DeviceClearance

Product code FZE— General, Plastic Surgery

DURALASTIC ANATOMICAL NASAL IMPLANTS

Classification name
Prosthesis, Nose, Internal
Device class
Class 2
Regulation
21 CFR 878.3680
Advisory panel
General, Plastic Surgery
Total cleared
42
First cleared
Most recent

Market context for product code FZE

FDA has cleared 42 devices under product code FZE between 1978 and 2024, filed by 25 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 FZE

Adverse events under product code FZE

product code FZE
Injury
138
Total
138

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 FZE

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