Sonitus Medical, Inc.
San Carlos, CA, US
Sonitus Medical, Inc. appears in FDA device records in San Carlos, CA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Sonitus Medical, Inc. in 2011.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 2 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1183-2012 | 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 conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | Terminated | ||
| Z-1182-2012 | 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 conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | Terminated | ||
| Z-1181-2012 | 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 conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | Terminated | ||
| Z-1180-2012 | 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 conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | Terminated | ||
| Z-1179-2012 | 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 conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA. | Sonitas received reports of stress cracking on the SoundBite Microphone Tube. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain