNova 2 088-0020-000222024-02-02
Sonova AG
Stride V5-UP 050-6834-R82024-02-02
Sonova AG
Stride V5-UP 050-6834-P82024-02-02
Sonova AG
Stride V5-UP 050-6834-P72024-02-02
Sonova AG
Stride V5-UP 050-6834-P62024-02-02
Sonova AG
Stride V5-UP 050-6834-P42024-02-02
Sonova AG
Stride V5-UP 050-6834-P22024-02-02
Sonova AG
Boots Hearingcare 2 088-0025-000212024-02-02
Sonova AG
Boots Hearingcare 2 088-0025-000202024-02-02
Sonova AG
myAudioNova 2 088-0020-000212024-02-02
Sonova AG
myAudioNova 2 088-0020-000202024-02-02
Sonova AG
myAudioNova 1 088-0020-000112024-02-02
Sonova AG
Stride V3-UP 050-6833-R82024-02-01
Sonova AG
Stride V3-UP 050-6833-P82024-02-01
Sonova AG
Stride V3-UP 050-6833-P72024-02-01
Sonova AG
Stride V3-UP 050-6833-P62024-02-01
Sonova AG
Stride V3-UP 050-6833-P42024-02-01
Sonova AG
Stride V1-UP 050-6832-R82024-02-01
Sonova AG
Stride V1-UP 050-6832-P72024-02-01
Sonova AG
Stride V1-UP 050-6832-P62024-02-01
Sonova AG
Stride V3-UP 050-6833-P22024-02-01
Sonova AG
Stride V1-UP 050-6832-P22024-02-01
Sonova AG
Relate4.0 Platinum UP BTE 050-6836-R8762024-01-29
Sonova AG
Relate4.0 Platinum UP BTE 050-6836-P6762024-01-29
Sonova AG
Relate4.0 Platinum UP BTE 050-6836-P4762024-01-29
Sonova AG
Relate4.0 Gold UP BTE 050-6835-R8762024-01-29
Sonova AG
Relate4.0 Gold UP BTE 050-6835-P6762024-01-29
Sonova AG
Relate4.0 Gold UP BTE 050-6835-P4762024-01-29
Sonova AG
Relate4.0 Silver UP BTE 050-6833-R8762024-01-29
Sonova AG
Relate4.0 Silver UP BTE 050-6833-P6762024-01-29
Sonova AG
Relate4.0 Silver UP BTE 050-6833-P4762024-01-29
Sonova AG
Vista V-UP Select 050-6858-R8442024-01-26
Sonova AG
Vista V-UP Select 050-6858-P7442024-01-26
Sonova AG
Vista V-UP Select 050-6858-P6442024-01-26
Sonova AG
Vista V-UP trial 050-6837-P6442024-01-26
Sonova AG
Vista V9-UP 050-6836-R8442024-01-26
Sonova AG
Vista V9-UP 050-6836-P7442024-01-26
Sonova AG
Vista V9-UP 050-6836-P6442024-01-26
Sonova AG
Vista V9-UP 050-6836-P4442024-01-26
Sonova AG
Vista V-UP Select 050-6858-P4442024-01-26
Sonova AG
Vista V7-UP 050-6835-R8442024-01-24
Sonova AG
Vista V7-UP 050-6835-P7442024-01-24
Sonova AG
Vista V7-UP 050-6835-P6442024-01-24
Sonova AG
Vista V7-UP 050-6835-P4442024-01-24
Sonova AG
Vista V5-UP 050-6834-R8442024-01-24
Sonova AG
Vista V5-UP 050-6834-P7442024-01-24
Sonova AG
Vista V5-UP 050-6834-P6442024-01-24
Sonova AG
Vista V5-UP 050-6834-P4442024-01-24
Sonova AG
Vista V3-UP 050-6833-R8442024-01-24
Sonova AG
Vista V3-UP 050-6833-P7442024-01-24
Sonova AG
Vista V3-UP 050-6833-P6442024-01-24
Sonova AG
Vista V3-UP 050-6833-P4442024-01-24
Sonova AG
Vista V1-UP 050-6832-R8442024-01-24
Sonova AG
Vista V1-UP 050-6832-P7442024-01-24
Sonova AG
Vista V1-UP 050-6832-P4442024-01-24
Sonova AG
Vista V1-UP 050-6832-P6442024-01-24
Sonova AG
AudioNova V9-UP 050-6836-P7652024-01-23
Sonova AG
AudioNova V9-UP 050-6836-P6652024-01-23
Sonova AG
AudioNova V9-UP 050-6836-P4652024-01-23
Sonova AG
AudioNova V7-UP 050-6835-R8652024-01-23
Sonova AG
AudioNova V3-UP 050-6833-R8652024-01-23
Sonova AG
AudioNova V3-UP 050-6833-P7652024-01-23
Sonova AG
AudioNova V3-UP 050-6833-P6652024-01-23
Sonova AG
AudioNova V3-UP 050-6833-P4652024-01-23
Sonova AG
AudioNova V1-UP 050-6832-R8652024-01-23
Sonova AG
AudioNova V1-UP 050-6832-P7652024-01-23
Sonova AG
AudioNova V1-UP 050-6832-P4652024-01-23
Sonova AG
AudioNova V1-UP 050-6832-P6652024-01-23
Sonova AG
AudioNova V7-UP 050-6835-P7652024-01-23
Sonova AG
AudioNova V7-UP 050-6835-P6652024-01-23
Sonova AG
AudioNova V7-UP 050-6835-P4652024-01-23
Sonova AG
AudioNova V5-UP 050-6834-R8652024-01-23
Sonova AG
AudioNova V5-UP 050-6834-P7652024-01-23
Sonova AG
AudioNova V5-UP 050-6834-P6652024-01-23
Sonova AG
AudioNova V5-UP 050-6834-P4652024-01-23
Sonova USA Inc. [Sonova AG]
