Company ยท US
Sonitus Medical Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2011. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LXB | Hearing Aid, Bone Conduction | 7 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |
| Mar 7, 2012 | Sonitus Medical Inc. SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with Terminated |
LXB | K110831 |