DeviceClearance

K230320

Substantially Equivalent

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube

Applicant
Medtronic Xomed, Inc.
Product code
ETN
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Jacksonville, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN
Death
7
Injury
327
Malfunction
2,776
Total
3,110

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 →

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