K864040

Substantially Equivalent

BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS

Applicant: C.R. Bard, Inc.
Product code: FAE
Advisory panel: Gastroenterology, Urology
Date received: 1986-10-16
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray Hill, NJ, US

Adverse events under product code FAE

product code FAE

Injury: 995
Total: 995

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.