DeviceClearance

Product code EWL— Ear, Nose, Throat

BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS

Classification name
Prosthesis, Laryngeal (Taub)
Device class
Class 2
Regulation
21 CFR 874.3730
Advisory panel
Ear, Nose, Throat
Total cleared
40
First cleared
Most recent

Market context for product code EWL

FDA has cleared 40 devices under product code EWL between 1980 and 2024, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code EWL

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 →

Recent clearances under product code EWL

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