BLOM-SINGER VOICE PROSTHESIS— 510(k) K812982

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K812982 for BLOM-SINGER VOICE PROSTHESIS, Substantially Equivalent on 1981-11-24. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1981-10-23
Decision date: 1981-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EWL

product code EWL

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.