Phonak Virto V2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Virto M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Naida V2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Naida M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Bolero V2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Bolero M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Bolero B2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Audeo M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Audeo B2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto V2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida V2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero V2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero B2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo B2014-01-06
Mario Castano [Sonova AG]
Phonak Virto V2014-01-06
Mario Castano [Sonova AG]
Phonak Virto V2014-01-06
Mario Castano [Sonova AG]
Phonak Virto M2014-01-06
Mario Castano [Sonova AG]
Phonak Virto M2014-01-06
Mario Castano [Sonova AG]
Phonak Naida V2014-01-06
Mario Castano [Sonova AG]
Phonak Naida V2014-01-06
Mario Castano [Sonova AG]
Phonak Naida M2014-01-06
Mario Castano [Sonova AG]
Phonak Naida M2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero V2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero V2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero M2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero M2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero B2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero B2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo M2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo M2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo B2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo B2014-01-06
Sonova USA Inc. [Sonova AG]
Unitron Vista2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Stride2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Stride P2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Stride P Dura2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Remote Plus2011-08-09
Sonova USA Inc. [Sonova AG]
PilotOne II2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Virto V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Virto M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Virto B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Sky V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Sky M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Sky B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida Link2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida Link CROS2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak CROS B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Brio 42011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Brio 32011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Bolero V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Bolero M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Bolero B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Audeo M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Audeo B2011-08-09
Sonova USA Inc. [Sonova AG]
Naida CI Connect2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Vista2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Stride2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Stride P2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Stride P Dura2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Remote Plus2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
PilotOne II2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Sky V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Sky M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Sky B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida Link2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida Link CROS2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak CROS B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Brio 42011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Brio 32011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Naida CI Connect2011-08-09
Mario Castano [Sonova AG]
Unitron Vista2011-08-09
Mario Castano [Sonova AG]
Unitron Vista2011-08-09
