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FDA 510(k) Applications for Medical Device Product Code "QDD"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN180026
Bose Corporation
Bose Hearing Aid
10/05/2018
K211008
Bose Corporation
Bose SoundControl Hearing Aids
05/05/2021
K213424
GN Hearing A/S
Jabra Enhance Plus
01/19/2022
K212609
Kaz USA, Inc., a Helen of Troy Company
BHA100 Series Braun Clear Hearing Aid
01/05/2022
K220303
MDHearingAid
MDHearingAid app, MDHearingAid Smart hearing aids
08/04/2022
K220403
WSAUD A/S
Vibe SF Self-Fitting Hearing Aid
08/12/2022
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