510(k) K133261— MEDOS HILITE 7000 & 7000 LT OXYGENATOR

Substantially Equivalent

Medos Medizintechnik AG

Clearance details

Applicant: Medos Medizintechnik AG
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2013-10-23
Decision date: 2014-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Ann Arbor, MI, US

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.