DeviceClearance

K240651

Substantially Equivalent

MRI Universal

Applicant
Stryker Leibinger GmbH & Co KG
Product code
JEY
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Freiburg, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY
Injury
1,542
Malfunction
2,292
Total
3,834

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.