DeviceClearance

K060971

Substantially Equivalent

OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS

Applicant
Omi Manufacturing Pty., Ltd.
Product code
MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deer Field, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MEG

product code MEG
Malfunction
1,373
Other
1
Total
1,374

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.