K120337

Substantially Equivalent

I-PORT ADVANCE INJECTION PORT

Applicant: Unomedical A/S
Product code: FOZ
Advisory panel: General Hospital
Date received: 2012-02-03
Decision date: 2012-02-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Osted, DK

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, 2020-01-01 through 2026-04-23. 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.