DeviceClearance

K810020

Substantially Equivalent

PANJE VOICE PROSTHESIS

Applicant
Xomed, Inc.
Product code
EWL
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arnold, MO, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EWL

product code EWL
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.