DeviceClearance

Product code EMX— Ear, Nose, Throat

EXPANDACEL NASAL TAMPONS

Classification name
Balloon, Epistaxis
Device class
Class 1
Regulation
21 CFR 874.4100
Advisory panel
Ear, Nose, Throat
Total cleared
47
First cleared
Most recent

Market context for product code EMX

FDA has cleared 47 devices under product code EMX between 1978 and 2022, filed by 30 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code EMX

Recent clearances under product code EMX

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