K963462

Substantially Equivalent

COMFOR FOAM LIMB HOLDERS- SINGLE STRAP

Applicant
Bird & Cronin, Inc.
Product code
FMQ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saint Paul, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FMQ

product code FMQ
Death
8
Total
8

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.