K131935

Substantially Equivalent

ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER

Applicant: Nipro Medical Corporation
Product code: KDI
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-27
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.