Mario Castano [Sonova AG]
Unitron Stride2011-08-09
Mario Castano [Sonova AG]
Unitron Stride2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P Dura2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P Dura2011-08-09
Mario Castano [Sonova AG]
Unitron Remote Plus2011-08-09
Mario Castano [Sonova AG]
Unitron Remote Plus2011-08-09
Mario Castano [Sonova AG]
PilotOne II2011-08-09
Mario Castano [Sonova AG]
PilotOne II2011-08-09
Mario Castano [Sonova AG]
Phonak Virto V2011-08-09
Mario Castano [Sonova AG]
Phonak Virto V2011-08-09
Mario Castano [Sonova AG]
Phonak Virto M2011-08-09
Mario Castano [Sonova AG]
Phonak Virto M2011-08-09
Mario Castano [Sonova AG]
Phonak Virto B2011-08-09
Mario Castano [Sonova AG]
Phonak Virto B2011-08-09
Mario Castano [Sonova AG]
Phonak Sky V2011-08-09
Mario Castano [Sonova AG]
Phonak Sky V2011-08-09
Mario Castano [Sonova AG]
Phonak Sky M2011-08-09
Mario Castano [Sonova AG]
Phonak Sky M2011-08-09
Mario Castano [Sonova AG]
Phonak Sky B2011-08-09
Mario Castano [Sonova AG]
Phonak Sky B2011-08-09
Mario Castano [Sonova AG]
Phonak Naida V2011-08-09
Mario Castano [Sonova AG]
Phonak Naida V2011-08-09
Mario Castano [Sonova AG]
Phonak Naida M2011-08-09
Mario Castano [Sonova AG]
Phonak Naida M2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link CROS2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link CROS2011-08-09
Mario Castano [Sonova AG]
Phonak Naida B2011-08-09
Mario Castano [Sonova AG]
Phonak Naida B2011-08-09
Mario Castano [Sonova AG]
Phonak CROS B2011-08-09
Mario Castano [Sonova AG]
Phonak CROS B2011-08-09
Mario Castano [Sonova AG]
Phonak Brio 42011-08-09
Mario Castano [Sonova AG]
Phonak Brio 42011-08-09
Mario Castano [Sonova AG]
Phonak Brio 32011-08-09
Mario Castano [Sonova AG]
Phonak Brio 32011-08-09
Mario Castano [Sonova AG]
Phonak Bolero V2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero V2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero M2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero M2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero B2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero B2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo M2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo M2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo B2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo B2011-08-09
Mario Castano [Sonova AG]
Naida CI Connect2011-08-09
Mario Castano [Sonova AG]
Naida CI Connect2011-08-09
Sonova USA Inc. [Sonova AG]
Virto M2006-09-14
Sonova USA Inc. [Sonova AG]
Unitron Vista2006-09-14
Sonova USA Inc. [Sonova AG]
Unitron Shine Rev2006-09-14
Sonova USA Inc. [Sonova AG]
Phonak Virto V2006-09-14
Sonova USA Inc. [Sonova AG]
Phonak Virto B2006-09-14
Sonova USA Inc. [Sonova AG]
Phonak Brio 32006-09-14
Sonova USA Inc. [Sonova AG]
Lyric32006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Virto M2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Vista2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Shine Rev2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto V2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto B2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Brio 32006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Lyric32006-09-14
Mario Castano [Sonova AG]
Virto M2006-09-14
Mario Castano [Sonova AG]
Virto M2006-09-14
Mario Castano [Sonova AG]
Unitron Vista2006-09-14
Mario Castano [Sonova AG]
Unitron Vista2006-09-14
Mario Castano [Sonova AG]
Unitron Shine Rev2006-09-14
Mario Castano [Sonova AG]
Unitron Shine Rev2006-09-14
Mario Castano [Sonova AG]
Phonak Virto V2006-09-14
Mario Castano [Sonova AG]
Phonak Virto V2006-09-14
Mario Castano [Sonova AG]
Phonak Virto B2006-09-14
Mario Castano [Sonova AG]
Phonak Virto B2006-09-14
Mario Castano [Sonova AG]
Phonak Brio 32006-09-14
Mario Castano [Sonova AG]
Phonak Brio 32006-09-14
Mario Castano [Sonova AG]
Lyric32006-09-14
Mario Castano [Sonova AG]
Lyric32006-09-14

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