DeviceClearance

K210818

Substantially Equivalent

TrueCare Biomedix Tamper Evident Cap

Applicant
Us Infusion Inc. D/B/A Truecare Biomedix-USA
Product code
FMF
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
South Miami, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF
Death
15
Injury
2,263
Malfunction
29,722
Other
17
Total
32,017

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.