DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS— 510(k) K854118

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K854118 for DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS, Substantially Equivalent on 1986-03-17. Applicant: Dacomed Corp..

Clearance details

Applicant: Dacomed Corp.
Product code: Code EWL
Advisory panel: Ear, Nose, Throat
Date received: 1985-10-09
Decision date: 1986-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.