DeviceClearance

Product code ETB— Ear, Nose, Throat

APACERAM OSSICULAR PROSTHESIS

Classification name
Prosthesis, Partial Ossicular Replacement
Device class
Class 2
Regulation
21 CFR 874.3450
Advisory panel
Ear, Nose, Throat
Total cleared
74
First cleared
Most recent

Market context for product code ETB

FDA has cleared 74 devices under product code ETB between 1976 and 2026, filed by 24 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 ETB

Recent clearances under product code ETB

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