DeviceClearance

K800786

Substantially Equivalent

INJECTION SITE, CODE NO. 3100

Applicant
Quest Medical, Inc.
Product code
FOZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ
Death
38
Injury
2,290
Malfunction
25,858
Other
11
Total
28,197

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.