HF-100 DIALYZER— 510(k) K802092

Substantially Equivalent

Bio-Med Corp.

FDA 510(k) clearance K802092 for HF-100 DIALYZER, Substantially Equivalent on 1980-12-18. Applicant: Bio-Med Corp..

Clearance details

Applicant: Bio-Med Corp.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1980-09-02
Decision date: 1980-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.