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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 5 of 5 Results
510(K) Number: K110831
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Product Description
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Recall
Class
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FDA Recall
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Recalling Firm
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SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately severe, severe... 3 03/07/2012 FEI # 3009200826
Sonitus Medical Inc.
SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, sever... 3 03/07/2012 FEI # 3009200826
Sonitus Medical Inc.
SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe... 3 03/07/2012 FEI # 3009200826
Sonitus Medical Inc.
SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe... 3 03/07/2012 FEI # 3009200826
Sonitus Medical Inc.
SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe... 3 03/07/2012 FEI # 3009200826
Sonitus Medical Inc.
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