K231700

Substantially Equivalent

Ziehm Vision FD

Applicant
Ziehm Imaging GmbH
Product code
OWB
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Nuremberg, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB
Death
49
Injury
340
Malfunction
36,973
Total
37,362

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.