DeviceClearance

K895012

Substantially Equivalent

E-Z-EM VACUUM ASPIRATION SYRINGE

Applicant
E-Z-Em, Inc.
Product code
GAA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Westbury, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAA

product code GAA
Malfunction
834
Total
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.