VERSA-FILL 120 & FILL SET 42-50— 510(k) K850051

Substantially Equivalent

Intl. Medical Industries

FDA 510(k) clearance K850051 for VERSA-FILL 120 & FILL SET 42-50, Substantially Equivalent on 1985-03-06. Applicant: Intl. Medical Industries.

Clearance details

Applicant: Intl. Medical Industries
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1985-01-08
Decision date: 1985-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.