Product code FZD— General, Plastic Surgery

CANAL WALL PROSTHESIS

Classification name
Prosthesis, Ear, Internal
Device class
Class 2
Regulation
21 CFR 878.3590
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

Market context for product code FZD

FDA has cleared 3 devices under product code FZD between 1985 and 2018, filed by 3 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

Top applicants under product code FZD

Recent clearances under product code FZD

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