DeviceClearance

K250423

Substantially Equivalent

mb-FIX Cranial Stabilization Systems

Applicant
Medical Bees GmbH
Product code
HBL
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Emmingen-Liptingen, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code HBL

product code HBL
Death
3
Injury
753
Malfunction
1,421
Total
2,177

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.