Unitron Hearing

FDA Filings

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

FDA Registration(s)
Registration Number3002808415
FEI Number3002808415
NameMario Castano
Owner & OperatorUNITRON HEARING
Contact Address20 BEASLEY DRIVE --
KITCHENER CA-ON Ontario N2E 1Y6 CA
Official Correspondent
  • Nelson Hu
  • 1-519-8950100-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address444 Commerce Street, Suite 112
Aurora, IL 60504 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Mario Castano [UNITRON HEARING]
Tinnitus Masker (jam, T Max, T Stride, flow, T Insera, Vista, Star, Relate, Au)2017-12-21
Mario Castano [UNITRON HEARING]
Tinnitus Masker (Vista T, Vista N, Stride, Max, NovaSense Elite 50, beat, Moxi 2, AQ, Moxi, N Moxi, Quantum, T Moxi)2017-12-21
Mario Castano [UNITRON HEARING]
Tinnitus Masker (DX Moxi, Vista DX, AudioNova DX, Shine Rev+, Vista Basic+, AN Basic+)2017-12-21
UNITRON HEARING
UNITRON TINNITUS MASKER FEATURE2013-05-07
Mario Castano [UNITRON HEARING]
sound (3, 5, 7, 9, HD 3, HD 5, HD 7, HD 9, SHD S13, SHD S13 Stream, SHD S312, SHD 10, XC R312)2011-06-24
Mario Castano [UNITRON HEARING]
jam (3, 5, 7, 9, HD 3, HD 5, HD 7, HD 9, SHD 3, SHD 5, SHD 7, SHD 9, SHD S312, SHD S13, SHD RS13)2011-06-24
Mario Castano [UNITRON HEARING]
flow (1, 2)2011-06-24
Mario Castano [UNITRON HEARING]
beat (675 UP, 13 SP, SHD RS675, SHD RS13)2011-06-24
Mario Castano [UNITRON HEARING]
Vista T (S 13, P 13, Rd 13, R 10, R 13, M 312, R 312, Rm 312)2011-06-24
Mario Castano [UNITRON HEARING]
Vista N (R 13, R 312, Rm 312, S 13, P 13, R 10, 10A IIC, 10A OMNI, W 10 A DIR, W 312 DIR, W 13 DIR)2011-06-24
Mario Castano [UNITRON HEARING]
Vista DX (R 312, R Li T, P Li, R Li)2011-06-24
Mario Castano [UNITRON HEARING]
Vista D R Li T2011-06-24
Mario Castano [UNITRON HEARING]
Vista D P Li2011-06-24
Mario Castano [UNITRON HEARING]
Vista D (R Li, R 312)2011-06-24
Mario Castano [UNITRON HEARING]
Vista Basic+ (P 13, M 312, UP 675, R 312, 13 W Dir, 312 W Dir)2011-06-24
Mario Castano [UNITRON HEARING]
Vista (SP, SPm, S 13, HP 13, R 13, Rm 312, R 312, 10A OMNI (IIC), 10A OMNI, 312 Dir, W 312 Dir, W 13 Dir)2011-06-24
Mario Castano [UNITRON HEARING]
Vista (HPm 13, P 13, HP 675, 13 Dir, 312 Dir, M 312)2011-06-24
Mario Castano [UNITRON HEARING]
T Stride (M, P, P Dura)2011-06-24
Mario Castano [UNITRON HEARING]
T Moxi (All, Dura, Fit, Kiss, Now)2011-06-24
Mario Castano [UNITRON HEARING]
T Max (UP, SP)2011-06-24
Mario Castano [UNITRON HEARING]
T Insera (Pro)2011-06-24
Mario Castano [UNITRON HEARING]
Stride (M, P, P Dura)2011-06-24
Mario Castano [UNITRON HEARING]
Star 3.0 (R Li, Rd 13)2011-06-24
Mario Castano [UNITRON HEARING]
Star 2.0 (R Li, Rd 13)2011-06-24
Mario Castano [UNITRON HEARING]
Star 1.0 (R 312)2011-06-24
Mario Castano [UNITRON HEARING]
Shine Rev+ (P, M, UP, RIC, 13 W Dir, 312 W Dir)2011-06-24
Mario Castano [UNITRON HEARING]
RELATE (W) (10A, 13, 312) (Dir, Omni)2011-06-24
Mario Castano [UNITRON HEARING]
Quantum (2)2011-06-24
Mario Castano [UNITRON HEARING]
NovaSense Elite 502011-06-24
Mario Castano [UNITRON HEARING]
N Moxi (Dura, Fit, Kiss, Now)2011-06-24
Mario Castano [UNITRON HEARING]
Moxi 2 (Dura, Kiss)2011-06-24
Mario Castano [UNITRON HEARING]
Moxi (Kiss)2011-06-24
Mario Castano [UNITRON HEARING]
Max2011-06-24
Mario Castano [UNITRON HEARING]
DX Stride P R2011-06-24
Mario Castano [UNITRON HEARING]
DX Moxi (Fit, Jump R T, Move R)2011-06-24
Mario Castano [UNITRON HEARING]
D Stride P R2011-06-24
Mario Castano [UNITRON HEARING]
D Moxi Jump R2011-06-24
Mario Castano [UNITRON HEARING]
D Moxi Jump R T2011-06-24
Mario Castano [UNITRON HEARING]
D Moxi Fit2011-06-24
Mario Castano [UNITRON HEARING]
AudioNova T (Rd 13, R 312, R 10, M 312, P 13, 10A W Omni)2011-06-24
Mario Castano [UNITRON HEARING]
AudioNova DX (R 312, R Li T, P Li, R Li)2011-06-24
Mario Castano [UNITRON HEARING]
AudioNova D (R Li, R 312)2011-06-24
Mario Castano [UNITRON HEARING]
Au 2 (R 312, R Li T)2011-06-24
Mario Castano [UNITRON HEARING]
Au (R 312, Rd 13, M 312, R Li)2011-06-24
Mario Castano [UNITRON HEARING]
AQ jam XC R2011-06-24
Mario Castano [UNITRON HEARING]
AQ (jam SHD RS, sound SHD S, HD S, sound XC R)2011-06-24
Mario Castano [UNITRON HEARING]
AN Basic+ (P 13, M 312, UP 675, R 312, 13 W Dir, 312 W Dir)2011-06-24
Mario Castano [UNITRON HEARING]
Vista P 13 (100,200)2006-02-01
Mario Castano [UNITRON HEARING]
Vista M 312 (300)2006-02-01
Mario Castano [UNITRON HEARING]
Vista HPm 13 (100,200,300)2006-02-01
Mario Castano [UNITRON HEARING]
Vista HP 675 (300)2006-02-01
Mario Castano [UNITRON HEARING]
Vista Basic+ 10A Omni2006-02-01
Mario Castano [UNITRON HEARING]
Vista 312 Dir (200,300)2006-02-01
Mario Castano [UNITRON HEARING]
Vista 13 Dir (200,300)2006-02-01
Mario Castano [UNITRON HEARING]
Vista 10A Omni (300)2006-02-01
Mario Castano [UNITRON HEARING]
Shine, Passport, Next, Element, Latitude, 360, Sona2006-02-01
Mario Castano [UNITRON HEARING]
Shine Rev2006-02-01
Mario Castano [UNITRON HEARING]
Shine Rev+ 10A Omni2006-02-01
Mario Castano [UNITRON HEARING]
AN Basic+ 10A Omni2006-02-01

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